1 of 998 DOCUMENTS US Fed News January 25, 2012 Wednesday 2:06 PM EST GRANT WILL FUND STUDY OF COGNITION AND SCHIZOPHRENIA LENGTH: 927 words SACRAMENTO, Calif., Jan. 25 -- The University of California issued the following press release: Michael Minzenberg, a UC Davis psychiatry researcher, has been awarded a prestigious three-year, $200,000 seed grant from the Dana Foundation to study the brains of patients being treated for schizophrenia to determine how additional treatment to improve cognition interacts with antipsychotic medication. "Cognition is very important in schizophrenia because it is a strong predictor of outcome. It determines whether a person can be a contributing member of a community, stay out of the hospital and live independently," said Minzenberg, associate professor in the Department of Psychiatry and Behavioral Sciences and a faculty member of the UC Davis Imaging Research Center. Schizophrenia is a chronic mental disorder characterized by decline in thought processes and loss of emotional responsiveness. It affects 3.2 million Americans, the majority of whom are not receiving treatment. It can lead to auditory hallucinations, paranoia and delusions. Despite the importance of cognition in the rehabilitation of those with schizophrenia, there are no U.S. Food and Drug Administration (FDA)-approved drugs for the improvement of cognition in this patient population. "Dr. Minzenberg is at the forefront of trying to develop therapies for impaired cognition in schizophrenia, using powerful new non-invasive brain imaging to measure the effects of drugs and other treatments on functional networks in the brain," said Cameron Carter, director of the Center for Neuroscience and the Imaging Research Center at UC Davis. "His work is suggesting that some of the other medications that patients are taking may interfere with the procognitive effects of some of the newer more promising therapies. If this proves to be true then it will be important to 'fine tune' patients' medications to optimize cognitive outcomes in people with schizophrenia and other brain disorders." Modafinil is a drug approved by the FDA for the treatment of narcolepsy. It is also known by the brand name Provigil. Narcolepsy is a chronic neurological disease characterized by sudden urges to sleep, episodes of loss of voluntary muscle tone, vivid dreams while falling asleep or upon awakening, and brief episodes of total paralysis while waking up from sleep. Both genetic and environmental factors appear to contribute to narcolepsy. Although no cure exists, medications can often help restore a patient's quality of life. Like other stimulants, Modafinil's side effects are relatively mild. It is used off-label to combat the effects of sedatives. Currently, it is not prescribed on a long-term basis to schizophrenia patients. However, Minzenberg and his colleagues conducted a small, unpublished pilot study that showed Modafinil can improve cognition in patients being treated for schizophrenia. "What we understand about how Modafinil works in the brain leads us to believe that it might be good for improving cognition deficits of our patients," Minzenberg said. Because the cause of schizophrenia is unknown, treatment focuses on eliminating symptoms. Antipsychotic drugs are effective at reducing its most serious symptoms: delusions and hallucinations. Any treatment to improve cognition cannot interact with these drugs in a negative way. "The use of antipsychotic medications is the standard of care in patients with schizophrenia. So, before we can move forward with a large clinical trial involving Modafinil's impact on cognition, we need to know how it interacts with these drugs." Cognition refers to a range of high-level brain functions, including the abilities to learn, remember information, organize, plan, problem-solve and understand and use language. It is thought to be controlled by an area of the brain called the locus coeruleus, which controls the body's physiological responses to stress and panic, commonly referred to as the "fight or flight" response. "This area of the brain also serves to coordinate activity in the entire brain as it performs almost any type of task or behavior," Minzenberg said. Minzenberg and his colleagues will conduct the study at the UC Davis Early Diagnosis and Preventive Treatment of Psychosis (EDAPT) Clinic. Researchers will enroll 60 patients newly diagnosed with schizophrenia. These patients will have a specialized brain scan performed, called functional magnetic resonance imaging or fMRI, and will be randomly assigned to an FDA-approved treatment for schizophrenia. After eight weeks of treatment, another fMRI scan will be conducted. The patients, who also will have been assigned to either a control or study group, will undergo a third scan while performing a cognitive task. Functional magnetic resonance imaging allows researchers to see changes in blood flow related to neural activity. Minzenberg and his colleagues will examine whether patients being treated with Modafinil perform better or worse, as measured by the changes in activity in locus coeruleus, depending on which antipsychotic medication they receive. "We are hoping to find evidence that using Modafinil we can improve brain function in stable schizophrenia patients," Minzenberg said. The New York-based Dana Foundation is a private philanthropic organization that supports clinical research in neuroscience and neuroimmunology and their interrelationship in human health and disease. For further information, visit www.dana.org. For any query with respect to this article or any other content requirement, please contact Editor at htsyndication@hindustantimes.com LOAD-DATE: January 26, 2012 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2012 HT Media Ltd. All Rights Reserved 2 of 998 DOCUMENTS CNS Drug News November 29, 2011 Modiodal approved for additional indication in Japan SECTION: NEWS LENGTH: 154 words Alfresa Pharma (Alfresa Holdings) has received approval in Japan of a partial change in the indications of Modiodal (modafinil) Tablets 100mg, a sleep disorder treatment that has been jointly developed in the country with Mitsubishi Tanabe Pharma. Since March 2007, Modiodal has been jointly marketed by the companies as a treatment for excessive daytime sleepiness associated with narcolepsy. The new indication, approved for the first time in Japan, is "excessive diurnal sleepiness accompanied with obstructive sleep apnoea syndrome under treatment for airway obstruction by continuous positive airway pressure therapy and the like". Modafinil is a wakefulness-enhancing agent to which Alfresa acquired the right to develop, manufacture and market in Japan from Cephalon in June 1998. The drug is currently approved in more than 30 countries, and in seven, including the US, it is marketed with approval for the new indication. LOAD-DATE: November 29, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: CNS Drug News Copyright 2011 Espicom Business Intelligence All Rights Reserved 3 of 998 DOCUMENTS CNS Drug News November 29, 2011 Modiodal approved for additional indication in Japan SECTION: NEWS LENGTH: 154 words Alfresa Pharma (Alfresa Holdings) has received approval in Japan of a partial change in the indications of Modiodal (modafinil) Tablets 100mg, a sleep disorder treatment that has been jointly developed in the country with Mitsubishi Tanabe Pharma. Since March 2007, Modiodal has been jointly marketed by the companies as a treatment for excessive daytime sleepiness associated with narcolepsy. The new indication, approved for the first time in Japan, is "excessive diurnal sleepiness accompanied with obstructive sleep apnoea syndrome under treatment for airway obstruction by continuous positive airway pressure therapy and the like". Modafinil is a wakefulness-enhancing agent to which Alfresa acquired the right to develop, manufacture and market in Japan from Cephalon in June 1998. The drug is currently approved in more than 30 countries, and in seven, including the US, it is marketed with approval for the new indication. LOAD-DATE: January 6, 2012 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: CNS Drug News Copyright 2011 Espicom Business Intelligence All Rights Reserved 4 of 998 DOCUMENTS The Pharmaceutical Journal November 29, 2011 Tuesday Modafinil indication and dosage error in BNF 62 LENGTH: 80 words HIGHLIGHT: An error is included under the indications and dosage information for modafinil that are printed in the British National Formulary 62... An error is included under the indications and dosage information for modafinil that are printed in the British National Formulary 62 (section 4.4, pp250-251). Modafinil is listed as indicated for the treatment of daytime sleepiness associated with narcolepsy, obstructive sleep apnoea syndrome and chronic shift work sleep disorder. The entry should list daytime sleepiness associated with narcolepsy only. Corrected indication and dosage information is available on the BNF website. LOAD-DATE: November 29, 2011 Tuesday LANGUAGE: ENGLISH PUBLICATION-TYPE: Journal Copyright 2011 PJ Online All Rights Reserved 5 of 998 DOCUMENTS IPR November 25, 2011 Friday 3:11 PM EST India Tender Notice: South Central Railway Seeks "Modafinil 100 Mg Tablets" LENGTH: 87 words DATELINE: SECUNDERABAD, Andhra Pradesh SECUNDERABAD, Andhra Pradesh, Dec. 5 -- South Central Railway has a requirement for "Modafinil 100 Mg Tablets." Tender Bidding Type: Domestic Competitive Bidding According to the description: "Tenders are invited for Supply of Modafinil 100 Mg Tab - 7500 Nos" The tender ref. no. is L-883/2011-2012. Project Location: India The expression of interest should be received by Dec. 5 till 1:00 p.m. For any query with respect to this article or any other content requirement, please contact Editor at htsyndication@hindustantimes.com LOAD-DATE: November 25, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 HT Media Ltd. All Rights Reserved 6 of 998 DOCUMENTS Targeted News Service November 7, 2011 Monday 10:51 PM EST Teva Pharmaceutical Industries Assigned Patent BYLINE: Targeted News Service LENGTH: 238 words DATELINE: Alexandria, Va. ALEXANDRIA, Va., Nov. 7 -- Teva Pharmaceutical Industries, Petah Tiqva, Israel, has been assigned a patent (8,048,222) developed by Arina Ceausu, Rishon Lezion, Israel, Anita Lieberman, Ramat Aviv, Israel, and Judith Aronhime, Rechovot, Israel, for a highly pure modafinil. The abstract of the patent published by the U.S. Patent and Trademark Office states: "The present invention provides an improved process for preparing modafinil, whereby it may be isolated in high purity by a single crystallization. The process produces modafinil free of sulphone products of over-oxidation and other byproducts. The invention further provides new crystalline Forms II-VI of modafinil and processes for preparing them. Each of the new forms is differentiated by a unique powder X-ray diffraction pattern. The invention further provides pharmaceutical compositions containing novel modafinil Forms II-IV and VI." The patent application was filed on Sept. 23, 2004 (10/947,228). The full-text of the patent can be found at http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetah tml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=8,048,222&OS=8,048,2 22&RS=8,048,222 Written by Satyaban Rath; edited by Hemanta Panigrahi. For more information about Targeted News Service federal patent awards please contact: Myron Struck, Editor, Direct: 703/866-4708, Cell: 703/304-1897, Myron@targetednews.com SR1107HP1107-666772 LOAD-DATE: November 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Targeted News Service LLC All Rights Reserved 7 of 998 DOCUMENTS Health Daily Digest November 4, 2011 Friday Modafinil may not affect Operating Skills of Weary Surgeons LENGTH: 164 words DATELINE: U.S. U.S., Nov. 4 -- Weary surgeons may benefit with the intake of sleep-fighting medication modafinil by having an enhanced brain power but it may not bring any changes in their operating skills, according to a new study. The research was carried out on 39 young surgeons. They were made to be awake throughout the night. As many as 50 percent of doctors were given a modafinil pill and the remaining were provided with a dummy pill. The doctors went through some psychological tests and did a virtual surgery on a simulator as early as 6 a.m in the morning. It was observed that having a sleep-fighting medication modafinil improved the brain power of weary surgeons but it was of no use as far as enhancing their operating skills in a simulator is concerned. Written by Manishika Miglani Published by HT Syndication with permission from Health Daily Digest. For any query with respect to this article or any other content requirement, please contact Editor at htsyndication@hindustantimes.com LOAD-DATE: November 15, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 HT Media Ltd. All Rights Reserved 8 of 998 DOCUMENTS Indian Patents News October 22, 2011 Saturday 6:30 AM EST Cephalon Inc Receives Patent for a Pharmaceutical Composition LENGTH: 262 words New Delhi, Oct. 22 -- Cephalon Inc received patent for a pharmaceutical composition on April 11, 2008. The patent number issued by the Indian Patent Office is 218719. Cephalon Inc had filed patent application number IN/PCT/2002/128/KOL for a pharmaceutical composition on Jan. 25, 2002. The inventors of the patent are Miller Matthew S and Scammell Thomas E. The International classification number is A61K31/165. The PCT International application number of the patent is PCT/US00/22338 and the application was filed on Aug. 16, 2000. According to the Controller General of Patents, Designs & Trade Marks, " Modafinil is effective in improving symptoms of attention deficit hyperactivity disorder and symptoms of multiple sclerosis fatigue. The administration of modafinil is also shown to activate the tuberomamillary neurons of the posterior hypothalamus, and thus exhibits activity in an area of the brain associated with normal wakefulness functions. A method of identifying a compound that selectively modulates activity of the tuberomamillary nucleus of the posterior hypothalamus is also disclosed." About the Company Cephalon, Inc. (NASDAQ: CEPH) is a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist with the DuPont Company, who served as the company's chairman and chief executive officer until his death in December 2010.[2] The company's name comes from the adjective "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases. LOAD-DATE: October 22, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 9 of 998 DOCUMENTS World Generic Market October 21, 2011 Teva completes Cephalon acquisition SECTION: NEWS LENGTH: 967 words Teva Pharmaceutical Industries announced on 14th October 2011 that it had completed its acquisition of Cephalon. The firm had initially announced it had acquired all of Cephalon's outstanding shares for US $81.50 per share in cash in May 2011; the deal amounted to a total enterprise value of some US $6.8 billion. With the acquisition of Cephalon now completed, Teva commented that the combined company would have a significant presence in over 60 countries and generated around US $20 billion in revenues on a pro-forma basis for the year ended June 2011. The completion of the deal came after two hurdles were cleared. On 7th October 2011, Teva reported that the US Federal Trade Commission had accepted a proposed consent order in connection with the transaction and granted early termination of the Hart-Scott-Rodino waiting period. The FTC had complained that the acquisition as originally proposed would have violated US antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended-release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The FTC commented that transmucosal fentanyl citrate lozenges are versions of a cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon / Watson Pharmaceuticals and Covidien, currently exist in the US. Teva's acquisition of Cephalon would have reduced this to two, and would have given Teva a more than 80% share of the sales of generic Actiq. Extended-release cyclobenzaprine hydrochloride is the generic form of Amrix. The FTC noted that Cephalon had acquired the rights to the branded version, which was approved by the FDA in 2007. Currently, no generic versions of the drug are marketed in the US, but the FTC argued that Teva and Cephalon were two of only a limited number of suppliers that could enter the market quickly with a generic version. As a result, combining the two firms would reduce competition in the future. Modafinil tablets are generic versions of the brand drug Provigil, marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. The FTC noted again that no companies currently market a generic version of the product, which had sales worth US $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceutical and Barr Laboratories (another Teva company) have all taken steps to enter the market, and are all eligible to seek the 180-days marketing exclusivity allowed under the Hatch-Waxman Act for being the first to file an ANDA. However, the FTC noted that each company had also signed an agreement with Cephalon to refrain from marketing a generic version until April 2012. The FTC contended that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day period. In order to replace the competition potentially lost through the acquisition, the FTC proposed a settlement order which would require Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, Actiq or generic extended-release cyclobenzaprine hydrochloride capsules, to Par Pharmaceutical Companies. With regard to modafinil, the FTC's proposed order required Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the US for one year. This would allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the agreement for another year. Across the Atlantic The second hurdle to the transaction had been in Europe. In April 2011, before Teva had announced its acquisition agreement, the European Commission reported that it had opened a formal antitrust investigation regarding an agreement between Teva and Cephalon that was unconnected with the acquisition. The EC had reported that in December 2005, the two firms had settled patent infringement disputes in the US and UK concerning modafinil, with Teva undertaking as part of the agreement not to sell its generic version in the European Economic Area markets before October 2012. The EC was investigating whether this agreement may have had the object or effect of hindering generic competition for the drug in the EEA. On 14th October 2011, the EC formally announced that it had cleared the proposed acquisition of Cephalon under the EU Merger Regulation. However, the decision was conditional upon the divestment of Cephalon's generic version of its Provigil product. The Commission commented that it had examined the effects of the proposed transaction on the market for modafinil drugs, having had concerns that the acquisition, as originally proposed, would have significantly reduced generic competition. The Commission determined that the divestment of Cephalon's generic pipeline modafinil product, as was offered by the company, would allow a competitor to emerge and compete effectively with the Teva / Cephalon combined company. The investigation did not reveal any other significant modification to the competitive situation and dynamics of other relevant markets, as a number of significant and credible competitors would continue to exercise a competitive constraint on the merged entity. Consequently, the Commission was happy with the modified transaction proposal. Teva noted that it was required to divest Cephalon's marketing authorisation of generic modafinil in France and grant to the purchaser of the marketing authorisation certain additional rights with respect to the entire EEA, including a covenant not to sue effective as of October 2012. LOAD-DATE: October 21, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: World Generic Markets Copyright 2011 Espicom Business Intelligence All Rights Reserved 10 of 998 DOCUMENTS World Generic Market October 21, 2011 Teva completes Cephalon acquisition SECTION: NEWS LENGTH: 967 words Teva Pharmaceutical Industries announced on 14th October 2011 that it had completed its acquisition of Cephalon. The firm had initially announced it had acquired all of Cephalon's outstanding shares for US $81.50 per share in cash in May 2011; the deal amounted to a total enterprise value of some US $6.8 billion. With the acquisition of Cephalon now completed, Teva commented that the combined company would have a significant presence in over 60 countries and generated around US $20 billion in revenues on a pro-forma basis for the year ended June 2011. The completion of the deal came after two hurdles were cleared. On 7th October 2011, Teva reported that the US Federal Trade Commission had accepted a proposed consent order in connection with the transaction and granted early termination of the Hart-Scott-Rodino waiting period. The FTC had complained that the acquisition as originally proposed would have violated US antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended-release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The FTC commented that transmucosal fentanyl citrate lozenges are versions of a cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon / Watson Pharmaceuticals and Covidien, currently exist in the US. Teva's acquisition of Cephalon would have reduced this to two, and would have given Teva a more than 80% share of the sales of generic Actiq. Extended-release cyclobenzaprine hydrochloride is the generic form of Amrix. The FTC noted that Cephalon had acquired the rights to the branded version, which was approved by the FDA in 2007. Currently, no generic versions of the drug are marketed in the US, but the FTC argued that Teva and Cephalon were two of only a limited number of suppliers that could enter the market quickly with a generic version. As a result, combining the two firms would reduce competition in the future. Modafinil tablets are generic versions of the brand drug Provigil, marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. The FTC noted again that no companies currently market a generic version of the product, which had sales worth US $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceutical and Barr Laboratories (another Teva company) have all taken steps to enter the market, and are all eligible to seek the 180-days marketing exclusivity allowed under the Hatch-Waxman Act for being the first to file an ANDA. However, the FTC noted that each company had also signed an agreement with Cephalon to refrain from marketing a generic version until April 2012. The FTC contended that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day period. In order to replace the competition potentially lost through the acquisition, the FTC proposed a settlement order which would require Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, Actiq or generic extended-release cyclobenzaprine hydrochloride capsules, to Par Pharmaceutical Companies. With regard to modafinil, the FTC's proposed order required Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the US for one year. This would allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the agreement for another year. Across the Atlantic The second hurdle to the transaction had been in Europe. In April 2011, before Teva had announced its acquisition agreement, the European Commission reported that it had opened a formal antitrust investigation regarding an agreement between Teva and Cephalon that was unconnected with the acquisition. The EC had reported that in December 2005, the two firms had settled patent infringement disputes in the US and UK concerning modafinil, with Teva undertaking as part of the agreement not to sell its generic version in the European Economic Area markets before October 2012. The EC was investigating whether this agreement may have had the object or effect of hindering generic competition for the drug in the EEA. On 14th October 2011, the EC formally announced that it had cleared the proposed acquisition of Cephalon under the EU Merger Regulation. However, the decision was conditional upon the divestment of Cephalon's generic version of its Provigil product. The Commission commented that it had examined the effects of the proposed transaction on the market for modafinil drugs, having had concerns that the acquisition, as originally proposed, would have significantly reduced generic competition. The Commission determined that the divestment of Cephalon's generic pipeline modafinil product, as was offered by the company, would allow a competitor to emerge and compete effectively with the Teva / Cephalon combined company. The investigation did not reveal any other significant modification to the competitive situation and dynamics of other relevant markets, as a number of significant and credible competitors would continue to exercise a competitive constraint on the merged entity. Consequently, the Commission was happy with the modified transaction proposal. Teva noted that it was required to divest Cephalon's marketing authorisation of generic modafinil in France and grant to the purchaser of the marketing authorisation certain additional rights with respect to the entire EEA, including a covenant not to sue effective as of October 2012. LOAD-DATE: January 6, 2012 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: World Generic Markets Copyright 2011 Espicom Business Intelligence All Rights Reserved 11 of 998 DOCUMENTS Global Insight October 19, 2011 Teva Sells Three Generic Products Rights to Par Pharma BYLINE: Georgette Calnan SECTION: In Brief LENGTH: 242 words US firm Par Pharmaceutical yesterday (18 October) announced the ownership of the rights to three products from Teva (Israel) as a result of the terms attached by the US Federal Trade Commission (FTC) to the latter's acquisition of Cephalon (US). Under the terms of the agreement, Par will now own the Abbreviated New Drug Applications (ANDAs) of the generic versions of Actiq (fentanyl citrate lozenges), Amriz (cyclobenzaprine extended-release--ER--capsules), as well as the US rights to market the generic version of Provigil (modafinil). According to Par's press release, citing IMS data, Actiq, Provigil and Amrix achieved annual sales in the US of USD173 million, USD1.1 billion and USD125 million respectively. Par will begin immediate shipment of all strengths of fentanyl citrate lozenges which were previously available from Teva. Cyclobenzaprine ER capsules and modafinil tablets are not yet available. Significance:The deal was part of the US Federal Trade Commission (FTC)'s conditional nod of Teva's acquisition of Cephalon. The sale of the ANDAs allowed Teva to complete its acquisition of Cephalon by its targeted deadline of 14 October. Par's acquisition of the three products preserves competition in all relevant markets. This will boost the US firm's generic drug portfolio which in turn could result in increased revenues. The acquisition of Amrix and Provigil ANDAs will allow Par to enter the generic market for both products next year. LOAD-DATE: October 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2011 World Markets Research Limited All Rights Reserved 12 of 998 DOCUMENTS India Investment News October 18, 2011 Tuesday 6:30 AM EST Par Pharmaceutical Acquires Three Generic Products from Teva Pharmaceuticals LENGTH: 173 words New Delhi, Oct. 18 -- Par Pharmaceutical Companies Inc. issued the following news release: Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced today that it acquired rights to three products from Teva Pharmaceuticals in connection with Teva's acquisition of Cephalon. Under terms of the agreement, Par will own the ANDAs of fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix, as well as the U.S. rights to market modafinil tablets, the generic version of Provigil. According to IMS Health data, annual sales in the U.S. for Actiq and the equivalent generic products are $173 million. Annual sales in the U.S. for Provigil and Amrix are approximately $1.1 billion and $125 million, respectively. Par is currently shipping to the trade all strengths of fentanyl citrate lozenges that were previously available from Teva. Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva and are not yet available. Source: Par Pharmaceutical Companies Inc. LOAD-DATE: January 3, 2012 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2011 Contify.com All Rights Reserved 13 of 998 DOCUMENTS Key Pharma News October 18, 2011 Tuesday Par acquires three generic products from Teva SECTION: NEWS LENGTH: 177 words Par Pharmaceutical Companies has acquired rights to three products from Teva Pharmaceutical Industries in connection with the latter's acquisition of Cephalon. Under terms of the agreement, Par will own the ANDAs for fentanyl citrate lozenges, a generic version of Actiq, which is indicated for the management of breakthrough cancer pain in patients aged >=16 years with malignancies who are already receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain, and cyclobenzaprine extended-release (ER) capsules, a generic version of Amrix, indicated as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions, as well as the US rights to market modafinil tablets, a generic version of Provigil, a wakefulness-promoting agent. Par is currently shipping all strengths of fentanyl citrate lozenges that were previously available from Teva. Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva, and are not yet available. LOAD-DATE: October 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: Pharma Company Insight Copyright 2011 Espicom Business Intelligence All Rights Reserved 14 of 998 DOCUMENTS Key Pharma News October 18, 2011 Tuesday Par acquires three generic products from Teva SECTION: NEWS LENGTH: 177 words Par Pharmaceutical Companies has acquired rights to three products from Teva Pharmaceutical Industries in connection with the latter's acquisition of Cephalon. Under terms of the agreement, Par will own the ANDAs for fentanyl citrate lozenges, a generic version of Actiq, which is indicated for the management of breakthrough cancer pain in patients aged >=16 years with malignancies who are already receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain, and cyclobenzaprine extended-release (ER) capsules, a generic version of Amrix, indicated as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions, as well as the US rights to market modafinil tablets, a generic version of Provigil, a wakefulness-promoting agent. Par is currently shipping all strengths of fentanyl citrate lozenges that were previously available from Teva. Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva, and are not yet available. LOAD-DATE: January 6, 2012 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: Pharma Company Insight Copyright 2011 Espicom Business Intelligence All Rights Reserved 15 of 998 DOCUMENTS PR Newswire October 18, 2011 Tuesday 9:00 AM EST Par Pharmaceutical Acquires Three Generic Products From Teva Pharmaceuticals; Par Begins Shipping Fentanyl Citrate Lozenges to the Trade Immediately LENGTH: 453 words DATELINE: WOODCLIFF LAKE, N.J., Oct. 18, 2011 Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced today that it acquired rights to three products from Teva Pharmaceuticals in connection with Teva's acquisition of Cephalon. Under terms of the agreement, Par will own the ANDAs of fentanyl citrate lozenges, a generic version of Actiq®, and cyclobenzaprine ER capsules, the generic version of Amrix®, as well as the U.S. rights to market modafinil tablets, the generic version of Provigil®. According to IMS Health data, annual sales in the U.S. for Actiq® and the equivalent generic products are $173 million. Annual sales in the U.S. for Provigil® and Amrix® are approximately $1.1 billion and $125 million, respectively. Par is currently shipping to the trade all strengths of fentanyl citrate lozenges that were previously available from Teva. Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva and are not yet available. About Par Pharmaceutical Companies, Inc. Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press release and other company information, visit www.parpharm.com. Safe Harbor Statement Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements. SOURCE Par Pharmaceutical Companies, Inc. CONTACT:Allison Wey, Vice President, Investor Relations and Corporate Affairs, Par Pharmaceutical Companies, Inc., +1-201-802-4000 URL: http://www.prnewswire.com LOAD-DATE: October 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 PR Newswire Association LLC All Rights Reserved 16 of 998 DOCUMENTS Europolitics (daily in English) October 17, 2011 Monday MERGERS : ISRAEL'S TEVA CLEARED TO BUY CEPHALON, SUBJECT TO CONDITIONS BYLINE: Sophie Mosca SECTION: No. 4286 LENGTH: 246 words The world's number one generic pharmaceutical company, Teva, obtained the European Commission's green light, on 13 October, to buy its American competitor, Cephalon, which is primarily an originator company. The EU executive nevertheless makes the EUR4.5 billion merger contingent on Cephalon's sale of its generic version of Provigil, a medicine used to treat excessive daytime sleepiness. The Commission determined that the two groups have a similar generic drug based on the same active ingredient as Provigil, namely modafinil, and that competition on the generic drug markets where modafinil is sold could be hampered. The commitment on the "divestment of Cephalon's generic pipeline modafinil product, as offered by the company, will allow a competitor to emerge and compete effectively with the merged entity," explains the EU executive. The investigation did not reveal any other significant modifications to the competitive situation and dynamics of other relevant markets, as a number of credible and significant competitors will continue to exercise a competitive constraint on the merged entity. The Commission concluded that the proposed transaction, as modified by the commitment, would not significantly impede effective competition in the European Economic Area. The US trade regulator, the Federal Trade Commission, made the merger conditional on Teva's divestment of its Provigil generic, its Actiq generic used to treat cancer and Amrix, a muscle relaxant. LOAD-DATE: October 14, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: EURE Copyright 2011 Europolitique All Rights Reserved 17 of 998 DOCUMENTS The Sunday Times (London) October 16, 2011 Sunday Edition 1; National Edition Doctors given drug perform better surgery; Tests of the brain-stimulant modafinil on exhausted surgeons produced remarkable results, says Jonathan Leake BYLINE: Jonathan Leake SECTION: NEWS; Pg. 15 LENGTH: 673 words IS your doctor on drugs? If not, perhaps they should be. A new study suggests that surgeons given "smart drugs" perform better, safer operations. Researchers gave sleepdeprived surgeons a brain stimulant called modafinil, known to boost memory and brain power, and then tested how good they were at thinking clearly, solving problems and carrying out simulated operations. The results were so convincing that scientists believe the medical profession could even be weaned off its current drug of choice: caffeine. The study, led by Lord Darzi, professor of surgery at Imperial College London and a junior health minister in the previous Labour government, suggests that doctors whose brains have been sharpened by the drug will perform better under pressure. What is more, he says, their extra brain power means they would think faster and react more decisively if something went wrong. "We found that when surgeons had taken modafinil they saw sharp improvements in their ability to solve problems and think flexibly. In fact, their performance was very good," said Barbara Sahakian, professor of psychiatry at Cambridge University. The sight of bleary-eyed doctors scrubbing up for surgery after sleepless nights in hospital has caused widespread concern over the risk to patients. But the usual remedy of strong coffee, taken orally in large quantities, can cause hand tremors, the last thing a surgeon needs during a tricky procedure. Sahakian suggests that modafinil could be a superior substitute for caffeine. Sahakian and Charlotte Housden, her research colleague, worked with Darzi and his surgical team in conducting the tests. Housden said: "Sleep deprivation is like being legally drunk - it causes problems with learning, memory and increased impulsiveness. This is particularly important for people with critical jobs like surgeons, pilots and drivers. "Imaging studies show that the pre-frontal cortex, which is where you do your thinking, undergoes changes in people who lack sleep." In the study, Housden and her colleagues tested 39 tired doctors who had worked all day and then stayed up all night. They were divided into two groups: one was given 200mg of modafinil while the other took a placebo. Then, from 6am to 8am, the doctors were subjected to a battery of tests to measure their cognitive skills, including carrying out virtual operations using a surgical training system. Compared with those who received modafinil, the doctors given a placebo achieved much lower scores on memory tasks, were more impatient, less able to solve problems and to think flexibly. Housden said: "Doctors who are deprived of sleep lose their ability to solve problems and think flexibly. It means that if they encounter a surgical problem they will find it harder to solve. "However, when they took modafinil they regained their ability to solve problems and think flexibly." Modafinil is currently available only on prescription but it has been approved in America for shift workers suffering from sleeping problems while at work. It is, however, widely available from online pharmacies for about 50p a tablet. One key concern is that modafinil has not been subjected to long-term safety tests. Sahakian suggests, however, that, subject to safety approval, modafinil could even be offered over the counter. In other jobs, the use of modafinil has already become widespread - if hidden. The military in Britain and America use the drug to keep soldiers and pilots awake on long missions and in recent years it has become popular with students and, increasingly, with business executives and other groups. Darzi says in his paper, published in the Annals of Surgery: "The continuing discourse over work hours, service provisions, graduate education, fatigue and patient safety strongly suggests that novel solutions might ultimately be required." If modafinil can make even the most exhausted of doctors bright-eyed and cheerful, then that is a problem solved. Of course, they could just cut the working hours instead. Additional reporting: Jan Piotrowski LOAD-DATE: October 16, 2011 LANGUAGE: ENGLISH GRAPHIC: Smart drugs might have benefited the medics in Carry on Doctor ALLSTAR PUBLICATION-TYPE: Newspaper JOURNAL-CODE: STS Copyright 2011 Times Newspapers Limited All Rights Reserved 18 of 998 DOCUMENTS Tendersinfo News October 15, 2011 Saturday 6:30 AM EST BELGIUM : Mergers: Commission approves the acquisition of Cephalon by Teva, subject to conditions LENGTH: 338 words The European Commission has cleared under the EU Merger Regulation the proposed acquisition of US-based pharmaceutical company Cephalon by the generic pharmaceutical company Teva of Israel. The decision is conditional upon the divestment of Cephalon's generic version of its "Provigil" drug. Provigil is indicated for the treatment of excessive daytime sleepiness associated with narcolepsy. Teva has also developed a generic version of the drug. In light of the commitments, the Commission concluded that the transaction does not raise competition concerns. The Commission examined the effects of the proposed transaction on the market for drugs based on Modafinil, the main active pharmaceutical ingredient of Provigil and the generic version developed by Teva as well as the one Cephalon has in the pipeline. The Commission was concerned that the proposed transaction, as initially notified, would have significantly reduced generic competition in the markets where Modafinil is sold. The Commission's investigation showed that the divestment of Cephalon's generic pipeline Modafinil product, as offered by the company, will allow a competitor to emerge and compete effectively with the merged entity. The investigation did not reveal any other significant modification to the competitive situation and dynamics of other relevant markets, as a number of credible and significant competitors will d continue to exercise a competitive constraint on the merged entity. The Commission therefore concluded that the proposed transaction, as modified by the commitment, would not significantly impede effective competition in the European Economic Area (EEA)1 or a substantial part of it. Teva is the world s largest generic pharmaceutical company. Cephalon is a primarily originator company, but also supplies generic pharmaceuticals in the EEA. The transaction was notified to the Commission on 25 August 2011. LOAD-DATE: October 15, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2011 Tendersinfo News, distributed by Contify.com All Rights Reserved 19 of 998 DOCUMENTS Globes (Tel Aviv, Israel) Distributed by McClatchy-Tribune Business News October 14, 2011 Friday Teva receives European approval for Cephalon acquisition BYLINE: Guy Katsovitch, Globes, Tel Aviv, Israel SECTION: BUSINESS AND FINANCIAL NEWS LENGTH: 272 words Oct. 14--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Cephalon Inc. (Nasdaq: CEPH ) announced today that they received approval from the European Commission to proceed with Teva's $7 billion acquisition of innovative drugs company Cephalon. A condition of the approval is that Teva must divest Cephalon's marketing authorization of generic modafinil in France and grant to the purchaser of this marketing authorization certain additional rights with respect to the entire European Economic Area, including a covenant not to sue effective as of October 2012. Teva received approval for the US authorities for the merger at the beginning of the week. Under that approval, Teva is required to divest two ANDAs for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix. Teva will also grant non-exclusive U.S. rights to an undisclosed company to market modafinil tablets, the generic version of Provigil, which had annual brand sales in the US of approximately $1.1 billion. With the European Commission approval, the parties have now obtained all regulatory approvals required to close the transaction and, accordingly, have scheduled a closing date of October 14, 2011. Teva projects that the deal will be accretive on a non-GAAP basis as soon as it is completed, and on a GAAP basis within four quarters. Teva also expects synergies of $500 million in the third year after completion. ___ (c)2011 the Globes (Tel Aviv, Israel) Visit the Globes (Tel Aviv, Israel) at www.globes.co.il/serveen/globes/nodeview.asp?fid=942 Distributed by MCT Information Services LOAD-DATE: October 15, 2011 LANGUAGE: ENGLISH ACC-NO: 20111014-TL-Teva-receives-European-approval-for-Cephalon-acquisition-1014-201110 14 PUBLICATION-TYPE: Newspaper JOURNAL-CODE: TL Copyright 2011 Globes (Tel Aviv, Israel) 20 of 998 DOCUMENTS States News Service October 14, 2011 Friday MERGERS: COMMISSION APPROVES THE ACQUISITION OF CEPHALON BY TEVA, SUBJECT TO CONDITIONS BYLINE: States News Service LENGTH: 459 words DATELINE: BRUSSELS The following information was released by the European Union: The European Commission has cleared under the EU Merger Regulation the proposed acquisition of US-based pharmaceutical company Cephalon by the generic pharmaceutical company Teva of Israel. The decision is conditional upon the divestment of Cephalon's generic version of its "Provigil" drug. Provigil is indicated for the treatment of excessive daytime sleepiness associated with narcolepsy. Teva has also developed a generic version of the drug. In light of the commitments, the Commission concluded that the transaction does not raise competition concerns. The Commission examined the effects of the proposed transaction on the market for drugs based on Modafinil, the main active pharmaceutical ingredient of Provigil and the generic version developed by Teva as well as the one Cephalon has in the pipeline. The Commission was concerned that the proposed transaction, as initially notified, would have significantly reduced generic competition in the markets where Modafinil is sold. The Commission's investigation showed that the divestment of Cephalon's generic pipeline Modafinil product, as offered by the company, will allow a competitor to emerge and compete effectively with the merged entity. The investigation did not reveal any other significant modification to the competitive situation and dynamics of other relevant markets, as a number of credible and significant competitors will d continue to exercise a competitive constraint on the merged entity. The Commission therefore concluded that the proposed transaction, as modified by the commitment, would not significantly impede effective competition in the European Economic Area (EEA)1 or a substantial part of it. Teva is the world's largest generic pharmaceutical company. Cephalon is a primarily originator company, but also supplies generic pharmaceuticals in the EEA. The transaction was notified to the Commission on 25 August 2011. Merger control rules and procedures The Commission, in 1989, was given the power to assess mergers and acquisitions involving companies with a turnover above certain thresholds (see Article 1 of the Merger Regulation). Its duty is to prevent concentrations that would significantly impede effective competition in the EEA or any substantial part of it. The vast majority of mergers do not pose competition problems and are cleared after a routine review. From the moment a transaction is notified, the Commission generally has a total of 25 working days to decide whether to grant approval (Phase I) or to start an in-depth investigation (Phase II). A non-confidential version of today's decision will be available at: http://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=2_M_6258 LOAD-DATE: October 14, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 States News Service 21 of 998 DOCUMENTS States News Service October 14, 2011 Friday PRELIMINARY STUDY EXAMINES EFFECTS OF 'COGNITIVE ENHANCEMENT' DRUG ON SLEEP-DEPRIVED DOCTORS BYLINE: States News Service LENGTH: 919 words DATELINE: LONDON The following information was released by Imperial College London: Researchers have carried out a preliminary study looking at the effects of the 'cognitive enhancement' drug modafinil on the performance of doctors who had been deprived of sleep for one night. Modafinil, discovered in the 1970s, is currently prescribed in the UK for the treatment of sleepiness associated with narcolepsy, sleep apnoea, and shift work sleep disorder, a condition that affects people who frequently have to work at night. In the new study of 39 people, published today in the Annals of Surgery by researchers from Imperial College London and the University of Cambridge, modafinil improved performance in a series of mental tasks when compared with placebo, but had no effect on the performance of a surgical motor skills task. The doctors did not interact with any patients during the exercise. See also: Annals of Surgery Imperial College London is not responsible for the content of external internet sites Department of Surgery and Cancer Faculty of Medicine Long periods without sleep are known to increase doctors' risk of making poor judgements and committing medical errors. The study was designed as a preliminary investigation into whether certain drugs might be effective at reversing some of the effects of fatigue. Colin Sugden, Clinical Lecturer in Surgery, Department of Surgery and Cancer at Imperial College London, who led the study, said: "This study set out to explore whether modafinil, a wakefulness-promoting drug, might help doctors to perform more effectively under conditions of fatigue when their performance might otherwise be compromised." In this randomised double-blind trial, 20 healthy male doctors took modafinil and 19 took a placebo after one night of sleep deprivation. All were asked to complete both a series of tasks that are commonly used in psychology research and a virtual reality surgical motor skills task. In the psychological tasks, the group that had taken modafinil performed better in tests of working memory and planning, were less impulsive decision-makers, and were more responsive to changing demands during a task. However, there was no significant difference between the two groups on the surgical motor skills task. Mr Sugden said: "Participants in the modafinil group were less impulsive, displayed greater flexibility and solved working memory and planning problems more efficiently than those in the placebo group. However, no benefit was seen in the performance of a basic motor skills task. This was a small, short-term study so we have to be very cautious about how the results are interpreted. Most importantly, it is not clear how performance on tests of mental function relate to how someone performs as a doctor." The researchers stress that these results remain to be confirmed with a larger sample size and ideally in a longer term study. The research explored the effects of one dose of modafinil over a short term and it was not designed to investigate the effects of repeated use, either on a person's physical and mental health or on their performance. Mr Sugden said: "Larger studies looking at the performance effects and safety of longer term use of the drug would need to be performed before we could draw conclusions about whether or not sleep-deprived doctors might benefit from taking it. There are also many challenging ethical considerations which will need to be thought through very carefully. "We should continue to do everything we can to ensure that doctors aren't in a situation where fatigue might impact upon their performance. We don't suggest that anyone should take modafinil to combat sleep deprivation, unless it has been prescribed by a doctor. The study was funded by Imperial College London. -ENDS- For further information please contact: Simon Levey Research Media Officer Imperial College London e-mail: s.levey@imperial.ac.uk Telephone: +44 (0)207 594 6702 or ext. 46702 Out of hours duty Press Officer: +44 (0)7803 886 248 Notes to editors: 1. Journal reference: C. Sugden et al. Effect of pharmacological enhancement on the cognitive and clinical psychomotor performance of sleep deprived doctors. Annals of Surgery, 2011 DOI: 10.1097/SLA.0b013e3182306c99 2. About Imperial College London Consistently rated amongst the world's best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 14,000 students and 6,000 staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment - underpinned by a dynamic enterprise culture. Since its foundation in 1907, Imperial's contributions to society have included the discovery of penicillin, the development of holography and the foundations of fibre optics. This commitment to the application of research for the benefit of all continues today, with current focuses including interdisciplinary collaborations to improve global health, tackle climate change, develop sustainable sources of energy and address security challenges. In 2007, Imperial College London and Imperial College Healthcare NHS Trust formed the UK's first Academic Health Science Centre. This unique partnership aims to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible. Website: www.imperial.ac.uk LOAD-DATE: October 14, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 States News Service 22 of 998 DOCUMENTS Globes [online] - Israel's Business Arena October 13, 2011 Thursday Teva receives European approval for Cephalon acquisition; The deal will be closed Friday. BYLINE: Guy Katsovitch LENGTH: 267 words Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Cephalon Inc. (Nasdaq: CEPH ) announced today that they received approval from the European Commission to proceed with Teva's $7 billion acquisition of innovative drugs company Cephalon. A condition of the approval is that Teva must divest Cephalon's marketing authorization of generic modafinil in France and grant to the purchaser of this marketing authorization certain additional rights with respect to the entire European Economic Area, including a covenant not to sue effective as of October 2012. Teva received approval for the US authorities for the merger at the beginning of the week. Under that approval, Teva is required to divest two ANDAs for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix. Teva will also grant non-exclusive U.S. rights to an undisclosed company to market modafinil tablets, the generic version of Provigil, which had annual brand sales in the US of approximately $1.1 billion. With the European Commission approval, the parties have now obtained all regulatory approvals required to close the transaction and, accordingly, have scheduled a closing date of October 14, 2011. Teva projects that the deal will be accretive on a non-GAAP basis as soon as it is completed, and on a GAAP basis within four quarters. Teva also expects synergies of $500 million in the third year after completion. Published by Globes [online], Israel business news - www.globes-online.com - on October 13, 2011 © Copyright of Globes Publisher Itonut (1983) Ltd. 2011 LOAD-DATE: October 14, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 Globes Publisher Itonut (1983) Ltd. All Rights Reserved 23 of 998 DOCUMENTS Globes [online] - Israel's Business Arena October 13, 2011 Thursday Teva receives European approval for Cephalon acquisition; The deal will be closed Friday. BYLINE: Guy Katsovitch LENGTH: 267 words Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Cephalon Inc. (Nasdaq: CEPH ) announced today that they received approval from the European Commission to proceed with Teva's $7 billion acquisition of innovative drugs company Cephalon. A condition of the approval is that Teva must divest Cephalon's marketing authorization of generic modafinil in France and grant to the purchaser of this marketing authorization certain additional rights with respect to the entire European Economic Area, including a covenant not to sue effective as of October 2012. Teva received approval for the US authorities for the merger at the beginning of the week. Under that approval, Teva is required to divest two ANDAs for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix. Teva will also grant non-exclusive U.S. rights to an undisclosed company to market modafinil tablets, the generic version of Provigil, which had annual brand sales in the US of approximately $1.1 billion. With the European Commission approval, the parties have now obtained all regulatory approvals required to close the transaction and, accordingly, have scheduled a closing date of October 14, 2011. Teva projects that the deal will be accretive on a non-GAAP basis as soon as it is completed, and on a GAAP basis within four quarters. Teva also expects synergies of $500 million in the third year after completion. Published by Globes [online], Israel business news - www.globes-online.com - on October 13, 2011 © Copyright of Globes Publisher Itonut (1983) Ltd. 2011 LOAD-DATE: October 14, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 Globes Publisher Itonut (1983) Ltd. All Rights Reserved 24 of 998 DOCUMENTS Federal Trade Commission Documents and Publications October 7, 2011 FTC Requires Sale of Generic Cancer Pain Drug and Muscle Relaxant as Conditions of Teva's $6.8 Billion Acquisition of Cephalon SECTION: OFFICE OF PUBLIC AFFAIRS LENGTH: 1052 words For Release: 10/07/2011 FTC Requires Sale of Generic Cancer Pain Drug and Muscle Relaxant as Conditions of Teva's $6.8 Billion Acquisition of Cephalon Par Pharmaceuticals Will Acquire Drug Assets, Enter Agreement To Make Generic Provigil To protect competition in the market for prescription drugs, the Federal Trade Commission will require Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 billion acquisition of rival drug firm Cephalon, Inc. In addition, the proposed settlement requires Teva to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalon's wakefulness drug Provigil in 2012. "This settlement preserves competitive markets for current generic drugs, which are key to holding down the cost of health care for consumers. It also ensures there will be competition among generic drugs introduced in the future," said Richard Feinstein, Director of the FTC's Bureau of Competition. According to the FTC's complaint (http://www.ftc.gov/os/caselist/1110166/111007tevacephaloncmpt.pdf), the acquisition as originally proposed would violate U.S. antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The markets for each of these drugs is described below. Transmucosal fentanyl citrate lozenges are versions of the cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon/Watson Pharmaceuticals, and Covidien, currently exist in the United States; this number would be reduced to two after Teva's acquisition of Cephalon. As originally proposed, the deal would have given Teva more than an 80 percent share of the sales of the generic Actiq product. Extended release cyclobenzaprine hydrochloride is an extended release version of the muscle relaxant Flexeril. Cephalon acquired the rights to the branded version of the drug, called Amrix, which was approved by the FDA in 2007. While no companies currently make or market a generic version of Amrix, Teva and Cephalon are two of only a limited number of suppliers that may be able to enter the market quickly with a generic product. Combining the two companies would result in less competition in the future. Modafinil tablets are versions of the brand name drug Provigil marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. No companies currently market a generic version of Provigil, which had sales of $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Inc., Mylan Pharmaceutical Inc., and Barr Laboratories, Inc. - which Teva now owns - all have taken steps toward entering the market, and all are eligible to seek a 180-day marketing exclusivity provided under federal law. However, each company also has signed an agreement with Cephalon to refrain from marketing generic Provigil until April 2012. The FTC contends that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day exclusivity period. In each of the three markets, Teva's acquisition of Cephalon would harm consumers by significantly reducing competition, leading to higher prices, the FTC contends. The proposed settlement order is designed to replace the competition lost through Teva's acquisition of Cephalon. First, it requires Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, and Actiq or generic extended release cyclobenzaprine hydrochloride capsules, to Par Pharmaceuticals, Inc., a generic drug manufacturer based in New Jersey. This divestiture must be completed within 10 days of the acquisition. Next, to remedy the consolidation of marketers of modafinil drugs during the 180-day exclusivity period, the proposed order requires Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the United States for one year. This will allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the modafinil supply agreement for another year. The Commission vote approving the complaint and proposed consent order was 4-0. The order will be published in the Federal Register shortly and will be subject to public comment for 30 days, until November 7, 2011, after which the Commission will decide whether to make it final. Comments can be submitted electronically here (https://ftcpublic.commentworks.com/ftc/tevacephalonconsent). NOTE: The Commission issues a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of a complaint is not a finding or ruling that the respondent has violated the law. A consent order is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000. The FTC's Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust@ftc.gov, or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 601 New Jersey Ave., Room 7117, Washington, DC 20580. To learn more about the Bureau of Competition, read Competition Counts (http://www.ftc.gov/competitioncounts). Like the FTC on Facebook (http://www.ftc.gov/leaving/facebook/index.shtml) and follow us on Twitter (http://www.ftc.gov/leaving/twitter/index.shtm). MEDIA CONTACT: Mitchell J. Katz, Office of Public Affairs 202-326-2161 STAFF CONTACT: Kari Wallace, Bureau of Competition 202-326-3085 (FTC File No. 111-0166) (Teva-Cephalon.final) LOAD-DATE: October 7, 2011 LANGUAGE: ENGLISH JOURNAL-CODE: FTDA Copyright 2011 Federal Information and News Dispatch, Inc. 25 of 998 DOCUMENTS States News Service October 7, 2011 Friday FTC REQUIRES SALE OF GENERIC CANCER PAIN DRUG AND MUSCLE RELAXANT AS CONDITIONS OF TEVA'S $6.8 BILLION ACQUISITION OF CEPHALON PAR PHARMACEUTICALS WILL ACQUIRE DRUG ASSETS, ENTER AGREEMENT TO MAKE GENERIC PROVIGIL BYLINE: States News Service LENGTH: 970 words DATELINE: WASHINGTON The following information was released by the Federal Trade Commission: To protect competition in the market for prescription drugs, the Federal Trade Commission will require Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 billion acquisition of rival drug firm Cephalon, Inc. In addition, the proposed settlement requires Teva to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalons wakefulness drug Provigil in 2012. This settlement preserves competitive markets for current generic drugs, which are key to holding down the cost of health care for consumers. It also ensures there will be competition among generic drugs introduced in the future, said Richard Feinstein, Director of the FTCs Bureau of Competition. According to the FTCs complaint, the acquisition as originally proposed would violate U.S. antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The markets for each of these drugs is described below. Transmucosal fentanyl citrate lozenges are versions of the cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon/Watson Pharmaceuticals, and Covidien, currently exist in the United States; this number would be reduced to two after Tevas acquisition of Cephalon. As originally proposed, the deal would have given Teva more than an 80 percent share of the sales of the generic Actiq product. Extended release cyclobenzaprine hydrochloride is an extended release version of the muscle relaxant Flexeril. Cephalon acquired the rights to the branded version of the drug, called Amrix, which was approved by the FDA in 2007. While no companies currently make or market a generic version of Amrix, Teva and Cephalon are two of only a limited number of suppliers that may be able to enter the market quickly with a generic product. Combining the two companies would result in less competition in the future. Modafinil tablets are versions of the brand name drug Provigil marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. No companies currently market a generic version of Provigil, which had sales of $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Inc., Mylan Pharmaceutical Inc., and Barr Laboratories, Inc. which Teva now owns all have taken steps toward entering the market, and all are eligible to seek a 180-day marketing exclusivity provided under federal law. However, each company also has signed an agreement with Cephalon to refrain from marketing generic Provigil until April 2012. The FTC contends that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day exclusivity period. In each of the three markets, Tevas acquisition of Cephalon would harm consumers by significantly reducing competition, leading to higher prices, the FTC contends. The proposed settlement order is designed to replace the competition lost through Tevas acquisition of Cephalon. First, it requires Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, and Actiq or generic extended release cyclobenzaprine hydrochloride capsules, to Par Pharmaceuticals, Inc., a generic drug manufacturer based in New Jersey. This divestiture must be completed within 10 days of the acquisition. Next, to remedy the consolidation of marketers of modafinil drugs during the 180-day exclusivity period, the proposed order requires Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the United States for one year. This will allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the modafinil supply agreement for another year. The Commission vote approving the complaint and proposed consent order was 4-0. The order will be published in the Federal Register shortly and will be subject to public comment for 30 days, until November 7, 2011, after which the Commission will decide whether to make it final. Comments can be submitted electronically here. NOTE: The Commission issues a complaint when it has reason to believe that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of a complaint is not a finding or ruling that the respondent has violated the law. A consent order is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000. The FTCs Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust@ftc.gov, or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 601 New Jersey Ave., Room 7117, Washington, DC 20580. To learn more about the Bureau of Competition, read Competition Counts. Like the FTC on Facebook and follow us on Twitter. MEDIA CONTACT: Mitchell J. Katz, Office of Public Affairs 202-326-2161 STAFF CONTACT: Kari Wallace, Bureau of Competition 202-326-3085 LOAD-DATE: October 8, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 States News Service 26 of 998 DOCUMENTS Targeted News Service October 7, 2011 Friday 2:16 AM EST FTC Requires Sale of Generic Cancer Pain Drug and Muscle Relaxant as Conditions of Teva's $6.8 Billion Acquisition of Cephalon BYLINE: Targeted News Service LENGTH: 968 words DATELINE: WASHINGTON The Federal Trade Commission issued the following news release: To protect competition in the market for prescription drugs, the Federal Trade Commission will require Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 billion acquisition of rival drug firm Cephalon, Inc. In addition, the proposed settlement requires Teva to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalon's wakefulness drug Provigil in 2012. "This settlement preserves competitive markets for current generic drugs, which are key to holding down the cost of health care for consumers. It also ensures there will be competition among generic drugs introduced in the future," said Richard Feinstein, Director of the FTC's Bureau of Competition. According to the FTC's complaint, the acquisition as originally proposed would violate U.S. antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The markets for each of these drugs is described below. Transmucosal fentanyl citrate lozenges are versions of the cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon/Watson Pharmaceuticals, and Covidien, currently exist in the United States; this number would be reduced to two after Teva's acquisition of Cephalon. As originally proposed, the deal would have given Teva more than an 80 percent share of the sales of the generic Actiq product. Extended release cyclobenzaprine hydrochloride is an extended release version of the muscle relaxant Flexeril. Cephalon acquired the rights to the branded version of the drug, called Amrix, which was approved by the FDA in 2007. While no companies currently make or market a generic version of Amrix, Teva and Cephalon are two of only a limited number of suppliers that may be able to enter the market quickly with a generic product. Combining the two companies would result in less competition in the future. Modafinil tablets are versions of the brand name drug Provigil marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. No companies currently market a generic version of Provigil, which had sales of $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Inc., Mylan Pharmaceutical Inc., and Barr Laboratories, Inc. - which Teva now owns - all have taken steps toward entering the market, and all are eligible to seek a 180-day marketing exclusivity provided under federal law. However, each company also has signed an agreement with Cephalon to refrain from marketing generic Provigil until April 2012. The FTC contends that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day exclusivity period. In each of the three markets, Teva's acquisition of Cephalon would harm consumers by significantly reducing competition, leading to higher prices, the FTC contends. The proposed settlement order is designed to replace the competition lost through Teva's acquisition of Cephalon. First, it requires Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, and Actiq or generic extended release cyclobenzaprine hydrochloride capsules, to Par Pharmaceuticals, Inc., a generic drug manufacturer based in New Jersey. This divestiture must be completed within 10 days of the acquisition. Next, to remedy the consolidation of marketers of modafinil drugs during the 180-day exclusivity period, the proposed order requires Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the United States for one year. This will allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the modafinil supply agreement for another year. The Commission vote approving the complaint and proposed consent order was 4-0. The order will be published in the Federal Register shortly and will be subject to public comment for 30 days, until November 7, 2011, after which the Commission will decide whether to make it final. Comments can be submitted electronically here. NOTE: The Commission issues a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of a complaint is not a finding or ruling that the respondent has violated the law. A consent order is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000. The FTC's Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action. To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust@ftc.gov, or write to the Office of Policy and Coordination, Bureau of Competition, Federal Trade Commission, 601 New Jersey Ave., Room 7117, Washington, DC 20580. To learn more about the Bureau of Competition, read Competition Counts. Like the FTC on Facebook and follow us on Twitter. Contact: Mitchell J. Katz, 202/326-2161 Copyright Targeted News Services TNS MT93 111008-3622578 61MarlizTagarum LOAD-DATE: October 8, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Targeted News Service LLC All Rights Reserved 27 of 998 DOCUMENTS US Fed News October 7, 2011 Friday 2:07 PM EST FTC REQUIRES SALE OF GENERIC CANCER PAIN DRUG AND MUSCLE RELAXANT AS CONDITIONS OF TEVA'S $6.8B ACQUISITION OF CEPHALON LENGTH: 788 words WASHINGTON, Oct. 7 -- The Federal Trade Commission issued the following press release: To protect competition in the market for prescription drugs, the Federal Trade Commission will require Teva Pharmaceutical Industries Ltd. to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its proposed $6.8 billion acquisition of rival drug firm Cephalon, Inc. In addition, the proposed settlement requires Teva to enter into a supply agreement that will allow a competing firm to sell a generic version of Cephalon's wakefulness drug Provigil in 2012. "This settlement preserves competitive markets for current generic drugs, which are key to holding down the cost of health care for consumers. It also ensures there will be competition among generic drugs introduced in the future," said Richard Feinstein, Director of the FTC's Bureau of Competition. According to the FTC's complaint, the acquisition as originally proposed would violate U.S. antitrust law by reducing competition in three markets: transmucosal fentanyl citrate lozenges used to treat cancer pain; extended release cyclobenzaprine hydrochloride used as a muscle relaxant; and modafinil tablets used to improve wakefulness. The markets for each of these drugs is described below. Transmucosal fentanyl citrate lozenges are versions of the cancer pain drug developed by Cephalon and marketed under the brand name Actiq. Three generic versions of the drug, manufactured and marketed by Teva, Cephalon/Watson Pharmaceuticals, and Covidien, currently exist in the United States; this number would be reduced to two after Teva's acquisition of Cephalon. As originally proposed, the deal would have given Teva more than an 80 percent share of the sales of the generic Actiq product. Extended release cyclobenzaprine hydrochloride is an extended release version of the muscle relaxant Flexeril. Cephalon acquired the rights to the branded version of the drug, called Amrix, which was approved by the FDA in 2007. While no companies currently make or market a generic version of Amrix, Teva and Cephalon are two of only a limited number of suppliers that may be able to enter the market quickly with a generic product. Combining the two companies would result in less competition in the future. Modafinil tablets are versions of the brand name drug Provigil marketed by Cephalon and used to treat excessive sleepiness caused by narcolepsy or shift work disorder. No companies currently market a generic version of Provigil, which had sales of $1 billion in 2010. Teva, Ranbaxy Pharmaceuticals, Inc., Mylan Pharmaceutical Inc., and Barr Laboratories, Inc. - which Teva now owns - all have taken steps toward entering the market, and all are eligible to seek a 180-day marketing exclusivity provided under federal law. However, each company also has signed an agreement with Cephalon to refrain from marketing generic Provigil until April 2012. The FTC contends that without the proposed settlement, Teva and Cephalon would have been two of only a limited number of suppliers of generic Provigil during the 180-day exclusivity period. In each of the three markets, Teva's acquisition of Cephalon would harm consumers by significantly reducing competition, leading to higher prices, the FTC contends. The proposed settlement order is designed to replace the competition lost through Teva's acquisition of Cephalon. First, it requires Teva to sell all of its rights and assets related to generic Actiq or transmucosal fentanyl citrate lozenges, and Actiq or generic extended release cyclobenzaprine hydrochloride capsules, to Par Pharmaceuticals, Inc., a generic drug manufacturer based in New Jersey. This divestiture must be completed within 10 days of the acquisition. Next, to remedy the consolidation of marketers of modafinil drugs during the 180-day exclusivity period, the proposed order requires Teva to enter into a supply agreement to provide Par with generic modafinil tablets in the United States for one year. This will allow Par to compete with a generic modafinil product during the 180-day exclusivity period. In addition, Par may extend the modafinil supply agreement for another year. The Commission vote approving the complaint and proposed consent order was 4-0. The order will be published in the Federal Register shortly and will be subject to public comment for 30 days, until November 7, 2011, after which the Commission will decide whether to make it final. Comments can be submitted electronically here (https://ftcpublic.commentworks.com/ftc/tevacephalonconsent). For any query with respect to this article or any other content requirement, please contact Editor at htsyndication@hindustantimes.com LOAD-DATE: October 10, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 HT Media Ltd. All Rights Reserved 28 of 998 DOCUMENTS Indian Patents News September 13, 2011 Tuesday 6:30 AM EST Cephalon Inc Receives Patent for Novel Pharmaceutical Formulations of Modafinil LENGTH: 262 words New Delhi, Sept. 13 -- Cephalon Inc received patent for novel pharmaceutical formulations of modafinil on Dec. 14, 2007. The patent number issued by the Indian Patent Office is 212727. Cephalon Inc had filed patent application number 633/KOLNP/2005 for novel pharmaceutical formulations of modafinil on April 13, 2005. The inventors of the patent are Vincent Corvari, George Grandolfi and Alpa Parikh. The International classification number is A61K7/28. The PCT International application number of the patent is PCT/US03/028528 and the application was filed on Sept. 11, 2003. According to the Controller General of Patents, Designs & Trade Marks, "A composition comprising modafinil, wherein modafinil comprises about 90% by weight of the composition; a lactose monohydrate which comprises about 3-10% of the composition by weight; a cross-linked sodium carboxymethyl cellulose, which comprises about 2-5% of the composition by weight; a polyvinyl pyrrolidone, which comprises about 2-5% of the composition by weight; and magnesium stearate, which comprises about 0.2-2.0% of the composition by weight." About the Company Cephalon, Inc. (NASDAQ: CEPH) is a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist with the DuPont Company, who served as the company's chairman and chief executive officer until his death in December 2010. The company's name comes from the adjective "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases. LOAD-DATE: September 13, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 29 of 998 DOCUMENTS Indian Patents News August 18, 2011 Thursday 6:30 AM EST Cephalon Inc Files Patent Application for Modafinil Pharmaceutical Compositions LENGTH: 275 words New Delhi, Aug. 18 -- USA based Cephalon Inc filed patent application for modafinil pharmaceutical compositions. The inventors are Heacock Craig, Parikh Alpa and Patel Piyush R. Cephalon Inc filed the patent application on Feb. 11, 2005. The patent application number is 00172/KOLNP/2005 A. The international classification number is A61K31/165. According to the Controller General of Patents, Designs & Trade Marks, "Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug." About the Company Cephalon, Inc. (Public, NASDAQ:CEPH) is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. In August 2009, Cephalon, Inc. acquired Arana Therapeutics Limited. In April 2010, the Company acquired Mepha, a pharmaceutical company. LOAD-DATE: August 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 30 of 998 DOCUMENTS Indian Patents News August 18, 2011 Thursday 6:30 AM EST Alembic Limited Files Patent Application for Process for the Preparation of 2-[(diphenylmethyl) Thio] Acetamide LENGTH: 342 words New Delhi, Aug. 18 -- India based Alembic Limited filed patent application for process for the preparation of 2-[(diphenylmethyl) thio] acetamide. The inventors are Bhatt Surendra B, Patel Jiten R, Panchasara Dinesh, Shah Hetal R, Deo Keshav and Kansal Vinod Kumar. Alembic Limited filed the patent application on Jan. 31, 2003. The patent application number is 130/MUM/2003. The international classification numbers are A61K31/165, C07C317/44 and C07C323/29. According to the Controller General of Patents, Designs & Trade Marks, "Process for the preparation of 2-[(diphenylmethyl) thioacetamide, an intermediate for the preparation of Modafinil which is a CNS stimulant and used for the treatment of narcolepsia. The process comprises reacting 2-[dipenylmethyl) thio] acetic acid with alcohols, in presence of catalytic amount of inorganic acid or organic acid at reflux temperature of alcohol to obtain corresponding ester which is reacted with ammonia to give 2- [(diphenylmethyl)thio]acetamide. If desired 2- [(diphenylmethyl) thioacetamide thus produced is reacted with hydrogen peroxide to produce Modafinil." About the Company Alembic Limited (Public, BOM:506235) is engaged in manufacturing synthetic active pharmaceutical ingredients (APIs), consisting of independent manufacturing blocks for Macrolides, non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs. The Company's veterinary products include antibiotics/anti-microbials injectables/orals, speciality injectables, endectocides, boli, feed supplements and poultry. The Company's therapeutic category includes anti-infectives, caphalosporins, anti-protozoal, musculo skeletal, erectile dtsfunction, anti-parkinsons, anti-depressants, anti-epileptics, CNS stimulant, anti anziety and cardiovascular. Its basket of formulation products contain 150 products in several forms belonging to diverse therapeutic segments, including anti-infective, cough and cold products to cardiovascular and oral anti-diabetics. The wholly owned subsidiary of the Company is Alembic Global Holding SA. LOAD-DATE: August 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 31 of 998 DOCUMENTS Targeted News Service August 6, 2011 Saturday 3:52 AM EST SRI International, HealthPartners Research Foundation Assigned Patent BYLINE: Targeted News Service LENGTH: 267 words DATELINE: Alexandria, Va. ALEXANDRIA, Va., Aug. 6 -- SRI International, Menlo Park, Calif., and HealthPartners Research Foundation, Minneapolis, have been assigned a patent (7,989,502) developed by five co-inventors for an "intranasal delivery of modafinil." The co-inventors are Mary Ann Katherine Greco, San Francisco, William Howard Frey II, White Bear Lake, Minn., Jacqueline DeRose, Santa Clara, Calif., Rachel Beth Matthews, Dayton, Minn., and Leah Ranae Bresin Hanson, Vadnais Heights, Minn. The abstract of the patent published by the U.S. Patent and Trademark Office states: "Modafinil is selectively delivered to the brain, minimizing delivery to the blood, of a person in need thereof by administering to the person a therapeutically-effective dosage of modafinil, wherein the dosage is less than 1 mg, formulated in a lipid microemulsion (LME) and selectively delivered to the upper third of the nasal cavity. The method may be implemented with an intranasal pharmaceutical delivery device loaded with a modafinil composition and adapted to deliver the dosage to the upper third of the nasal cavity." The patent application was filed on Feb. 6, 2009 (12/367,496). The full-text of the patent can be found at http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=% 2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,989,502.PN.&OS=PN/7,989,502&RS= PN/7,989,502 Written by Shabnam Sheikh; edited by Jaya Anand. For more information about Targeted News Service federal patent awards please contact: Myron Struck, Editor, Direct: 703/866-4708, Cell: 703/304-1897, Myron@targetednews.com SH0806JA0806-604728 LOAD-DATE: September 22, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Targeted News Service LLC All Rights Reserved 32 of 998 DOCUMENTS Indian Patents News July 31, 2011 Sunday 6:30 AM EST Alembic Limited Files Patent Application for Process for the Preparation of Modafinil of Formula II LENGTH: 314 words New Delhi, July 31 -- India based Alembic Limited filed patent application for process for the preparation of Modafinil of formula II. The inventors are Bhatt Surendra B, Patel Jiten R, Panchasara Dinesh, Shah Hetal R, Deo Keshav and Kansal Vinod Kumar. Alembic Limited filed the patent application on Dec. 21, 2004. The patent application number is 1387/MUM/2004 A. The international classification number is A61K31/400. According to the Controller General of Patents, Designs & Trade Marks, "Process for the preparation of Modafinil which is a CNS stimulant and used for the treatment of narcolepsia. The process comprises reacting 2-[(diphenylmethyl)thio]acetic acid with alcohols, in presence of catalytic amount of inorganic acid or organic acid at reflux temperature of alcohol to obtain corresponding ester which is reacted with ammonia to give 2-[(diphenylmethyl)thio]acetamide, which is reacted with hydrogen peroxide to produce Modafinil." About the Company Alembic Limited (Public, BOM:506235) is engaged in manufacturing synthetic active pharmaceutical ingredients (APIs), consisting of independent manufacturing blocks for Macrolides, non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs. The Company's veterinary products include antibiotics/anti-microbials injectables/orals, speciality injectables, endectocides, boli, feed supplements and poultry. The Company's therapeutic category includes anti-infectives, caphalosporins, anti-protozoal, musculo skeletal, erectile dtsfunction, anti-parkinsons, anti-depressants, anti-epileptics, CNS stimulant, anti anziety and cardiovascular. Its basket of formulation products contain 150 products in several forms belonging to diverse therapeutic segments, including anti-infective, cough and cold products to cardiovascular and oral anti-diabetics. The wholly owned subsidiary of the Company is Alembic Global Holding SA. LOAD-DATE: July 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 33 of 998 DOCUMENTS Spicy IP July 30, 2011 Saturday 9:00 PM EST Does size matter: the case of an anti-narcoleptic drug, modafinil? BYLINE: Rajiv Kr. Choudhry LENGTH: 1245 words Long post follows: About a month ago, the UK Chancery division patents courts (England and Wales) rendered an opinion (http://www.bailii.org/ew/cases/EWHC/Patents/2011/1591.html) (Justice Floyd) regarding claim construction in defining size of particles of an anti-narcoleptic drug, modafinil, in pharmaceutical compositions. The patent court construed patent claims to determine whether there is an infringement, if any. Facts: The dispute involves three patents related to the drug modafinil, used to treat sleep disorders such as narcolepsy. Orchid Europe is the manufacturer of generic modafinil and Mylan intended to manufacture the drug in UK. Cephalon is the proprietor, an exclusive licensee in the UK and a sub-licensee of the patents involved (European Patents (https://data.epo.org/publication-server/?lg=en) (UK) Numbers 0 731 698 ("698"), 0 966 962 ("962") and 1 088 549 ("549")). These patents contain a very similar disclosure with differentiated claims, and they all claim a priority date of 6th October 1994. Mylan denied infringement and challenged the validity of all three Cephalon patents on the grounds of lack of inventive step and insufficiency. Background: Modafinil, the active substance, was discovered and developed by a French company, Lafon. Cephalon licensed modafinil in the USA in 1994 and conducted further tests on it to bring it to the market as an agent to treat sleep disorders. In the course of the tests in the US, modafinil caused more side effects than in Europe in corresponding trials involving equivalent doses. The cause was traced to smaller particle size of the input active pharmaceutical ingredient ("API") of the lots used in the US trials. In the first human trials performed on non-commercial samples of modafinil ("early lots"), the median particle size diameter was between 80 and 150 m. The studies in US involved "late lots", revealed unanticipated side effects at doses of 800 mg per day. These late lots employed a particle size of 30 to 50 m. This led the patentee to conclude that the late lots could be more readily absorbed than the early lots, and therefore leading to an increased plasma concentration (increased bioavailability) of modafinil. Claims: Each patent claimed different formulations of modafinil, with different particle sizes. The relevant portions of the first independent claims of each patent are reproduced below. '698 patent '962 patent '549 patent ....comprising .... .... ... wherein at least about modafinil particles, wherein comprising 95% of the cumulative total of at least about 95% of the modafinil said modafinil particles in cumulative total of particles said composition have a modafinil particles in said having a diameter of less than about 200 composition have a diameter median m and wherein the median of less than about 200 particle size particle size is about 10 to 60 micrometers (m). of about 2 to m. about 60 m... Issue: "Whether the claims were referring to the particle size within the composition (Cephalon's contention) or whether they were referring to the particle size in the active ingredient used to make the composition (Mylan's contention)." Additionally, during the tabletting process, the size of the particles in the final finished tablet differed from that in the API from which the tablets are made. Therefore, the sizes of the particles in the API did not correspond to the size of the particles in the finished tablets, and vice versa. Claim construction and analysis: In the claim construction, both sides pointed to claim language that supported their particular construction. For example, Cephalon pointed to the '698 patent, which claimed 'compositions comprising' modafinil particles and hence referring to the size of the particles in the final tablets. Mylan pointed to the claims in the '962 patent for use of ' modafinil particles ...at least about 95% of the cumulative total of said particles have a diameter of less than about 200 micrometers for the manufacture of a pharmaceutical composition " and hence points to the particle size in the input API, as it is used in the manufacturing process.Several industry practices were listed to aid in the interpretation of claims, one of which was, "[A] general practice in the pharmaceutical industry was not to measure particle size in a solid formulation, but to make measurements on the input API." Conclusion: Based on the common knowledge, the Judge concluded that the patentee must have meant particle size to be measured on the bulk API. "Particle size is never measured in the dosage form, and the skilled person would not know how to do so." Although it routine industry practice to measure the particle size of API, the particle size in finished tablets could not have been measured at the priority date of the patents (1994). Additionally, particle size of the API has a direct correlation with bioavailability in the final tablet. Therefore contentions of Mylan were accepted. Infringement: Both parties agreed that if Mylan's construction of the claims was the correct one, there was no infringement. Obviousness: Mylan contended that the patents were invalid in view of prior publications, 'Drugs of the future, and Nguyen, a PCT application applied for by Lafon. On the basis of 'common general knowledge' and the knowledge of the relationship between lower particle size and improved plasma concentration or bioavailability, it was held that it would be routine to investigate the particle size to improve the bioavailability of a compound, with the expectation that this investigation would be fruitful. Hence Cephalon patents were obvious in view of the first publication. As regards the Nguyen publication, no dosage for modafinil specified but it did provide a formulation with a particle size of 2-5 m. J. Floyd rejected the contention that it would require significant experimentation/investment to the results of Nguyen to reach an appropriate dosage for modafinil. "The skilled person is entitled to implement a disclosure in a technically obvious way, even if doing so might not appear commercially attractive. Had I not come to the conclusions I had already reached in relation to obviousness, I would have required the claims to be limited so as to avoid the attack."Significance to Indian scenario:Shamnad, in a previous post (http://spicyipindia.blogspot.com/2007/09/section-3d-and-efficacy-more-cases_09. html), referred to a need for having broad guidelines for defining 'efficacy.' In that post, the question was whether increased bioavailability would constitute as a significant enhancement in efficacy. If this case was decided under the Indian law, increased bioavailability and (therefore efficacy) would have been the argument to counter a 3(d) opposition and it would have overcome the challenge. This case therefore highlights when the patent office should undertake the 3(d) analysis: Only when the basic issues (inventive and non-obvious) should the Controller decide the issue of patentability under section 3(d). This case also highlights whether it makes sense to equate bioavailability to efficacy. The exclusionary test (http://spicyipindia.blogspot.com/2010/08/exclusionary-definition-for-term.html) may perhaps make more sense in such a scenario for formulation applications like the one described here. LOAD-DATE: October 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2011 Spicy IP, distributed by Contify.com All Rights Reserved 34 of 998 DOCUMENTS Indian Patents News July 19, 2011 Tuesday 6:30 AM EST Cephalon Inc Files Patent Application for Pharmaceutical Formulations of Modafinil LENGTH: 286 words New Delhi, July 19 -- USA based Cephalon Inc filed patent application for pharmaceutical formulations of modafinil. The inventors are Craig Heacock, Alpa Parikh and Piyush Patel. Cephalon Inc filed the patent application on April 13, 2005. The patent application number is 00632/KOLNP/2005 A. The international classification numbers are A61K 31/165 and A61P 25/00. According to the Controller General of Patents, Designs & Trade Marks, "Compositions of modafinil and methods of treating neurologically related conditions with the administration of modafinil. Also compositions that include modafinil and one or more excipients such as diluents, disintegrants, binders and lubricants." About the Company Cephalon, Inc. (Public, NASDAQ:CEPH) is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. In August 2009, Cephalon, Inc. acquired Arana Therapeutics Limited. In April 2010, the Company acquired Mepha, a pharmaceutical company. LOAD-DATE: July 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 35 of 998 DOCUMENTS Washington Drug Letter July 11, 2011 Monday Barr Must Produce Settlement Docs in Provigil Pay-for-Delay Case SECTION: Vol. 43 No. 27 LENGTH: 153 words A federal court is ordering Teva subsidiary Barr Pharmaceuticals to disclose a number of previously withheld documents in a long-running Provigil antitrust case. The 18 documents "relate to the settlement between Barr and Provigil maker Cephalon and how, financially, the settlement terms would affect Chemagis," Barr's active pharmaceutical ingredient supplier and partner in developing generic Provigil (modafinil). Barr must produce the documents by July 12, according to the Tuesday filing in the U.S. District court for the Eastern District of Pennsylvania. The case, King Drug Company of Florence, Inc. et al. v. Cephalon, Inc. et al., concerns settlements made between Cephalon and several generic-drug makers to delay generic versions of sleepiness drug Provigil (modafinil). The suit was initially filed in 2006. Teva did not return a request for comment by press time. -- Kevin O'Rourke Release date: July 11, 2011 LOAD-DATE: July 9, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2011 Washington Business Information, Inc. All Rights Reserved 36 of 998 DOCUMENTS Drug Industry Daily July 7, 2011 Thursday Court Orders Barr to Produce Settlement Documents in Provigil Pay-for-Delay Case SECTION: Vol. 10 No. 132 LENGTH: 391 words A federal court is ordering Teva subsidiary Barr Pharmaceuticals to disclose a number of previously withheld documents in a long-running Provigil antitrust case. The 18 documents "relate to the settlement between Barr and Cephalon and how, financially, the settlement terms would affect Chemagis," Barr's active pharmaceutical ingredient supplier and partner in developing generic Provigil ( modafinil). Barr must produce the documents by July 12. The case, King Drug Company of Florence, Inc. et al. v. Cephalon, Inc. et al., concerns settlements made between Cephalon and several generic-drug makers to delay generic versions of Cephalon's sleepiness drug Provigil (modafinil). The suit was initially filed in 2006. A collection of distributors and pharmacies, including CVS, allege the settlements "constitute an unlawful restraint of trade" and have sued Cephalon, Barr and three other generic companies for antitrust violations, according to Tuesday's filing in the U.S. District court for the Eastern District of Pennsylvania. The plaintiffs are seeking access to communications between Barr and Chemagis between December 2005 and January 2006 -- prior to Barr's February 2006 agreement with Cephalon regarding generic Provigil. The plaintiffs also argued that Barr waived attorney-client privilege on other communications from the settlement with Cephalon, and must allow discovery of the documents, but presiding judge Mitchell Goldberg denied that motion. Since the case began, Teva has acquired a number of the companies involved, including Barr. In a twist that shocked many analysts, Teva outbid Valeant in May to buy Cephalon for $6.8 billion (DID, May 3). The Provigil agreement has been the subject of government scrutiny for several years. In 2006, the FTC asked Cephalon for information about settlements it made with generic companies (DID, March 17, 2006). The European Commission also recently announced that it had launched an investigation into the agreement between Cephalon and Teva to delay generic Provigil (DID, May 2). An FTC report released in May found deals struck between brand and generic pharmaceutical companies are on the rise, despite efforts to restrict agreements that delay market entry of cheaper drugs (DID, May 5). Teva did not return a request for comment by press time. -- Kevin O'Rourke Release date: July 7, 2011 LOAD-DATE: July 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2011 Washington Business Information, Inc. All Rights Reserved 37 of 998 DOCUMENTS Indian Patents News July 1, 2011 Friday 6:30 AM EST Cephalon Inc. Files Patent Application for Novel Pharmaceutical Formulations of Modafinil LENGTH: 282 words New Delhi, July 1 -- USA based Cephalon Inc. filed patent application for novel pharmaceutical formulations of modafinil. The inventors are Corvari Vincent, Grandolfi George and Parikh Alpa. Cephalon Inc. filed the patent application on Dec. 12, 2003. The patent application number is 01616/KOLNP/2003 A. The international classification numbers are A61K31/165, 9/20 and 9/16. According to the Controller General of Patents, Designs & Trade Marks, "The present invention is related to compositions of modafinil, including compositions of modafinil and one or more diluents, disintegrants, binders and lubricants, and the processes for the preparation thereof." About the Company Cephalon, Inc. (Public, NASDAQ:CEPH) is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. In August 2009, Cephalon, Inc. acquired Arana Therapeutics Limited. In April 2010, the Company acquired Mepha, a pharmaceutical company. LOAD-DATE: July 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 38 of 998 DOCUMENTS Indian Patents News June 30, 2011 Thursday 6:30 AM EST Cephalon Inc Files Patent Application for Novel Pharmaceutical Formulations of Modafinil LENGTH: 283 words New Delhi, June 30 -- USA based Cephalon Inc filed patent application for novel pharmaceutical formulations of modafinil. The inventors are Vincent Corvari, George Grandolfi and Alpa Parikh. Cephalon Inc filed the patent application on April 13, 2005. The patent application number is 00633/KOLNP/2005A. The international classification numbers are A61K 31/165 9/16,9/20 and 9/48. According to the Controller General of Patents, Designs & Trade Marks, "The present invention is related to compositions of modafinil, including compositions of modafinil and one or more diluents, disintegrants, binders and lubricants, and the processes for their preparation thereof." About the Company Cephalon, Inc. (Public, NASDAQ:CEPH) is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. In August 2009, Cephalon, Inc. acquired Arana Therapeutics Limited. In April 2010, the Company acquired Mepha, a pharmaceutical company. LOAD-DATE: June 30, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 39 of 998 DOCUMENTS The Irish Times May 17, 2011 Tuesday Student abuse of wakefulness drug leads to restrictions BYLINE: DR MUIRIS HOUSTON SECTION: HEALTH; Health News; Pg. 2 LENGTH: 417 words DOCTORS HAVE been warned to severely restrict their use of a wakefulness promoting drug with a history of abuse by students seeking to boost exam performance because of new concerns about its safety. In its latest Drug Safety newsletter, the Irish Medicines Board has advised prescribers that the drug Modafinil must no longer be used to treat excessive sleepiness associated with sleep apnoea (a condition where breathing stops during sleep), chronic shift work sleep disorder and other causes of hypersomnia. Modafinil, which is marketed under the trade name Provigil, may now only be prescribed for adults with excessive drowsiness due to narcolepsy. Although never sanctioned by global drugs regulators for short-term use by students preparing for exams or facing imminent project deadlines, there is some evidence that Modafinil has been used in this way. A 2009 survey of Cambridge University students found 10 per cent of students had said they used performance-enhancing drugs to help them study. In the US, it has been reported that up to 25 per cent of students at some US universities have been purchasing drugs such as Ritalin and Provigil in an effort to boost memory and concentration. A recent systematic review by German doctors found Modafinil improved attention for well-rested individuals, while maintaining wakefulness, memory and executive functions to a significantly higher degree in sleep-deprived individuals than did a placebo (dummy pill). However, repeated doses of Modafinil appeared to induce overconfidence in a person s own cognitive performance and the drug lost its potency as sleep deprivation increased. But the European Medicines Agency has carried out a safety review of the wakefulness drug and concluded that the risk-benefit balance was positive only for patients with the sleep disorder narcolepsy. It has also expressly forbidden the use of Modafinil in people up to the age of 18 and in patients with uncontrolled high blood pressure. It wants doctors to carry out an electrocardiogram of the heart before starting the drug and it wants those prescribed Modafinil to have their blood pressure and heart rate monitored regularly. The IMB advises that the drug must be used with caution in patients with a history of psychosis, depression or mania. It also wants doctors to review the treatment of patients taking Modafinil at their next routine appointment. Modafinil should be withdrawn in patients who experience skin reactions or psychiatric symptoms, the regulator says. LOAD-DATE: May 16, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 The Irish Times All Rights Reserved 40 of 998 DOCUMENTS The Irish Times May 17, 2011 Tuesday Waking up to the use and abuse of 'study drugs' in Irish colleges BYLINE: LOUISE HOLDEN SECTION: HEALTH; Your Health; Pg. 5 LENGTH: 833 words Will Irish students follow their US counterparts by using neuro-enhancing drugs in the run-up to exams? STUDY DRUGS are an established feature of American campus life and there is increasing evidence to suggest that pressured employees are using neuro-enhancing drugs to improve performance in the workplace. These drugs, which are prescribed to treat disorders such as ADHD and narcolepsy, have also been found to increase concentration and energy for specific tasks. American children who grew up on drug treatments for disorders such as ADHD are finding that when they reach third level, and beyond, their prescribed bottle of Ritalin or Adderall is a prized commodity. These drugs, as well as the narcolepsy treatment Modafinil, are now widely used off-label in the US, especially by students hoping to boost their study performance and employees seeking a competitive edge. All through college I took Ritalin in the weeks coming up to my exams. I would take a pill, stay up for 14 hours studying, then take another and sit the exam. Then I d sleep. It was common practice on campus, a recent graduate of the University of Mississippi told The Irish Times. This graduate would buy from other students who got prescribed Ritalin to treat symptoms of ADHD and sold them on for about $5 a pill. Is there any evidence that these drugs are being used in Irish universities or workplaces? Dr Ciara Kelly, a GP in Co Wicklow, believes that while there is likely to be some abuse of neuro-enhancing drugs in Ireland, it is on a very small scale. She cautions against patients experimenting with these drugs. In some users, Ritalin has been linked with anxiety, raised blood pressure and palpitations. There are probably users who boost their concentration and energy levels without any negative side effects, but for other users the effect could be disastrous, she says. Modafinil (often sold under the name Provigil) is another prescription drug that has found favour among students looking for an academic edge. Usually prescribed for people suffering from sleep apnoea or narcolepsy, the drug is reported to help the user stay awake, and on task, for long periods an obvious attraction for a hassled student counting down to exams. The perception among some students is that these drugs are harmless, but this week the Irish Medicines Board has issued a warning to GPs to severely restrict the prescription of Modafinil/Provigil to adult sufferers of narcolepsy. The IMB has warned that doctors should not prescribe the drug for excessive sleepiness, due to concerns about its safety. Both Modafinil and Ritalin/Adderall have been linked to increased blood pressure. Doctors have this week been warned to carry out electrocardiograms on patients prior to prescribing Modafinil. Another cause of concern is the potential interaction between these drugs and prescribed medications in users. Any substance that interferes with the binding of other drugs to proteins in the blood could make prescribed drugs, such as the contraceptive pill, less effective, says Orla Hardiman, consultant neurologist at the Beaumont Hospital in Dublin. However, she says that she has not come across incidents of off-label Ritalin or Modafinil use in Ireland. These drugs can cause seizures in students prone to epilepsy. If they were in wide use here, I would expect to be treating seizures as result. I am not. Dr Hardiman is not concerned about the issue in Ireland for the moment because, she says, these drugs are not widely available here. These are controlled substances and they are not easy to get, she says. However, given the routine use of these drugs in the US, and growing concerns about their impact in the UK, do we need to be watchful here? Gary Redmond of the Union of Students in Ireland does not believe there is widespread use of study drugs in Ireland, and has come across only a small number of incidents here. However, he is concerned about the level of stress that students are under, now that the jobs market is so small. He worries that the new economic reality might feed an appetite for drugs that are perceived to enhance academic performance. A couple of years ago final year students already had jobs lined up before graduating, says Redmond. Now they know they will be competing for a small pool of jobs, and with many planning to emigrate, they will be competing with the top students from international universities. Students are under unprecedented pressure to get top grades. Gary believes the best way to protect students against the creep of drug-enhanced study is to reform assessment practices at both second and third level. Final terminal exams that account for a large proportion of the overall grade are too stressful for students. This is an even bigger problem at Leaving Cert level, where students are also at risk from these types of drugs. We need to take a step back and look at new ways of assessing students that would make the abuse of study drugs less attractive. LOAD-DATE: May 16, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 The Irish Times All Rights Reserved 41 of 998 DOCUMENTS Drug Industry Daily May 2, 2011 Monday EC Launches Pay-For-Delay Investigation into Cephalon, Teva Over Provigil SECTION: Vol. 10 No. 86 LENGTH: 243 words The European Commission (EC) has launched an informal investigation into a potential pay-for-delay agreement between Cephalon and Teva Pharmaceutical regarding the narcolepsy treatment Provigil. The EC's ex officio investigation will examine a December 2005 patent dispute settlement and additional side deals between the companies to see if it hindered the entry of generic Provigil (modafinil) in Europe, which would breach an EU regulation on restrictive business practices. Under the settlement, Teva agreed to not sell generic modafinil before October 2012. There has been no finding that Cephalon's actions were improper and the EC is simply investigating, Natalie de Vane, a Cephalon spokeswoman, told DID. Cephalon is also under investigation from the FTC for an alleged pay-for-delay deal with Watson over Provigil (DID, Jan. 25). But Cephalon views the settlement with Teva and its conduct as entirely proper and intends to fully cooperate with the EC, de Vane said. She also pointed out the EC is examining the impact of patent settlements on competition. The EC has requested copies of patent-settlement agreements from some pharmaceutical companies to ensure generic medicines are not delayed from the market (DID, Jan. 18). The EC has become more forceful with pharmaceutical companies, such as raiding them for pay-for-delay agreement information, instead of requesting copies of such documents (DID, Dec. 6, 2010). -- Molly Cohen Release date: May 2, 2011 LOAD-DATE: May 2, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2011 Washington Business Information, Inc. All Rights Reserved 42 of 998 DOCUMENTS Europolitics (daily in English) May 2, 2011 Monday ANTI-TRUST POLICY : EU LAUNCHES PROBE INTO MODAFINIL DEAL BYLINE: Eric van Puyvelde SECTION: No. 4192 LENGTH: 289 words An agreement between the American pharmaceutical company Cephalon and Teva, an Israeli manufacturer of generic medicines, could prevent the arrival of the generic product Modafinil on the European Economic Area (EEA) market. On April 28, the European Commission opened an inquiry into this agreement, based on EU rules relating to restrictive commercial practises (Article 101). Modafinil is a medication used in the treatment of sleep problems. In December 2005, Cephalon and Teva resolved litigation relating to patents in the United Kingdom and the United States concerning Modafinil (commercial brand name Provigil®) via a friendly agreement, which saw Teva agreeing not to sell its product Modafinil on the EEA market before October 2012. A series of accessory agreements was included in the friendly accord, which is also the subject of a litigation procedure by the United States' anti-trust authority, the FTC, for abuse of a leading position on the market. In the last few years, the European Commission has been leading a drive against pharmaceutical laboratories suspected of impeding the arrival on the EU market of generic and less expensive versions of their star' medicines. In 2008 and 2009, the Commission carried out a huge inquiry into the sector, which resulted in the launch of legal proceedings against several companies: in July 2009, against the French company Servier, and a series of manufacturers of generic medicines, including Teva, suspected of working together to delay the commercialisation of certain generic medicines, and in January 2010 against the Danish group Lundbeck. In December 2010, the Commission carried out further inquiries into the sector, notably into the British company AstraZeneca. LOAD-DATE: April 29, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: EURE Copyright 2011 Europolitique All Rights Reserved 43 of 998 DOCUMENTS PharmaGossip April 29, 2011 Friday 11:05 AM EST Antitrust: Commission opens investigation against pharmaceutical companies Cephalon and Teva BYLINE: insider LENGTH: 744 words Apr. 29, 2011 (PharmaGossip delivered by Newstex) -- IP/11/511 Brussels, 28 April 2011 Antitrust: Commission opens investigation against pharmaceutical companies Cephalon and Teva The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European Economic Area. Modafinil is a medicine used for the treatment of certain types of sleeping disorders. The opening of proceedings does not mean that the Commission has conclusive proof of an infringement, only that it will investigate the case as a matter of priority. The Commission has started an ex officio investigation to assess an agreement between Cephalon, Inc. (NASDAQ:CEPH) and Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) that may have the object or effect of hindering the entry of generic Modafinil products in the markets of the European Economic Area. In particular it is assessed whether the agreement is in breach of the EU Treaty's rules on restrictive business practices (Article 101). In December 2005 Cephalon and Teva settled patent infringement disputes in the United Kingdom and the United States concerning Modafinil (brand name Provigil®). As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in the EEA markets before October 2012. A series of side deals were included into the settlement agreement, which is also subject to antitrust litigation in the United States initiated by the US antitrust authority FTC. The opening of proceedings does not mean that the Commission has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority. There is no legal deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of each case, the extent to which the undertakings concerned co-operate with the Commission and the exercise of the rights of defence. Background to antitrust investigations Article 101 of the Treaty on the Functioning of the EU prohibits agreements and concerted practices which may affect trade and prevent or restrict competition. The implementation of this provision is defined in the Antitrust Regulation (Council Regulation No 1/2003) which can be applied by the Commission and by the national competition authorities of EU Member States. Article 11(6) of the Antitrust Regulation provides that the initiation of proceedings by the Commission relieves the competition authorities of the Member States of their competence to also apply Articles 101 and 102 (ban on abuse of a dominant market position) to the practices concerned. Article 16(1) provides that national courts must avoid giving decisions which would conflict with a decision contemplated by the Commission in proceedings that it has initiated. The Commission has informed the parties and the competition authorities of the Member States, that it has opened proceedings in this case. Background on investigation of the pharma sector In 2008 and 2009 the Commission carried out a broad inquiry of the pharmaceutical sector. Among others, the inquiry pointed to significant risks for European consumers stemming from certain types of patent settlements between originator and generic companies aimed at delaying the arrival into the market of cheaper generic medicines (sometimes also referred to as "pay-for-delay" settlements). The Commission regularly monitors potentially problematic patent settlements. The second such monitoring exercise was launched in January and the results are expected before the summer break (see IP/10/887 and IP/11/40). The Commission has a number of ongoing individual investigations into suspected anti-competitive practice. In July 2010, the Commission took warmth from the confirmation, by the General Court, of the Commission's decision in the AstraZeneca case, which was its first abuse decision in the pharmaceutical sector. The company had misused the regulatory framework to prevent or, in the very least, delay the market entry of competing generic products, something that has now clearly been ruled as illegal. AstraZeneca (NYSE:AZN) has appealed the decision of the General Court. via europa.eu Posted via email from Jack's posterous Newstex ID: PHAG-0001-103327812 LOAD-DATE: April 29, 2011 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs on Demand® shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs on Demand®. Reader's comments reflect their individual opinion and their publication within Blogs on Demand® shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2011 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2011 PharmaGossip 44 of 998 DOCUMENTS Agence France Presse -- English April 28, 2011 Thursday 3:38 PM GMT EU opens anti-trust probe into stay-awake drug deal LENGTH: 346 words DATELINE: BRUSSELS, April 28 2011 European antitrust authorities announced Thursday the opening of a formal antitrust probe into US drugs company Cephalon and Israel-based generic drugs firm Teva over stay-awake drug Modafinil. The controversial anti-tiredness drug, marketed under the brand-name Provigil, can keep people awake for days and is normally used to treat the rare sleeping disorder narcolepsy. But it became popular among night-workers such as truckers and was even tested in its early days for military use. The probe concerns a deal struck between the two that "may have had the object or effect of hindering the entry of generic Modafinil" into the European Economic Area. The European Commission "has started an ex officio investigation to assess an agreement between Cephalon, Inc. and Teva Pharmaceutical Industries Ltd.," a statement said. A probe does not indicate "a definitive finding of an infringement," it stressed, but means it will be investigated as "a matter of priority," although there is no set deadline for an outcome. The case arises from a December 2005 deal to settle patent infringement disputes in Britain and the United States, which saw Teva undertake not to sell its generic Modafinil products in the European single market before October 2012. Side deals are also under investigation by US antitrust authorities. The EU has been probing the sector repeatedly since a report showed that the number of new drugs reaching the market annually had dropped by over a third since 2000 and that people were being deprived of innovative, affordable and safe medicine. Generic drugs are far cheaper -- the report said they cost on average 40 percent less two years after they enter the market -- and save patients and insurance firms money without compromising on effectiveness. Among initial tactics often used to hold up generic entry, drug developers were found to file multiple patent applications for the same medicine, leaving little scope for generics to be developed. In the worst example uncovered, 1,300 separate filings were made for a single medicine across the 27-nation EU. LOAD-DATE: April 29, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Agence France Presse All Rights Reserved 45 of 998 DOCUMENTS Kuwait News Agency (KUNA) April 28, 2011 Thursday EU probes US, Israeli firms for preventing entry of cheap generic drugs to LENGTH: 212 words The European Commission opened Thursday a formal investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European market. Modafinil is a medicine used for the treatment of certain types of sleeping disorders. In particular the probe will assess whether the agreement is in breach of the EU competition rules, said the EU's executive body in a statement. In December 2005, Cephalon and Teva settled patent infringement disputes in the United Kingdom and the United States concerning Modafinil (brand name Provigil). As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in the European markets before October 2012. EU rules prohibit agreements and practices which may affect trade and prevent or restrict competition. In 2008 and 2009, the European Commission carried out a broad inquiry of the pharmaceutical sector. Among others, the inquiry pointed to significant risks for European consumers stemming from certain types of patent settlements between originator and generic companies aimed at delaying the arrival into the market of cheaper generic medicines. LOAD-DATE: May 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire JOURNAL-CODE: 365 Copyright 2011 KUNA. All Rights Reserved Syndigate.info, Al Bawaba.com 46 of 998 DOCUMENTS M2 PressWIRE April 28, 2011 Thursday Antitrust: Commission opens investigation against pharmaceutical companies Cephalon and Teva LENGTH: 696 words April 28, 2011 Brussels --The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European Economic Area. Modafinil is a medicine used for the treatment of certain types of sleeping disorders. The opening of proceedings does not mean that the Commission has conclusive proof of an infringement, only that it will investigate the case as a matter of priority. The Commission has started an ex officio investigation to assess an agreement between Cephalon, Inc. and Teva Pharmaceutical Industries Ltd. that may have the object or effect of hindering the entry of generic Modafinil products in the markets of the European Economic Area. In particular it is assessed whether the agreement is in breach of the EU Treaty's rules on restrictive business practices (Article 101). In December 2005 Cephalon and Teva settled patent infringement disputes in the United Kingdom and the United States concerning Modafinil (brand name Provigil®). As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in the EEA markets before October 2012. A series of side deals were included into the settlement agreement, which is also subject to antitrust litigation in the United States initiated by the US antitrust authority FTC. The opening of proceedings does not mean that the Commission has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority. There is no legal deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of each case, the extent to which the undertakings concerned co-operate with the Commission and the exercise of the rights of defence. Background to antitrust investigations Article 101 of the Treaty on the Functioning of the EU prohibits agreements and concerted practices which may affect trade and prevent or restrict competition. The implementation of this provision is defined in the Antitrust Regulation (Council Regulation No 1/2003) which can be applied by the Commission and by the national competition authorities of EU Member States. Article 11(6) of the Antitrust Regulation provides that the initiation of proceedings by the Commission relieves the competition authorities of the Member States of their competence to also apply Articles 101 and 102 (ban on abuse of a dominant market position) to the practices concerned. Article 16(1) provides that national courts must avoid giving decisions which would conflict with a decision contemplated by the Commission in proceedings that it has initiated. The Commission has informed the parties and the competition authorities of the Member States, that it has opened proceedings in this case. Background on investigation of the pharma sector In 2008 and 2009 the Commission carried out a broad inquiry of the pharmaceutical sector. Among others, the inquiry pointed to significant risks for European consumers stemming from certain types of patent settlements between originator and generic companies aimed at delaying the arrival into the market of cheaper generic medicines (sometimes also referred to as "pay-for-delay" settlements). The Commission regularly monitors potentially problematic patent settlements. The second such monitoring exercise was launched in January and the results are expected before the summer break (see IP/10/887 and IP/11/40). The Commission has a number of ongoing individual investigations into suspected anti-competitive practice. In July 2010, the Commission took warmth from the confirmation, by the General Court, of the Commission's decision in the AstraZeneca case, which was its first abuse decision in the pharmaceutical sector. The company had misused the regulatory framework to prevent or, in the very least, delay the market entry of competing generic products, something that has now clearly been ruled as illegal. AstraZeneca has appealed the decision of the General Court. LOAD-DATE: April 28, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire JOURNAL-CODE: M2PW Copyright 2011 Normans Media Limited All Rights Reserved 47 of 998 DOCUMENTS States News Service April 28, 2011 Thursday ANTITRUST: COMMISSION OPENS INVESTIGATION AGAINST PHARMACEUTICAL COMPANIES CEPHALON AND TEVA BYLINE: States News Service LENGTH: 699 words DATELINE: BRUSSELS The following information was released by the European Union: The European Commission has opened a formal antitrust investigation to assess whether an agreement between US-based pharmaceutical company Cephalon and Israel-based generic drugs firm Teva may have had the object or effect of hindering the entry of generic Modafinil in the European Economic Area. Modafinil is a medicine used for the treatment of certain types of sleeping disorders. The opening of proceedings does not mean that the Commission has conclusive proof of an infringement, only that it will investigate the case as a matter of priority. The Commission has started an ex officio investigation to assess an agreement between Cephalon, Inc. and Teva Pharmaceutical Industries Ltd. that may have the object or effect of hindering the entry of generic Modafinil products in the markets of the European Economic Area. In particular it is assessed whether the agreement is in breach of the EU Treaty's rules on restrictive business practices (Article 101). In December 2005 Cephalon and Teva settled patent infringement disputes in the United Kingdom and the United States concerning Modafinil (brand name Provigil). As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in the EEA markets before October 2012. A series of side deals were included into the settlement agreement, which is also subject to antitrust litigation in the United States initiated by the US antitrust authority FTC. The opening of proceedings does not mean that the Commission has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority. There is no legal deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of each case, the extent to which the undertakings concerned co-operate with the Commission and the exercise of the rights of defence. Background to antitrust investigations Article 101 of the Treaty on the Functioning of the EU prohibits agreements and concerted practices which may affect trade and prevent or restrict competition. The implementation of this provision is defined in the Antitrust Regulation (Council Regulation No 1/2003) which can be applied by the Commission and by the national competition authorities of EU Member States. Article 11(6) of the Antitrust Regulation provides that the initiation of proceedings by the Commission relieves the competition authorities of the Member States of their competence to also apply Articles 101 and 102 (ban on abuse of a dominant market position) to the practices concerned. Article 16(1) provides that national courts must avoid giving decisions which would conflict with a decision contemplated by the Commission in proceedings that it has initiated. The Commission has informed the parties and the competition authorities of the Member States, that it has opened proceedings in this case. Background on investigation of the pharma sector In 2008 and 2009 the Commission carried out a broad inquiry of the pharmaceutical sector. Among others, the inquiry pointed to significant risks for European consumers stemming from certain types of patent settlements between originator and generic companies aimed at delaying the arrival into the market of cheaper generic medicines (sometimes also referred to as "pay-for-delay" settlements). The Commission regularly monitors potentially problematic patent settlements. The second such monitoring exercise was launched in January and the results are expected before the summer break (see IP/10/887 and IP/11/40). The Commission has a number of ongoing individual investigations into suspected anti-competitive practice. In July 2010, the Commission took warmth from the confirmation, by the General Court, of the Commission's decision in the AstraZeneca case, which was its first abuse decision in the pharmaceutical sector. The company had misused the regulatory framework to prevent or, in the very least, delay the market entry of competing generic products, something that has now clearly been ruled as illegal. AstraZeneca has appealed the decision of the General Court. LOAD-DATE: April 28, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 States News Service 48 of 998 DOCUMENTS Xinhua General News Service April 28, 2011 Thursday 4:27 PM EST EU launches antitrust probe into Cephalon, Teva SECTION: WORLD NEWS; Political LENGTH: 162 words DATELINE: BRUSSELS April 28 The European Union (EU) antitrust regulator said on Thursday it had launched a probe into pharmaceutical companies Cephalon and Teva for possible collusion to keep a generic drug out of the EU market. The U.S.-based Cephalon and Israel-based Teva, the two leading generic drugs makers in the world, in December 2005 settled patent infringement disputes in Britain and the United States concerning Modafinil, a sleep-disorder drug with brand name Provigil. As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in European markets before October 2012. The investigation is to assess whether the agreement "may have had the object or effect of hindering the entry of generic Modafinil," the European Commission said. The commission said the opening of proceedings does not mean that it has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority. LOAD-DATE: April 29, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Xinhua News Agency 49 of 998 DOCUMENTS Xinhua General News Service April 28, 2011 Thursday 1:20 AM EST EU launches antitrust probe into Cephalon, Teva SECTION: WORLD NEWS; Political LENGTH: 162 words DATELINE: BRUSSELS April 28 The European Union (EU) antitrust regulator said on Thursday it had launched a probe into pharmaceutical companies Cephalon and Teva for possible collusion to keep a generic drug out of the EU market. The U.S.-based Cephalon and Israel-based Teva, the two leading generic drugs makers in the world, in December 2005 settled patent infringement disputes in Britain and the United States concerning Modafinil, a sleep-disorder drug with brand name Provigil. As part of the settlement agreement Teva undertook not to sell its generic Modafinil products in European markets before October 2012. The investigation is to assess whether the agreement "may have had the object or effect of hindering the entry of generic Modafinil," the European Commission said. The commission said the opening of proceedings does not mean that it has a definitive finding of an infringement, but indicates that it will investigate the case as a matter of priority. LOAD-DATE: April 30, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Xinhua News Agency 50 of 998 DOCUMENTS The Pharmaceutical Journal February 23, 2011 Wednesday Modafinil's indications restricted LENGTH: 256 words Modafinil (Provigil) has had its licensed indications restricted and can now only be used to treat excessive sleepiness in adult patients with narcolepsy. The drug is no longer licensed for treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and moderate to severe chronic shift work sleep disorder. The move follows an assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which has concluded that the benefit/risk profile for modafinil is no longer favourable for these conditions. Cephalon (UK) Ltd, the company that markets Provigil, has written to healthcare professionals in the UK advising them of the change. In its letter the company explains that safety concerns, including psychiatric and serious skin reactions and the potential for cardiovascular adverse effects are now considered to outweigh the limited benefits of modafinil in obstructive sleep apnoea and chronic shift work sleep disorder. As well as restricting modafinil's indications, the CHMP has concluded that it should not be used by children, pregnant or lactating women or by patients with uncontrolled hypertension or cardiac arrhythmias. It also recommends that the starting daily dose is 200mg and that the drug is used with caution in patients with a history of psychosis, depression or mania, or substance abuse. Cephalon says there is no need for patients to stop treatment immediately but that they should have their treatment reviewed at their next routine appointment. LOAD-DATE: February 23, 2011 Wednesday LANGUAGE: ENGLISH PUBLICATION-TYPE: Journal Copyright 2011 PJ Online All Rights Reserved 51 of 998 DOCUMENTS The Associated Press February 18, 2011 Friday 01:58 PM GMT Turkish team to sue lab for Taurasi doping report BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 462 words DATELINE: ANKARA, Turkey Diana Taurasi's Turkish club demanded an apology Friday and the resignation of the directors of the doping lab that issued an apparent "false positive" report on the American basketball player. Fenerbahce also said it would take legal action. Sekip Mosturoglu, a member of Fenerbahce's executive board, accused the Ankara-based lab of "inadequacies" and said its report declaring Taurasi's "A" and "B" samples positive for the banned stimulant modafinil had sullied both the reputation of both the WNBA star and Fenerbahce. "This is the greatest scandal in world sports," Mosturoglu said. "They cannot get away with simple apologies." Fenerbahce terminated Taurasi's contract after she tested positive following a Nov. 13 league game. The Turkish Basketball Federation subsequently suspended her from play but lifted the suspension Wednesday. Mosturoglu said Taurasi's absence had put Fenerbahce's chances to win the Euroleague at "risk." He also faulted some Turkish Basketball Federation officials for refusing to allow Taurasi's "B" sample to be tested at another lab and demanded their resignations, too. "Our club will take every kind of legal action to the compensation of our losses," Mosturoglu said. Taurasi insisted all along that she never used performance-enhancing drugs. The 28-year-old American will be able to compete at the 2012 Olympics now that she has been cleared of the doping charges. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Mosturoglu said Fenerbahce would work hard to convince Taurasi and teammate Penny Taylor to return. Taylor left Fenerbahce in a show of solidarity with Taurasi. But Taurasi, who plans to return to the WNBA when the season begins in June, told The Associated Press on Wednesday that her return to the Turkish league was "pretty unlikely." Nevertheless, thousands of Turkish fans urged the star to come back, posting messages on the specially-created comebackdiana.com website. The World Anti-Doping Agency, which can suspend or revoke the accreditation for doping labs, said it has asked the lab to explain why it declared Taurasi positive for modafinil. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara facility for three months in 2009 for failing to meet international standards. Mosturoglu said the lab had accepted its mistake only after an international drug-testing expert looking into the Taurasi case pointed out the lab's error. The federation this week also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out at the same lab. Associated Press Writer Selcan Hacaoglu contributed to this report. LOAD-DATE: February 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 52 of 998 DOCUMENTS Associated Press Worldstream February 18, 2011 Friday 1:51 PM GMT Fenerbahce to sue lab for Taurasi doping report BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 469 words DATELINE: ANKARA Turkey Diana Taurasi's Turkish club demanded an apology Friday and the resignation of the directors of the local doping lab that issued an apparent "false positive" report on the American basketball player. Fenerbahce also said it would take legal action against those responsible. Sekip Mosturoglu, a member of Fenerbahce's executive board, accused the Ankara-based lab of "inadequacies" and said its report declaring Taurasi's "A" and "B" samples positive for the banned stimulant modafinil had sullied both the reputation of both the WNBA star and Fenerbahce. "This is the greatest scandal in world sports," Mosturoglu said. "They cannot get away with simple apologies." Fenerbahce terminated Taurasi's contract after she tested positive following a Nov. 13 league game. The Turkish Basketball Federation subsequently suspended her from play but lifted the suspension Wednesday. Mosturoglu said Taurasi's absence had put Fenerbahce's chances to win the Euroleague at "risk." He also faulted some Turkish Basketball Federation officials for refusing to allow Taurasi's "B" sample to be tested at another lab and demanded their resignations, too. "Our club will take every kind of legal action to the compensation of our losses," Mosturoglu said. Taurasi insisted all along that she never used performance-enhancing drugs. The 28-year-old American will be able to compete at the 2012 Olympics now that she has been cleared of the doping charges. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Mosturoglu said Fenerbahce would work hard to convince Taurasi and teammate Penny Taylor to return. Taylor left Fenerbahce in a show of solidarity with Taurasi. But Taurasi, who plans to return to the WNBA when the season begins in June, told The Associated Press on Wednesday that her return to the Turkish league was "pretty unlikely." Nevertheless, thousands of Turkish fans urged the star to come back, posting messages on the specially-created comebackdiana.com website. The World Anti-Doping Agency, which can suspend or revoke the accreditation for doping labs, said it has asked the Ankara lab to explain why it declared Taurasi positive for modafinil. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara facility for three months in 2009 for failing to meet international standards. Mosturoglu said the lab had accepted its mistake only after an international drug-testing expert looking into the Taurasi case pointed out the lab's error. The federation this week also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out at the same lab. Associated Press writer Selcan Hacaoglu contributed to this report. LOAD-DATE: February 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 53 of 998 DOCUMENTS Associated Press Online February 18, 2011 Friday 1:58 PM GMT Turkish team to sue lab for Taurasi doping report BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 462 words DATELINE: ANKARA Turkey Diana Taurasi's Turkish club demanded an apology Friday and the resignation of the directors of the doping lab that issued an apparent "false positive" report on the American basketball player. Fenerbahce also said it would take legal action. Sekip Mosturoglu, a member of Fenerbahce's executive board, accused the Ankara-based lab of "inadequacies" and said its report declaring Taurasi's "A" and "B" samples positive for the banned stimulant modafinil had sullied both the reputation of both the WNBA star and Fenerbahce. "This is the greatest scandal in world sports," Mosturoglu said. "They cannot get away with simple apologies." Fenerbahce terminated Taurasi's contract after she tested positive following a Nov. 13 league game. The Turkish Basketball Federation subsequently suspended her from play but lifted the suspension Wednesday. Mosturoglu said Taurasi's absence had put Fenerbahce's chances to win the Euroleague at "risk." He also faulted some Turkish Basketball Federation officials for refusing to allow Taurasi's "B" sample to be tested at another lab and demanded their resignations, too. "Our club will take every kind of legal action to the compensation of our losses," Mosturoglu said. Taurasi insisted all along that she never used performance-enhancing drugs. The 28-year-old American will be able to compete at the 2012 Olympics now that she has been cleared of the doping charges. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Mosturoglu said Fenerbahce would work hard to convince Taurasi and teammate Penny Taylor to return. Taylor left Fenerbahce in a show of solidarity with Taurasi. But Taurasi, who plans to return to the WNBA when the season begins in June, told The Associated Press on Wednesday that her return to the Turkish league was "pretty unlikely." Nevertheless, thousands of Turkish fans urged the star to come back, posting messages on the specially-created comebackdiana.com website. The World Anti-Doping Agency, which can suspend or revoke the accreditation for doping labs, said it has asked the lab to explain why it declared Taurasi positive for modafinil. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara facility for three months in 2009 for failing to meet international standards. Mosturoglu said the lab had accepted its mistake only after an international drug-testing expert looking into the Taurasi case pointed out the lab's error. The federation this week also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out at the same lab. Associated Press Writer Selcan Hacaoglu contributed to this report. LOAD-DATE: February 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 54 of 998 DOCUMENTS The Associated Press State & Local Wire February 18, 2011 Friday 1:58 PM GMT Turkish team to sue lab for Taurasi doping report BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 462 words DATELINE: ANKARA Turkey Diana Taurasi's Turkish club demanded an apology Friday and the resignation of the directors of the doping lab that issued an apparent "false positive" report on the American basketball player. Fenerbahce also said it would take legal action. Sekip Mosturoglu, a member of Fenerbahce's executive board, accused the Ankara-based lab of "inadequacies" and said its report declaring Taurasi's "A" and "B" samples positive for the banned stimulant modafinil had sullied both the reputation of both the WNBA star and Fenerbahce. "This is the greatest scandal in world sports," Mosturoglu said. "They cannot get away with simple apologies." Fenerbahce terminated Taurasi's contract after she tested positive following a Nov. 13 league game. The Turkish Basketball Federation subsequently suspended her from play but lifted the suspension Wednesday. Mosturoglu said Taurasi's absence had put Fenerbahce's chances to win the Euroleague at "risk." He also faulted some Turkish Basketball Federation officials for refusing to allow Taurasi's "B" sample to be tested at another lab and demanded their resignations, too. "Our club will take every kind of legal action to the compensation of our losses," Mosturoglu said. Taurasi insisted all along that she never used performance-enhancing drugs. The 28-year-old American will be able to compete at the 2012 Olympics now that she has been cleared of the doping charges. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Mosturoglu said Fenerbahce would work hard to convince Taurasi and teammate Penny Taylor to return. Taylor left Fenerbahce in a show of solidarity with Taurasi. But Taurasi, who plans to return to the WNBA when the season begins in June, told The Associated Press on Wednesday that her return to the Turkish league was "pretty unlikely." Nevertheless, thousands of Turkish fans urged the star to come back, posting messages on the specially-created comebackdiana.com website. The World Anti-Doping Agency, which can suspend or revoke the accreditation for doping labs, said it has asked the lab to explain why it declared Taurasi positive for modafinil. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara facility for three months in 2009 for failing to meet international standards. Mosturoglu said the lab had accepted its mistake only after an international drug-testing expert looking into the Taurasi case pointed out the lab's error. The federation this week also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out at the same lab. Associated Press Writer Selcan Hacaoglu contributed to this report. LOAD-DATE: February 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 55 of 998 DOCUMENTS The Associated Press State & Local Wire February 18, 2011 Friday 1:58 PM GMT LENGTH: 507 words BC-BKL--Doping-Taurasi, 1st Ld-Writethru,0657 Turkish team to sue lab for Taurasi doping report 2030 Eds: Updates with details; adds byline. AP Photo NY150, NY161 sptd/rrosenblatt elfd/lon/clehourites fasst4922 fasst4921 By SUZAN FRASER Associated Press ANKARA, Turkey (AP) Diana Taurasi's Turkish club demanded an apology Friday and the resignation of the directors of the doping lab that issued an apparent "false positive" report on the American basketball player. Fenerbahce also said it would take legal action. Sekip Mosturoglu, a member of Fenerbahce's executive board, accused the Ankara-based lab of "inadequacies" and said its report declaring Taurasi's "A" and "B" samples positive for the banned stimulant modafinil had sullied both the reputation of both the WNBA star and Fenerbahce. "This is the greatest scandal in world sports," Mosturoglu said. "They cannot get away with simple apologies." Fenerbahce terminated Taurasi's contract after she tested positive following a Nov. 13 league game. The Turkish Basketball Federation subsequently suspended her from play but lifted the suspension Wednesday. Mosturoglu said Taurasi's absence had put Fenerbahce's chances to win the Euroleague at "risk." He also faulted some Turkish Basketball Federation officials for refusing to allow Taurasi's "B" sample to be tested at another lab and demanded their resignations, too. "Our club will take every kind of legal action to the compensation of our losses," Mosturoglu said. Taurasi insisted all along that she never used performance-enhancing drugs. The 28-year-old American will be able to compete at the 2012 Olympics now that she has been cleared of the doping charges. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Mosturoglu said Fenerbahce would work hard to convince Taurasi and teammate Penny Taylor to return. Taylor left Fenerbahce in a show of solidarity with Taurasi. But Taurasi, who plans to return to the WNBA when the season begins in June, told The Associated Press on Wednesday that her return to the Turkish league was "pretty unlikely." Nevertheless, thousands of Turkish fans urged the star to come back, posting messages on the specially-created comebackdiana.com website. The World Anti-Doping Agency, which can suspend or revoke the accreditation for doping labs, said it has asked the lab to explain why it declared Taurasi positive for modafinil. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara facility for three months in 2009 for failing to meet international standards. Mosturoglu said the lab had accepted its mistake only after an international drug-testing expert looking into the Taurasi case pointed out the lab's error. The federation this week also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out at the same lab. Associated Press Writer Selcan Hacaoglu contributed to this report. LOAD-DATE: February 19, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 56 of 998 DOCUMENTS The Associated Press February 17, 2011 Thursday 05:48 PM GMT WADA could suspend Turkish lab in Taurasi case BYLINE: By STEPHEN WILSON, AP Sports Writer SECTION: SPORTS NEWS LENGTH: 732 words DATELINE: LONDON The World Anti-Doping Agency could suspend the Turkish drug-testing laboratory that reported an apparent "false positive" for American basketball star Diana Taurasi. WADA director general David Howman told The Associated Press on Thursday the agency has asked the Ankara lab to explain why it declared Taurasi's samples positive for the banned stimulant modafinil, a decision which led to her contract being terminated by her Turkish club. "We are still awaiting all the information from the laboratory," Howman said. "It appears that it was a false positive. In any of those cases we need to review all the data to determine whether any steps need to be taken, including any steps against the laboratory." WADA can suspend and revoke the accreditation of doping labs. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara center for three months in 2009 for failing to meet international standards. "Anything which goes wrong has to be a worry," Howman said. "That's why we have to investigate it pretty thoroughly. The reputation of the athlete who's been aggrieved is pretty important, too, and that has to be acknowledged." The Turkish lab reported that Taurasi's "A" and "B" samples both tested positive for modafinil following a Turkish league game on Nov. 13. Her club, Fenerbahce, terminated her contract last month and she was suspended by the Turkish Basketball Federation. The federation lifted the suspension Wednesday, saying the lab retracted its positive finding after it "evaluated" Taurasi's statements in her defense. The federation also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out by the same lab. False positives are rare in international drug testing. "We have more of an issue with false negatives," Howman said. The WADA-accredited lab in Malaysia was suspended for false positives last year. The lab is appealing the decision to the Court of Arbitration for Sport. "There is a process that has to be followed, including the gathering of all the data," Howman said in a telephone interview from Montreal. "If it's sufficiently bad, then the lab should go to a disciplinary panel and have a hearing. They've got a right to put every excuse and reasoning before the panel." Taurasi insisted all along that she never used performance-enhancing drugs. "It's really good that the facts came out and the truth came out," Taurasi told the AP on Wednesday. "Life can throw you curveballs at any given time. I can be mad and angry, but I will move forward." The 28-year-old Taurasi intends to return to the WNBA when the season begins in June. The Mercury guard has led the U.S. league in scoring the last four seasons. She is also now eligible to compete for the U.S. at the 2012 London Olympics. The Turkish Doping Control Center at the Hacettepe University declined to comment on the case Thursday. But the HaberTurk newspaper quoted Ugur Erdener, dean of the university, as admitting the lab made a mistake. "There are two evaluations to analyze the test results and the average of them is taken. The (lab) officials' evaluation was based on one data. However, the average should have been taken as the base," Erdener was quoted as saying. Fenerbahce President Aziz Yildirim met Turkey's Prime Minister Recep Tayyip Erdogan to discuss the case Thursday. No statement was made after the meeting but Ali Koc, a club official, denied reports that Fenerbahce asked authorities to shut down the doping lab. Turgay Demirel, president of the Turkish Basketball Federation, said two soccer players were also cleared of doping after the lab retracted its reports about them. "It is very sad for our country that an institution accredited to WADA committed such a huge mistake," he said. "Both Turkey, Turkish sports and Turkish basketball could pay a fairly high price for this. Sportsmen and federations or clubs in their countries and even us could file compensation suits against this institution." Demirel said about 3,500 doping tests have been carried out annually in Turkey, with most analyzed by the Ankara lab. "From now on, I don't think the certificate of Hacettepe University can remain valid," Demirel said. "But we will have to use centers in Lisbon, Cologne or maybe Athens." Associated Press writer Selcan Hacaoglu in Ankara contributed to this report. LOAD-DATE: February 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 57 of 998 DOCUMENTS The Houston Chronicle February 17, 2011 Thursday 3 STAR EDITION Taurasi cleared of doping charge WNBA star will be eligible for 2012 Games BYLINE: CHRONICLE NEWS SERVICES SECTION: SPORTS; Pg. 2 LENGTH: 330 words Diana Taurasi was always confident she would be cleared of doping allegations. It finally happened on Wednesday. Taurasi had her provisional suspension lifted by the Turkish Basketball Federation, which said the lab that returned a positive test retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. "I got the news this morning at 5 a.m. and was in shock," Taurasi told the Associated Press by phone from her Phoenix home. "It was kind of like the first time when I heard the test result had come back positive. It's really good that the facts came out and the truth came out." Taurasi had insisted that she never used performance-enhancing drugs, even though she had her contract terminated by Turkish club Fenerbahce last month. The lab that tested her sample said the results came back positive for the stimulant modafinil. "Life can throw you curveballs at any given time," said Taurasi, who will also be able to compete in the 2012 Olympics. "I can be mad and angry, but I will move forward ." With the lifting of the suspension, Taurasi is free to continue playing in the Turkish basketball league, although she doesn't plan on going back there. "That's pretty unlikely," the 28-year-old WNBA star said. "I'm here in Phoenix working out and am more focused on getting myself in the best shape of my life and going from there." She intends to return to the WNBA when the season begins in June. The Mercury guard has led the league in scoring the last four seasons and signed a multiyear extension last August. Fenerbahce had terminated Taurasi's contract after the lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH GRAPHIC: ROSS D. FRANKLIN: AP REVERSAL: After months of uncertainty, Diana Taurasi received good news from the Turkish Basketball Federation. PUBLICATION-TYPE: Newspaper Copyright 2011 The Houston Chronicle Publishing Company All Rights Reserved 58 of 998 DOCUMENTS Associated Press Worldstream February 17, 2011 Thursday 5:25 PM GMT WADA could suspend Turkish lab in Taurasi case BYLINE: By STEPHEN WILSON, AP Sports Writer SECTION: SPORTS NEWS LENGTH: 733 words DATELINE: LONDON The World Anti-Doping Agency could suspend the Turkish drug-testing laboratory that reported an apparent "false positive" for American basketball star Diana Taurasi. WADA director general David Howman told The Associated Press on Thursday the agency has asked the Ankara lab to explain why it declared Taurasi's samples positive for the banned stimulant modafinil, a decision which led to her contract being terminated by her Turkish club. "We are still awaiting all the information from the laboratory," Howman said. "It appears that it was a false positive. In any of those cases we need to review all the data to determine whether any steps need to be taken, including any steps against the laboratory." WADA can suspend and revoke the accreditation of doping labs. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara center for three months in 2009 for failing to meet international standards. "Anything which goes wrong has to be a worry," Howman said. "That's why we have to investigate it pretty thoroughly. The reputation of the athlete who's been aggrieved is pretty important, too, and that has to be acknowledged." The Turkish lab reported that Taurasi's "A" and "B" samples both tested positive for modafinil following a Turkish league game on Nov. 13. Her club, Fenerbahce, terminated her contract last month and she was suspended by the Turkish Basketball Federation. The federation lifted the suspension Wednesday, saying the lab retracted its positive finding after it "evaluated" Taurasi's statements in her defense. The federation also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out by the same lab. False positives are rare in international drug testing. "We have more of an issue with false negatives," Howman said. The WADA-accredited lab in Malaysia was suspended for false positives last year. The lab is appealing the decision to the Court of Arbitration for Sport. "There is a process that has to be followed, including the gathering of all the data," Howman said in a telephone interview from Montreal. "If it's sufficiently bad, then the lab should go to a disciplinary panel and have a hearing. They've got a right to put every excuse and reasoning before the panel." Taurasi insisted all along that she never used performance-enhancing drugs. "It's really good that the facts came out and the truth came out," Taurasi told the AP on Wednesday. "Life can throw you curveballs at any given time. I can be made and angry, but I will move forward." The 28-year-old Taurasi intends to return to the WNBA when the season begins in June. The Mercury guard has led the U.S. league in scoring the last four seasons. She is also now eligible to compete for the U.S. at the 2012 London Olympics. The Turkish Doping Control Center at the Hacettepe University declined to comment on the case Thursday. But the HaberTurk newspaper quoted Ugur Erdener, dean of the university, as admitting the lab made a mistake. "There are two evaluations to analyze the test results and the average of them is taken. The (lab) officials' evaluation was based on one data. However, the average should have been taken as the base," Erdener was quoted as saying. Fenerbahce President Aziz Yildirim met Turkey's Prime Minister Recep Tayyip Erdogan to discuss the case Thursday. No statement was made after the meeting but Ali Koc, a club official, denied reports that Fenerbahce asked authorities to shut down the doping lab. Turgay Demirel, president of the Turkish Basketball Federation, said two football players were also cleared of doping after the lab retracted its reports about them. "It is very sad for our country that an institution accredited to WADA committed such a huge mistake," he said. "Both Turkey, Turkish sports and Turkish basketball could pay a fairly high price for this. Sportsmen and federations or clubs in their countries and even us could file compensation suits against this institution." Demirel said about 3,500 doping tests have been carried out annually in Turkey, with most analyzed by the Ankara lab. "From now on, I don't think the certificate of Hacettepe University can remain valid," Demirel said. "But we will have to use centers in Lisbon, Cologne or maybe Athens." Associated Press writer Selcan Hacaoglu in Ankara contributed to this report. LOAD-DATE: February 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 59 of 998 DOCUMENTS Associated Press Online February 17, 2011 Thursday 5:48 PM GMT WADA could suspend Turkish lab in Taurasi case BYLINE: By STEPHEN WILSON, AP Sports Writer SECTION: SPORTS NEWS LENGTH: 732 words DATELINE: LONDON The World Anti-Doping Agency could suspend the Turkish drug-testing laboratory that reported an apparent "false positive" for American basketball star Diana Taurasi. WADA director general David Howman told The Associated Press on Thursday the agency has asked the Ankara lab to explain why it declared Taurasi's samples positive for the banned stimulant modafinil, a decision which led to her contract being terminated by her Turkish club. "We are still awaiting all the information from the laboratory," Howman said. "It appears that it was a false positive. In any of those cases we need to review all the data to determine whether any steps need to be taken, including any steps against the laboratory." WADA can suspend and revoke the accreditation of doping labs. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara center for three months in 2009 for failing to meet international standards. "Anything which goes wrong has to be a worry," Howman said. "That's why we have to investigate it pretty thoroughly. The reputation of the athlete who's been aggrieved is pretty important, too, and that has to be acknowledged." The Turkish lab reported that Taurasi's "A" and "B" samples both tested positive for modafinil following a Turkish league game on Nov. 13. Her club, Fenerbahce, terminated her contract last month and she was suspended by the Turkish Basketball Federation. The federation lifted the suspension Wednesday, saying the lab retracted its positive finding after it "evaluated" Taurasi's statements in her defense. The federation also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out by the same lab. False positives are rare in international drug testing. "We have more of an issue with false negatives," Howman said. The WADA-accredited lab in Malaysia was suspended for false positives last year. The lab is appealing the decision to the Court of Arbitration for Sport. "There is a process that has to be followed, including the gathering of all the data," Howman said in a telephone interview from Montreal. "If it's sufficiently bad, then the lab should go to a disciplinary panel and have a hearing. They've got a right to put every excuse and reasoning before the panel." Taurasi insisted all along that she never used performance-enhancing drugs. "It's really good that the facts came out and the truth came out," Taurasi told the AP on Wednesday. "Life can throw you curveballs at any given time. I can be mad and angry, but I will move forward." The 28-year-old Taurasi intends to return to the WNBA when the season begins in June. The Mercury guard has led the U.S. league in scoring the last four seasons. She is also now eligible to compete for the U.S. at the 2012 London Olympics. The Turkish Doping Control Center at the Hacettepe University declined to comment on the case Thursday. But the HaberTurk newspaper quoted Ugur Erdener, dean of the university, as admitting the lab made a mistake. "There are two evaluations to analyze the test results and the average of them is taken. The (lab) officials' evaluation was based on one data. However, the average should have been taken as the base," Erdener was quoted as saying. Fenerbahce President Aziz Yildirim met Turkey's Prime Minister Recep Tayyip Erdogan to discuss the case Thursday. No statement was made after the meeting but Ali Koc, a club official, denied reports that Fenerbahce asked authorities to shut down the doping lab. Turgay Demirel, president of the Turkish Basketball Federation, said two soccer players were also cleared of doping after the lab retracted its reports about them. "It is very sad for our country that an institution accredited to WADA committed such a huge mistake," he said. "Both Turkey, Turkish sports and Turkish basketball could pay a fairly high price for this. Sportsmen and federations or clubs in their countries and even us could file compensation suits against this institution." Demirel said about 3,500 doping tests have been carried out annually in Turkey, with most analyzed by the Ankara lab. "From now on, I don't think the certificate of Hacettepe University can remain valid," Demirel said. "But we will have to use centers in Lisbon, Cologne or maybe Athens." Associated Press writer Selcan Hacaoglu in Ankara contributed to this report. LOAD-DATE: February 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 60 of 998 DOCUMENTS The Associated Press State & Local Wire February 17, 2011 Thursday 5:48 PM GMT WADA could suspend Turkish lab in Taurasi case BYLINE: By STEPHEN WILSON, AP Sports Writer SECTION: SPORTS NEWS LENGTH: 732 words DATELINE: LONDON The World Anti-Doping Agency could suspend the Turkish drug-testing laboratory that reported an apparent "false positive" for American basketball star Diana Taurasi. WADA director general David Howman told The Associated Press on Thursday the agency has asked the Ankara lab to explain why it declared Taurasi's samples positive for the banned stimulant modafinil, a decision which led to her contract being terminated by her Turkish club. "We are still awaiting all the information from the laboratory," Howman said. "It appears that it was a false positive. In any of those cases we need to review all the data to determine whether any steps need to be taken, including any steps against the laboratory." WADA can suspend and revoke the accreditation of doping labs. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara center for three months in 2009 for failing to meet international standards. "Anything which goes wrong has to be a worry," Howman said. "That's why we have to investigate it pretty thoroughly. The reputation of the athlete who's been aggrieved is pretty important, too, and that has to be acknowledged." The Turkish lab reported that Taurasi's "A" and "B" samples both tested positive for modafinil following a Turkish league game on Nov. 13. Her club, Fenerbahce, terminated her contract last month and she was suspended by the Turkish Basketball Federation. The federation lifted the suspension Wednesday, saying the lab retracted its positive finding after it "evaluated" Taurasi's statements in her defense. The federation also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out by the same lab. False positives are rare in international drug testing. "We have more of an issue with false negatives," Howman said. The WADA-accredited lab in Malaysia was suspended for false positives last year. The lab is appealing the decision to the Court of Arbitration for Sport. "There is a process that has to be followed, including the gathering of all the data," Howman said in a telephone interview from Montreal. "If it's sufficiently bad, then the lab should go to a disciplinary panel and have a hearing. They've got a right to put every excuse and reasoning before the panel." Taurasi insisted all along that she never used performance-enhancing drugs. "It's really good that the facts came out and the truth came out," Taurasi told the AP on Wednesday. "Life can throw you curveballs at any given time. I can be mad and angry, but I will move forward." The 28-year-old Taurasi intends to return to the WNBA when the season begins in June. The Mercury guard has led the U.S. league in scoring the last four seasons. She is also now eligible to compete for the U.S. at the 2012 London Olympics. The Turkish Doping Control Center at the Hacettepe University declined to comment on the case Thursday. But the HaberTurk newspaper quoted Ugur Erdener, dean of the university, as admitting the lab made a mistake. "There are two evaluations to analyze the test results and the average of them is taken. The (lab) officials' evaluation was based on one data. However, the average should have been taken as the base," Erdener was quoted as saying. Fenerbahce President Aziz Yildirim met Turkey's Prime Minister Recep Tayyip Erdogan to discuss the case Thursday. No statement was made after the meeting but Ali Koc, a club official, denied reports that Fenerbahce asked authorities to shut down the doping lab. Turgay Demirel, president of the Turkish Basketball Federation, said two soccer players were also cleared of doping after the lab retracted its reports about them. "It is very sad for our country that an institution accredited to WADA committed such a huge mistake," he said. "Both Turkey, Turkish sports and Turkish basketball could pay a fairly high price for this. Sportsmen and federations or clubs in their countries and even us could file compensation suits against this institution." Demirel said about 3,500 doping tests have been carried out annually in Turkey, with most analyzed by the Ankara lab. "From now on, I don't think the certificate of Hacettepe University can remain valid," Demirel said. "But we will have to use centers in Lisbon, Cologne or maybe Athens." Associated Press writer Selcan Hacaoglu in Ankara contributed to this report. LOAD-DATE: February 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 61 of 998 DOCUMENTS The Associated Press State & Local Wire February 17, 2011 Thursday 5:48 PM GMT LENGTH: 775 words BC-BKL--WADA-Doping-Taurasi, 1st Ld-Writethru,0936 WADA could suspend Turkish lab in Taurasi case 2030 Eds: Updates with detail, quotes. AP Photo NY161, NY150 sptd/rrosenblatt elfd/lon/clehourites fasst4922 fasst4921 By STEPHEN WILSON AP Sports Writer LONDON (AP) The World Anti-Doping Agency could suspend the Turkish drug-testing laboratory that reported an apparent "false positive" for American basketball star Diana Taurasi. WADA director general David Howman told The Associated Press on Thursday the agency has asked the Ankara lab to explain why it declared Taurasi's samples positive for the banned stimulant modafinil, a decision which led to her contract being terminated by her Turkish club. "We are still awaiting all the information from the laboratory," Howman said. "It appears that it was a false positive. In any of those cases we need to review all the data to determine whether any steps need to be taken, including any steps against the laboratory." WADA can suspend and revoke the accreditation of doping labs. WADA, which has 35 accredited labs worldwide, previously suspended the Ankara center for three months in 2009 for failing to meet international standards. "Anything which goes wrong has to be a worry," Howman said. "That's why we have to investigate it pretty thoroughly. The reputation of the athlete who's been aggrieved is pretty important, too, and that has to be acknowledged." The Turkish lab reported that Taurasi's "A" and "B" samples both tested positive for modafinil following a Turkish league game on Nov. 13. Her club, Fenerbahce, terminated her contract last month and she was suspended by the Turkish Basketball Federation. The federation lifted the suspension Wednesday, saying the lab retracted its positive finding after it "evaluated" Taurasi's statements in her defense. The federation also lifted the provisional suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in tests carried out by the same lab. False positives are rare in international drug testing. "We have more of an issue with false negatives," Howman said. The WADA-accredited lab in Malaysia was suspended for false positives last year. The lab is appealing the decision to the Court of Arbitration for Sport. "There is a process that has to be followed, including the gathering of all the data," Howman said in a telephone interview from Montreal. "If it's sufficiently bad, then the lab should go to a disciplinary panel and have a hearing. They've got a right to put every excuse and reasoning before the panel." Taurasi insisted all along that she never used performance-enhancing drugs. "It's really good that the facts came out and the truth came out," Taurasi told the AP on Wednesday. "Life can throw you curveballs at any given time. I can be mad and angry, but I will move forward." The 28-year-old Taurasi intends to return to the WNBA when the season begins in June. The Mercury guard has led the U.S. league in scoring the last four seasons. She is also now eligible to compete for the U.S. at the 2012 London Olympics. The Turkish Doping Control Center at the Hacettepe University declined to comment on the case Thursday. But the HaberTurk newspaper quoted Ugur Erdener, dean of the university, as admitting the lab made a mistake. "There are two evaluations to analyze the test results and the average of them is taken. The (lab) officials' evaluation was based on one data. However, the average should have been taken as the base," Erdener was quoted as saying. Fenerbahce President Aziz Yildirim met Turkey's Prime Minister Recep Tayyip Erdogan to discuss the case Thursday. No statement was made after the meeting but Ali Koc, a club official, denied reports that Fenerbahce asked authorities to shut down the doping lab. Turgay Demirel, president of the Turkish Basketball Federation, said two soccer players were also cleared of doping after the lab retracted its reports about them. "It is very sad for our country that an institution accredited to WADA committed such a huge mistake," he said. "Both Turkey, Turkish sports and Turkish basketball could pay a fairly high price for this. Sportsmen and federations or clubs in their countries and even us could file compensation suits against this institution." Demirel said about 3,500 doping tests have been carried out annually in Turkey, with most analyzed by the Ankara lab. "From now on, I don't think the certificate of Hacettepe University can remain valid," Demirel said. "But we will have to use centers in Lisbon, Cologne or maybe Athens." Associated Press writer Selcan Hacaoglu in Ankara contributed to this report. LOAD-DATE: February 18, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 62 of 998 DOCUMENTS The Associated Press February 16, 2011 Wednesday 08:56 PM GMT Taurasi cleared of doping charges BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 702 words Diana Taurasi was always confident she would be cleared of doping allegations. It finally happened on Wednesday. Taurasi had her provisional suspension lifted by the Turkish Basketball Federation, which said the lab that returned a positive test retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. "I got the news this morning at 5 a.m. and was in shock," Taurasi told The Associated Press by phone from her Phoenix home. "It was kind of like the first time when I heard the test result had come back positive. It's really good that the facts came out and the truth came out." Taurasi had insisted that she never used performance-enhancing drugs, even though she had her contract terminated by Turkish club Fenerbahce last month. The lab that tested her sample had said the results came back positive for the stimulant modafinil. "Life can throw you curveballs at any given time," said Taurasi, who will also be able to compete in the 2012 Olympics. "I can be mad and angry, but I will move forward. Not everyone has the same financial resources I did. Hopefully this will let people know every process has holes and to wait for the facts to come out before making decisions." With the lifting of the suspension, Taurasi is also free to continue playing in the Turkish basketball league, although she doesn't plan on going back there anytime soon. "That's pretty unlikely," the 28-year-old WNBA star said. "I'm here in Phoenix working out and am more focused on getting myself in the best shape of my life and going from there." She intends to return to the WNBA when the season begins in June. The Mercury guard has led the league in scoring the last four seasons and signed a multiyear extension last August. The last two months haven't been easy for the former UConn star. Yet she kept her faith that she would be cleared. "I tried to handle it as best as possible," Taurasi said. "There might have been times in my own private moments when I was angry or questioned why me, but I am glad the truth came out. It's scary that our careers can be taken away from us." Taurasi was the first prominent WNBA player to test positive for a banned substance. Had she not been cleared, Taurasi could have missed the London Games, because the International Olympic Committee bars any athlete given a doping penalty of six months or more from competing. Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. "It's always great when the right result happens," Taurasi's lawyer Howard Jacobs said. "When it happens reasonably quickly it's even better." The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. "I was thrilled to read today's report that the precautionary ban on Diana had been lifted by the Turkish Federation," UConn and U.S. basketball coach Geno Auriemma said in a statement. "Throughout this entire ordeal, Dee maintained her innocence and for her to be exonerated makes me incredibly happy for her," Auriemma said. "I hope she can put this behind her and focus all her efforts on continuing to be the best player in the world." Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championship this past October. "We're delighted that Diana has been cleared and can now put this behind her and continue her remarkable basketball career," USA Basketball executive director Jim Tooley said in a statement. "She has been an exemplary member of numerous USA Basketball teams since 2000, and we look forward to her continued involvement with USA Basketball." Associated Press writers Selcan Hacaoglu and Suzan Fraser in Ankara contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 63 of 998 DOCUMENTS Associated Press Worldstream February 16, 2011 Wednesday 1:55 PM GMT Turkey lifts provisional doping ban on Taurasi BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 463 words DATELINE: ANKARA Turkey Turkey's basketball federation lifted American star Diana Taurasi's provisional doping suspension Wednesday after a lab retracted its finding that she tested positive. The Turkish Basketball Federation said the lab retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say outright if the lab had made a mistake. The federation said Taurasi was free to continue playing in the Turkish basketball league, a decision which is also likely to revive her chances of playing for the United States at the 2012 London Olympics. "The federation has decided to lift the precautionary ban imposed on player Diana Lorena Taurasi to prevent the club and the player from being aggrieved further," the Turkish body said in a statement. Taurasi, who has insisted that she never used performance-enhancing drugs, had her contract terminated by Turkish club Fenerbahce last month after the lab said she tested positive for modafinil in December. It was not clear if Taurasi would return to Turkey. Taurasi said in an interview with The Associated Press last month that "there's no way I've ever taken anything. ... Only thing that I'm guilty of is taking too many jump shots." Taurasi intends to return to the WNBA when the season begins in June. The Phoenix guard has led the U.S. league in scoring the last four seasons and signed a multiyear extension last August. Fenerbahce President Aziz Yildirim said Wednesday he was furious that Taurasi had been banned even though she was apparently innocent. "Our player was right. We will pursue this. We have documents," the club's website quoted Yildirim as saying. "This is a disgrace ... it probably cost us the European Championship." Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her both "A" and "B" samples tested positive for the banned stimulant modafinil following a Turkish league game on Nov. 13. Taurasi had been suspended by Fenerbahce ever since. The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Wednesday's decision is expected to clear the way for Taurasi to play in the Olympics. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championships. Associated Press Writer Suzan Fraser contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 64 of 998 DOCUMENTS Associated Press Online February 16, 2011 Wednesday 4:48 PM GMT Turkey lifts provisional doping ban on Taurasi BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 543 words DATELINE: ANKARA Turkey Turkey's basketball federation lifted American star Diana Taurasi's provisional doping suspension Wednesday after a lab retracted its finding that she tested positive for a performance-enhancing substance. The Turkish Basketball Federation said the lab retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. Taurasi not only is free to continue playing in the Turkish basketball league, she also is cleared to participate for the United States at the 2012 London Olympics. "The Federation has decided to lift the precautionary ban imposed on player Diana Lorena Taurasi to prevent the club and the player from being aggrieved further," the Turkish body said in a statement Wednesday. Taurasi, who has insisted that she never used performance-enhancing drugs, had her contract terminated by Turkish club Fenerbahce last month after the lab said she tested positive for modafinil in December. It was not clear whether Taurasi would return to Turkey. Taurasi said in an interview with The Associated Press last month that "there's no way I've ever taken anything. ... Only thing that I'm guilty of is taking too many jump shots." Taurasi intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension last August. Fenerbahce President Aziz Yildirim said Wednesday he was furious that Taurasi had been banned even though she was apparently innocent. "Our player was right. We will pursue this. We have documents," Yildirim said on the club's website. "This is a disgrace. ... It probably cost us the European Championship." Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for the stimulant modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. The decision Wednesday is expected to clear the way for Taurasi to play in the Olympics. The International Olympic Committee bars any athlete who receives a doping penalty of six months or more from competing in the next games. "I was thrilled to read today's report that the precautionary ban on Diana had been lifted by the Turkish Federation," UConn and U.S. basketball coach Geno Auriemma said in a statement. "Throughout this entire ordeal, Dee maintained her innocence and for her to be exonerated makes me incredibly happy for her," Auriemma said. "I hope she can put this behind her and focus all her efforts on continuing to be the best player in the world." Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championships. Associated Press Writer Suzan Fraser in Ankara and AP Basketball Writer Doug Feinberg in New York contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 65 of 998 DOCUMENTS Associated Press Online February 16, 2011 Wednesday 8:57 PM GMT Taurasi cleared of doping charges BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 702 words Diana Taurasi was always confident she would be cleared of doping allegations. It finally happened on Wednesday. Taurasi had her provisional suspension lifted by the Turkish Basketball Federation, which said the lab that returned a positive test retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. "I got the news this morning at 5 a.m. and was in shock," Taurasi told The Associated Press by phone from her Phoenix home. "It was kind of like the first time when I heard the test result had come back positive. It's really good that the facts came out and the truth came out." Taurasi had insisted that she never used performance-enhancing drugs, even though she had her contract terminated by Turkish club Fenerbahce last month. The lab that tested her sample had said the results came back positive for the stimulant modafinil. "Life can throw you curveballs at any given time," said Taurasi, who will also be able to compete in the 2012 Olympics. "I can be mad and angry, but I will move forward. Not everyone has the same financial resources I did. Hopefully this will let people know every process has holes and to wait for the facts to come out before making decisions." With the lifting of the suspension, Taurasi is also free to continue playing in the Turkish basketball league, although she doesn't plan on going back there anytime soon. "That's pretty unlikely," the 28-year-old WNBA star said. "I'm here in Phoenix working out and am more focused on getting myself in the best shape of my life and going from there." She intends to return to the WNBA when the season begins in June. The Mercury guard has led the league in scoring the last four seasons and signed a multiyear extension last August. The last two months haven't been easy for the former UConn star. Yet she kept her faith that she would be cleared. "I tried to handle it as best as possible," Taurasi said. "There might have been times in my own private moments when I was angry or questioned why me, but I am glad the truth came out. It's scary that our careers can be taken away from us." Taurasi was the first prominent WNBA player to test positive for a banned substance. Had she not been cleared, Taurasi could have missed the London Games, because the International Olympic Committee bars any athlete given a doping penalty of six months or more from competing. Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. "It's always great when the right result happens," Taurasi's lawyer Howard Jacobs said. "When it happens reasonably quickly it's even better." The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. "I was thrilled to read today's report that the precautionary ban on Diana had been lifted by the Turkish Federation," UConn and U.S. basketball coach Geno Auriemma said in a statement. "Throughout this entire ordeal, Dee maintained her innocence and for her to be exonerated makes me incredibly happy for her," Auriemma said. "I hope she can put this behind her and focus all her efforts on continuing to be the best player in the world." Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championship this past October. "We're delighted that Diana has been cleared and can now put this behind her and continue her remarkable basketball career," USA Basketball executive director Jim Tooley said in a statement. "She has been an exemplary member of numerous USA Basketball teams since 2000, and we look forward to her continued involvement with USA Basketball." Associated Press writers Selcan Hacaoglu and Suzan Fraser in Ankara contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 66 of 998 DOCUMENTS The Associated Press State & Local Wire February 16, 2011 Wednesday 5:09 PM GMT Turkey lifts provisional doping ban on Taurasi BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 550 words DATELINE: ANKARA Turkey Turkey's basketball federation lifted American star Diana Taurasi's provisional doping suspension Wednesday after a lab retracted its finding that she tested positive for a performance-enhancing substance. The Turkish Basketball Federation said the lab retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. Taurasi not only is free to continue playing in the Turkish basketball league, she also is cleared to participate for the United States at the 2012 London Olympics. "The Federation has decided to lift the precautionary ban imposed on player Diana Lorena Taurasi to prevent the club and the player from being aggrieved further," the Turkish body said in a statement Wednesday. The former Connecticut women's basketball star, who has insisted that she never used performance-enhancing drugs, had her contract terminated by Turkish club Fenerbahce last month after the lab said she tested positive for modafinil in December. It was not clear whether Taurasi would return to Turkey. Taurasi said in an interview with The Associated Press last month that "there's no way I've ever taken anything. ... Only thing that I'm guilty of is taking too many jump shots." Taurasi intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension last August. Fenerbahce President Aziz Yildirim said Wednesday he was furious that Taurasi had been banned even though she was apparently innocent. "Our player was right. We will pursue this. We have documents," Yildirim said on the club's website. "This is a disgrace. ... It probably cost us the European Championship." Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for the stimulant modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. The decision Wednesday is expected to clear the way for Taurasi to play in the Olympics. The International Olympic Committee bars any athlete who receives a doping penalty of six months or more from competing in the next games. "I was thrilled to read today's report that the precautionary ban on Diana had been lifted by the Turkish Federation," UConn and U.S. basketball coach Geno Auriemma said in a statement. "Throughout this entire ordeal, Dee maintained her innocence and for her to be exonerated makes me incredibly happy for her," Auriemma said. "I hope she can put this behind her and focus all her efforts on continuing to be the best player in the world." Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championships. Associated Press Writer Suzan Fraser in Ankara and AP Basketball Writer Doug Feinberg in New York contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 67 of 998 DOCUMENTS The Associated Press State & Local Wire February 16, 2011 Wednesday 5:09 PM GMT LENGTH: 595 words BC-BKL--Doping-Taurasi, 3rd Ld-Writethru,0548 Turkey lifts provisional doping ban on Taurasi Eds: Adds comment from Geno Auriemma. usae/swingfield sptd/dskretta elfd/lon/srwilson elfd/lon/clehourites fasst4922 fasst4921 By SELCAN HACAOGLU Associated Press ANKARA, Turkey (AP) Turkey's basketball federation lifted American star Diana Taurasi's provisional doping suspension Wednesday after a lab retracted its finding that she tested positive for a performance-enhancing substance. The Turkish Basketball Federation said the lab retracted its report after it "evaluated" Taurasi's statements in her defense. The federation did not say whether the lab made a mistake. Taurasi not only is free to continue playing in the Turkish basketball league, she also is cleared to participate for the United States at the 2012 London Olympics. "The Federation has decided to lift the precautionary ban imposed on player Diana Lorena Taurasi to prevent the club and the player from being aggrieved further," the Turkish body said in a statement Wednesday. The former Connecticut women's basketball star, who has insisted that she never used performance-enhancing drugs, had her contract terminated by Turkish club Fenerbahce last month after the lab said she tested positive for modafinil in December. It was not clear whether Taurasi would return to Turkey. Taurasi said in an interview with The Associated Press last month that "there's no way I've ever taken anything. ... Only thing that I'm guilty of is taking too many jump shots." Taurasi intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension last August. Fenerbahce President Aziz Yildirim said Wednesday he was furious that Taurasi had been banned even though she was apparently innocent. "Our player was right. We will pursue this. We have documents," Yildirim said on the club's website. "This is a disgrace. ... It probably cost us the European Championship." Fenerbahce had terminated Taurasi's contract after the Ankara-based lab within Hacettepe University confirmed that her "A" and "B" samples tested positive for the stimulant modafinil following a Turkish league game Nov. 13. Taurasi had been suspended by Fenerbahce ever since. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. The federation also lifted the provisional doping suspension for American player Monique Coker, who plays for Ceyhan Belediyesi and had tested positive for modafinil in doping tests carried out by the same lab. The decision Wednesday is expected to clear the way for Taurasi to play in the Olympics. The International Olympic Committee bars any athlete who receives a doping penalty of six months or more from competing in the next games. "I was thrilled to read today's report that the precautionary ban on Diana had been lifted by the Turkish Federation," UConn and U.S. basketball coach Geno Auriemma said in a statement. "Throughout this entire ordeal, Dee maintained her innocence and for her to be exonerated makes me incredibly happy for her," Auriemma said. "I hope she can put this behind her and focus all her efforts on continuing to be the best player in the world." Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championships. Associated Press Writer Suzan Fraser in Ankara and AP Basketball Writer Doug Feinberg in New York contributed to this report. LOAD-DATE: February 17, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 68 of 998 DOCUMENTS Cancer Drug News February 10, 2011 Lundbeck granted commercial rights to Cephalon products in Canada and/or Latin America SECTION: NEWS LENGTH: 447 words Lundbeck has been granted commercial rights to several Cephalon products in Canada and Latin America. As part of the agreement, Lundbeck will register and commercialise several key products that are currently available in the US and/or Europe on behalf of Cephalon. Key products in the agreement include Fentora (fentanyl buccal tablet) [C-II], Provigil (modafinil), Treanda (bendamustine), Trisenox (arsenic trioxide) injection, Myocet (liposomal doxorubicin) and Nuvigil (armodafinil). According to Lundbeck, the Cephalon brands will significantly strengthen its position in these markets while leveraging on existing sales and marketing capabilities, adding significant sales in Canada and Latin America from 2012. The Cephalon products for improving wakefulness, Provigil and Nuvigil, as well as the pain product, Fentora, are considered to have a strong fit to Lundbeck's already strong central nervous system franchise. Lundbeck is currently successfully promoting modafinil in Mexico. Nuvigil is expected to be approved in Canada and Latin America in the 2012-2014 time period, and Lundbeck expects to promote these products with the existing sales and marketing organisation. Also included in the deal is the Cephalon oncology product, Treanda, which is to be commercialised by Lundbeck in Canada. The new oncology franchise in Canada will be complemented by Trisenox and the pain product, Fentora. Treanda has proven clinical activity in the treatment of haematological malignancies, including those refractory to conventional anticancer agents. Treanda is expected to be filed during 2011 in Canada, and Lundbeck will establish a dedicated oncology sales organisation in Latin America and Canada in order to achieve the full potential of the oncology portfolio. The financial terms were not disclosed, but Lundbeck is to pay double-digit royalties on sales, which will be the main overall revenue stream for Cephalon from these products in these territories. Product Indication Territory Provigil, Improve wakefulness in adults who Canada (Nuvigil only) Nuvigil experience excessive sleepiness and Latin America due to treated obstructive sleep apnoea, shift work disorder, or narcolepsy Treanda Treatment of indolent B-cell Canada non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Fentora Compound for breakthrough pain in Canada and Latin America opioid-tolerant patients with cancer Trisenox Cytotoxin for acute promyelocytic Canada leukaemia Myocet1 Cytotoxin for metastatic breast Latin America cancer 1Myocet will be included in the agreement at a later stage. Cephalon holds exclusive rights to market and develop Treanda, which is licensed from Astellas Deutschland (Astellas Pharma LOAD-DATE: February 10, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: Cancer Drug News Copyright 2011 Espicom Business Intelligence All Rights Reserved 69 of 998 DOCUMENTS Drug Delivery Insight February 9, 2011 Lundbeck expands commercial opportunities in Canada/Latin America with help from Cephalon SECTION: NEWS LENGTH: 404 words Lundbeck has been granted commercial rights to a number of Cephalon products in Canada and Latin America. As part of the agreement, Lundbeck will register and commercialise several key products that are currently available in the US and/or Europe, on behalf of Cephalon. Key products in the agreement include Fentora (fentanyl buccal tablet) [C-II], Provigil (modafinil tablet), Treanda (bendamustine hydrochloride injection), Trisenox (arsenic trioxide injection), Myocet (liposomal- doxorubicin) and Nuvigil (armodafinil tablet). The Cephalon products for improving wakefulness, Provigil and Nuvigil, as well as the pain product, Fentora, have a strong fit to Lundbeck's CNS franchise and will contribute to the continued growth in both Canada and Latin America. Lundbeck is currently successfully promoting modafinil in Mexico. Provigil and Nuvigil address a market with a substantial under-diagnosed and under-treated patient group. Nuvigil is expected to be approved in Canada and Latin America in the 2012 to 2014 time period. In 2009, Cephalon realised revenue of US $73 million in the US on Nuvigil and in the first nine months of 2010, revenues were US $127 million. Lundbeck expects to promote these products with the existing sales and marketing organisation. Also included in the deal is the leading Cephalon oncology product Treanda, which is to be commercialised by Lundbeck in Canada. Treanda will add significantly to revenue and earnings in Lundbeck's Canadian business. The new oncology franchise in Canada will be complemented by Trisenox and Fentora. Treanda has proven clinical activity in the treatment of haematological malignancies, including those refractory to conventional anti-cancer agents. In 2008, the American Society of Clinical Oncology recognised Treanda as one of the major advances in cancer treatment. In 2009, Cephalon realised total revenue of US $222 million on the product and in the first nine months of 2010, revenue reached US $285 million in the US. Treanda is expected to be filed during 2011 in Canada and Lundbeck will establish a dedicated oncology sales organisation in Latin America and Canada in order to achieve the full potential of the oncology portfolio. The financial terms of the agreement have not been disclosed, but Lundbeck is to pay double-digit royalties on sales which will be the main overall revenue stream for Cephalon from these products in these territories. LOAD-DATE: February 9, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: Drug Delivery Insight Copyright 2011 Espicom Business Intelligence All Rights Reserved 70 of 998 DOCUMENTS US Fed News February 9, 2011 Wednesday 10:00 AM EST US Patent Issued to NeuroHealing Pharmaceuticals on Feb. 8 for "Modafinil-Based Treatment for Premature Ejaculation" (Massachusetts Inventor) LENGTH: 142 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., Feb. 9 -- United States Patent no. 7,884,135, issued on Feb. 8, was assigned to NeuroHealing Pharmaceuticals Inc. (Newton, Mass.). "Modafinil-Based Treatment for Premature Ejaculation" was invented by Daniel E. Katzman (Newton, Mass.). According to the abstract released by the U.S. Patent & Trademark Office: "Methods and compositions comprising modafinil are described for treating premature ejaculation in a male individual." The patent was filed on Aug. 13, 2007, under Application No. 12/310,175. For further information please visit: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetah tml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7884135&OS=7884135&R S=7884135 For any query with respect to this article or any other content requirement, please contact Editor at htsyndication@hindustantimes.com LOAD-DATE: February 11, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 HT Media Ltd. All Rights Reserved 71 of 998 DOCUMENTS Global Insight February 8, 2011 Lundbeck Obtains Commercial Rights to Several Cephalon Products in Canada, Latin America BYLINE: Anne-Charlotte Honore SECTION: In Brief LENGTH: 324 words Danish firm Lundbeck has been granted commercial rights to several Cephalon products in Canada and/or Latin America. Under the terms of agreement, Lundbeck will register and commercialise Provigil (modafinil) and Nuvigil (armodafinil) in Canada (Nuvigil only) and Latin America; Treanda (bendamustine HCI) in Canada; Fentora (fentanyl buccal tablet) in Canada and Latin America; Trisenox (arsenic trioxide) in Canada and at a later stage Myocet (liposomal doxorubicin) in Latin America. Lundbeck will pay double-digit royalties on sales to Cephalon. Financial terms were not disclosed. Significance:All products in-licensed from Cephalon are already approved in the United States, meaning that the clinical and regulatory risk is minimal for Lundbeck which takes here the opportunity to expand its presence in Latin America and Canada while strengthening its CNS and oncology franchises. Cephalon's drugs Treanda (bendamustine HCI), Provigil (modafinil) and Nuvigil (armodafinil) are expected to boost Lundbeck's sales performance in Canada and Latin America from 2012 onwards. Nuvigil is expected to be approved in the period 2012-14 in Canada and Latin America while Treanda is set to be filed during 2011 in Canada. Lundbeck said it will set a "dedicated oncology sales organisation in Latin America and Canada in order to achieve the full potential of the oncology portfolio". Its new oncology franchise in Canada will be composed of Treanda (bendamustine HCI) for the treatment of indolent B-cell non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), Fentora (fentanyl buccal tablet) for breakthrough pain in opioid-tolerant patients with cancer and of Trisenox (arsenic trioxide) for acute promyelocytic leukaemia (APL). Fentora (fentanyl buccal tablet) will be the only oncology-related Cephalon product commercialised by Lundbeck in Latin America until Myocet (liposomal doxorubicin) is included in the deal at a later stage. LOAD-DATE: April 30, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2011 World Markets Research Limited All Rights Reserved 72 of 998 DOCUMENTS Cynic Central February 5, 2011 Saturday 10:09 PM EST Losers and plastic dolls, women's basketball remains boring and Serbia gets in on a Week O' Riots BYLINE: andy LENGTH: 2072 words Feb. 5, 2011 (Cynic Central delivered by Newstex) -- - If I actually cared about womens basketball (or anyone else did), then this would be a fascinating story. One of the most accomplished players in the history of a sport embroiled in a scandal over whether or not she used performance-enhancing drugs, with the added intrigue of an international component to the saga. But alas, it is womens basketball and so Diana Taurasi testing positive in Turkey for the banned stimulant Modafinil and subsequently passing a polygraph test last month in which she insisted she never took the drug isnt a big deal. Taurasi used the polygraph results as part of a written defense that Taurasi sent to the Turkish Basketball Federation last week in which she seeks dismissal of the case against her. The test was conducted by former Chicago police officer John Fritz, who said he asked Taurasi two "relevant" questions Jan. 18: Did you at any time take the drug Modafinil or any similar generic brand name drug? And did you lie to club management when you denied ever using the drug Modafinil or any similar generic brand name drug? Fritz's report states that her score showed "that Subject was truthful when she answered 'no' to the above relevant questions." So whats at stake here? For the average sports fan, nothing. That average sports fan doesnt pay attention to the WNBA, so he or she surely pays even less attention to international womens hoops. For Taurasi, there is much more to lose. She was fired by her Turkish club, Fenerbahce, in December and faces a ban of up to two years that endangers her chance to play for the United States at the 2012 London Olympics. Also, if she is ultimately found guilty and officially suspended, Taurasi would also be subject to a World Anti-Doping Agency (WADA) rule that would erase any time she served if she went to play for the WNBA. The rule is intended to prevent banned athletes from merely going to play in leagues not regulated by WADA to sidestep a ban. Taurasi's Los Angeles defense attorney, Howard Jacobs, is arguing for dismissal of her case and has criticized several irregularities in the way her case was handled by Turkish authorities. Chief among those criticisms is the handling of her urine samples prior to testing, including a seven-day period, he says, during which there was no documentation indicating where they were kept during transportation from Istanbul to Ankara. That could be a problem because WADA maintains specific criteria for identifying Modafinil in labs and Jacobs insists Taurasi's results fell outside the agency's allowable margin of error. Questioning this particular lab in Ankara is a wise move because the lab had its drug-testing credentials suspended by WADA for three months in 2009 due to problems with its methods. As for Modafinil, it is a stimulant prescribed to treat narcolepsy patients who suffer (OOTC:WLVTQ) from excessive sleepiness and need help staying up - the very sort of thing that would help anyone trying to watch womens professional basketball. The next step in the process for Taurasi is to wait for the Turkish Basketball Federation to rule. After that, the first appeal would be to the Turkish Sports and Youth Arbitration Association, and if necessary, the international Court for Arbitration in Sport, which is the Supreme Court for doping cases. The legal battle could take a few months, but odds are it won't be any more boring than your typical WNBA game......... - Attention, Massachusetts residents: Rep. Cleon Turner or a member of his staff will soon be coming to your driveway or parking lot to clean the snow and ice off your car before you get out on the road......wait, you mean thats not going to happen? Then Turners idea for a law that would fine drivers for not cleaning winter debris off their car before pulling onto the road is just asinine. Sure, having snow and chunks of ice come flying off the car in front of you can be tough, but a little bit of safe driving on your part can alleviate much of the danger. The incident that took place Friday morning on I-93 in Andover, when ice flew off of a tractor trailer in front of a Honda Civic and landed so hard that it cracked the windshield is scary, to be certain, but the driver of that car was unharmed and the incident was nothing more than a blip on the radar. Its certainly no reason to overreact, but overreact someone must in every situation and in this case, its Rep. Cleon Turner. oeIm more concerned about having legislation there or a statute there eventually that will give police the tools they need to stop a vehicle and say, [#x2dc]Look. You need to clean the snow off your vehicle because its dangerous, said Rep. Turner. Great, an alarmist lawmaker looking to make a name for himself. And by making a name for himself, I mean this kook wants to fine people $500 for not brushing the snow and ice off their ride. Left unsaid is exactly what the standard will be. After all, if you brush off 95 percent of the snow on the roof of your SUV but miss one chunk that flies off and a cop sees it, then what? Or how about someone elses debris flies off their car, lands on your roof and then flies off your roof, but the cop only sees it come from your vehicle? Its a ginormous can of worms youre opening here, Rep. Cleon Turner, quite a can of worms.......... - My bad In writing about Fridays riots in Sri Lanka, I made it seem like they were the capper on a week of uprisings stretching from north Africa to the Middle East to Asia, but that was a mistake. To imply that would be to overlook the great riot effort turned in by tens of thousands of Serbian opposition supporters who have rallied against their government, calling for early elections and economic reforms. This group of outraged Serbs was led in their uprising by the Serbian Progressive Party. SPP leader Tomislav Nikolic addressed the crowd in front of the parliament building in the capital, Belgrade. While the gathering may not have produced the sort of furor and awe-inspiring violence that the clashes in Egypt have produced this week, the numbers were impressive. Serbian police estimate at least 55,000 people gathered for the rally, but objective observers put the number closer to 70,000. In his remarks, Nikolic did a solid job of inflaming the crowd by calling for higher wages and an end to government corruption. Claiming that the other side is corrupt and dishonest is always a solid play and so is referencing the recent protests in Tunisia and Egypt and saying that governments around the world are learning they need to listen to the people. Even if your situation has nothing to do with theirs and nothing in common with what they are going through, try to tie it to a higher cause. I like it.....check that, I love it. Even though parliamentary elections are scheduled for 2012 in Serbia, the opposition wants them held sooner. Much like President Hosni Mubarak is dragging his feet and trying to prolong his reign of terror in Egypt by promising not to seek re-election but refusing to resign early, the current regime in Serbia seems content to take the same course even as rising prices, unemployment and poverty have led to discontent with the pro-European Union government. Unfortunately, protests have remained mostly peaceful thus far and only a handful of dissidents have been arrested. The time has come to change that if those demanding change actually want to see it happen............ - How do you know your life is waaaaaay out of control? When youre texting multiple porn stars from rehab to inform them that your partying days are finished, thats when. Im looking right at you, Charlie Sheen (not that I needed to specify) because youre the one breaking out the BlackBerry from Promises or whatever rehab facility youve checked in to this time and firing off texts to Bambi, Ginger, Destiny and the girls to let them know that no longer will you be renting $1,000-a-night hotel room with hot tubs and balconies and using those rooms to have massive porn-star-and-coke orgies until you pass out and are rushed to the hospital. On some level, I suppose you could give the "Two and a Half Men" star credit for attempting to get clean and return to the show by the end of February, but thats the sort of vow were heard from Sheen before and it always ends the same way - with him face down in a pile of the Bolivian marching powder, surrounded by women who take some on film from strangers for money. But hey, maybe this is that moment of clarity for Sheen, the one where everything comes into focus. Lets check out his texts to his porn star pals: "Please lose the number, we are closed ... please drive through ... thank you," he wrote to one. "Right now we are on lockdown," he texted another. Hang on.....right now? So youre on lockdown for the time being, but maybe not for long? And no, I dont care that sheen urged these women not to contact him when his treatment ends. There are too many porn stars out there and too much Colombian nose candy to be snorted for Sheen to stay down for too long. Yes, an alleged 36-hour cocaine and drinking bender with several porn actresses led to his hospitalization Jan. 28, but coke addicts are not renowned for their commitment to anything but blow and a relapse would surprise no one. On account of not wanting to see anyone snort themselves into an early grave, I hope Im wrong, but I doubt it............ - One of my biggest pet peeves in life: people who pretend that a) dogs are human members of their family or b) anyone who acts as if fictional characters are real. This story involves the latter half of that beef and it centers on Mattel, the world's largest toy company, which has launched a digital marketing campaign in hopes of reuniting none other than Barbie and Ken. If you remember, Mattel oebroke up the two plastic dolls on Valentine's Day in 2004. Since then, they have led separate, but successful lives. However, Mattel has pretended that Ken is something other than an overpriced piece of plastic crap made by sweatshop workers in Indonesia and had him revamping his mind, body and soul to win Barbie back since 2006. That quest has now kicked into high gear, as Ken hopes to win back his plastic woman in time for Valentine's Day, with a little help from the social networking universe. Thats right, Mattel is asking Facebook, Twitter, Foursquare and YouTube losers who have far, far too much time on their hands and have wasted a sufficient amount of time on Facebook oeYes/No quizzes and oeLike my status and Ill post on your wall ploys to vote on whether Barbie should "take Ken back" or not. From those platforms, losers are directed to barbieandken.com, where users can vote and check out a Love-O-Meter, gauging voters' feelings on the topic. The campaign marks Ken's 50th anniversary and comes just in time for the release of a new "Sweet Talking Ken" doll that Mattel describes as "the ultimate boyfriend for every occasion," because he "says whatever you want him to say!" Oh Mattel, how I love your feeble attempts and relationship humor. The extent of the online world Mattel has crafted for Ken is truly disturbing. On Facebook, Twitter and Foursquare, fans can follow Ken's adventures to win back the love of his plastic, inanimate life, follow along with tweets promoting his romantic efforts and even get involved in a text campaign, where users can text THUMBS UP or THUMBS DOWN to 51684 to vote on whether the two dolls should get together again. According to the tiny plastic dolls Twitter page, Ken is also busy following his favorite sports team, the Lakers, and reading Men's Health and Esquire. Hes oevisited the Metropolitan Museum of Art in an attempt to infuse culture into his fake life. Sadly, there are kooks out there who are actually interacting with Ken as if they would a real person. Oh, and Ken is an Apple fan, using a MacBook Prop and enjoying his Internet time by browsing on Google (NASDAQ:GOOG) Chrome. Mattel has really embarrassed itself on this whole project, going back to last year's Fashion's Night Out event in New York City where it staged a "Catch Me If You Ken" promotion. Perhaps the most absurd part of the show has been Ken appearing on Canadian entertainment show ETalk and buying a spot in Us Weekly to confess his love. Now please excuse me while I go find something to vomit into............ Newstex ID: CYNC-0001-100440633 LOAD-DATE: February 6, 2011 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs on Demand® shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs on Demand®. Reader's comments reflect their individual opinion and their publication within Blogs on Demand® shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2011 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2011 Cynic Central 73 of 998 DOCUMENTS Star-News (Wilmington, NC) February 1, 2011 Tuesday 1ST Edition SECTION: Pg. 2C LENGTH: 430 words Taurasi denies taking modafinil Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told the Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She said she intends to return to the WNBA when the season begins in June. Tennis rankings truly global LONDON | For the first time, the top 10 players in the women's tennis rankings represent 10 different countries. Eleven different nations are represented among the top 11 spots and 30 different countries among the top 60 in Monday's rankings. "Having 10 different players represent the top 10 rankings shows how truly global tennis has become," WTA Chair and CEO Stacey Allaster said. Denmark's Caroline Wozniacki remained No. 1, followed by Australian Open champion Kim Clijsters of Belgium, Russia's Vera Zvonareva, Italy's Francesca Schiavone and Australia's Sam Stosur. The next five: Venus Williams of the United States, China's Li Na, Jelena Jankovic of Serbia, Victoria Azarenka of Belarus and Poland's Agnieszka Radwanska. Israel's Shahar Peer moved to a career high of No. 11. King's son: Mets' talk premature NEW YORK | Martin Luther King Jr.'s oldest son says any discussion of his potential interest in becoming a minority owner of the New York Mets is premature. Martin Luther King III said he was contacted Saturday by television executive Larry Meli, who is interested in putting together a group that would include former Mets first baseman Ed Kranepool and Donn Clendenon Jr., whose father was MVP of the Mets' 1969 World Series victory. King said he encouraged Meli because it would increase diversity. But King also said he was not actively putting together a group. in other baseball news | Pitcher R.A. Dickey has agreed to a $7.8 million, two-year contract with the New York Mets and outfielder Angel Pagan has agreed to a $3.5 million, one-year deal. Dickey, a 36-year-old knuckleballer who revived his career last season, gets a $1 million signing bonus. ... Right-hander Edinson Volquez and the Cincinnati Reds have agreed to a one-year contract worth $1,625,000. The deal, which avoided salary arbitration, includes $50,000 in performance bonuses: $25,000 each for 24 and 28 starts. - From wire service reports LOAD-DATE: February 4, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 Star-News, Inc. All Rights Reserved 74 of 998 DOCUMENTS The Associated Press January 31, 2011 Monday 04:00 AM GMT AP Interview: Taurasi denies taking modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 777 words Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 75 of 998 DOCUMENTS The Associated Press January 31, 2011 Monday 06:52 PM GMT AP Interview: Taurasi denies taking stimulant BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 892 words Diana Taurasi insists she did nothing wrong. The former Connecticut women's basketball star says she hadn't even heard of the banned stimulant modafinil until she found out she had tested positive for it. And no matter what those results showed, Taurasi is adamant that she never used performance-enhancing drugs. "I've never needed anything to help me. Only thing that I'm guilty of is taking too many jump shots," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. "There's no way I've ever taken anything," she said. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward. "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce this month after both her A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi. Her lawyer, Howard Jacobs, said it was delivered Monday. Despite reports of Taurasi's positive test surfacing last month, Jacobs only received the official report from the federation on Wednesday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. WADA spokesman Catherine Coley wrote in an e-mail to the AP that the organization won't comment until the case is resolved "in order to protect the integrity of the proceedings." For Taurasi's part, her lawyers noted she passed a polygraph test and that the Turkish lab was suspended by WADA for three months in 2009. The player's legal team also contends that the lab has failed to properly identify modafinil and that there are questions about the chain of custody for Taurasi's test. After Taurasi tested positive, two of her teammates in Turkey refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first time Taurasi has run into trouble during her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it might be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out," she said. "At the end of the day you can try and convince the whole world, but if you know it's true and you've never taken performance-enhancing drugs, that's what you have to live by." LOAD-DATE: February 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 76 of 998 DOCUMENTS The Bismarck Tribune January 31, 2011 Monday SECTION: SPORTS LENGTH: 764 words Taurasi denies taking modafinil Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she said Sunday. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury. The 28-year-old also plans to play for the U.S. team and Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment - the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 The Bismarck Tribune, a division of Lee Enterprises All Rights Reserved 77 of 998 DOCUMENTS Jezebel January 31, 2011 Monday 2:21 PM EST Could Diana Taurasi Be Exonerated For Doping? [Sports] LENGTH: 515 words Jan. 31, 2011 (Gawker Media delivered by Newstex) -- Basketball star Diana Taurasi tested positive for a banned drug, and her shot at the 2012 Olympics could be in jeopardy. But she swears she didn't take anything " we asked an expert if she could be telling the truth. The former UConn star dropped from her Turkish team earlier this month when a second sample of her urine tested positive for the banned stimulant modafinil. The Turkish league hasn't formally suspended her, but if they do, she could be barred from competing in the 2012 Olympics " any suspension of six months or longer would make her ineligible. Yesterday, she told the AP she hadn't taken the drug: "I've never needed anything to help me. Only thing that I'm guilty of is taking too many jump shots." And her lawyer Howard Jacobs is projecting confidence, saying, "This will be resolved well in advance of 2012." So could Taurasi really be innocent? Daniel M. Rosen, author of Dope: A History of Performance Enhancement in Sports from the Nineteenth Century to Today told me Taurasi could be telling the truth. He explains, Lab testing is a curious thing. One of the things we need to know about it is that no test is perfect. Just because the A and the B samples actually give the same result doesn't necessarily mean that the result is correct. There are these funny things called false positives. [...] The fact that the lab got the same result both times only means that the test was consistent, but the way the anti-doping system works is that there's really no taking into account the idea of false positives, [...] so if the lab says you're positive, you're basically screwed. And even if modafinil did show up in Taurasi's bloodstream, she might not have intentionally put it there. Rosen gave me numerous examples of athletes who tested positive for banned substances after accidentally consuming them in supplements, over-the-counter medications, and even contaminated meat. If Taurasi can show that she inadvertently ingested the modafinil, she might be able to get a reduced punishment. Her best shot at full exoneration, though, is to show sloppy handling of her sample or some "break in the chain of custody" that might have led to contamination. Jacobs notes that the lab in question has been suspended in the past by the World Anti-Doping Agency " Rosen says such suspensions can occur for a variety of reasons, including simply not performing enough tests, but questions about the lab's bona fides could help Taurasi's defense. When it comes to an Olympic bid, though, time is not on her side. Says Rosen, "some of these appeals take forever, and it all depends on how fast the various arbitration panels move, and how fast the arbitrators come up with their decisions." Even if Taurasi's appeal makes it all the way to the highest authority, Court of Arbitration for Sport, their decision could take six months. So despite Jacobs's optimism, Rosen says, "I'm afraid that she's probably not going to be able to compete." AP Interview: Taurasi Denies Taking Stimulant [AP] Newstex ID: GAWK-0016-100296348 LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. 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PUBLICATION-TYPE: Web Blog Copyright 2011 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2011 Jezebel 78 of 998 DOCUMENTS Associated Press Worldstream January 31, 2011 Monday 4:02 AM GMT AP Interview: Taurasi denies taking modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 773 words Women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told The Associated Press by telephone Sunday from her parents' home in California. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 79 of 998 DOCUMENTS Associated Press Online January 31, 2011 Monday 6:53 PM GMT AP Interview: Taurasi denies taking stimulant BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 892 words Diana Taurasi insists she did nothing wrong. The former Connecticut women's basketball star says she hadn't even heard of the banned stimulant modafinil until she found out she had tested positive for it. And no matter what those results showed, Taurasi is adamant that she never used performance-enhancing drugs. "I've never needed anything to help me. Only thing that I'm guilty of is taking too many jump shots," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. "There's no way I've ever taken anything," she said. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward. "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce this month after both her A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi. Her lawyer, Howard Jacobs, said it was delivered Monday. Despite reports of Taurasi's positive test surfacing last month, Jacobs only received the official report from the federation on Wednesday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. WADA spokesman Catherine Coley wrote in an e-mail to the AP that the organization won't comment until the case is resolved "in order to protect the integrity of the proceedings." For Taurasi's part, her lawyers noted she passed a polygraph test and that the Turkish lab was suspended by WADA for three months in 2009. The player's legal team also contends that the lab has failed to properly identify modafinil and that there are questions about the chain of custody for Taurasi's test. After Taurasi tested positive, two of her teammates in Turkey refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first time Taurasi has run into trouble during her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it might be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out," she said. "At the end of the day you can try and convince the whole world, but if you know it's true and you've never taken performance-enhancing drugs, that's what you have to live by." LOAD-DATE: February 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 80 of 998 DOCUMENTS Associated Press Online January 31, 2011 Monday 9:20 AM GMT AP Interview: Taurasi denies taking modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 777 words Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: February 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 81 of 998 DOCUMENTS The Associated Press State & Local Wire January 31, 2011 Monday 4:00 AM GMT AP Interview: Taurasi denies taking modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 777 words Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 82 of 998 DOCUMENTS The Associated Press State & Local Wire January 31, 2011 Monday 4:00 AM GMT LENGTH: 810 words BC-BKL--Taurasi Speaks, 1st Ld-Writethru,0958 AP Interview: Taurasi denies taking modafinil 2030 Eds: Updates with details, quotes. AP Photo NY157 sptd/rrusso fasst4921 By DOUG FEINBERG AP Basketball Writer Former UConn women's basketball star Diana Taurasi is adamant: No matter what the test results showed, she never used performance-enhancing drugs. "There's no way I've ever taken anything," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for the stimulant modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward." "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce earlier this month after both her and A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi, and her lawyer, Howard Jacobs, said it would be delivered by Monday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. Efforts to reach WADA officials by telephone for comment were not immediately successful. After Taurasi's positive test, two of her Turkish teammates refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. "I've never needing anything to help me. Only thing that I'm guilty of is taking too many jump shots. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first trouble Taurasi has run into trouble in her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it may be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out. At the end of the day you can try and convince the whole world but if you know it's true and you've never taken performance-enhancing drugs that's what you have to live by." LOAD-DATE: January 31, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 83 of 998 DOCUMENTS The Associated Press State & Local Wire January 31, 2011 Monday 6:53 PM GMT AP Interview: Taurasi denies taking stimulant BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 892 words Diana Taurasi insists she did nothing wrong. The former Connecticut women's basketball star says she hadn't even heard of the banned stimulant modafinil until she found out she had tested positive for it. And no matter what those results showed, Taurasi is adamant that she never used performance-enhancing drugs. "I've never needed anything to help me. Only thing that I'm guilty of is taking too many jump shots," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. "There's no way I've ever taken anything," she said. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward. "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce this month after both her A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi. Her lawyer, Howard Jacobs, said it was delivered Monday. Despite reports of Taurasi's positive test surfacing last month, Jacobs only received the official report from the federation on Wednesday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. WADA spokesman Catherine Coley wrote in an e-mail to the AP that the organization won't comment until the case is resolved "in order to protect the integrity of the proceedings." For Taurasi's part, her lawyers noted she passed a polygraph test and that the Turkish lab was suspended by WADA for three months in 2009. The player's legal team also contends that the lab has failed to properly identify modafinil and that there are questions about the chain of custody for Taurasi's test. After Taurasi tested positive, two of her teammates in Turkey refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first time Taurasi has run into trouble during her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it might be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out," she said. "At the end of the day you can try and convince the whole world, but if you know it's true and you've never taken performance-enhancing drugs, that's what you have to live by." LOAD-DATE: February 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 84 of 998 DOCUMENTS The Associated Press State & Local Wire January 31, 2011 Monday 6:53 PM GMT LENGTH: 935 words BC-BKL--Taurasi Speaks, 1st Ld-Writethru,1172 AP Interview: Taurasi denies taking stimulant 2030 Eds: Updates with WADA comment and details of Taurasi's defense. AP Photo NY157 sptd/jaffleck sptd/mfitzpatrick sptd/rrusso fasst4921 By DOUG FEINBERG AP Basketball Writer Diana Taurasi insists she did nothing wrong. The former Connecticut women's basketball star says she hadn't even heard of the banned stimulant modafinil until she found out she had tested positive for it. And no matter what those results showed, Taurasi is adamant that she never used performance-enhancing drugs. "I've never needed anything to help me. Only thing that I'm guilty of is taking too many jump shots," she told The Associated Press by telephone Sunday night from her parents' home in Chino, Calif. In her first interview since testing positive in December for modafinil, Taurasi and her lawyer blamed the Turkish lab where the sample was analyzed. "There's no way I've ever taken anything," she said. Taurasi is regarded by many as one of the best women's players in the world. She was the first prominent WNBA player to test positive for a banned substance. Taurasi said she intends to return to the WNBA when the season begins in June. The Phoenix guard has led the league in scoring the last four seasons and signed a multiyear extension with the Mercury last August. The 28-year-old also plans to play for the U.S. team and coach Geno Auriemma in the 2012 Olympics. She's already helped the Americans win the last two gold medals. Taurasi has talked to Auriemma, who coached her in college, at length since she tested positive. He said he'll stand by her. "My goal has been to play basketball," she said. "Things have come up in my life, but that's life for you. ... This one was an unexpected one. I've been doing the right thing for my career. I'll take this and move forward. "I went from being really angry to wondering, 'Why me?' I won't let it bring me down," she said. Taurasi's contract was terminated by the Turkish club Fenerbahce this month after both her A and B samples tested positive. The Turkish federation still hasn't announced a punishment the organization was awaiting a response from Taurasi. Her lawyer, Howard Jacobs, said it was delivered Monday. Despite reports of Taurasi's positive test surfacing last month, Jacobs only received the official report from the federation on Wednesday. Taurasi faces a ban of up to two years and said she will appeal any suspension. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "This will be resolved well in advance of 2012," Jacobs said. "My understanding is that we have the right of appeal to the sport of arbitration body in Turkey. That could take a couple of months. All the appeals should be done by the end of this year." Taurasi said she was at her home in Turkey, on her couch, when the Fenerbahce general manager handed her the paper stating that she had tested positive for modafinil. Taurasi said the news shocked her. "I had never heard of it and couldn't pronounce it," she said. "I had to Google it to find out the side effects. I never have come in contact with it." The drug has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Jacobs said he's handled about 75 athlete drug cases, including those of Floyd Landis and Marion Jones. He's questioning the lab's handling of Taurasi's sample and pointed out that it had been suspended by WADA. WADA spokesman Catherine Coley wrote in an e-mail to the AP that the organization won't comment until the case is resolved "in order to protect the integrity of the proceedings." For Taurasi's part, her lawyers noted she passed a polygraph test and that the Turkish lab was suspended by WADA for three months in 2009. The player's legal team also contends that the lab has failed to properly identify modafinil and that there are questions about the chain of custody for Taurasi's test. After Taurasi tested positive, two of her teammates in Turkey refused to have their samples examined by that same lab. "I have the most respect for the testing process. When it's not done the right way, when protocol isn't followed, I do have some problems with it," Taurasi said. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. This isn't the first time Taurasi has run into trouble during her career. She served one day in jail and was suspended by the Mercury for two games in 2009 after pleading guilty to a DUI charge. "The DUI was a mistake I made and I owned up to and I did my time," she said. "That really did help me in the long run growing up as a person. This is different, waking up one morning and having something pinned on you that you had no clue about. It's been a difficult month coming to terms with everything. I know I've never taken it." Taurasi, who said she's been tested at least three times a year since joining the WNBA, knows that it might be tough to get rid of the stigma that she's doping even if she's vindicated. "I trust that the truth will come out," she said. "At the end of the day you can try and convince the whole world, but if you know it's true and you've never taken performance-enhancing drugs, that's what you have to live by." LOAD-DATE: February 1, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 85 of 998 DOCUMENTS Indian Patents News January 25, 2011 Tuesday 6:30 AM EST Cephalon Inc. Files Patent Application for Methods for the Separation of Modafinil LENGTH: 258 words New Delhi, Jan. 25 -- USA based Cephalon Inc. filed patent application for methods for the separation of modafinil. The inventors are Wilhelm Hauck, Oliver Ludemann-Hombourger, Yvan Ruland, Nelson Landmesser and John Mallamo. Cephalon Inc. filed the patent application on Feb. 7, 2007. The patent application number is 465/KOLNP/2007 A. The international classification numbers are C07B57/00 and C07C317/24. According to the Controller General of Patents, Designs & Trade Marks, "The present invention is directed to a process for the isolation of the enantiomeric forms of modafinil with high enantiomeric purity and high overall yields by means of a continuous chromatographic process." Cephalon, Inc. is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. LOAD-DATE: January 25, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 86 of 998 DOCUMENTS Chicago Daily Herald January 8, 2011 Saturday L2 Edition Taurasi's breach damages WNBA SECTION: SPORTS; Pg. 2 LENGTH: 587 words What a dope Diana Taurasi appears to be. On Thursday, Taurasi, arguably the best female basketball player in the world, had her contract with the Turkish team she plays for during the WNBA's off-season voided. For doping. She has reportedly denied the charges in conversations with her former college coach, Geno Auriemma of Connecticut. It will be interesting to see what her next move is. For now, this certainly is a surreal development, to say the least. In the world of professional sports, women's basketball is the closest thing to squeaky clean. For more than a decade, the WNBA has being trying to emulate its professional sports brethren by developing a quality and high-level sports entertainment option. Just without the drugs. It's no secret that just about every men's professional sports league has had bouts with drug problems over the course of their histories. From Major League Baseball to the NFL to the NBA, we've seen athletes ruin their careers with steroids, hard-core street drugs and even the misuse of prescription medications. Fifteen years into its existence, the WNBA hasn't really had to face those demons. "I'd say that only 2 to 5 percent of the players in the WNBA even risk violating the substance policy," said Chicago Sky strength and conditioning coach Ann Crosby. "When I say that, people are always like, 'Really?' But it's true. The WNBA really doesn't have the problems that a lot of sports leagues have with drugs." Yes, but when it rains on the WNBA, it apparently pours. This isn't a benchwarmer in trouble. This is the face of the league. Not good news for the WNBA. Taurasi, who has been an A-list superstar ever since she was drafted by the Phoenix Mercury in 2004, has tested positive for the banned stimulant modafinil. On Thursday, her second sample, or "B" sample, confirmed what her original sample read in November. Taurasi's team in Turkey made its decision to terminate her contract after the "B" sample also came back positive. Modafinil is used to counter excessive sleepiness due to narcolepsy, sleep apnea and other sleep disorders. It is on the World Anti-Doping Agency's list and is the substance that got American sprinter Kelli White into trouble in 2004. She won gold medals in the 100 and 200 meters at the 2003 World Championships. But those results were stricken from the records in the wake of news that White tested positive for modafinil as well as the steroid THG. White received a two-year ban from competition. Taurasi also faces tough repercussions. She could be banned for up to two years from the Turkish league. And that would comprise her standing with the U.S. women's national basketball team for the 2012 Olympics in London. Already a two-time gold medalist, Taurasi would not be allowed to participate in any Olympic event if she is saddled with a ban of two years or more by any other athletic agency. On top of all that, Taurasi would likely be faced with a punishment from the WNBA for the 2011 season. "She could be hit with a triple whammy, and that's such a bummer for the league because she is such a draw. People come out to see her play," said Crosby, who confirmed that the Sky has never had a substance violation in its six years of existence. Crosby helps to ensure every Sky player is in compliance. "I'm not sure how the WNBA will deal with it, but I would think she would get some kind of suspension, whether it be for two or three games or more," Crosby said. "Things like this are really dealt with on a case-by-case basis." pbabcock@dailyherald.com LOAD-DATE: January 10, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2011 Paddock Publications, Inc. 87 of 998 DOCUMENTS The New York Times January 7, 2011 Friday Late Edition - Final Taurasi's Deal Terminated As Test Confirms Violation BYLINE: By JERE LONGMAN SECTION: Section B; Column 0; Sports Desk; Pg. 11 LENGTH: 373 words Diana Taurasi's Olympic and professional basketball career grew more uncertain Thursday when the Turkish basketball federation said it had confirmed her doping violation and that her club team in Istanbul had terminated her contract. Taurasi, 28, considered by many the world's top women's basketball player, had been suspended from her Istanbul team since the ''A'' sample of a two-part urinalysis tested positive last month for the banned stimulant modafinil. The ''B'' sample also tested positive, the Turkish basketball federation said Thursday on its Web site. The federation also posted a notice saying that Taurasi's team, Fenerbahce, had dropped her. No sanctions were announced, but Taurasi now faces a suspension from international competition of up to two years, according to the rules of the World Anti-Doping Agency. Through her lawyer, she has denied knowingly taking any prohibited substances. A suspension longer than six months would leave Taurasi ineligible to compete for the United States at the 2012 London Games, according to a rule implemented by the International Olympic Committee. Any proposed suspension by the Turkish federation was not likely to be for less than six months, said Taurasi's lawyer, Howard L. Jacobs. She could appeal any suspension. Jacobs said he could not take his next step until he received official notification of a doping violation. ''At some point, they're going to have to tell me and provide me with lab documents,'' Jacobs said. ''So far that has not happened.'' Earlier this week, Geno Auriemma, who coached Taurasi at Connecticut and will be the 2012 United States Olympic coach, said that Taurasi told him she never took modafinil, an alertness drug designed to treat sleep disorders. Taurasi plays for the Phoenix Mercury of the W.N.B.A. during the summer and for Fenerbahce during the league's off-season. It remained unclear whether Taurasi's W.N.B.A. eligibility would be affected. The Turkish lab that performed Taurasi's urinalysis has previously been suspended for a brief period by WADA, Jacobs noted. Two of Taurasi's teammates at Fenerbahce recently agreed to provide urine samples only if they would be tested in Germany. ''The whole thing is unbelievably stressful,'' Jacobs said. URL: http://www.nytimes.com LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH GRAPHIC: PHOTO: Diana Taurasi, playing in a W.N.B.A. playoff game for the Phoenix Mercury in 2010, tested positive for the stimulant modafinil. (PHOTOGRAPH BY ERIC GAY/ASSOCIATED PRESS) PUBLICATION-TYPE: Newspaper Copyright 2011 The New York Times Company 88 of 998 DOCUMENTS The Associated Press January 6, 2011 Thursday 04:21 PM GMT Taurasi has Turkish contract voided for doping BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 447 words DATELINE: ANKARA, Turkey American basketball star Diana Taurasi had her contract terminated by Turkish club Fenerbahce on Thursday after her "B" sample tested positive for doping. The Istanbul-based club made its decision after the Turkish Basketball Federation announced the results of the doping test on its website. Taurasi faces a ban of up to two years, putting in jeopardy her chances of playing for the United States at the 2012 London Olympics. The federation has not announced a decision on Taurasi's punishment. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil following a Turkish league game on Nov. 13. Taurasi had been suspended by Fenerbahce ever since. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Taurasi helped the Americans win gold medals at the past two Olympics and was the leading scorer when the U.S. won the women's world championships. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. On Tuesday, Geno Auriemma, the United States coach for the 2012 Olympics, said the former University of Connecticut star told him that she did not take modafinil. He also said he didn't know if Taurasi had any problems with sleeplessness. One of the most decorated women's players in history, Taurasi led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points last season. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with Phoenix in August. The Mercury have not commented publicly on the doping case. Taurasi is one of many American stars who play overseas in the winter because salaries are significantly higher than in the WNBA. She played in Russia for four years for Spartak before joining the Turkish league this season. Taurasi was leading the league in scoring with 24.6 points per game. Two of Taurasi's teammates at Fenerbahce have resisted doping tests in Turkey because they do not trust the lab that tests the samples. Australian player Penny Taylor and Czech teammate Hana Horakova provided samples only after the Turkish federation agreed to send them to Germany for testing at a lab in Cologne. The two players were tested after Fenerbahce's Turkish league game on Sunday. Modafinil has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 89 of 998 DOCUMENTS Indian Patents News January 6, 2011 Thursday 6:30 AM EST Organisation De Synthese Mondiale Orsymonde Files Patent Application for Modafinil Synthesis Process LENGTH: 140 words New Delhi, Jan. 6 -- France based Organisation De Synthese Mondiale Orsymonde filed patent application for modafinil synthesis process. The inventor is Rose Sebastien. Organisation De Synthese Mondiale Orsymonde filed the patent application on Nov. 16, 2006. The patent application number is 3018/CHENP/2005 A. The international classification number is C07C 315/00. According to the Controller General of Patents, Designs & Trade Marks, "The invention relates to a process for preparing modafinil having a defined granulometry which comprises the steps of: a) preparing a solution of DMSAM ; b) contacting the solution obtained with NH3 at a predetermined temperature and a predetermined stirring; and c) isolating the modafinil formed, wherein said temperature and said stirring are predetermined in order to obtain said defined granulometry." LOAD-DATE: January 6, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 90 of 998 DOCUMENTS Associated Press Worldstream January 6, 2011 Thursday 4:03 PM GMT Taurasi's 'B' sample positive for banned stimulant BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 435 words DATELINE: ANKARA Turkey American basketball star Diana Taurasi's "B" sample tested positive for doping, a result which threatens her chances of playing for the United States at the 2012 London Olympics. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil following a Turkish league game on Nov. 13. The Fenerbahce player, who faces a two-year doping ban, had her contract with the club terminated Thursday following the announcement of the positive result on the website of the Turkish Basketball Federation. The federation, however, has yet to make a decision on Tauarsi's punishment. If Taurasi is suspended for more than six months it would put her 2012 Olympic status in jeopardy. She helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. On Tuesday, Geno Auriemma, the United States coach for the 2012 Olympics, said the former University of Connecticut star told him that she did not take modafinil. He also said he didn't know if Taurasi had any problems with sleeplessness. Taurasi led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with Phoenix in August. Taurasi is one of many American stars who play overseas in the winter because salaries are significantly higher than in the WNBA. She played in Russia for four years for Spartak before joining the Turkish league this season. Taurasi was leading the league in scoring with 24.6 points per game. Two of Taurasi's teammates at Fenerbahce have resisted doping tests in Turkey because they do not trust the lab that tested her samples. Australian player Penny Taylor and Czech teammate Hana Horakova provided samples only after the Turkish federation agreed to send them to Germany for testing at a lab in Cologne. The two players were tested after Fenerbahce's Turkish league game against Besiktas on Sunday. Modafinil has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 91 of 998 DOCUMENTS Associated Press Online January 6, 2011 Thursday 3:45 PM GMT Taurasi's 'B' sample positive for banned stimulant BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 440 words DATELINE: ANKARA Turkey Diana Taurasi's "B" sample tested positive for doping, putting in jeopardy her chances of playing for the United States at the 2012 London Olympics. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil following a Turkish league game on Nov. 13. The Fenerbahce player, who has been provisionally suspended by the team, could now be banned for two years. The Turkish Basketball Federation, which announced the positive "B" sample result Thursday on its website, said there was no immediate decision on Tauarsi's punishment. Fenerbahce said the club would make a final decision on her case at a later date. If Taurasi is suspended for more than six months it could keep her from playing in the 2012 Olympics. She helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. On Tuesday, Geno Auriemma, the U.S. coach for the 2012 Olympics, said the former University of Connecticut star told him that she did not take modafinil. He also said he didn't know if Taurasi had any problems with sleeplessness. Taurasi led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points last season. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with Phoenix in August. Taurasi is one of many American stars who play overseas in the winter because salaries are significantly higher than in the WNBA. She played in Russia for four years for Spartak before joining the Turkish league this season. Taurasi was leading the league in scoring with 24.6 points per game. Two of Taurasi's teammates at Fenerbahce have resisted doping tests in Turkey because they do not trust the lab that tested her samples. Australian player Penny Taylor and Czech teammate Hana Horakova provided samples only after the Turkish federation agreed to send them to Germany for testing at a lab in Cologne. The two players were tested after Fenerbahce's Turkish league game on Sunday. Modafinil has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both of her medals were stripped after she tested positive for the stimulant. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 92 of 998 DOCUMENTS Associated Press Online January 6, 2011 Thursday 3:59 PM GMT Taurasi has Turkish contract voided for doping BYLINE: By SELCAN HACAOGLU, Associated Press SECTION: SPORTS NEWS LENGTH: 583 words DATELINE: ANKARA Turkey American basketball star Diana Taurasi has had her contract terminated by Turkish club Fenerbahce after her "B" sample tested positive for doping. The Istanbul club says the decision was made Thursday following the results announcement by the Turkish Basketball Federation. Taurasi faces a ban of up to two years, putting in jeopardy her chances of playing for the United States at the 2012 London Olympics. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil following a Turkish league game on Nov. 13. Taurasi had been suspended by Fenerbahce ever since. The Turkish federation, which announced the positive "B" sample result on its website, says there has been no immediate decision on Taurasi's punishment. THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below. ANKARA, Turkey (AP) Diana Taurasi's "B" sample tested positive for doping, putting in jeopardy her chances of playing for the United States at the 2012 London Olympics. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil following a Turkish league game on Nov. 13. The Fenerbahce player, who has been provisionally suspended by the team, could now be banned for two years. The Turkish Basketball Federation, which announced the positive "B" sample result Thursday on its website, said there was no immediate decision on Tauarsi's punishment. Fenerbahce said the club would make a final decision on her case at a later date. If Taurasi is suspended for more than six months it could keep her from playing in the 2012 Olympics. She helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. On Tuesday, Geno Auriemma, the U.S. coach for the 2012 Olympics, said the former University of Connecticut star told him that she did not take modafinil. He also said he didn't know if Taurasi had any problems with sleeplessness. Taurasi led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points last season. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with Phoenix in August. Taurasi is one of many American stars who play overseas in the winter because salaries are significantly higher than in the WNBA. She played in Russia for four years for Spartak before joining the Turkish league this season. Taurasi was leading the league in scoring with 24.6 points per game. Two of Taurasi's teammates at Fenerbahce have resisted doping tests in Turkey because they do not trust the lab that tested her samples. Australian player Penny Taylor and Czech teammate Hana Horakova provided samples only after the Turkish federation agreed to send them to Germany for testing at a lab in Cologne. The two players were tested after Fenerbahce's Turkish league game on Sunday. Modafinil has been involved in several major doping cases, including that of American sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both of her medals were stripped after she tested positive for the stimulant. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 93 of 998 DOCUMENTS The Associated Press State & Local Wire January 6, 2011 Thursday 3:07 PM GMT Taurasi's 'B' sample positive for banned stimulant SECTION: SPORTS NEWS LENGTH: 136 words DATELINE: ANKARA Turkey The Turkish Basketball Federation says American star Diana Taurasi's "B" sample tested positive for doping. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil, following a Turkish league game on Nov. 13. The Fenerbahce player, who has been provisionally suspended by the team, could be banned for two years. If Taurasi is suspended for more than six months it would put her 2012 Olympics status with the U.S. national basketball team in jeopardy. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Taurasi led the WNBA in scoring for a league-record fourth straight year this past season, averaging 22.6 points. The five-time All-Star signed a multiyear contract extension with Phoenix in August. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 94 of 998 DOCUMENTS The Associated Press State & Local Wire January 6, 2011 Thursday 3:07 PM GMT LENGTH: 167 words BC-BKL--Doping-Taurasi,0289 Taurasi's 'B' sample positive for banned stimulant 2030 Eds: APNewsNow. AP Photo TXEG107 sptd/dskretta elfd/lon/clehourites fasst4922 fasst4921 ANKARA, Turkey (AP) The Turkish Basketball Federation says American star Diana Taurasi's "B" sample tested positive for doping. Taurasi's "A" sample tested positive last month for the banned stimulant modafinil, following a Turkish league game on Nov. 13. The Fenerbahce player, who has been provisionally suspended by the team, could be banned for two years. If Taurasi is suspended for more than six months it would put her 2012 Olympics status with the U.S. national basketball team in jeopardy. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. Taurasi led the WNBA in scoring for a league-record fourth straight year this past season, averaging 22.6 points. The five-time All-Star signed a multiyear contract extension with Phoenix in August. LOAD-DATE: January 7, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 95 of 998 DOCUMENTS Indian Patents News January 5, 2011 Wednesday 6:30 AM EST Mallinckrodt Inc. Files Patent Application for Improved Process for Preparing Benzhydrylthioacetamide LENGTH: 252 words New Delhi, Jan. 5 -- USA based Mallinckrodt Inc. filed patent application for improved process for preparing benzhydrylthioacetamide. The inventor is Liang Sidney. Mallinckrodt Inc. filed the patent application on April 21, 2006. The patent application number is 1383/CHENP/2006 A. The international classification number is C07C317/44. According to the Controller General of Patents, Designs & Trade Marks, "The present invention is directed to an improved process for preparing modafinil wherein benzhydrylthioacetate is prepared in high yield and purity by the reaction of a haloacetate with the reaction product of thiourea and benzhydrol. The reaction employing the haloacetate is conducted in a solvent comprising an organic solvent such as methanol having dissolved therein an organic base or an inorganic basic salt such as sodium bicarbonate. The resulting benzhydrylthioacetate can be amidated and then oxidized to provide the pharmaceutical grade modafinil in high yield and purity." Mallinckrodt, Inc. designs, manufactures, and distributes respiratory care, imaging products, and prescription pharmaceuticals. It offers contrast media and delivery systems, radiopharmaceuticals, and urology imaging systems for the diagnosis and treatment of diseases in various imaging procedures. The company also provides peptide products, including amino acid derivatives and resins, as well as solid liquid phase peptides, and hybrid fragment synthesis; and active pharmaceutical ingredients and specialty generics. LOAD-DATE: January 5, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Indian Patents News, distributed by Contify.com All Rights Reserved 96 of 998 DOCUMENTS Associated Press Worldstream January 3, 2011 Monday 6:16 PM GMT Report: Diana Taurasi's B sample also positive BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 494 words DATELINE: ANKARA Turkey Diana Taurasi's backup doping sample also came back positive for a banned substance and the American basketball star faces a possible two-year ban, Turkish news reports said Monday. The Turkish basketball federation did not immediately confirm the reports by the Dogan News agency and private NTV news channel, and neither news outlet cited a source for their reports. An official at Taurasi's Turkish club, Fenerbahce, also would not confirm the report and said the team had not yet been notified of the result. WNBA standout and former University of Connecticut star Taurasi tested positive for the stimulant modafinil while playing in Turkey's professional women's league. She was tested following a league game on Nov. 13 and the positive result was confirmed last month. Taurasi had been provisionally suspended by Fenerbahce pending the result of her "B" sample test, which was analyzed at the doping lab at Hacettepe University in Ankara. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to drug manufacturers. The stimulant has been involved in several major doping cases, including that of U.S. sprinter Kelli White, and is on the World Anti-Doping Agency's list of banned substances. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. If the positive "B" sample finding is confirmed by Turkey's basketball federation, it could lead to a ban of up to two years for Taurasi. It could also put Taurasi's 2012 Olympics standing with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Meanwhile, two of Taurasi's teammates at Fenerbahce resisted doping tests in Turkey because they do not trust the lab that tested her samples, Turkey's Haberturk newspaper said. Australian forward Penny Taylor and Hana Horakova of the Czech Republic provided samples only after the Turkish federation agreed to send them to Germany for testing at a lab in Cologne. The two players were tested after Fenerbahce's Turkish league game against Besiktas late Sunday. A Fenerbahce official confirmed the report. Taurasi led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. Taurasi was leading the league in scoring this season with 24.6 points a game. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. LOAD-DATE: January 4, 2011 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2011 Associated Press All Rights Reserved 97 of 998 DOCUMENTS Indian Patents News December 28, 2010 Tuesday 6:30 AM EST Cephalon Inc Files Patent Application for Modafinil Compositions LENGTH: 199 words New Delhi, Dec. 28 -- USA based Cephalon Inc filed patent application for modafinil compositions. The inventors are Magali Bourghol Hickey, Matthew Peterson, Orn Almarsson and Mark Oliveria. Cephalon Inc filed the patent application on Feb. 20, 2006. The patent application number is 00371/KOLNP/2006 A. The international classification number is A61K. According to the Controller General of Patents, Designs & Trade Marks, "Co-crystals and solvates of racemic, enantiomerically pure and enantiomerically mixed modafinil are formed and several important physical properties are modulated. The solubility, dissolution, bioavailability, dose response, and stability of modafinil can be modulated to improve efficacy in pharmaceutical compositions." Cephalon, Inc. (NASDAQ: CEPH) is a U.S. biopharmaceutical company co-founded in 1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist with the DuPont Company, who served as the company's chairman and chief executive officer until his death in December 2010. The company's name comes from the adjective "cephalic" meaning "related to the head or brain," and it was established primarily to pursue treatments for neurodegenerative diseases. LOAD-DATE: December 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 98 of 998 DOCUMENTS Indian Patents News December 27, 2010 Monday 6:30 AM EST Cephalon Inc Files Patent Application for Modafinil Compositions LENGTH: 283 words New Delhi, Dec. 27 -- UAE based Cephalon Inc filed patent application for modafinil compositions. The inventors are Magali Bourghol Hickey, Matthew Peterson, Orn Almarssonh and Mark Oliveira. Cephalon Inc filed the patent application on Sept. 4, 2006. The patent application number is 2534/KOLNP/2006 A. The international classification number is C07C 317/10. According to the Controller General of Patents, Designs & Trade Marks, "Polymorphs and solvates of racemic, enantiomerieally pure, and enantiomeriealiy mixed modafinil and formed and discussed, In addition, said forms are described as useful for the treatment of many conditions including, but not limited to, narcolepsy." Cephalon, Inc. (Public, NASDAQ:CEPH) is an international biopharmaceutical company engaged in the discovery, development and commercialization of products in four core therapeutic areas: central nervous system (CNS), pain, oncology and inflammatory disease. In addition to conducting an active research and development program, it markets seven products in the United States and numerous products in various countries throughout Europe and the world. Its principal product are its wakefulness products, PROVIGIL (modafinil) Tablets [C-IV] and NUVIGIL (armodafinil) Tablets [C-IV], which comprised 51% of its total consolidated net sales during the year ended December 31, 2009. During 2009, Cephalon, Inc. acquired an exclusive, worldwide license to the ImmuPharma investigational compound, LUPUZOR, which is in Phase IIb development for the treatment of systemic lupus erythematosus. In August 2009, Cephalon, Inc. acquired Arana Therapeutics Limited. In April 2010, the Company acquired Mepha, a pharmaceutical company. LOAD-DATE: December 27, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 99 of 998 DOCUMENTS PR Newswire December 27, 2010 Monday 8:30 AM EST Cephalon Receives Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated With Jet Lag Disorder LENGTH: 822 words DATELINE: FRAZER, Pa., Dec. 27, 2010 FRAZER, Pa., Dec. 27, 2010 /PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA. "Cephalon believes we met the agreed upon safety and efficacy endpoints in the NUVIGIL sNDA clinical study conducted under a Special Protocol Assessment. However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "As a result, the company is no longer pursuing this indication." About NUVIGIL NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. In patients with OSA, NUVIGIL is used along with airway treatments for this condition. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) in labeled indications were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.nuvigil.com. About Cephalon, Inc. Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at www.cephalon.com. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide the Cephalon current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion. Contacts: Media: Candace Steele Flippin 610-727-6231 (office) csteele@cephalon.com Investor Relations: Chip Merritt 610-738-6376 (office) cmerritt@cephalon.com Joseph Marczely 610-883-5894 (office) jmarczely@cephalon.com SOURCE Cephalon, Inc. CONTACT:Media: Candace Steele Flippin, +1-610-727-6231 (office), csteele@cephalon.com, or Investor Relations: Chip Merritt, +1-610-738-6376 (office), cmerritt@cephalon.com, or Joseph Marczely, +1-610-883-5894 (office), jmarczely@cephalon.com URL: http://www.prnewswire.com LOAD-DATE: December 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 PR Newswire Association LLC All Rights Reserved 100 of 998 DOCUMENTS The Sunday Times (Australia) December 26, 2010 Sunday 6 - Early Edition SHORTPASSES SECTION: Pg. 105 LENGTH: 397 words Murphy, Kelly back V8 SUPERCARS: Holden legend Greg Murphy's career is set to continue with former teammate Rick Kelly throwing the Kiwi icon a V8 lifeline. The former Bathurst winner is set to sign with Kelly Brothers Racing in a move that evokes memories of the famous K-Mart racing team. Murphy and Kelly won back-to-back Bathurst titles together in 2003-04. The duo will return to the golden days next year, with the talented veteran joining his former partner in a Pepsi-backed car. Maradona: I'm clean SOCCER: Diego Maradona says he is taking the president of the Argentine Football Association to court, accusing Julio Grondona of spreading false information about his problems with drugs and alcohol. Maradona says he has not had drugs or alcohol for six years. Grondona implied in a television interview this week that Maradona was using again. ``There are reasons for what happens (with Maradona) and everybody knows them,'' Grondona said. Taurasi drug shock BASKETBALL: American star Diana Taurasi tested positive for Modafinil while playing in a professional women's league in Turkey, the country's federation said. Neither her lawyer nor her team, Fenerbahce, would confirm Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of US sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy or sleep apnea. Smith all-a-Twitter CRICKET: South African captain Graeme Smith appealed for help on Twitter after discovering his much-loved Test cap had been stolen ahead of the Second Test against India. Smith said his green Proteas cap, which he was given for his first Test in 2002, had gone missing while travelling from Cape Town to Durban for the match beginning today. ``Realise this is a long shot, but had my test cap that I've used since my 1st test for proteas stolen on travel up to durbs,'' Smith tweeted. Leonardo's big leap SOCCER: Leonardo has crossed the great San Siro divide, with the former AC Milan coach being named as the successor to Rafael Benitez as boss of Inter Milan. The appointment makes him the first person to have coached both Milan giants. Long on personality, short on managerial experience, Leonardo Nascimento de Araujo was appointed AC Milan manager in May 2009, succeeding Chelsea-bound Carlo Ancelotti when still lacking the required managerial badges. LOAD-DATE: December 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: SDT Copyright 2010 Nationwide News Pty Limited All Rights Reserved 101 of 998 DOCUMENTS Buffalo News (New York) December 25, 2010 Saturday FINAL EDITION Around & About / News and notes SECTION: SPORTS; Pg. C3 LENGTH: 535 words Heat, Lakers ready to play Kobe Bryant and Lakers coach Phil Jackson haven't really checked out the Miami Heat much this season. They've caught late-night highlights and maybe logged a few minutes with a game from the opposite coast, but not a whole lot more. It's finally time for the two-time champions to get an up-close look at their most intriguing challengers. When LeBron James, Chris Bosh and -- maybe -- Dwyane Wade take on the Lakers in the NBA's Christmas showcase today (5 p.m., Chs. 7, 11), most players in both uniforms hesitate to pile any extra significance onto a television-manufactured event. Most minimize every aspect of it, saying it's no more than a holiday amusement for fans seeking a break from present-opening and eggnog-drinking. "I don't think it's a measuring stick for us," James said. "It's just another game." Yet competitiveness usually trumps Christmas for elite NBA players. Just ask Bryant -- or don't, since he tellingly hasn't spoken to the media since getting ejected from the Lakers' last game. "The personalities that are going to be matching up in this game, I don't know if it can get any bigger," said Derek Fisher, the Lakers point guard. The contest is one of five on the NBA schedule for today; all will be televised. ----- Taurasi fails test Diana Taurasi is facing one of the most difficult challenges to her stellar basketball career. The WNBA standout and former UConn star tested positive for a mild stimulant while playing in a pro league in Turkey, her lawyer told The Associated Press on Thursday night. Howard Jacobs said Taurasi's "A" sample came back positive from a lab in Turkey last week. He said the substance "was not a steroid or recreational drug," and that Taurasi has asked that her "B" sample be tested. The Turkish basketball federation said Friday that the substance in Taurasi's positive test was modafinil. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift work sleep disorder or sleep apnea, according to the website for prescription drug Provigil, which contains the substance. Neither Jacobs nor Taurasi's team, Fenerbahce, would confirm it was modafinil, which has been involved in several major doping cases. ----- Fay will step down David Fay is retiring from the U.S. Golf Association, his two decades as executive director marked by a steady push for golf's return to the Olympics and for the U.S. Open to be held on golf courses that anyone could play at a reasonable price. Fay's announcement Friday was somewhat of a surprise, although he turned 60 two months ago and said it was an important milestone for cancer survivors. He joined the USGA in 1978 and became its sixth executive director in 1989, serving under 12 presidents. Mike Butz, the deputy executive director since 1995, will take over Jan. 1 until a national search to find Fay's replacement. "Things are in good order," Fay said in a statement. "Our senior staff leaders, each of whom I have put into place, are highly talented and motivated. And looking ahead, there are a number of multiyear projects on the drawing board ... which makes this, for me, a good time to move on. Leave on a high note, as Seinfeld would say." From News and wire service reports. LOAD-DATE: December 27, 2010 LANGUAGE: ENGLISH DOCUMENT-TYPE: Briefs PUBLICATION-TYPE: Newspaper Copyright 2010 The Buffalo News All Rights Reserved 102 of 998 DOCUMENTS The Houston Chronicle December 25, 2010 Saturday 3 STAR EDITION Taurasi's woes compound Positive test could jeopardize Olympic status BYLINE: CHRONICLE NEWS SERVICES SECTION: SPORTS; Pg. 2 LENGTH: 436 words NEW YORK - WNBA standout and former Con- necticut star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor Fenerbahce, her team, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Howard Jacobs, Taurasi's lawyer, told the Associated Press. "We'll revisit it after the 'B' sample returns. They shouldn't be speaking about it at all." Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi, 28, has been provisionally suspended pending the testing of her "B" sample, early next month. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next Games. She has missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test Nov. 13, after the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national titles as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. LOAD-DATE: December 27, 2010 LANGUAGE: ENGLISH GRAPHIC: TAURASI PUBLICATION-TYPE: Newspaper Copyright 2010 The Houston Chronicle Publishing Company All Rights Reserved 103 of 998 DOCUMENTS Lewiston Morning Tribune (Idaho) December 25, 2010 Saturday Officials say substance in Taurasi case is modafinil :Turkish officials claim U.S. star tested positive for stimulant typically used to treat sleep disorders BYLINE: DOUG FEINBERG LENGTH: 735 words NEW YORK - WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. --- Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH GRAPHIC: No Caption: Diana Taurasi drives on Laura Summerton during an exhibition game this year between the U.S. and Australia. PUBLICATION-TYPE: Newspaper Copyright 2010 Tribune Publishing Co. All Rights Reserved 104 of 998 DOCUMENTS Monterey County Herald (California) December 25, 2010 Saturday Taurasi tests positive for stimulant in Turkey BYLINE: The Monterey County Herald SECTION: SPORTS LENGTH: 736 words NEW YORK (AP) WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH GRAPHIC: PUBLICATION-TYPE: Newspaper Copyright 2010 The Monterey County Herald All Rights Reserved 105 of 998 DOCUMENTS The New York Times December 25, 2010 Saturday Late Edition - Final Positive Test Could Mean Olympic Ban For Taurasi BYLINE: By JERE LONGMAN SECTION: Section B; Column 0; Sports Desk; Pg. 7 LENGTH: 958 words The Turkish basketball federation said Friday that the star player Diana Taurasi had tested positive for a stimulant that was identified as modafinil, a drug that enhances wakefulness and vigilance and is designed to treat narcolepsy, sleep apnea and sleep disorders related to shift work. Modafinil is also used off-label to combat jet lag and attention deficit disorder and recreationally to enhance alertness. The stimulant does not cause the anxiety and jitteriness associated with amphetamines. Athletes who use modafinil as a banned performance-enhancing substance, however, face suspension from competition for up to two years, according to the rules of the World Anti-Doping Agency. That could keep Taurasi from playing in the 2012 Olympics. Taurasi's case could still be declared a false positive and dismissed. But even if it were determined that Taurasi had taken the stimulant inadvertently, and a two-year ban were reduced, she could still face the loss of her Olympic eligibility. The International Olympic Committee instituted a controversial rule in 2008 that prohibits athletes from competing in the next Winter or Summer Games if they have served a doping suspension of six months or longer. Taurasi has been provisionally suspended by her Turkish club team, Fenerbahce of Istanbul, until the drug testing is completed, Howard L. Jacobs, Taurasi's California-based lawyer, said Friday. So far, she has missed two or three games, Jacobs said. Her doping case was first reported by The Associated Press. ''She doesn't believe that she's ever taken anything that's banned; the most logical explanation at this point is that the test is simply wrong,'' Jacobs said in a telephone interview. Taurasi, 28, a six-foot guard and forward, starred at the University of Connecticut and has won two league titles with the Phoenix Mercury of the W.N.B.A. She was named the league's most valuable player in 2009 and has led the league in scoring four times. She and Australia's Lauren Jackson are regarded by many as the two best women's players in the world. Taurasi played on the United States teams that won gold at the 2004 and 2008 Olympics, and in October, she helped lead the Americans to a gold medal at the world championships. She is considered vital to the Americans' chances of winning another gold at the 2012 London Olympics, where the favored Americans will be coached by Geno Auriemma, Taurasi's college coach. The news about Taurasi emerged only days after UConn set the major-college basketball record with its 89th consecutive victory. And although her doping case is unresolved, it was the second recent public embarrassment for Taurasi, who spent a day in jail in 2009 and was briefly suspended by the Mercury after pleading guilty to a charge of driving under the influence. A routine drug test was administered to Taurasi after a Fenerbahce game in early November, Jacobs said. Each urine sample is divided into two parts, an A sample and B sample. The A sample has tested positive, but the B sample has yet to be tested, Jacobs said. If an athlete's B sample comes back negative, the A sample is considered to have been a false positive, and the case is dismissed. Jacobs said that he hoped the B sample would be tested ''as soon as possible,'' perhaps the first week in January, but that the holidays ''were complicating things.'' Taurasi was upset that news about her test leaked before the testing was completed, Jacobs said. And because the entire case would be thrown out with a negative B sample, he said it was premature to talk about any possible sanctions like Olympic ineligibility. ''That's jumping three or four steps down the road,'' Jacobs said. ''Right now, we're focusing on getting the B sample tested. If it's negative, all this goes away.'' If the B sample does test positive, Jacobs will probably argue that Taurasi took the stimulant without her knowledge, perhaps in a mislabeled product like a supplement. ''When you're in a foreign country where you don't speak the language, it opens up possibilities,'' Jacobs said. It is unclear what sanctions would be applied by the Turkish basketball federation if the B sample returned positive, Jacobs said. Under the rules of the World Anti-Doping Agency, modafinil belongs to a class of drugs that calls for a two-year suspension from competition. It is also uncertain how Taurasi's W.N.B.A. eligibility would be affected. There are relatively few cases of known use of modafinil by athletes, especially not in association with other substances. Perhaps the most notorious case involved the American sprinter Kelli White, who tested positive for the stimulant while winning the 100 and 200 meters at the 2003 world track and field championships in Paris. White was later stripped of her medals upon admitting that modafinil was used with a cocktail of other prohibited substances as part of the Bay Area Laboratory Co-operative scandal. Other sports stars like Barry Bonds and Marion Jones were eventually linked to Balco. Dr. Gary Wadler of New York, chairman of the antidoping agency's prohibited list committee, said the illicit use by athletes of modafinil to gain an edge was ''another example of the advances of modern medicine being bastardized for non-legitimate purposes.'' ''It has stimulant effects akin to amphetamines,'' Wadler said. If Taurasi's B sample does test positive, and any suspension is reduced to six months to two years, her Olympic eligibility could still remain unsettled until shortly before the London Olympics. As of now, the International Olympic Committee does not permit a waiver request until an athlete is named to the team, Jacobs said. ''Somebody before London is going to challenge that rule,'' Jacobs said. ''It's a virtual certainty.'' URL: http://www.nytimes.com LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH GRAPHIC: PHOTO: The former UConn star Diana Taurasi, right, helped lead the United States to a gold medal at the world championships in October. (PHOTOGRAPH BY JAROSLAV OZANA/CTK, VIA ASSOCIATED PRESS) PUBLICATION-TYPE: Newspaper Copyright 2010 The New York Times Company 106 of 998 DOCUMENTS St. Louis Post-Dispatch (Missouri) December 25, 2010 Saturday THIRD EDITION Sports Digest SECTION: SPORTS; Pg. B2 LENGTH: 510 words DATELINE: 0 Taurasi's Olympic status in limbo after drug test Basketball player Diana Taurasi's positive test for a banned stimulant while playing professionally in Turkey could threaten her eligibility to play for the United States in the 2012 London Olympics. The Turkish basketball federation said Friday that she tested positive for a stimulant that was identified as modafinil, a drug that enhances wakefulness and vigilance and is designed to treat narcolepsy, sleep apnea and sleep disorders related to shift work. It also is used off-label to combat jet lag and attention deficit disorder, and it is used recreationally to enhance alertness. Athletes who use modafinil as a banned performance-enhancing substance, however, face suspension from competition for up to 2 years, according to the rules of the World Anti-Doping Agency. Taurasi's case still could be declared a false positive and dismissed. But even if it were determined that Taurasi took the stimulant inadvertently, and a 2-year ban was reduced, she still could face the loss of Olympic eligibility. She has been provisionally suspended by her Turkish club team, Fenerbahce of Istanbul, until the drug-testing procedure is completed. "She doesn't believe that she's ever taken anything that's banned; the most logical explanation at this point is that the test is simply wrong," said Howard L. Jacobs, Taurasi's lawyer. Taurasi, 28, a 6-foot guard, starred at the University of Connecticut and has won 2 WNBA titles while with Phoenix. She was named the WNBA's most valuable player in 2009 and has led the league in scoring 4 times. Taurasi played on the U.S. teams that won gold at the 2004 and 2008 Olympics. (New York Times) Fay to leave USGA - David Fay, 60, has decided to retire from the U.S. Golf Association after 21 years as the executive director, leaving a legacy that includes his successful push to stage the U.S. Open on public golf courses. Mike Butz, the deputy executive director, will replace Fay on an interim basis. Fay was behind bringing the U.S. Open to Bethpage Black in New York in 2002. It was such a big success that it returned in 2009, along with going to another public course at Torrey Pines in 2008. In coming years the U.S. Open will go to Chambers Bay outside Seattle and Erin Hills in Wisconsin, also public courses. (AP) Elsewhere - Diego Maradona says he is taking the president of Argentina's soccer federation to court, accusing Julio Grondona of spreading false information about his problems with drugs and alcohol. Maradona said he has not had drugs or alcohol for 6 years. Grondona implied in a TV interview this week that Maradona was using again. Maradona has been involved in a spat with Grondona since July, when Maradona's contract as national coach was not renewed. ... Former Clemson baseball coach Bill Wilhelm, who led the Tigers to more than 1,100 wins and 6 College World Series berths, died in Columbia, S.C., at age 81. A cause of death was not given. He coached the Tigers from 1958-1993 and never had a losing year. He had a record of 1,161-536-10. (AP) LOAD-DATE: December 27, 2010 LANGUAGE: ENGLISH DOCUMENT-TYPE: BRIEF PUBLICATION-TYPE: Newspaper Copyright 2010 St. Louis Post-Dispatch, Inc. All Rights Reserved 107 of 998 DOCUMENTS Tulsa World (Oklahoma) December 25, 2010 Saturday Final Edition Sports FYI BYLINE: Staff and Wire Reports SECTION: Sports; Pg. B2 LENGTH: 477 words Basketball Taurasi tests positive for modafinil: WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs said. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." The team's website said: "(Taurasi) is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out." If the "B' sample comes back positive, it could put her 2012 Olympics status in jeopardy. Players suspended for fighting in stands: The two Mississippi State players caught on camera fighting in the stands of the Diamond Head Classic have been suspended indefinitely and sent home from Hawaii. Renardo Sidney and Elgin Bailey, who are roommates, were involved in a fistfight after the Bulldogs' game Thursday night. The altercation lasted for several minutes before being broken up by teammates and coaches. MSU athletic director Scott Stricklin sent out a tweet on Friday saying "The actions that took place in Hawaii were embarrassing to all of us who love Mississippi State. This behavior will not be tolerated." Coach Rick Stansbury expressed his disappointment in a press release: "In my 13 years as a head coach, we've never had anything like this happen before," he said. It's the latest in a string of issues for Sidney. The NCAA ruled last March he had to repay $11,800 in improper benefits and sit out the remainder of the 2010 season and nine more games this season. Baseball Padres sign Hawpe: The San Diego Padres have agreed to terms of a one-year contract with Brad Hawpe to play first base, two people with knowledge said on Friday. Hawpe will replace three-time All-Star Adrian Gonzalez, who was traded to the Boston Red Sox earlier this month. Hawpe has mostly been an outfielder in seven big league seasons, with a handful of starts at first base. He was released by Colorado in August and signed by Tampa Bay. LOAD-DATE: December 26, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 The Tulsa World 108 of 998 DOCUMENTS The Washington Post December 25, 2010 Saturday Suburban Edition Taurasi tested positive for modafinil SECTION: SPORTS; Pg. D02 LENGTH: 757 words WNBA standout and former Connecticut star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the Web site for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce . . . tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's attorney, Howard Jacobs, told the Associated Press. "We'll revisit it after the 'B' sample returns. They shouldn't be speaking about it at all." Right-handed pitcher Ricky Nolasco has signed a three-year, $26.5 million contract with the Florida Marlins. Nolasco is expected to earn $6 million in 2011, $9 million in 2012 and $11.5 in 2013. He made $3.8 million last season, when he went 14-9 with a 4.51 ERA. The 28-year-old missed the final month after undergoing arthroscopic right knee surgery. . . . The San Diego Padres have agreed to terms of a one-year contract with Brad Hawpe to play first base, two people with knowledge of the deal told the Associated Press. They spoke on condition of anonymity because the deal is pending Hawpe passing a physical exam. Hawpe will replace three-time all-star Adrian Gonzalez, who was traded to the Boston Red Sox earlier this month. . . . The Pittsburgh Pirates claimed minor league left-hander Aaron Thompson off waivers and designated left-hander Wil Ledezma for assignment. Thompson was left unprotected by the Washington Nationals, who acquired him from Florida for first baseman Nick Johnson in 2009. Thompson, who made 26 starts at Class AA Harrisburg last season, was a first-round pick in 2005. Buffalo Sabres leading scorer Derek Roy will miss the rest of the season after tearing his left quadriceps tendon. General Manager Darcy Regier announced the center is expected to miss between four to six months, and will have surgery to repair the injury in the next couple of days. Roy was hurt Thursday in the first period of a 4-3 loss to Florida when he was driven into the boards by Dmitry Kulikov. . . . David Fay is retiring from the U.S. Golf Association, his two decades as executive director marked by a steady push for golf's return to the Olympics and for the U.S. Open to be held on golf courses that anyone could play. Fay's announcement was somewhat of a surprise, although he turned 60 two months ago and said it was an important milestone for cancer survivors. He joined the USGA in 1978 and became its sixth executive director in 1989. Mike Butz, the deputy executive director since 1995, will take over Jan. 1 until a national search to find Fay's replacement. . . . The two Mississippi State players caught on camera fighting in the stands of the Diamond Head Classic in Honolulu have been suspended indefinitely and sent home from Hawaii. Renardo Sidney and Elgin Bailey, who are roommates, were involved in a fistfight after the Bulldogs' game Thursday night. The altercation lasted for several minutes before being broken up by teammates and coaches. "I'm very sorry for this incident," Sidney said in a statement released by the university. "I had no intention of this ever happening. I apologize for embarrassing my family, all the Mississippi State fans, my teammates and coaches. I will learn from this and move on." MSU Athletic Director Scott Stricklin sent out a tweet, saying "The actions that took place in Hawaii were embarrassing to all of us who love Mississippi State. This behavior will not be tolerated." In a release from the university, Coach Rick Stansbury expressed his disappointment. "In my 13 years as a head coach, we've never had anything like this happen before," he said. "I am very disappointed in the actions of Elgin Bailey and Renardo Sidney and in no way does it reflect the overall picture of our program. It is not how we want our men's basketball team to be viewed nationally." LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH DISTRIBUTION: Every Zone PUBLICATION-TYPE: Newspaper Copyright 2010 The Washington Post All Rights Reserved 109 of 998 DOCUMENTS The Associated Press December 24, 2010 Friday 10:18 PM GMT Federation: Taurasi tests positive for modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 733 words DATELINE: NEW YORK WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 110 of 998 DOCUMENTS Breaking News from globeandmail.com December 24, 2010 Friday 2:37 PM GMT WNBA's Taurasi tests positive for banned substance; Women s league All-Star fails drug test while playing in Turkish pro league BYLINE: DOUG FEINBERG New York AP SECTION: GLOBESPORTS LENGTH: 736 words ABSTRACT Women s league All-Star fails drug test while playing in Turkish pro league FULL TEXT Diana Taurasi is facing one of the most difficult challenges to her stellar basketball career. The WNBA standout and former UConn star tested positive for a mild stimulant while playing in a pro league in Turkey, her lawyer told The Associated Press on Thursday night. Howard Jacobs said Taurasi's "A" sample came back positive from a lab in Turkey last week. He said the substance "was not a steroid or recreational drug," and that Taurasi has asked that her "B" sample be tested. The Turkish basketball federation said Friday that the substance in Taurasi's positive test was modafinil. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift work sleep disorder or sleep apnea, according to the website for prescription drug Provigil, which contains the substance. Neither Jacobs nor Taurasi's team, Fenerbahce, would confirm it was modafinil, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Taurasi has been provisionally suspended pending the testing of her "B" sample in the first week of January. She has already missed three games with Fenerbahce. In a statement posted on its website, the team said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentially has been breached and doping claims have been made even before the results of her test are out," the team said. Taurasi's positive test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. "We're taking it one step at a time," Jacobs said. "I'd rather not say what it is at this stage, they've only tested the 'A' sample. Somehow it leaked over in Turkey. We're waiting for the 'B' sample to be tested. We've had some difficulty with getting a date so far, mostly because of the holidays. We're hoping to get it as soon as we can." UConn coach Geno Auriemma could not be reached for comment by telephone. "While she is fully cooperating with authorities, there are serious doubts about the accuracy of the test results," Jacobs said in a statement to the AP. "We are confident that Diana will be fully vindicated once all the evidence is reviewed. She regrets that someone has violated the confidentiality rules of this process, and will make no further statement at this time." WNBA spokesman Ron Howard said the league had no comment. "In the 10 years of competition at the collegiate, professional and Olympic level," said Jacobs. "Diana Taurasi has never taken, been suspected of using, or tested positive for any performance enhancing substance." Jacobs said he didn't know what the length of the suspension would be, nor was he familiar with the details of the Turkish league's anti-doping code. He also said it was too early to know how this might affect Taurasi's eligibility for the London 2012 Olympics. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Taurasi, who has won two Olympic gold medals, helped guide the U.S. national team to the world championship in early October. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Reached at the Miami Heat-Phoenix Suns game, Rick Weltz, president of the Suns and Mercury, said the team had no comment. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 24, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2010 The Globe and Mail, a division of CTVglobemedia Publishing Inc. All Rights Reserved 111 of 998 DOCUMENTS St. Paul Pioneer Press (Minnesota) December 24, 2010 Friday Quick Hits / Taurasi may face Olympic ban BYLINE: From news services SECTION: SPORTS LENGTH: 510 words Diana Taurasi's positive test for a banned stimulant while playing professionally in Turkey could threaten her eligibility to play for the United States in the 2012 London Olympics. The Turkish basketball federation said Friday that Taurasi had tested positive for a stimulant identified as modafinil, a drug designed to treat narcolepsy, sleep apnea and sleep. It also is used off-label to combat jet lag and to enhance alertness. Athletes who use modafinil as a banned performance-enhancing substance face suspension from competition for up to two years, according to World Anti-Doping Agency rules. Even if it were determined that Taurasi took the stimulant inadvertently, and a two-year ban were reduced, she still could face the loss of Olympic eligibility.Colleges / NCAA weighs tougher penalties The NCAA has been busy this year investigating schools from Auburn to Georgia to North Carolina while trying to crack down on problems tied to sports agents. Most of the investigations are open cases with unknown consequences for the schools. But recommendations made by an NCAA panel two years ago for stricter punishments for schools tabbed as serious rules violators remain under consideration and could mark the first substantive revision to the NCAA's penalty system since 1985. "It's definitely not a dead issue," NCAA spokeswoman Stacey Osburn said. The panel's report is confidential. But interviews with the group's former chairman and others knowledgeable about its contents indicate the recommendations include: · A requirement that all schools found guilty of major violations lose scholarships. Current NCAA rules list that sanction as a "presumptive" penalty. · TV bans, a penalty not applied to Division I violators since 1996. · Clarified penalties for repeat offenders. The "death penalty" -- a program-crippling blow that keeps a team off the field while banning recruiting and scholarship awards -- has been on the books for 25 years but applied only once, to Southern Methodist for a pay-for-play football scandal in 1987. Repeat violators are defined as schools that run afoul of the NCAA more than once every five years. Miscellaneous / Marlins' Nolasco signs 3-year deal Right-handed pitcher Ricky Nolasco has signed a three-year, $26.5 million contract with the Florida Marlins. Nolasco, 28, made $3.8 million last season, when he went 14-9 with a 4.51 earned-run average. · The San Diego Padres agreed to terms of a one-year contract with Brad Hawpe to play first base, two people with knowledge of the deal told the Associated Press. Hawpe will replace three-time all-star Adrian Gonzalez, who was traded to the Boston Red Sox this month. · Former Clemson baseball coach Bill Wilhelm, who led the Tigers to more than 1,100 wins and six College World Series appearances, died in a Clemson, S.C., hospital. He was 81. · David Fay, 60, is retiring from the U.S. Golf Association, his two decades as executive director marked by a steady push for golf's return to the Olympics and for the U.S. Open to be held on golf courses that anyone could play at a reasonable price. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH GRAPHIC: PUBLICATION-TYPE: Newspaper Copyright 2010 St. Paul Pioneer Press All Rights Reserved 112 of 998 DOCUMENTS Associated Press Worldstream December 24, 2010 Friday 2:31 PM GMT Federation: Taurasi tested positive for modafinil BYLINE: By SUZAN FRASER, Associated Press SECTION: SPORTS NEWS LENGTH: 608 words DATELINE: ANKARA Turkey Basketball great Diana Taurasi tested positive for the stimulant modafinil and was provisionally suspended pending the result of her "B" sample test in January, Turkey's basketball federation and team officials said Friday. Taurasi was tested last month, following a Turkish league game between her team Fenerbahce and Istanbul University. A lab in the capital Ankara detected the stimulant in her "A" sample, the federation said in a statement. "A final decision (on her situation) will be taken as soon as the process leading to the opening of the 'B' sample is complete," the federation said. Taurasi's lawyer, Howard Jacobs, told The Associated Press Thursday that the player, who has so far missed three games with Fenerbahce, has stayed away from performance enhancing substances throughout her 10 years of competition at college, professional and Olympic level. "Diana Taurasi has never taken, been suspected of using, or tested positive for any performance enhancing substance," he said. Fenerbahce said in a statement posted on its website that Taurasi was upset that the doping claims broke before the testing process was finalized. Taurasi and teammate Anna Vajda were routinely tested following the Nov. 13 league game, the club said. Vajda tested negative for any banned substances, it said. Taurasi requested the "B" sample test, with the result to be disclosed on Jan. 2 or Jan. 4 in the presence of lawyers, Fenerbahce said. "She is extremely disturbed that her right to confidentially has been breached and doping claims have been made even before the results of her test are out," Fenerbahce said. Neither Jacobs nor Fenerbahce confirmed that Taurasi tested positive for modafinil, a banned stimulant involved in several major doping cases, including that of Kelli White. White won the 100 and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for modafinil. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift work sleep disorder or sleep apnea, according to the website for prescription drug Provigil, which contains the substance. Jacobs told the AP in a statement that while the player was fully cooperating with authorities, "there are serious doubts about the accuracy of the test results." "We are confident that Diana will be fully vindicated once all the evidence is reviewed." Jacobs said it was too early to tell how this might affect Taurasi's eligibility for the 2012 Olympics in London. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the subsequent games. Taurasi helped lead the University of Connecticut to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. Taurasi, who has won two Olympic gold medals, helped guide the U.S. national team to the world championship in early October. She led the WNBA in scoring for a league-record four straight years, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a drunk-driving charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi leads the league in scoring with 24.6 points a game. AP Basketball Writer Doug Feinberg in New York and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 113 of 998 DOCUMENTS Associated Press Worldstream December 24, 2010 Friday 10:07 PM GMT Federation: Taurasi tests positive for modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 728 words DATELINE: NEW YORK Basketball great Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 114 of 998 DOCUMENTS Associated Press Online December 24, 2010 Friday 6:24 PM GMT WNBA's Taurasi tests positive for banned substance BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 721 words DATELINE: NEW YORK Diana Taurasi is facing one of the most difficult challenges to her stellar basketball career. The WNBA standout and former UConn star tested positive for a mild stimulant while playing in a pro league in Turkey, her lawyer told The Associated Press on Thursday night. Howard Jacobs said Taurasi's "A" sample came back positive from a lab in Turkey last week. He said the substance "was not a steroid or recreational drug," and that Taurasi has asked that her "B" sample be tested. The Turkish basketball federation said Friday that the substance in Taurasi's positive test was modafinil. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift work sleep disorder or sleep apnea, according to the website for prescription drug Provigil, which contains the substance. Neither Jacobs nor Taurasi's team, Fenerbahce, would confirm it was modafinil, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Taurasi has been provisionally suspended pending the testing of her "B" sample in the first week of January. She has already missed three games with Fenerbahce. In a statement posted on its website, the team said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentially has been breached and doping claims have been made even before the results of her test are out," the team said. Taurasi's positive test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. "We're taking it one step at a time," Jacobs said. "I'd rather not say what it is at this stage, they've only tested the 'A' sample. Somehow it leaked over in Turkey. We're waiting for the 'B' sample to be tested. We've had some difficulty with getting a date so far, mostly because of the holidays. We're hoping to get it as soon as we can." UConn coach Geno Auriemma could not be reached for comment by telephone. "While she is fully cooperating with authorities, there are serious doubts about the accuracy of the test results," Jacobs said in a statement to the AP. "We are confident that Diana will be fully vindicated once all the evidence is reviewed. She regrets that someone has violated the confidentiality rules of this process, and will make no further statement at this time." WNBA spokesman Ron Howard said the league had no comment. "In the 10 years of competition at the collegiate, professional and Olympic level," said Jacobs. "Diana Taurasi has never taken, been suspected of using, or tested positive for any performance enhancing substance." Jacobs said he didn't know what the length of the suspension would be, nor was he familiar with the details of the Turkish league's anti-doping code. He also said it was too early to know how this might affect Taurasi's eligibility for the London 2012 Olympics. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Taurasi, who has won two Olympic gold medals, helped guide the U.S. national team to the world championship in early October. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Reached at the Miami Heat-Phoenix Suns game, Rick Weltz, president of the Suns and Mercury, said the team had no comment. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 115 of 998 DOCUMENTS Associated Press Online December 24, 2010 Friday 10:18 PM GMT Federation: Taurasi tests positive for modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: SPORTS NEWS LENGTH: 740 words DATELINE: NEW YORK WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. (This version CORRECTS to "confidentiality") LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 116 of 998 DOCUMENTS The Associated Press State & Local Wire December 24, 2010 Friday 6:24 PM GMT WNBA's Taurasi tests positive for banned substance BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: STATE AND REGIONAL LENGTH: 721 words DATELINE: NEW YORK Diana Taurasi is facing one of the most difficult challenges to her stellar basketball career. The WNBA standout and former UConn star tested positive for a mild stimulant while playing in a pro league in Turkey, her lawyer told The Associated Press on Thursday night. Howard Jacobs said Taurasi's "A" sample came back positive from a lab in Turkey last week. He said the substance "was not a steroid or recreational drug," and that Taurasi has asked that her "B" sample be tested. The Turkish basketball federation said Friday that the substance in Taurasi's positive test was modafinil. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift work sleep disorder or sleep apnea, according to the website for prescription drug Provigil, which contains the substance. Neither Jacobs nor Taurasi's team, Fenerbahce, would confirm it was modafinil, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Taurasi has been provisionally suspended pending the testing of her "B" sample in the first week of January. She has already missed three games with Fenerbahce. In a statement posted on its website, the team said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentially has been breached and doping claims have been made even before the results of her test are out," the team said. Taurasi's positive test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. "We're taking it one step at a time," Jacobs said. "I'd rather not say what it is at this stage, they've only tested the 'A' sample. Somehow it leaked over in Turkey. We're waiting for the 'B' sample to be tested. We've had some difficulty with getting a date so far, mostly because of the holidays. We're hoping to get it as soon as we can." UConn coach Geno Auriemma could not be reached for comment by telephone. "While she is fully cooperating with authorities, there are serious doubts about the accuracy of the test results," Jacobs said in a statement to the AP. "We are confident that Diana will be fully vindicated once all the evidence is reviewed. She regrets that someone has violated the confidentiality rules of this process, and will make no further statement at this time." WNBA spokesman Ron Howard said the league had no comment. "In the 10 years of competition at the collegiate, professional and Olympic level," said Jacobs. "Diana Taurasi has never taken, been suspected of using, or tested positive for any performance enhancing substance." Jacobs said he didn't know what the length of the suspension would be, nor was he familiar with the details of the Turkish league's anti-doping code. He also said it was too early to know how this might affect Taurasi's eligibility for the London 2012 Olympics. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. Taurasi, who has won two Olympic gold medals, helped guide the U.S. national team to the world championship in early October. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Reached at the Miami Heat-Phoenix Suns game, Rick Weltz, president of the Suns and Mercury, said the team had no comment. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 117 of 998 DOCUMENTS The Associated Press State & Local Wire December 24, 2010 Friday 10:18 PM GMT LENGTH: 791 words BC-BKL--Taurasi-Banned Substance, 7th Ld-Writethru,0982 Federation: Taurasi tests positive for modafinil 2030 Eds: Corrects to "confidentiality.". This story is part of AP's general news and sports services. AP Photo NY164, NY163, NY133 sptd/rrosenblatt sptd/sbuttar sptd/hrumberg sptd/jkosik fasst4921 By DOUG FEINBERG AP Basketball Writer NEW YORK (AP) WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 118 of 998 DOCUMENTS The Associated Press State & Local Wire December 24, 2010 Friday 10:18 PM GMT Federation: Taurasi tests positive for modafinil BYLINE: By DOUG FEINBERG, AP Basketball Writer SECTION: STATE AND REGIONAL LENGTH: 733 words DATELINE: NEW YORK WNBA standout and former UConn star Diana Taurasi tested positive for modafinil while playing in a professional women's league in Turkey, the country's basketball federation said Friday. Neither her lawyer nor her team, Fenerbahce, would confirm that Taurasi tested positive for the stimulant, which has been involved in several major doping cases, including that of U.S. sprinter Kelli White. Modafinil is used to counter excessive sleepiness due to narcolepsy, shift-work sleep disorder or sleep apnea, according to the website for the prescription drug Provigil, which contains the substance. The Turkish Basketball Federation statement cited a report from the lab at Hacettepe University and said: "... the urine sample taken from Diana Taurasi as a part of the regular process, after a game between Istanbul University and Fenerbahce ... tested positive for modafinil, one of the illegal substances on WADA's banned stimulants list, according to preliminary test results." WADA is the World Anti-Doping Agency. "We're not going to confirm what the drug is," Taurasi's lawyer, Howard Jacobs, told The Associated Press Friday. "We'll revisit it after the "B" sample returns. They shouldn't be speaking about it at all." White won the 100- and 200-meter races at the 2003 world championships in Paris, but both her medals were stripped after she tested positive for the stimulant. Jacobs said Taurasi's "A" sample came back positive last week and that the substance "was not a steroid or recreational drug." Taurasi has been provisionally suspended pending the testing of her "B" sample, sometime early next month. She has already missed three games with Fenerbahce. The team's website said she and another player were asked to submit to a test on Nov. 13, following the game against Istanbul. It said they were selected as a result of a draw. The other player tested negative. Fenerbahce said Taurasi was upset that the doping claims broke before the testing process was finalized. "She is extremely disturbed that her right to confidentiality has been breached and doping claims have been made even before the results of her test are out," the team's website said. If the "B' sample comes back positive, it could put her 2012 Olympics status with the U.S. national basketball team in jeopardy. She has helped the team win gold medals at the past two Olympics and was the leading scorer at the women's world championships, which the Americans won in early October. The International Olympic Committee bars any athlete given a doping penalty of six months or more from competing in the next games. "At this point we're aware of the situation and we're monitoring things and letting the process take its course," USA Basketball spokesman Craig Miller said. "Until that happens we can't comment." Taurasi's test came to light two days after the top-ranked Huskies won their 89th straight game, surpassing the UCLA men's winning streak from 1971-74. Taurasi helped lead UConn to three straight national championships as well as 70 consecutive victories from 2001-03. She was the AP Player of the Year in 2003. UConn's Geno Auriemma, who coached Taurasi and will lead the 2012 Olympic team, couldn't be reached for comment by telephone Friday. At the WNBA All-Star game last summer, Taurasi said the grind of playing basketball continuously for seven straight years was beginning to wear on her. At the time, she indicated fatigue could eventually force her to skip either the WNBA or European seasons. Taurasi is one of many WNBA stars who play overseas in the winter because of higher salaries. The best players can make up to 10 times their WNBA salaries, which top out at about $100,000. She led the WNBA in scoring for a league-record fourth straight year, averaging 22.6 points per game. The five-time All-Star and two-time WNBA champion signed a multiyear contract extension with the Phoenix Mercury in August. Taurasi served one day in jail and was suspended by the team for two games in 2009 after pleading guilty to a DUI charge. She played in Russia for four years for powerhouse Spartak before joining the Turkish League this season. That league also features WNBA stars Sylvia Fowles, Penny Taylor and Seimone Augustus. Taurasi is leading the league in scoring this season with 24.6 points a game. Associated Press Writers Suzan Fraser in Ankara, Turkey, and Erol Israfil in Istanbul contributed to the report. LOAD-DATE: December 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Associated Press All Rights Reserved 119 of 998 DOCUMENTS Canadian Medical Association. Journal December 14, 2010 Uplifting tales of life in the emergency department BYLINE: Deady, Brian SECTION: Pg. E870 Vol. 182 No. 18 ISSN: 0820-3946; CODEN: CMAJAX LENGTH: 688 words Books Uplifting tales of life in the emergency department The Night Shift: Real Life in the Heart of the E.R. Dr. Brian Goldman HarperCollins Publishers Ltd., 2010. Brian Goldman is one of those rare individuals who simultaneously pursues two careers. He has toiled for more than 20 years as an emergency physician at Mount Sinai Hospital in Toronto, Ontario while working as a medical journalist for the CBC, currently as host of CBC radio's White Coat, Black Art. Without claiming the same far-reaching influence of American media darlings, Oprah's Dr. Oz or CNN's Dr. Sanjay Gupta, he is as close as we get in this country to a medical celebrity. Goldman trades on his media personality with a book of his experiences in the emergency department and I am happy to report that it's a satisfying read. The storyline proceeds as if over one night shift, but the author concedes in the introduction that the book is a composite of his most interesting cases over the many years of his career. In addition to being a medical memoir, it's also a compilation of other physician's stories. The Night Shift rolls out along a timeline that begins at 9:15 pm one Friday evening as Goldman sets off to work. He arrives for a 10 pm start and is immediately thrust into the action. Cases are then laid out in chronological order, each one allowing the writer to riff onto other anecdotes. Along the way, the author weighs in on the many topics fundamental to emergency physicians including interactions with patients, police, consultants, residents and nurses, medical error and the schadenfreude that we sometimes feel (but shouldn't) when talking about a colleague's diagnostic blunder. Trauma care is central to the idea of what makes emergency medicine absorbing - at least in the public's mind - and Mount Sinai is not a trauma hospital, but this obstacle is neatly hurdled when our doctor-journalist draws on his radio interviews to bring the stories of other Canadian emergency physicians to the page. Reading like a who's who of Canadian emergency medicine, their narratives add considerable storytelling muscle to the book's physique. I was particularly struck by former Vancouver General emergency specialist, Bruce Campana, who is quoted throughout the volume. He should consider writing his own book. The pace is fast and the writing is engaging, but make no mistake, this is a book written for the nonmedical public. To that end, while the reader in me enjoyed the tour, my inner physician was sometimes nonplussed with the clinical explanations. For example, in describing the writhing discomfort of a 30-year-old woman, we learn that "It (the patient's abdomen) was rigid, which now suggested peritonitis, an inflammation of the membrane that lines part of the abdominal cavity, often caused by infection and treatable with antibiotics." While the patient, it quickly becomes apparent, is not suffering from this condition, the statement as presented is incomplete. Although I doubt it would detract from the flow of the paragraph for most readers, surely this gross simplification is likely to induce metaphorical scalpscratching among MDs. Goldman himself comes across as earnest, dedicated and diagnostically astute. And while he didn't have to do so, he bravely discusses his own perceived weaknesses as an emergency physician, medical miscalculations, sleep disorder and use of a prescription drug modafinil to stay alert during night shifts. Goldman admits to disliking criticism but these tablets serve as an example of the occasionally weak editing of the text. For example, at 9:15 pm on the way to his shift, "I popped a couple of modafinil pills." At 2:44 am, "I took a modafinil and headed to my next patient." At 5:18 am, "I resisted the urge to pop another modafinil. ... I do worry that one day I'll need three pills, then four, then five." Dear Brian, either that day has arrived or your editor needs a little pharmacologic assistance in the awake and alert department. But these comments seem like mere grousing. I finished the book surprisingly uplifted and proud to be part of the club which Goldman so ably describes. LOAD-DATE: December 20, 2010 LANGUAGE: ENGLISH ACC-NO: 2216346761 GRAPHIC: Photographs DOCUMENT-TYPE: Book Review-Favorable PUBLICATION-TYPE: Other (Periodical) JOURNAL-CODE: CMAJ Copyright 2010 Micromedia Limited All Rights Reserved Canadian Business and Current Affairs Copyright 2010 Canadian Medical Association 120 of 998 DOCUMENTS Indian Patents News December 14, 2010 Tuesday 6:30 AM EST Teva Pharmaceutical Industries Ltd Files Patent Application for Crystalline and Pure Modafinil and Process of Preparing the Same LENGTH: 348 words New Delhi, Dec. 14 -- Israel based Teva Pharmaceutical Industries Ltd filed patent application for crystalline and pure modafinil and process of preparing the same. The Inventors are Claude Singer, Neomi Gershon, Arina Ceausu, Anita Lieberman and Judith Aronhime. Teva Pharmaceutical Industries Ltd filed the patent application Oct. 26, 2006. The patent application number is 1259/MUMNP/2006 A. The International classification numbers are A61K31/165, C07C315/02 and C07C315/06. According to the Controller General of Patents, Designs & Trade Marks, "The present invention provides an improved process for preparing modafinil, whereby it may be isolated in high purity by a single crystallization. The process produces modafinil free of sulphone products of over-oxidation and other byproducts. The invention further provides new crystalline Forms II-VI of modafinil and processes for preparing them. Each of the new forms is differentiated by a unique powder X-ray diffraction pattern. The invention further provides pharmaceutical compositions containing novel modafinil Forms II-IV and VI." Teva Pharmaceutical Industries Limited (Teva) (Public, NASDAQ:TEVA) is a global pharmaceutical company that develops, produces and markets generic drugs covering all treatment categories. The Company has a pharmaceutical business, whose principal products are Copaxone for multiple sclerosis and Azilect for Parkinson's disease, respiratory products and women's health products. Teva's active pharmaceutical ingredient (API) business provides vertical integration to Teva's own pharmaceutical production. The Company's global operations are conducted in North America, Europe, Latin America, Asia and Israel. Teva has operations in more than 60 countries, including 38 finished dosage pharmaceutical manufacturing sites in 17 countries, 15 generic research and development (R&D) centers operating mostly within certain manufacturing sites and 21 API manufacturing sites around the world. On January 29, 2009, the Company sold its Israeli animal health product line to Phibro Animal Health Corporation. LOAD-DATE: December 14, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 121 of 998 DOCUMENTS The Times (London) December 7, 2010 Tuesday Edition 1; National Edition Pop go the pep pills; Jaded students, housewives, even doctors, have turned to smart drugs. Dr Margaret McCartney asks whether it is such a wise move BYLINE: Margaret McCartney SECTION: T2;FEATURES; Pg. 9 LENGTH: 1004 words It's the middle of the night and I'm e-mailing my anesthesiologist friend in the US. "I'm tired," I moan, although with the time-difference it is already evening for him. He, however, is organised and bright of eye. "You need modafinil," he replies, his e-mail pert and swift. "Seriously, it's the best thing." As a Scottish GP with too much to do, I harbour a suspicion of most drugs, prescribed or not. But as I cast my eyes around the room, piled with washing and ironing, and contemplate the week's taxi service requirements for my children, I realise that he is merely telling me what I'd rather not know: that lots of people, from students to housewives, have turned to "smart drugs". In 2000, it became apparent that the American Armed Forces were using such drugs, including Dexedrine and Restoril, to "prevent fatigue and maintain combat-ready performance" in pilots, according to a report. Only a few months ago, the British Medical Journal ran an editorial, "Pharmacological enhancement of performance in doctors", in which the authors, who were doctors and scientists, stated that the use of caffeine, Viagra, antidepressants and multivitamins was common and acceptable. Although the issues relating to the use of such medication might be complex, they wrote, "performance-enhancing drugs may have benefits for healthy, non-fatigued individuals". They concluded that "early indications are that members of society are more likely to agree with cognitive enhancement [of doctors] if motivations for using them are seen to be unselfish". But what's the reality behind the alluring prospect of better fighter pilots and more effective surgeons? Do "smart drugs" have the potential to make us smarter or do the side-effects do more harm than good? Amphetamines What are they: This group of drugs includes Dexedrine and treatments prescribed for attention deficit hyperactivity disorder (ADHD). Amphetamines are Class B drugs, also known as speed, which have long been favoured by clubbers keen to dance the night away. The drugs have been used in diet pills, for their effect on increasing metabolism, and are still sold illegally for this purpose. Useful for a boost? Even in cases of ADHD, they should be used only after other psychological and behavioural measures have been tried, according to NICE, the health service's treatment watchdog. Studies that suggest that there are benefits from taking amphetamines have involved only small numbers of patients - the studies that the BMJ report referred to involved 70 men and no women, and focused on lab tests, rather than real-life tasks. What are the side-effects: Addiction, cardiac problems, overdose, jitteriness and paranoia. There is a lack of research into the effects of amphetamines on routine tasks, including driving. Modafinil What is it: This drug, marketed as Provigil, can be prescribed to deal with "daytime sleepiness" caused by shift working or for narcolepsy (a condition where the person falls asleep without warning). However it is available on the internet, allowing buyers to use it for tiredness unrelated to shift work. Useful for a boost? A study published in the New England Journal of Medicine in 2005 compared 209 people with "shift-work disorder" who were given either modafinil or a placebo. Those taking modafinil reported less sleepiness during their night shift, but the real revelation was the proportion of people who reported an accident or a near accident on their commute home to bed. In the placebo group, it was 58 per cent and in the modafinil group, a third. So although fewer people in the group taking the drug were at risk of an accident, the proportion was still worryingly high. Another study claiming that emergency doctors worked smarter with modafinil was widely publicised, even though it had only 25 participants and the results were measured with paper-based tests rather than real-life outcomes. Modafinil was put on the list of banned drugs for athletes in 2004. What are the side-effects? Anxiety, high blood pressure, agitation and decreased libido as well as mania and suicidal thoughts. As many studies have been short, the longer-term effects, good or bad, aren't known. Some studies using MRI scans have suggested that the drug affects not just cognitive circuits but emotional ones. Is this a good thing? No one knows. Donepezil What is it: Known as Aricept, the drug for treating dementia, studies have recently suggested that it improves learning in people without dementia better than a placebo. It is not, at present, licensed for use to treat anything other than Alzheimer's. Useful for a boost? The study had just 12 people in it and has to be regarded as very preliminary. Other studies - notably from the US - have examined the use of Aricept in older adults and haven't found medium or longer-term boosts to learning or memory. Internet chatrooms are full of students who swear by it but, on the evidence at present, they'd be better off swotting instead. What are the side-effects? Heart irregularities but, in people who are prescribed it, it's usually tolerated. Pro-plus What is it: This is the older version of the modern smart pill, known to students everywhere. The makers say it "gives you a fast-acting caffeine boost that relieves fatigue and tiredness and helps you feel more awake". Two tablets contain 100mg of caffeine: in Starbucks, a small (short) coffee contains 160mg caffeine, with the biggest containing 400mg. Useful for a boost? Caffeine raises the heart rate and blood pressure, waking up tired minds. It's a quick fix that rapidly wears off so the dose has to be topped up. A Cochrane review - which examines all the evidence available - found some evidence that caffeine improved performance and memory in shift workers. What are the side-effects? Caffeine is legal, easy to obtain and delicious to drink. But we all know that getting to sleep after too much is difficult, and, of course, if sleep is what you really need, caffeine might end up being your enemy rather than your friend. LOAD-DATE: December 7, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: TIM Copyright 2010 Times Newspapers Limited All Rights Reserved 122 of 998 DOCUMENTS Indian Patents News November 19, 2010 Friday 6:30 AM EST Universitatsklinikum Freiburg Files Patent Application for the Gene PRV-1 and its Use LENGTH: 249 words New Delhi, Nov. 19 -- Germany based Universitatsklinikum Freiburg filed patent application for the gene PRV-1 and its use. The inventor is Heike Pahl. Universitatsklinikum Freiburg filed the patent application on March 27, 2002. The patent application number is IN/PCT/2002/00335/DEL A. The international classification number is A61K31/16. According to the Controller General of Patents, Designs & Trade Marks, "This invention relates to new uses of Modafinil and its D/L enantiomers, particularly the new uses in the pharmaceutical preparation field. This invention provides new uses of Modafinil and its D/L enantiomers in preparing the medicine for increasing and enhancing the quantity and quality of normal spermatozoa in male mammals, the medicine for enhancing the pregnant capacity in female mammals, the medicine for treating infertility, subfertility and sex dysfunction in male and female mammals, and the medicine for enhancing the sexual function in mammals." The University Medical Center Freiburg (Universitatsklinikum Freiburg) in Freiburg, Germany is the teaching hospital and part of the medical research unit of the University of Freiburg and home to its Faculty of Medicine. The medical center is one of the largest and most reputable in Europe, due to its extensive clinical capabilities and advances in research. Medical services at the University of Freiburg date back to the university's founding in 1457, as the Faculty of Medicine was one of the four founding faculties. LOAD-DATE: November 19, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 123 of 998 DOCUMENTS CNS Drug News October 25, 2010 FDA approves REMS for Nuvigil and Provigil SECTION: NEWS LENGTH: 252 words On 21st October, Risk Evaluation and Mitigation Strategies (REMS) for Cephalon's medications, Nuvigil (armodafinil) Tablets [C-IV] and Provigil (modafinil) Tablets [C-IV], were approved by the FDA. Nuvigil, the longer-lasting isomer of modafinil, is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnoea (OSA), shift work disorder (SWD) or narcolepsy. Meanwhile, Provigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated OSA, shift work sleep disorder, also known as SWD, and narcolepsy. Both the Nuvigil and Provigil REMS consist of a medication guide to inform patients about the potential risks associated with the use of these medications, a communication plan and a timetable for submission of assessments of the REMS. The communication plan includes a "Dear Healthcare Professional" letter, a prescriber brochure, a pharmacist action letter and a dedicated REMS internet site. The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions. The current product labelling for both medications contains a bolded warning that includes these risks. Neither medication is approved for use in the paediatric population for any indication. In accordance with the approved REMS, the company is currently updating Nuvigil and Provigil labelling to include the medication guide. LOAD-DATE: October 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: CNS Drug News Copyright 2010 Espicom Business Intelligence All Rights Reserved 124 of 998 DOCUMENTS PR Newswire October 22, 2010 Friday 4:38 PM EST Cephalon Announces FDA Approval of Risk Evaluation and Mitigation Strategies for NUVIGIL and PROVIGIL; REMS Addresses Potential Risks Currently Included In Labeling LENGTH: 1087 words DATELINE: FRAZER, Pa., Oct. 22 FRAZER, Pa., Oct. 22 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL® (armodafinil) Tablets [C-IV] and PROVIGIL® (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA). Both the NUVIGIL and PROVIGIL REMS consist of a Medication Guide to inform patients about the potential risks associated with the use of these medications, a communication plan and a timetable for submission of assessments of the REMS. The communication plan includes a Dear Healthcare Professional Letter, a Prescriber Brochure, a Pharmacist Action Letter and a dedicated REMS Internet Site. The introduction of the NUVIGIL and PROVIGIL REMS programs is consistent with the company's commitment to safe and appropriate use of its medications. The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions. The current product labeling for both medications contains a bolded warning that includes these risks. Neither medication is approved for use in the pediatric population for any indication. In accordance with the approved REMS, the company is currently updating NUVIGIL and PROVIGIL labeling to include the Medication Guide. The NUVIGIL and PROVIGIL Medication Guides will be available on each product website, www.nuvigil.com and www.provigil.com, and will be dispensed with every prescription. Information on both products is also available by calling 1-800-896-5855. More information on Cephalon and its products is available at www.cephalon.com. About NUVIGIL NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. In patients with OSA, NUVIGIL is used along with other medical treatments for this condition. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.nuvigil.com. About PROVIGIL PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. In patients with OSA, PROVIGIL is used along with other medical treatments for this condition. The PROVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults and children taking modafinil. PROVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (greater than five percent) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness and dyspepsia. Full prescribing information for PROVIGIL is available at www.provigil.com. About Cephalon, Inc. Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at www.cephalon.com. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide the Cephalon current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion. Contacts: Media: Candace Steele Flippin 610-727-6231 (office) csteele@cephalon.com Investor Relations: Chip Merritt 610-738-6376 (office) cmerritt@cephalon.com Joseph Marczely 610-883-5894 (office) jmarczely@cephalon.com SOURCE Cephalon, Inc. CONTACT:CONTACT: Media: Candace Steele Flippin, +1-610-727-6231, csteele@cephalon.com, or Investor Relations: Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com, or Joseph Marczely, +1-610-883-5894, jmarczely@cephalon.com, all of Cephalon, Inc. URL: http://www.prnewswire.com LOAD-DATE: October 23, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 PR Newswire Association LLC All Rights Reserved 125 of 998 DOCUMENTS Indian Patents News October 15, 2010 Friday 6:30 AM EST Wockhardt Ltd Files Patent Application for Bilayer Tablet Composition of Modafinil LENGTH: 284 words New Delhi, Oct. 15 -- India based Wockhardt Ltd filed patent application for bilayer tablet composition of modafinil. The inventors are Jain Nitin Anand Kumar, Murali Narayanan and Jain Girish Kumar. Wockhardt Ltd filed the patent application on April 27, 2007. The patent application number is 811/MUM/2007 A. The International classification number is A61K9/20. According to the Controller General of Patents, Designs & Trade Marks, "The present invention provides a bilayer tablet comprising modafinil or pharmaceutical^ acceptable salts thereof wherein the tablet comprises micronized and unmicronized modafinil particles. Modafinil is a wakefulness-promoting agent indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. It has molecular weight of 273.36. The chemical name of modafinil is (2-[(diphenylmethyl) sulfinyl] acetamide. Its empirical formula is C15H15NO2S." Wockhardt Limited (WL) (Public, BOM:532300) is an India-based an integrated pharmaceutical, biotechnology and healthcare company. The Company is a subsidiary of Khorakwala Holdings and Investments Private Limited. The Company's cardiology division covers lifestyle diseases, which include diabetes and nephrology, supported by biotechnology products, such as Wosulin, Glaritus and Wepox. As of March 31, 2010, the Company had seven hospitals with 800 inpatient beds. The Company's subsidiaries includes Wockhardt Biopharm Limited, Vinton Healthcare Limited, Wockhardt Infrastructure Development Limited, Wockhardt UK Holdings Limited, CP Pharmaceuticals Limited, Wallis Group Limited and The Wallis Laboratory Limited. LOAD-DATE: October 15, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 126 of 998 DOCUMENTS Indian Patents News October 15, 2010 Friday 6:30 AM EST Wockhardt Ltd Files Patent Application for Pharmaceutical Composition of Modafinil or Salts Thereof LENGTH: 241 words New Delhi, Oct. 15 -- India based Wockhardt Ltd filed patent application for pharmaceutical composition of modafinil or salts thereof. The inventors are Huda Inderjeetsingh, Murali Narayanan and Jain Girish Kumar. Wockhardt Ltd filed the patent application on April 27, 2007. The patent application number is 810/MUM/2007 A. The International classification number is A61K9/16. According to the Controller General of Patents, Designs & Trade Marks, "The present invention provides a pharmaceutical composition of modafinil or pharmaceutical^ acceptable salts thereof comprising mixture of micronized and unmicronized modafinil particles, sodium starch glycolate in admixture with one or more pharmaceutically acceptable excipients." Wockhardt Limited (WL) (Public, BOM:532300) is an India-based an integrated pharmaceutical, biotechnology and healthcare company. The Company is a subsidiary of Khorakwala Holdings and Investments Private Limited. The Company's cardiology division covers lifestyle diseases, which include diabetes and nephrology, supported by biotechnology products, such as Wosulin, Glaritus and Wepox. As of March 31, 2010, the Company had seven hospitals with 800 inpatient beds. The Company's subsidiaries includes Wockhardt Biopharm Limited, Vinton Healthcare Limited, Wockhardt Infrastructure Development Limited, Wockhardt UK Holdings Limited, CP Pharmaceuticals Limited, Wallis Group Limited and The Wallis Laboratory Limited. LOAD-DATE: October 15, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 127 of 998 DOCUMENTS Mondaq September 22, 2010 Wednesday 12:00 AM EST "Grave Consequences" Defence may be Asserted Against a Generic in a Section 8 Action Under The PM(NOC) Regulations BYLINE: Mr Intellectual Property Group LENGTH: 869 words Sep. 22, 2010 (Mondaq delivered by Newstex) -- Apotex Inc. v. Shire Canada Inc., 2010 FC 828 In an action brought by Apotex Inc. (Apotex) to recover damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133)(Regulations) in respect of the medicine modafinil, Shire Canada Inc. (Shire) brought this motion for leave to amend its statement of defence, alleging two new defences. Apotex opposed Shire's motion, arguing that the proposed amendments did not disclose a reasonable defence and ought not to be permitted. The prothonotary struck out the first proposed amendment, finding that a defence based on the outcome of a separate infringement action to which Shire was not a party would be speculative and hypothetical, but permitted the second proposed amendment which alleged a "grave consequences" defence. Background Apotex filed an abbreviated new drug submission (ANDS), seeking a notice of compliance (NOC) that would allow it to market its generic Apo-modafinil tablets, by comparing its tablets to Shire's modafinil product. Shire had listed Canadian patent no. 2,201,967 (the '967 patent) on the patent register in respect of its modafinil tablets. On March 16, 2006, Apotex served a notice of allegation (NOA) on Shire, alleging that the claims of its '967 patent were invalid, void and of no effect. In response, Shire commenced an application for an order prohibiting the issuance of a NOC to Apotex. This application was dismissed two years later, on April 25, 2008. Apotex obtained a NOC shortly after the judgment was released and now seeks damages under section 8 of the Regulations for the delay in issuance of the NOC resulting from Shire's unsuccessful application for a prohibition order. Defence based on a separate action by Cephalon Inc. (NASDAQ:CEPH) For its first proposed new defence, Shire proposed to rely on the outcome of a separate infringement action against Apotex commenced by the owner of the '967 patent, Cephalon Inc. (Cephalon). Shire argued that, should the '967 patent be found to be valid and infringed in that other action, Apotex should not be entitled to recover any damages in the present proceeding based on the loss of infringing sales. The prothonotary struck this proposed defence, finding that the outcome of the Cephalon action was an uncertain future event which was not susceptible of being determined or even influenced in the context of the present action. This was the essence of a speculative and hypothetical pleading that ought to be struck. Moreover, these issues could not be determined unless and until the proceedings by Cephalon in the other court file were resolved. This would unreasonably delay, embarrass and prejudice the trial of the present action by Apotex againt Shire. Defence based on the "Grave Consequences" Doctrine For its second proposed new defence, Shire sought to rely on the existence of Canadian patent no. 2,165,824 (the '824 patent), a second patent listed on the patent register against Shire's modafinil tablets. In particular, in a NOA served on Shire by Apotex, dated August 30, 2005, Apotex alleged that it would not infringe the '824 patent on the basis of its draft product monograph and gave an undertaking that it would not make, use or sell its tablets for the patented use of treatment of sleep apnea or ventilation problems of central origin. However, according to Shire, Apotex's product monograph does include the patented indication, and Apotex has sold its modafinil tablets for such use in breach of its undertaking. Shire therefore seeks to allege that Apotex breached this undertaking, giving rise to the possible finding of "grave consequences", alluded to by the Federal Court of Appeal, in the form of a denial of any remedy for delayed entry into the market pursuant to section 8 of the Regulations. Apotex argued that subsection 8(5) of the Regulations, which requires the court to take into account "all matters that it considers relevant to the assessment of the amount, including any conduct [of the parties] which contributed to delay the disposition of the application", should be interpreted as any valid defence arising exclusively in the context of the very prohibition proceeding that was dismissed or discontinued. The prothonotary, however, found that Apotex's argument raised a difficult question that should not be determined on a motion to strike. It was reasonably arguable that the Court could conclude that Apotex's breach of an undertaking, if established, could affect the assessment of damages. Apotex therefore did not meet the very heavy onus of showing that this proposed defence was plainly and obviously devoid of any merit and stood no chance of success whatsoever. The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Mr Intellectual Property Group Stikeman Elliott LLP Suite 5300 Commerce Court West 199 Bay Street Toronto M5L 1B9 CANADA Tel: 4168695500 Fax: 4169470866 E-mail: info@stikeman.com URL: www.stikeman.com Click Here for related articles(c) Mondaq Ltd, 2010 - Tel. +44 (0)20 8544 8300 - Newstex ID: MNDQ-5508-48970758 LOAD-DATE: September 22, 2010 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs on Demand® shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs on Demand®. Reader's comments reflect their individual opinion and their publication within Blogs on Demand® shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2010 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2010 Mondaq 128 of 998 DOCUMENTS Mondaq Business Briefing September 22, 2010 Canada: "Grave Consequences" Defence may be Asserted Against a Generic in a Section 8 Action Under The PM(NOC) Regulations BYLINE: Intellectual Property Group LENGTH: 839 words Apotex Inc. v. Shire Canada Inc., 2010 FC 828 In an action brought by Apotex Inc. (Apotex) to recover damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133) (Regulations) in respect of the medicine modafinil, Shire Canada Inc. (Shire) brought this motion for leave to amend its statement of defence, alleging two new defences. Apotex opposed Shire's motion, arguing that the proposed amendments did not disclose a reasonable defence and ought not to be permitted. The prothonotary struck out the first proposed amendment, finding that a defence based on the outcome of a separate infringement action to which Shire was not a party would be speculative and hypothetical, but permitted the second proposed amendment which alleged a "grave consequences" defence. Background Apotex filed an abbreviated new drug submission (ANDS), seeking a notice of compliance (NOC) that would allow it to market its generic Apo-modafinil tablets, by comparing its tablets to Shire's modafinil product. Shire had listed Canadian patent no. 2,201,967 (the '967 patent) on the patent register in respect of its modafinil tablets. On March 16, 2006, Apotex served a notice of allegation (NOA) on Shire, alleging that the claims of its '967 patent were invalid, void and of no effect. In response, Shire commenced an application for an order prohibiting the issuance of a NOC to Apotex. This application was dismissed two years later, on April 25, 2008. Apotex obtained a NOC shortly after the judgment was released and now seeks damages under section 8 of the Regulations for the delay in issuance of the NOC resulting from Shire's unsuccessful application for a prohibition order. Defence based on a separate action by Cephalon Inc. For its first proposed new defence, Shire proposed to rely on the outcome of a separate infringement action against Apotex commenced by the owner of the '967 patent, Cephalon Inc. (Cephalon). Shire argued that, should the '967 patent be found to be valid and infringed in that other action, Apotex should not be entitled to recover any damages in the present proceeding based on the loss of infringing sales. The prothonotary struck this proposed defence, finding that the outcome of the Cephalon action was an uncertain future event which was not susceptible of being determined or even influenced in the context of the present action. This was the essence of a speculative and hypothetical pleading that ought to be struck. Moreover, these issues could not be determined unless and until the proceedings by Cephalon in the other court file were resolved. This would unreasonably delay, embarrass and prejudice the trial of the present action by Apotex againt Shire. Defence based on the "Grave Consequences" Doctrine For its second proposed new defence, Shire sought to rely on the existence of Canadian patent no. 2,165,824 (the '824 patent), a second patent listed on the patent register against Shire's modafinil tablets. In particular, in a NOA served on Shire by Apotex, dated August 30, 2005, Apotex alleged that it would not infringe the '824 patent on the basis of its draft product monograph and gave an undertaking that it would not make, use or sell its tablets for the patented use of treatment of sleep apnea or ventilation problems of central origin. However, according to Shire, Apotex's product monograph does include the patented indication, and Apotex has sold its modafinil tablets for such use in breach of its undertaking. Shire therefore seeks to allege that Apotex breached this undertaking, giving rise to the possible finding of "grave consequences", alluded to by the Federal Court of Appeal, in the form of a denial of any remedy for delayed entry into the market pursuant to section 8 of the Regulations. Apotex argued that subsection 8(5) of the Regulations, which requires the court to take into account "all matters that it considers relevant to the assessment of the amount, including any conduct [of the parties] which contributed to delay the disposition of the application", should be interpreted as any valid defence arising exclusively in the context of the very prohibition proceeding that was dismissed or discontinued. The prothonotary, however, found that Apotex's argument raised a difficult question that should not be determined on a motion to strike. It was reasonably arguable that the Court could conclude that Apotex's breach of an undertaking, if established, could affect the assessment of damages. Apotex therefore did not meet the very heavy onus of showing that this proposed defence was plainly and obviously devoid of any merit and stood no chance of success whatsoever. The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Mr Intellectual Property Group Stikeman Elliott LLP Suite 5300 Commerce Court West 199 Bay Street Toronto M5L 1B9 CANADA Tel: 4168695500 Fax: 4169470866 E-mail: info@stikeman.com URL: www.stikeman.com LOAD-DATE: October 4, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Mondaq Ltd. All Rights Reserved 129 of 998 DOCUMENTS Reuters Health Medical News September 15, 2010 Wednesday 9:00 PM EST Armodafinil does not improve cognitive deficits in schizophrenia SECTION: DRUG & DEVICE DEVELOPMENT LENGTH: 408 words DATELINE: NEW YORK Adjunctive armodafinil, the longer-lasting isomer of modafinil, doesn't improve cognitive deficits in patients with schizophrenia, researchers report in an August 24th online paper in the Journal of Clinical Psychiatry. Dr. John M. Kane, of The Zucker Hillside Hospital in Glen Oaks, New York, and colleagues randomized 60 patients (mean age 43 years) with stable schizophrenia to adjunctive treatment with once-daily placebo or armodafinil 50, 100, or 200 mg. Fifteen patients were assigned to each group; 49 (82%) completed the 4-week study. Changes in cognitive deficits from baseline to the final visit were similar following armodafinil or placebo, as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score. Mean changes ranged from 1.9 with 50 mg to 2.9 with 200 mg; scores in the placebo group fell in the middle. In two previous trials, modafinil-treated patients didn't differ from placebo-treated patients in the Scale for the Assessment of Negative Symptoms (SANS) scores. Similarly, in the current study, there were no clinically meaningful reductions in the SANS total score. Armodafinil was generally well tolerated. The most common adverse events were diarrhea and headache. Treatment did not cause psychosis to worsen. Patients who received armodafinil 200 mg did have greater improvement in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) than those who received placebo, but the results were not statistically significant. The mechanism of action of armodafinil is not known. "A weak DAT (dopamine transporter) inhibitor such as armodafinil, which may preferentially influence the dopaminergic activity in the prefrontal cortex but not in the limbic system, could, hypothetically, reduce negative symptoms without worsening positive symptoms--the effect suggested in this study," Dr. Kane and colleagues write. They also say that "treating negative symptoms of schizophrenia is important because these symptoms are debilitating for patients and because antipsychotic therapies are often not adequate to treat them." Their conclusion is that more study is needed to determine the potential efficacy of modafinil on negative symptoms. The study was sponsored by Cephalon, the manufacturer of armodafinil, which either employs or has financial relationships with all the paper's seven authors. SOURCE: http://link.reuters.com/fek83p SOURCE: J Clin Psychiatry 2010. LOAD-DATE: September 16, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Reuters Health All Rights Reserved 130 of 998 DOCUMENTS Generic Line August 4, 2010 Wednesday FTC Denies Improper Behavior in Watson Pay-for-Delay Case SECTION: Vol. 27 No. 15 LENGTH: 575 words The FTC says it did not engage in improper behavior as part of its pay-for-delay investigation into Watson Pharmaceuticals and has reaffirmed its request to subpoena CEO Paul Bisaro to see if the company brokered an illicit deal to keep Provigil generics off the market. The commission also rebuts an accusation from Bisaro that it attempted to broker a deal between Watson and Apotex to produce a generic version of Provigil ( modafinil), according to a detailed FTC filing to the U.S. District Court for the District of Columbia. The FTC is still waiting for Bisaro to explain whether a 2006 agreement Watson entered into with Cephalon, Provigil's manufacturer, included a stipulation that Watson delay launching generic modafinil in exchange for payments, it says. The commission was required to answer questions from Bisaro's lawyers as part of an order issued last month by Judge Alan Kay (Generic Line, July 21). "This Court finds that the facts before it present a strong possibility that the FTC did share confidential information with Watson's competitor, that it did attempt to broker a deal between Apotex and Watson that would require Watson to relinquish any statutory 'first filer' rights it had acquired, and that it did initiate this investigation to pressure Watson to relinquish these rights and to harass it when it refused," Kay wrote. During conversations with Watson counsel Steven Sunshine in March 2009, Markus Meier, assistant director in the FTC's Bureau of Competition, brought up an idea "through a series of hypothetical questions" that would involve Watson licensing, relinquishing or sharing its 180-day marketing exclusivity, the commission says. Sunshine then authorized Meier to contact Apotex regarding a possible deal between the two companies, the FTC adds. After informing Apotex of Watson's interests, the FTC says it didn't play any role in further discussions between the companies, nor did it divulge proprietary information as claimed by Bisaro. But Kay sided with Watson, saying that the commission pressured the company to enter into the deal. "The facts before us suggest that the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex," Kay said. Heightened Suspicions The FTC's suspicions into Watson's actions were heightened in January 2009 when it learned that on the same day a second patent related to Provigil was listed in the FDA's Orange Book, Watson filed an ANDA challenging it. That would give Watson "first-filer" status. "FTC staff sought to understand practically how a generic company would be aware of a later-issued patent so that it would be in the position to file an ANDA amendment on precisely the same day that the brand company listed such later issued patent with the FDA," the commission says in its filing. "Put simply, FTC staff was trying to assess whether a generic company was likely to have such information independently or whether such information was likely available to the generic only as a result of collusion with the brand company to create an additional barrier to impede potential generic entry," it continues. Watson told Generic Line it would not respond to the FTC's filing in keeping with its policy of not commenting on ongoing litigation. -- Jonathan Block Release date: Aug. 4, 2010 LOAD-DATE: August 6, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 131 of 998 DOCUMENTS Washington Drug Letter August 2, 2010 Monday FTC: Nothing Improper Done in Investigation of Watson SECTION: Vol. 42 No. 30 LENGTH: 306 words The FTC says it did not engage in improper behavior as part of its pay-for-delay investigation into Watson Pharmaceuticals and has reaffirmed its request to subpoena CEO Paul Bisaro to see if the company brokered an illicit deal to keep Provigil generics off the market. The commission also rebuts an accusation from Bisaro that it attempted to broker a deal between Watson and Apotex to produce a generic version of Provigil ( modafinil), according to a detailed FTC filing to the U.S. District Court for the District of Columbia. The FTC is still waiting for Bisaro to explain whether a 2006 agreement Watson entered into with Cephalon, Provigil's manufacturer, included a stipulation that Watson delay launching generic modafinil in exchange for payments, it says. The commission was required to answer questions from Bisaro's lawyers as part of an order issued earlier this month by Judge Alan Kay (WDL, July 19). The FTC's suspicions into Watson's actions were heightened in January 2009 when it learned that on the same day a second patent related to Provigil was listed in the FDA's Orange Book, Watson filed an ANDA challenging it. That would give Watson "first-filer" status. "FTC staff sought to understand practically how a generic company would be aware of a later-issued patent so that it would be in the position to file an ANDA amendment on precisely the same day that the brand company listed such later issued patent with the FDA," the commission says in its filing. "Put simply, FTC staff was trying to assess whether a generic company was likely to have such information independently or whether such information was likely available to the generic only as a result of collusion with the brand company to create an additional barrier to impede potential generic entry," it continues. -- Jonathan Block Release date: Aug. 2, 2010 LOAD-DATE: August 2, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 132 of 998 DOCUMENTS Global Insight July 29, 2010 EMA Recommends Limiting Use of Modafinil to Narcolepsy Treatment BYLINE: Brendan Melck SECTION: In Brief LENGTH: 228 words The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has concluded a safety review of drugs including the active pharmaceutical ingredient modafinil, concluding with the recommendation that drugs including this API should only be used to treat narcolepsy. The drug should no longer be used in the treatment of idiopathic hypersomnia, shift-work sleep disorder, or excessive sleepiness associated with obstructive sleep apnoea, the committee concluded. The safety review was initiated due to concerns relating to potential skin and subcutaneous tissue reactions and psychiatric disorders resulting from the use of modafinil. The CHMP decided that only in the case of narcolepsy did modafinil's benefits outweigh its risks, and so all other indications should be removed from its marketing authorisation. Its recommendations have now been passed to the European Commission for final approval. Significance:The decision of the CHMP (assuming the Commission gives it binding approval) will certainly have some effect on producers of drugs containing modafinil, such as the drug's developer Cephalon (U.S.), with its Provigil product, Mitsubishi Tanabe of Japan, with its Modiodal, and generics producers. Such producers can expect to suffer some consequences in reduced revenues from these products if the recommendation is approved. LOAD-DATE: July 29, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2010 World Markets Research Limited All Rights Reserved 133 of 998 DOCUMENTS Drug Industry Daily July 26, 2010 Monday FTC Denies Improper Behavior in Watson Pay-for-Delay Investigation SECTION: Vol. 9 No. 143 LENGTH: 468 words The FTC says it did not engage in improper behavior as part of its pay-for-delay investigation into Watson Pharmaceuticals and has reaffirmed its request to subpoena CEO Paul Bisaro to see if the company brokered an illicit deal to keep Provigil generics off the market. The commission also rebutted an accusation from Bisaro that it attempted to broker a deal between Watson and Apotex to produce a generic version of Provigil (modafinil), according to a detailed filing to the U.S. District Court for the District of Columbia on Thursday. The FTC says it is still waiting for the executive to explain whether a 2006 agreement Watson entered into with Cephalon, Provigil's manufacturer, included a stipulation that Watson delay launching generic modafinil in exchange for payments. The commission was required to answer questions from Bisaro's lawyers as part of an order given earlier this month by Judge Alan Kay (DID, July 15). According to the FTC, during conversations with Watson counsel Steven Sunshine in March 2009, Markus Meier, assistant director in the agency's Bureau of Competition, brought up an idea "through a series of hypothetical questions" that would involve Watson licensing, relinquishing or sharing its 180-day marketing exclusivity. The commission says Sunshine then authorized Meier to contact Apotex regarding a possible deal between Apotex and Watson. The FTC further states that after informing Apotex of Watson's interests, it didn't play any role in further discussions between the two companies, nor did it ever divulge proprietary information as claimed by Bisaro. The FTC's suspicions into Watson were heightened in January 2009, after finding out that on the same day a second patent related to Provigil was listed in the FDA's Orange Book, Watson filed an ANDA challenging it. That would give Watson "first-filer" status. "FTC staff sought to understand practically how a generic company would be aware of a later-issued patent so that it would be in the position to file an ANDA amendment on precisely the same day that the brand company listed such later issued patent with the FDA," according to the commission's filing. "Put simply, FTC staff was trying to assess whether a generic company was likely to have such information independently or whether such information was likely available to the generic only as a result of collusion with the brand company to create an additional barrier to impede potential generic entry." Watson told DID it would not respond to the FTC's filing, as it has a policy of not commenting on ongoing litigation. Congress is attempting to scuttle pay-for-delay deals in the future. A provision in the supplemental war appropriations bill, currently before the Senate, would ban the practice (DID, July 6). -- Jonathan Block Release date: July 26, 2010 LOAD-DATE: July 26, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 134 of 998 DOCUMENTS Global Insight July 26, 2010 New Zealand's Pharmac Seeks Feedback on Modavigil Application BYLINE: Aparna Krishnan SECTION: In Brief LENGTH: 202 words New Zealand's drug reimbursement agency, Pharmac, has proposed funding CSL Biotherapies' Modavigil (modafinil) under the restricted Special Authority criteria. The drug is intended for patients with narcolepsy, but the agency has sought to restrict its use to patients with narcolepsy who cannot tolerate methylphenidate or dexamphetamine or in whom both methylphenidate and dexamphetamine are contraindicated. Pharmac has sought feedback on the proposal in view of the proposed drug funding from 1 October 2010. Significance:If approved, modafinil 100-mg tablets would be listed in Section B of the Pharmaceutical Schedule at a price and subsidy of NZ$72.50 (US$52.8) per pack of 30 tablets. The scope of overall reimbursement revenues from the drug is expected to be affected due to the restrictions. It is significant to note that the Pharmacology and Therapeutics Advisory Committee reviewed CSL's application for modafinil in February 2007 and recommended restricted listing use to patients with diagnosed excessive daytime sleepiness associated with narcolepsy and who cannot tolerate methylphenidate and dexamphetamine or in whom methylphenidate and dexamphetamine were contraindicated, with a low priority. LOAD-DATE: July 27, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2010 World Markets Research Limited All Rights Reserved 135 of 998 DOCUMENTS The Pharmaceutical Journal July 26, 2010 Modafinil use should be restricted to narcolepsy, says European Medicines Agency LENGTH: 246 words Modafinil should be used for the treatment of narcolepsy only, the European Medicines Agency has advised. Currently, modafinil is licensed for the treatment of daytime sleepiness associated with narcolepsy, obstructive sleep apnoea syndrome and chronic shift work. However, a review by the agency's Committee for Medicinal Products for Human Use concluded that the benefits of modafinil only outweigh the risks when used for the treatment of narcolepsy - and that all other indications should be withdrawn from the medicine's marketing authorisation. The review was initiated because of safety concerns about psychiatric disorders and serious skin and subcutaneous tissue reactions associated with modafinil. The CHMP found the risk of developing skin and hypersensitivity reactions to be higher in children than in adults and also recommend that modafinil should not be prescribed for people under 18 years of age. The CHMP also identified a number of cardiovascular risks associated with the drug and advised that it should be contraindicated in patients with uncontrolled moderate-to-severe hypertension and in patients with cardiac arrhythmias. The CHMP's recommendations have been forwarded to the European Commission for the adoption of a binding decision valid throughout the EU. The decision-making phase usually takes two to three months and the European Commission follows the CHMP's scientific opinion in almost all cases, a spokeswoman for the EMA told PJ Online.   LOAD-DATE: July 30, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Journal Copyright 2010 PJ Online All Rights Reserved 136 of 998 DOCUMENTS CNS Drug News July 23, 2010 EMA recommends restricting use of modafinil SECTION: NEWS LENGTH: 361 words The European Medicines Agency (EMA) has recommended restricting the use of modafinil-containing medicines. The medicine should only be used to treat sleepiness associated with narcolepsy. Doctors and patients should no longer use the medicine for the treatment of idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder. Modafinil is a wakefulness-promoting agent, currently licensed in 21 countries in Europe. It is available as Modasomil, Modiodal, Provigil and Vigil (from Cephalon), and as generic medicines. The review by the Agency's CHMP was initiated because of a number of safety concerns, relating to psychiatric disorders, skin and subcutaneous tissue reactions, as well as significant off-label use and potential for abuse. On the basis of the available data, the Committee concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication of narcolepsy. For all other indications, the Committee found that the risk for development of skin or hypersensitivity reactions and neuropsychiatric disorders outweighed the evidence for clinically-important efficacy. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines. The risk of development of serious skin and hypersensitivity adverse reactions appears to be higher in children than in adults. The Committee concluded that the product information should carry a recommendation saying that modafinil should not be prescribed to children. The CHMP also identified particular cardiovascular risks with modafinil and recommended that the use of the medicine be contraindicated in patients with uncontrolled moderate-to-severe hypertension and in patients with cardiac arrhythmias. There are some reports that modafinil is being used recreationally for "performance enhancement". However, the data seen by the Committee did not allow it to make firm recommendations regarding this risk. The CHMP has requested that the marketing authorisation holders continue to provide further information to monitor the potential for abuse. LOAD-DATE: July 23, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: CNS Drug News Copyright 2010 Espicom Business Intelligence All Rights Reserved 137 of 998 DOCUMENTS Elsevier Global Medical News July 22, 2010 Thursday 08:06 PM GMT EMA Announces Review Findings, Decisions on Modafinil, Rotarix, and More BYLINE: By Jennie Smith, Elsevier Global Medical News LENGTH: 774 words A number of drugs ranging from treat sleep apnea medications to vaccines have been under review by the European Medicines Agency, and these review findings, as well as other decisions made by the agency were announced July 22. In a written statement, the agency reported that it would restrict the prescribing of medicines containing modafinil to people with narcolepsy only - preferably laboratory-confirmed narcolepsy - and requested that manufacturers change their product labeling accordingly. Concluding a 3-year review of the medications, the EMA cited concerns about abuse of the wakefulness-promoting drug, along with reports of psychiatric reactions including psychosis, adverse cardiovascular reactions, and serious allergic skin reactions, in its decision. The drug should no longer be used to treat obstructive sleep apnea, shift-work sleep disorder, or idiopathic hypersomnia, the agency said, all indications for which it is licensed in the European Union. The new, restricted indication must be approved by the European Commission before it becomes binding. According to the EMA's new prescribing information, modafinil should be used "only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy has been made in accordance with ICSD [International Classification of Sleep Disorders] diagnostic criteria. Such an evaluation usually consists, in addition to the patient's history, of sleep measurements testing in a laboratory setting." The agency said it also was asking manufacturers to collect data on why modafinil was being prescribed off label and investigating reports of its abuse among university students. Also on July 22, the EMA said it had concluded a review of topical medicines containing the nonsteroidal anti-inflammatory drug ketoprofen. The drug has been licensed since 1978 in all European countries but the Netherlands, but recently has been plagued by reports of increased skin photosensitivity, photoallergy even in dim light, and cosensitization with octocrylene, a chemical used in sunscreens. In December 2009, France suspended the marketing authorization of medicines containing ketoprofen and asked the EMA to consider a similar ban in the EU. Though the EMA did not follow suit, concluding that the risk of reaction was very low, it did advise that topical ketoprofen be used only when prescribed and that manufacturers strengthen product warnings on sun exposure and octocrylene. These recommendations, too, await European Commission approval before they are binding. The EMA found that the porcine circovirus type 1 (PCV1) particles present in the Rotarix vaccine posed no health risk to the public. Rotarix is an oral vaccine used in infants, particularly in developing countries, to protect against gastroenteritis-causing rotavirus infections. The agency began its review of the vaccine after the surprise discovery of PCV1 in batches of the vaccine in March (J. Virol. 2010;84:6033-40). Data from tests carried out by the manufacturer, GlaxoSmithKline, "showed that the vaccine contained only very small amounts of live PCV1. The viral particles may have always been present in the vaccine, and have been found in the raw material used to make the vaccine. Their presence was detected only now because of the emergence of new technology," the agency said. Nonetheless, the EMA noted, the manufacturer has since pledged to eliminate PCV1 from future batches of vaccine. Earlier in the month, July 9, the EMA announced that it was reviewing medicines containing rosiglitazone, a second-line diabetes treatment used alone (Avandia) or in combination with metformin (Avandamet) or glimepiride (Avaglim). Since rosiglitazone's initial EU marketing authorization 10 years ago, rosiglitazone-containing regimens been associated with increased cardiovascular risks that product information and warnings have been altered to reflect. The EMA said on July 22 that it was continuing to evaluate newly published findings on rosiglitazone and cardiovascular events, including myocardial infarction, heart failure, and stroke (JAMA 2010;304 [doi:10.1001/jama.2010.920] and Arch. Intern Med. 2010;170 [doi:10.1001/archinternmed.2010.207]). The rosiglitazone review, the EMA said, would not be finished until September 2010. Until then, it cautioned clinicians to adhere closely to existing warnings and not prescribe rosiglitazone for patients with current or previous heart failure, acute coronary syndrome, ischemic heart disease, or peripheral arterial disease. Rosiglitazone and insulin can be used together only in exceptional cases and under close supervision. LOAD-DATE: July 22, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: NewsWire Copyright 2010 Elsevier Inc., International Medical News Group All Rights Reserved 138 of 998 DOCUMENTS Generic Line July 21, 2010 Wednesday Judge Orders FTC to Answer for Tactics in Provigil Case SECTION: Vol. 27 No. 14 LENGTH: 506 words A federal judge has ordered the FTC to answer questions about allegations it released proprietary information as it tried to thwart a reverse-payment settlement between Watson Pharmaceuticals and Cephalon over Cephalon's drug Provigil. Judge Alan Kay of the U.S. District Court of the District of Columbia this month issued an order instructing the FTC to answer questions posed in a motion by Watson CEO Paul Bisaro, who claims the commission shared proprietary company information with Apotex. The FTC challenged Watson's licensing agreement -- a "pay-for-delay" deal -- for the excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping the result would be cheaper modafinil generics. "This Court finds that the facts before it present a strong possibility that the FTC did share confidential information with Watson's competitor, that it did attempt to broker a deal between Apotex and Watson that would require Watson to relinquish any statutory 'first filer' rights it had acquired, and that it did initiate this investigation to pressure Watson to relinquish these rights and to harass it when it refused," Kay wrote. Bisaro has claimed that the FTC's efforts to subpoena him as part of a pay-for-delay investigation was tantamount to harassment, prompting his lawyers to file a request that the commission answer questions related to its alleged information sharing (Generic Line, June 9). The FTC must provide the court, by July 23, descriptions of communications it had with the FDA and third parties regarding potential marketing exclusivity for generic modafinil and whether any confidential information was disclosed. 'Rock and a Hard Place' "The facts before us suggest that the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex," Kay added. Glenn Lammi, an attorney with the Washington Legal Foundation, told Generic Line Kay's ruling was "extraordinary, considering how infrequently judges allow discoveries in these cases." Kay, however, rejected a request from Bisaro's lawyers to depose Markus Meier, assistant director of the FTC's Bureau of Competition Health Care Division. Last month, two senators pressed FTC Chairman Jon Leibowitz on the agency's alleged action in the Watson matter, with Leibowitz claiming Meier did not breach the company's confidentiality (Generic Line, June 23). FTC Bureau of Competition Director Richard Feinstein disagreed with Kay's ruling, adding the agency has done nothing improper. The FTC "is simply trying to complete a law enforcement investigation into whether there is an agreement to keep generic drugs off the market and out of the hands of consumers," Feinstein said. "We are disappointed that our investigation has been sidetracked by the unfounded implications of opposing counsel." -- Jonathan Block Release date: July 21, 2010 LOAD-DATE: July 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 139 of 998 DOCUMENTS Global Insight July 21, 2010 U.S. Court Reprimands FTC over Provigil Decision BYLINE: Aparna Krishnan SECTION: In Brief LENGTH: 265 words The U.S. Federal Trade Commission (FTC) has been reprimanded by a U.S. court, which indicated a "strong possibility" of engaging improperly in litigation relating to the sleep drug Provigil (modafinil). According to a written order by the judge at the U.S. District Court for the District of Columbia, the improper conduct refers to the FTC's sharing of confidential information about Provigil marketer, Watson Pharma, with its competitor, the generics firm Apotex (Canada), in an attempt to broker a deal between the two. The judge noted, "the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex". The full order can be accessedhere. However, in an email statement to Reuters, the FTC Competition Bureau Director, Richard Feinstein, has strongly denied wrongdoing. Significance:The public reproach of the FTC's actions reflects on the federal agency's attempts to intervene in such generic drug deals. The FTC has been a strong and vocal advocator of prohibiting the "pay-for-delay" generic deals and has suggested that such agreements between innovators and generic drug makers keep lower cost generic drugs off the market. On the Provigil case, Watson Pharma entered into an agreement with Cephalon (U.S.) along with other generic drug makers to sell modafinil. The innovator, Cephalon, recently lost its bid to dismiss the pay-for-delay lawsuit in Pennsylvania (seeUnited States: 31 March 2010:). LOAD-DATE: July 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2010 World Markets Research Limited All Rights Reserved 140 of 998 DOCUMENTS Washington Drug Letter July 19, 2010 Monday Judge Orders FTC to Answer Watson CEO's Allegations SECTION: Vol. 42 No. 28 LENGTH: 496 words A federal judge has ordered the FTC to answer questions about allegations it released proprietary information as it tried to thwart a reverse-payment settlement between Watson Pharmaceuticals and Cephalon over Cephalon's drug Provigil. Judge Alan Kay of the U.S. District Court of the District of Columbia Tuesday issued an order instructing the FTC to answer questions posed in a motion by Watson CEO Paul Bisaro, who claims the commission shared proprietary company information with Apotex. The FTC challenged Watson's licensing agreement -- a "pay-for-delay" deal -- for the excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping the result would be cheaper modafinil generics. "This Court finds that the facts before it present a strong possibility that the FTC did share confidential information with Watson's competitor, that it did attempt to broker a deal between Apotex and Watson that would require Watson to relinquish any statutory 'first filer' rights it had acquired, and that it did initiate this investigation to pressure Watson to relinquish these rights and to harass it when it refused," Kay wrote. Bisaro has claimed the FTC's efforts to subpoena him as part of a pay-for-delay investigation was tantamount to harassment, prompting his lawyers to file a request that the commission answer questions related to its alleged information sharing (WDL, June 7). The FTC must provide the court, by July 23, descriptions of communications it had with the FDA and third parties regarding potential marketing exclusivity for generic modafinil and whether any confidential information was disclosed. "The facts before us suggest that the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex," Kay added. Glenn Lammi, an attorney with the Washington Legal Foundation, told WDL Kay's ruling was "extraordinary, considering how infrequently judges allow discoveries in these cases." Kay, however, rejected a request from Bisaro's lawyers to depose Markus Meier, assistant director of the FTC's Bureau of Competition Health Care Division. Last month, two senators pressed FTC Chairman Jon Leibowitz on the agency's alleged action in the Watson matter, with Leibowitz claiming Meier did not breach the company's confidentiality (WDL, June 14). FTC Bureau of Competition Director Richard Feinstein disagreed with Kay's ruling, adding the agency has done nothing improper. The FTC "is simply trying to complete a law enforcement investigation into whether there is an agreement to keep generic drugs off the market and out of the hands of consumers," Feinstein said. "We are disappointed that our investigation has been sidetracked by the unfounded implications of opposing counsel." -- Jonathan Block Release date: July 19, 2010 LOAD-DATE: July 19, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 141 of 998 DOCUMENTS Drug Industry Daily July 15, 2010 Thursday Judge Orders FTC to Answer Watson CEO's Allegations SECTION: Vol. 9 No. 136 LENGTH: 497 words A federal judge has ordered the FTC to answer questions about allegations it released proprietary information as it tried to thwart a reverse-payment settlement between Watson Pharmaceuticals and Cephalon over Cephalon's drug Provigil. Judge Alan Kay of the U.S. District Court of the District of Columbia Tuesday issued an order instructing the FTC to answer questions posed in a motion by Watson CEO Paul Bisaro, who claims the commission shared proprietary company information with Apotex. The FTC challenged Watson's licensing agreement -- a "pay-for-delay" deal -- for the excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping the result would be cheaper modafinil generics. "This Court finds that the facts before it present a strong possibility that the FTC did share confidential information with Watson's competitor, that it did attempt to broker a deal between Apotex and Watson that would require Watson to relinquish any statutory 'first filer' rights it had acquired, and that it did initiate this investigation to pressure Watson to relinquish these rights and to harass it when it refused," Kay wrote. Bisaro has claimed that the FTC's efforts to subpoena him as part of a pay-for-delay investigation was tantamount to harassment, prompting his lawyers to file a request that the commission answer questions related to its alleged information sharing (DID, June 1). The FTC must provide the court, by July 23, descriptions of communications it had with the FDA and third parties regarding potential marketing exclusivity for generic modafinil and whether any confidential information was disclosed. "The facts before us suggest that the FTC sought to place Watson between a rock and a hard place, where the only way Watson could clear its name and escape further FTC scrutiny was to give in to the pressure the FTC was placing on Watson to enter into the business deal with Apotex," Kay added. Glenn Lammi, an attorney with the Washington Legal Foundation, told DID Kay's ruling was "extraordinary, considering how infrequently judges allow discoveries in these cases." Kay, however, rejected a request from Bisaro's lawyers to depose Markus Meier, assistant director of the FTC's Bureau of Competition Health Care Division. Last month, two senators pressed FTC Chairman Jon Leibowitz on the agency's alleged action in the Watson matter, with Leibowitz claiming Meier did not breach the company's confidentiality (DID, June 11). FTC Bureau of Competition Director Richard Feinstein disagreed with Kay's ruling, adding the agency has done nothing improper. The FTC "is simply trying to complete a law enforcement investigation into whether there is an agreement to keep generic drugs off the market and out of the hands of consumers," Feinstein said. "We are disappointed that our investigation has been sidetracked by the unfounded implications of opposing counsel." -- Jonathan Block Release date: July 15, 2010 LOAD-DATE: July 15, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 142 of 998 DOCUMENTS Indian Patents News July 12, 2010 Monday 6:30 AM EST French Inventors Develop 'Combination of Modafinil and an Antagonist or Inverse Agonist of the H3 Receptor' LENGTH: 107 words New Delhi, July 12 -- Schwartz Jean-Charles and Lecomte Jeanne-Marie of Bioprojet, Paris, France have developed 'combination of modafinil and an antagonist or inverse agonist of the H3 receptor'.Bioprojet filed the patent application on Feb. 18, 2009. The patent application number is 380/MUMNP/2009 A.According to the Controller General of Patents, Designs & Trade Marks, "The invention relates to the combination of modafinil and at least one antagonist or inverse agonist of the histamine H3 receptor, which is particularly useful for the treatment of narcolepsy-cataplexy and more generally for sleeping, vigilance or attention disorders." LOAD-DATE: July 12, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 143 of 998 DOCUMENTS The Express July 7, 2010 Wednesday Edition 1; National Edition 'Smart drugs' help students pass exams BYLINE: Sarah OGrady SECTION: NEWS; Pg. 7 LENGTH: 246 words MORE students than ever are using "smart drugs" to boost their exam performance, senior drug advisers warn. A growing number of undergraduates - and their professors - are buying prescription drugs such as Modafinil and Ritalin over the internet from suppliers as far away as India. Barbara Sahakian, professor of clinical neuropsychology at the University of Cambridge, said: "I've seen students tear open the envelope from Mumbai in excitement. "But when you are accessing drugs over the internet it's completely unsupervised. "You might be on other drugs or have some preexisting condition that means you shouldn't be taking it." Studies show Modafinil increases motivation and ability to concentrate, but it can be dangerous for people with high blood pressure. Side effects of Ritalin can include mood swings, increased heart rate, dizziness and insomnia. Prof Sahakian was asked to research the problem by the Advisory Council for the Misuse of Drugs. She has called for a Government policy review on smart drugs. A recent survey of 1,000 Cambridge undergraduates showed that one in 10 had used cognitive-enhancing drugs - also known as "professor's little helpers". Another third said they would use them if they had access to them. One in five academics also admitted taking the drugs. But fears are growing that students who order the drugs online could be exposing themselves to health risks or buying counterfeit drugs. They can also get hooked and can't wean themselves off them. LOAD-DATE: July 7, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: DXP Copyright 2010 Express Newspapers All Rights Reserved 144 of 998 DOCUMENTS Indian Patents News June 24, 2010 Thursday 6:30 AM EST Irish Inventors Develop Nanoparticulate Formulations of Modafinil LENGTH: 173 words New Delhi, June 24 -- Jenkins Scott, Liversidge Gary and Manser David of Elan Corporation, PLC, Dublin, Ireland have developed nanoparticulate formulations of modafinil.Elan Corporation, PLC filed the patent application on Jan. 16, 2009. The patent application number is 210/KOLNP/2009 A.According to the Controller General of Patents, Designs & Trade Marks, "The present invention is directed to compositions comprising a nanoparticulate modafinil compositions, or a salt(s), or an enantiomer(s), or a prodrug(s), or a polymorph(s) or derivative thereof, having improved bioavailability. The nanoparticulate modafinil composition formulation particles of the composition have an effective average particle size of less than about 2000 nm and are useful in the treatment of dyssomnias, including but not limited to, narcolepsy, chronic fatigue, eating disorders, compulsive behaviors, ADIID, addictions, substance abuse, sleepiness, nervous system diseases, conditions, syndromes, and symptoms and related diseases, conditions, and symptoms." LOAD-DATE: June 24, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 145 of 998 DOCUMENTS Generic Line June 9, 2010 Wednesday Watson CEO Alleges FTC Harassment in Provigil Pay-for-Delay Case SECTION: Vol. 27 No. 12 LENGTH: 339 words Watson Pharmaceuticals CEO Paul Bisaro is accusing the FTC of harassment in its effort to get him to testify in an ongoing case regarding a pay-for-delay settlement with Cephalon. "The FTC's pursuit of the subpoena demonstrates that its conduct is nothing short of harassment," Bisaro's lawyers claim in a document submitted recently to the U.S. District Court for the District of Columbia. Enforcing the subpoena would be tantamount to abuse of the court's process, they add. The FTC challenged Watson's licensing agreement for Cephalon's excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping to provide cheaper modafinil generics, according to court documents. Cephalon reached the settlement with Watson in 2006, allowing Watson partner Carlsbad Technology to manufacture the modafinil generic prior to patent expiry. Four other generic-drug makers also made deals with Cephalon on Provigil generics (Generic Line, May 12). The deals have been the subject of several lawsuits against the companies involved, the latest of which came May 27 when the supermarket and pharmacy chain Giant Eagle challenged the settlements in a suit filed in the U.S. District Court for the Northern District of Ohio. Cephalon's settlements with the various generic makers delay competition and amount to an effort to monopolize the market for Provigil, the suit says. In his action, Bisaro claims he should not be subpoenaed in Federal Trade Commission v. Paul M. Bisaro since he was not employed by Watson when the agreement with Cephalon was signed. The FTC is pursuing the subpoena either to pressure Watson into reaching an agreement with Apotex or to retaliate against the company, Bisaro's lawyers say. They also accuse the FTC of sharing with Apotex some of Watson's privileged information, submitted to the FDA, as evidenced by an internal email Apotex forwarded to Watson. The FTC has said ending pay-for-delay settlements is a top priority. -- Jonathan Block Release date: June 9, 2010 LOAD-DATE: June 9, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 146 of 998 DOCUMENTS Washington Drug Letter June 7, 2010 Monday Watson CEO Claims FTC Subpoena Is Harassment or Retaliation SECTION: Vol. 42 No. 23 LENGTH: 341 words Watson Pharmaceuticals CEO Paul Bisaro is accusing the FTC of harassment in its effort to get him to testify in an ongoing case regarding a pay-for-delay settlement with Cephalon. "The FTC's pursuit of the subpoena demonstrates that its conduct is nothing short of harassment," Bisaro's lawyers claim in a document submitted recently to the U.S. District Court for the District of Columbia. Enforcing the subpoena would be tantamount to abuse of the court's process, they add. The FTC challenged Watson's licensing agreement for Cephalon's excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping to provide cheaper modafinil generics, according to court documents. Cephalon reached the settlement with Watson in 2006, allowing Watson partner Carlsbad Technology to manufacture the modafinil generic prior to patent expiry. Four other generic-drug makers also made deals with Cephalon on Provigil generics (WDL, May 3). Settlements Challenged The deals have been the subject of several lawsuits against the companies involved, the latest of which came May 27 when the supermarket and pharmacy chain Giant Eagle challenged the settlements in a suit filed in the U.S. District Court for the Northern District of Ohio. Cephalon's settlements with the various generic makers delay competition and amount to an effort to monopolize the market for Provigil, the suit says. In his action, Bisaro claims he should not be subpoenaed in Federal Trade Commission v. Paul M. Bisaro since he was not employed by Watson when the agreement with Cephalon was signed. The FTC is pursuing the subpoena either to pressure Watson into reaching an agreement with Apotex or to retaliate against the company, Bisaro's lawyers say. They also accuse the FTC of sharing some of Watson's privileged information, submitted to the FDA, with Apotex, as evidenced by an internal email Apotex forwarded to Watson. The FTC has said ending pay-for-delay settlements is a top priority. -- Jonathan Block Release date: June 7, 2010 LOAD-DATE: June 7, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 147 of 998 DOCUMENTS PR Newswire June 2, 2010 Wednesday 4:30 PM EST Cephalon Provides Clinical Update on Phase II Study of NUVIGIL as an Adjunctive Therapy in Adults with Schizophrenia LENGTH: 947 words DATELINE: FRAZER, Pa., June 2 FRAZER, Pa., June 2 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the primary endpoint was not met in a Phase II clinical trial that examined NUVIGIL® (armodafinil) Tablets [C-IV] as an adjunctive therapy for the treatment of the negative symptoms of schizophrenia, which include problems with motivation and emotional withdrawal. The analysis of the data showed that treatment with armodafinil did not lessen the severity of the negative symptoms of schizophrenia compared to placebo in the 24-week study. As a result of the outcome of this trial, Cephalon has decided not to move forward with this clinical program. The trial was designed to evaluate whether armodafinil treatment (150, 200, or 250 mg/day) was more effective than placebo treatment as an adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia, as assessed by the primary outcome measure of the Positive and Negative Syndrome Scale. Although an interim analysis showed a trend towards a positive dose dependent treatment effect, it was not statistically significant and not maintained in the final analysis of all patients. Armodafinil was generally well tolerated in the study and the side effects were consistent with the known safety profile. Results of this study will be presented at a future medical meeting. "While we are disappointed that the results of this study did not demonstrate a benefit for this patient population, Cephalon remains committed to the NUVIGIL clinical development plan," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "We are continuing our discussions with the agency on our application for excessive sleepiness associated with jet lag disorder and Phase III trials are on track evaluating armodafinil in bipolar depression and excessive sleepiness resulting from traumatic brain injury." About NUVIGIL NUVIGIL is the longer-lasting isomer of modafinil. It is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder, bipolar depression, traumatic brain injury, or their associated symptoms. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults in association with the use of armodafinil and in adults and children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at http://www.nuvigil.com/. About Cephalon, Inc. Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at http://www.cephalon.com/. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion. Contacts: Media: Investor Relations: Candace Steele Flippin Chip Merritt 610-727-6231 (office) 610-738-6376 (office) csteele@cephalon.com cmerritt@cephalon.com SOURCE Cephalon, Inc. CONTACT:Media: Candace Steele Flippin, +1-610-727-6231 (office), csteele@cephalon.com, Investor Relations: Chip Merritt, +1-610-738-6376 (office), cmerritt@cephalon.com URL: http://www.prnewswire.com LOAD-DATE: June 3, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 PR Newswire Association LLC All Rights Reserved 148 of 998 DOCUMENTS Drug Industry Daily June 1, 2010 Tuesday Watson CEO Accuses FTC of Harassment in Pay-for-Delay Case SECTION: Vol. 9 No. 105 LENGTH: 337 words Watson Pharmaceuticals CEO Paul Bisaro is accusing the FTC of harassment in its effort to get him to testify in an ongoing case regarding a pay-for-delay settlement with Cephalon. "The FTC's pursuit of the subpoena demonstrates that its conduct is nothing short of harassment," Bisaro's lawyers claim in a document submitted recently to the U.S. District Court for the District of Columbia. Enforcing the subpoena would be tantamount to abuse of the court's process, they add. The FTC challenged Watson's licensing agreement for Cephalon's excessive sleepiness drug Provigil (modafinil) and tried to broker an agreement between Watson and Apotex instead, hoping to provide cheaper modafinil generics, according to court documents. Cephalon reached the settlement with Watson in 2006, allowing Watson partner Carlsbad Technology to manufacture the modafinil generic prior to patent expiry. Four other generic-drug makers also made deals with Cephalon on Provigil generics (DID, April 27). The deals have been the subject of several lawsuits against the companies involved, the latest of which came Thursday when the supermarket and pharmacy chain Giant Eagle challenged the settlements in a suit filed in the U.S. District Court for the Northern District of Ohio. Cephalon's settlements with the various generic makers delay competition and amount to an effort to monopolize the market for Provigil, the suit says. In his action, Bisaro claims he should not be subpoenaed in Federal Trade Commission v. Paul M. Bisaro since he was not employed by Watson when the agreement with Cephalon was signed. The FTC is pursuing the subpoena either to pressure Watson into reaching an agreement with Apotex or to retaliate against the company, Bisaro's lawyers say. They also accuse the FTC of sharing some of Watson's privileged information, submitted to the FDA, with Apotex, citing an internal email Apotex forwarded to Watson. The FTC has said ending pay-for-delay settlements is a top priority. -- Jonathan Block Release date: June 1, 2010 LOAD-DATE: June 1, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 149 of 998 DOCUMENTS Fleet Owner June 1, 2010 Help in a pill or a cup SECTION: Pg. 35 LENGTH: 498 words Songwriters may love to romanticize outlaw truckers who take amphetamines to keep driving for days, but the reality is drivers (who are routinely tested for illegal drug use) favor the same stimulant everyone else uses in our Starbucks culture - caffeine. When it comes to staying alert behind the driver's wheel, "caffeine is a very useful tool," according to Todd Dawson of Circadian. "It does what it's supposed to - it boosts reaction times, but it's overused in our society. Taken in high amounts, caffeine can not only create health problems, but you build up a tolerance." Instead of drinking coffee throughout the day, perhaps consuming as much as eight cups, truck drivers should drink a cup or two at the start of their workday and then another one or two cups only when they begin to feel drowsy later in the day. "The [caffeine] benefit is much higher when it's used carefully," Dawson says. Gerald Krueger, who is putting together a report on stimulants, hypnotics and nutritional supplements for the Transportation Research Board, agrees that caffeine used properly is a practical tool to help retain alertness. What concerns him are the "energy boost" products and other supplements marketed at truckstops. While caffeine is often a major component in these products, "there's not been much good, solid medical research published to be able to assess whether they're good or bad," says Krueger. Prescription stimulant drugs have much stronger effects than caffeine, but most of the well-known ones such as amphetamines have serious side effects. However, lately there's been a good deal of attention focused on a new stimulant compound known as Modafinil, which is available in the U.S. as the prescription drug Provigil. Krueger says that while Modafinil does boost alertness much like caffeine, an attractive feature is that "while under the influence of Modafinil, one can apparently still decide to go to sleep, for example, something no other stimulant would permit you to do." Krueger also said that the U.S. military administers prescription stimulants, including Modafinil, in some very select operational circumstances, but only after evaluating how individuals perform when taking the drugs in controlled settings and then monitoring them closely if they do take them in the field. "Currently, there doesn't seem to be any practical application in trucking for stimulants other than using caffeine because there's no way to control their use with a large population like truck drivers," says Krueger. "But we shouldn't hide our head in the sand. We should be doing good quality medical research on these compounds to see if there are practical applications for newer compounds as they are developed." For now, though, Krueger believes the best solution for drivers is "the natural way." Combining proper sleep habits with an understanding of circadian rhythms, "they can use the strengths of knowing more about their own body's physiology to help manage fatigue," he says. LOAD-DATE: June 10, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Magazine Copyright 2010 Penton Business Media, Inc. All Rights Reserved 150 of 998 DOCUMENTS Indian Patents News May 31, 2010 Monday 6:30 AM EST American Inventors Develop Pharmaceutical Formulations of Modafinil LENGTH: 136 words New Delhi, May 31 -- Craig Heacock, Alpa Parikh and Piyush Patel of Cephalon, Inc, West Chester, USA have developed pharmaceutical formulations of modafinil .Cephalon, Inc filed the patent application on Aug. 10, 2007. The patent application number is 2937/KOLNP/2007 A.According to the Controller General of Patents, Designs & Trade Marks, "Use of a composition consisting essentially of about 250 to about 450 mg of solid modafinil and one or more diluents, each independently chosen from a starch, a lactose monohydrate or a microcrystalline cellulose; one or more disintegrates, each independently chosen from a pre gelatinized starch or a cross-linked sodium carboxymethly cellulose; a binder; and a lubricant for preparation of a medicament for treating attention deficit hyperactivity disorder in a human subject." LOAD-DATE: June 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 151 of 998 DOCUMENTS Prospect May 27, 2010 Going mental BYLINE: Barbara J Sahakian and Ahmed D Mohamed LENGTH: 748 words Who could object to drugs that help people affected by mental disorders such as schizophrenia? Such treatments, known as pharmacological cognitive enhancers (PCEs) can improve memory, attention and motivation. Methylphenidate (Ritalin), for example, helps children with attention deficit hyperactivity disorder (ADHD) focus better in school, often making an important difference to their lives. Modafinil (Provigil) helps people stay awake and is licensed for the treatment of narcolepsy, a condition that causes sufferers to fall asleep involuntarily. So far, so good. But the past few years have seen an unprecedented rise in the use of PCEs by healthy people. For many students, the temptation to pop a few pills to aid concentration-especially at exam time-is hard to resist. Most of them see it as harmless and ethically acceptable. Others see it as cheating and, as yet, few universities have formal policies on the issue. According to a 2004 report in the Journal of the American Medical Association, around 90 per cent of modafinil is used by healthy, non-sleep-deprived individuals. In March 2009, an informal survey of 1,000 students by the Cambridge University student newspaper Varsity showed that one in ten were taking prescription drugs for cognitive enhancement. The year before, Nature conducted a poll of 1,400 scientists from 60 different countries. One in five respondents used drugs for cognitive enhancement, of which 62 per cent reported taking methylphenidate and 44 per cent modafinil, mainly to improve concentration. Fifteen per cent said they took beta-blockers for anxiety, when such drugs are normally prescribed to reduce blood pressure or irregular heart rhythms. One American professor said he obtained his drugs through his primary care doctor by claiming to have jet lag, while one British professor got his through the internet to "enhance productivity" and "for important intellectual challenges." More worrying, a 2009 survey by the US National Institute on Drug Abuse (Nida) found that 1.8 per cent of 13 to 14 year olds, 3.6 per cent of 15 to 16 year olds and 2.1 per cent of 17 to 18 year olds abused methylphenidate. The widespread use of cognition- enhancing drugs is perhaps not surprising given that the Academy of Medical Sciences's 2008 report on brain science, addiction and drugs suggested that a 10 per cent improvement in memory score could lead to a higher A-level grade or degree classification. Small improvements in intellectual performance can lead to significant improvements in outcomes. But what are the advantages and disadvantages of healthy people using PCEs? On the plus side, since PCEs may help those with low cognitive performance, it might be possible to mitigate the effects of poverty on the brain through their use. This could have positive effects on society and the economy as a whole: it has been estimated that a 3 per cent population-wide increase in IQ could reduce poverty rates by up to 25 per cent and increase GDP by up to 1.5 per cent. Of course, even healthy adults who normally function well do not necessarily do their best all the time, because of sleep deprivation, jet lag or other stressors. And PCEs might also enable us to perform better in pleasurable and competitive situations. For instance, Anjan Chatterjee, a neurologist at the University of Pennsylvania, reported that musicians often use beta-blockers to dampen physical tremors, improving their performance. Psychostimulants have also been used to boost soldiers in combat, shift workers and pilots. But not enough is known about the long-term side effects of PCEs, especially in the developing brain. A 2009 report by Nida found that modafinil stimulated areas in the brain known to trigger drug seeking behaviour and addiction. We must also consider why these drugs are being used. Is the pressure to do well in exams, clinch a business deal, or keep up with our "24/7 society" pushing people to use them, instead of traditional means of boosting cognition, such as exercise? Clearly, neuroscientists need to work together with social scientists, philosophers, ethicists, policymakers and other experts to establish clear, safe and ethical rules for PCE use in healthy people. This is the only way that the major advances now being made in brain science can be put to maximum benefit-and minimal harm. Barbara J Sahakian is a professor of clinical neuropsychology at Cambridge University. Ahmed D Mohamed is a PhD student at Clare Hall, Cambridge ? LOAD-DATE: May 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Magazine Copyright 2010 Prospect Magazine All Rights Reserved 152 of 998 DOCUMENTS Generic Line May 12, 2010 Wednesday FTC Labels Pay-for-Delay Fight an Agency Top Priority in 2010 SECTION: Vol. 27 No. 10 LENGTH: 502 words The FTC is making its fight against pay-for-delay settlements between brand- and generic-drug makers a top priority this year. The patent settlements, in which brand companies reward generic-drug makers to delay the introduction of less expensive versions of their medicines, keep generic drugs off the market for an average of 17 months longer than agreements without payments and will cost consumers and taxpayers $35 billion over the next 10 years, the commission says in its annual report. The FTC also is pursuing actions against drugmakers in federal court cases. In one case, the agency lodged a complaint against Cephalon in 2008, alleging the drugmaker paid four companies to refrain from selling generic versions of its sleep drug Provigil (modafinil) until 2012 (Generic Line, Feb. 20, 2008). The company entered into seemingly separate transactions worth a total of more than $200 million, the FTC said in 2008 (Generic Line, May 28, 2008). For example, Teva Pharmaceuticals agreed not to launch generic Provigil until April 2012 in exchange for a license agreement relating to its modafinil patents and patent applications worth up to $125 million in Provigil royalties. Cephalon also agreed to buy modafinil active pharmaceutical ingredient from Teva at prices higher than what it had been paying, the commission alleged at the time. The case is still pending in the U.S. District Court for the Eastern District of Pennsylvania, the FTC says. In a separate case, the commission obtained $2.1 million from Bristol-Myers Squibb (BMS) for failing to inform the FTC of agreements reached with Canadian drugmaker Apotex regarding potential generic competition for blockbuster drug Plavix, according to the report. The commission charged that, as part of a patent settlement with Apotex, BMS promised it would not compete with Apotex during the first 180 days that Apotex marketed its generic version of the drug. The FTC suffered a defeat, however, in a case in which it claimed reverse payment, or pay-for-delay, settlements Solvay Pharmaceuticals made with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Laboratories for the marketing of generic AndroGel (testosterone) violated federal antitrust laws. The U.S. District Court for the Northern District of Georgia dismissed the case in February, saying patent litigation is too complex and the results too uncertain to assert such a claim (Generic Line, March 3). The agency also had hoped that a ban on the agreements would be included in healthcare overhaul legislation signed into law earlier this year, but the provision was not included in the final bill. Sen. Herb Kohl (D-Wis.) has indicated he will fight for his pay-for-delay bill, Preserve Access to Affordable Generics Act, S. 369, to be considered as an individual piece of legislation by the full Senate or piggyback on another bill (Generic Line, March 31). The FTC annual report is available at www.ftc.gov/os/2010/04/2010ChairmansReport_screen.pdf. -- David Belian Release date: May 12, 2010 LOAD-DATE: May 12, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 153 of 998 DOCUMENTS Penton Insight May 11, 2010 Helping drivers stay alert BYLINE: By Jim Mele, editor-in-chief LENGTH: 561 words When it comes to staying alert behind the driver's wheel,"caffeine is a very useful tool," according to ToddDawson, vp of the fatigue management company Circadian. "It does what it'ssupposed to - it boosts reaction times, but it'soverused in our society. Taken in high amounts, caffeine can notonly create health problems, but you build up atolerance." The stimulant effect of the caffeine in two cups of coffee lastsfive to seven hours, he said. Instead of drinking coffee throughoutthe day, perhaps consuming as much as eight cups, truck driversshould drink a cup or two at the start of their work day and thenanother one or two cups only when they begin to feel drowsy laterin the day. "The benefit [from caffeine] is much higher whenit's used carefully," Dawson said Gerald Krueger, a well-known researcher who is currentlyputting together a report on stimulants, hypnotics and nutritionalsupplements for the Transportation Research Board, agrees thatcaffeine used properly is a practical tool to help truck driversretain alertness during those naturally occurring times when aperson becomes drowsy. What concerns him are the "energy boost" productsand other nutritional supplements commonly marketed to drivers attruckstops.  While caffeine is often a major component inthese products, "there's not been much good solidmedical research published to be able to assess whetherthey're good or bad, or whether they produce interactionswith other substances like allergy medicines," Kruegersaid. Prescription stimulant drugs have much stronger effects thancaffeine, but most of the well-known ones such as amphetamines haveserious side effects that after long-term use might includeinsomnia and addiction.  However lately there's been agood deal of attention focused on a new stimulant compound known asmodafinil which is available in the U.S. as the prescription drugProVigil.  Krueger said that while modafinil does boostalertness much like caffeine, an  attractive feature is that"while under the influence of modafinil, one can apparentlystill decide to go to sleep, to take a nap for example, somethingno other stimulant would permit you to do." Krueger also said that the U.S. military administersprescription stimulants, including modafinil, in some very selectoperational circumstances, but only after evaluating howindividuals perform when taking the drugs in controlled settingsand then monitoring them closely if they do take them in thefield. "Currently there doesn't seem to be any practicalapplication in trucking for stimulants other than using caffeinebecause there's no way to control their use with alarge population like truck drivers," said Krueger. "But we shouldn't hide our head in the sand,"said Krueger. "We should be doing good quality medicalresearch on these compounds to see if there are practicalapplications for some newer compounds as they aredeveloped."  For example, he pointed out that the U.S.military explored and now safely issues caffeinated chewing gum totired troops, and this would seem to be an appropriate applicationfor commercial drivers as well. For now, though, Krueger believes the best solution for driversis "the natural way." Combining proper sleep habitswith an understanding for their circadian rhythms, "they canuse the strengths of knowing more about their own body'sphysiology to help manage fatigue," Krueger noted. LOAD-DATE: May 12, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Web Publication Copyright 2010 Penton Business Media, Inc. All Rights Reserved 154 of 998 DOCUMENTS Washington Drug Letter May 3, 2010 Monday FTC Fight Against Pay-for-Delay Becomes a Top Priority in 2010 SECTION: Vol. 42 No. 18 LENGTH: 496 words The FTC is making its fight against pay-for-delay settlements between brand- and generic-drug makers a top priority this year. The patent settlements, in which brand companies reward generic-drug makers to delay the introduction of less expensive versions of their medicines, keep generic drugs off the market for an average of 17 months longer than agreements without payments and will cost consumers and taxpayers $35 billion over the next 10 years, the commission says in its annual report. The FTC also is pursuing actions against drugmakers in federal court cases. In one case, the agency lodged a complaint against Cephalon in 2008, alleging the drugmaker paid four companies to refrain from selling generic versions of its sleep drug Provigil (modafinil) until 2012 (WDL, Feb. 18, 2008). The company entered into seemingly separate transactions worth a total of more than $200 million, the FTC said in 2008 (WDL, May 26, 2008). For example, Teva Pharmaceuticals agreed not to launch generic Provigil until April 2012 in exchange for a license agreement relating to its modafinil patents and patent applications worth up to $125 million in Provigil royalties. Cephalon also agreed to buy modafinil active pharmaceutical ingredient from Teva at prices higher than what it had been paying, the commission alleged at the time. The case is still pending in the U.S. District Court for the Eastern District of Pennsylvania, the FTC says. In a separate case, the commission obtained $2.1 million from Bristol-Myers Squibb (BMS) for failing to inform the FTC of agreements reached with Canadian drugmaker Apotex regarding potential generic competition for blockbuster drug Plavix, according to the report. The commission charged that, as part of a patent settlement with Apotex, BMS promised it would not compete with Apotex during the first 180 days that Apotex marketed its generic version of the drug. The FTC suffered a defeat, however, in a case in which it claimed reverse payment, or pay-for-delay, settlements Solvay Pharmaceuticals made with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Laboratories for the marketing of generic AndroGel (testosterone) violated federal antitrust laws. The U.S. District Court for the Northern District of Georgia dismissed the case in February, saying patent litigation is too complex and the results too uncertain to assert such a claim (WDL, March 1). The agency also had hoped that a ban on the agreements would be included in healthcare overhaul legislation signed into law earlier this year, but the provision was not included in the final bill. Sen. Herb Kohl (D-Wis.) has indicated he will fight for his pay-for-delay bill, Preserve Access to Affordable Generics Act, S. 369, to be considered as an individual piece of legislation by the full Senate or piggyback on another bill (WDL, March 22). The FTC annual report is available at www.ftc.gov/os/2010/04/2010ChairmansReport_screen.pdf. -- David Belian Release date: May 3, 2010 LOAD-DATE: May 3, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 155 of 998 DOCUMENTS Drug Industry Daily April 27, 2010 Tuesday FTC: Ending Pay-for-Delay Settlements is Top Priority SECTION: Vol. 9 No. 81 LENGTH: 503 words The FTC is making its fight against pay-for-delay settlements between brand- and generic-drug makers a top priority this year. The patent settlements, in which brand companies reward generic-drug makers to delay the introduction of less expensive versions of their medicines, keep generic drugs off the market for an average of 17 months longer than agreements without payments and will cost consumers and taxpayers $35 billion over the next 10 years, the commission says in its annual report. The FTC also is pursuing actions against drugmakers in federal court cases. In one case, the agency lodged a complaint against Cephalon in 2008, alleging the drugmaker paid four companies to refrain from selling generic versions of its sleep drug Provigil (modafinil) until 2012 (DID, Feb. 15, 2008). The company entered into seemingly separate transactions worth a total of more than $200 million, the FTC said in 2008 (DID, May 23, 2008). For example, Teva Pharmaceuticals agreed not to launch generic Provigil until April 2012 in exchange for a license agreement relating to its modafinil patents and patent applications worth up to $125 million in Provigil royalties. Cephalon also agreed to buy modafinil active pharmaceutical ingredient from Teva at prices higher than what it had been paying, the commission alleged at the time. The case is still pending in the U.S. District Court for the Eastern District of Pennsylvania, the FTC says. In a separate case, the commission obtained $2.1 million from Bristol-Myers Squibb (BMS) for failing to inform the FTC of agreements reached with Canadian drugmaker Apotex regarding potential generic competition for blockbuster drug Plavix, the commission says in the report. The commission charged that, as part of a patent settlement with Apotex, BMS promised that it would not compete with Apotex during the first 180 days that Apotex marketed its generic version of the drug. The agency suffered a defeat, however, in a case in which it claimed reverse payment, or pay-for-delay, settlements Solvay Pharmaceuticals made with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Laboratories for the marketing of generic AndroGel (testosterone) violated federal antitrust laws. The U.S. District Court for the Northern District of Georgia dismissed the case in February, saying patent litigation is too complex and the results too uncertain to assert such a claim (DID, Feb. 25). The agency had also hoped that a ban on the agreements would be included in healthcare overhaul legislation signed into law earlier this year, but the provision failed to be included in the final bill. Sen. Herb Kohl (D-Wis.), however, has indicated that he will fight for his pay-for-delay bill Preserve Access to Affordable Generics Act, S. 369, to be considered as an individual piece of legislation by the full Senate or piggyback on another bill (DID, March 23). The FTC annual report can be found at www.ftc.gov/os/2010/04/2010ChairmansReport_screen.pdf. -- David Belian Release date: April 27, 2010 LOAD-DATE: April 27, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2010 Washington Business Information, Inc. All Rights Reserved 156 of 998 DOCUMENTS The Guardian (London) - Final Edition April 6, 2010 Tuesday Education: Smart work: Students are increasingly taking neuroenhancing drugs to fight fatigue and help them concentrate. But how safe are they - and is it cheating? BYLINE: Catherine Nixey SECTION: GUARDIAN EDUCATION PAGES; Pg. 1 LENGTH: 1362 words It is an all too common story: a diligent student works hard and finally achieves a coveted place at Cambridge University. Once there, the pressure becomes too great and they turn to drugs. These days, however, the old narrative has changed. Instead of the spliffs that apparently so delighted generations of our politicians, the latest fad is for educational, not recreational, drugs. "It was the summer term of my second year," explains Raj Perera, in his final year of a natural sciences degree at Cambridge University. "I'm an international student, which means my parents are paying £20,000 for every year I am here. That sort of money puts a huge pressure on you. But last summer, I had two weeks to go before my exams, and I had done pretty much no revision. It was a make-or-break moment. So I bought modafinil." Modafinil is one of the new neuroenhancing "smart drugs" now being taken by growing numbers of students. It was originally developed for the treatment of narcolepsy, but is now used by students to combat fatigue. Another popular choice is Ritalin, originally designed as a treatment for attention deficit hyperactivity disorder (ADHD). Both increase levels of dopamine levels in the brain - and the alertness and wakefulness of those taking them. So popular have these drugs become that last month Barbara Sahakian, professor of clinical neuropsychology at Cambridge University's psychiatry department, warned that their use has "enormous implications" and that universities must act on them - even mentioning dope testing as one possibility. But this is not happening. "What universities are doing about (them) is nothing," she says. Last year, Sahakian was co-opted on to a committee, set up by the Medical Advisory Council on the Misuse of Drugs, to look at the use of cognitive enhancing drugs by healthy people. One American study, cited in the journal Nature, estimated that up to 25% of students at some campuses had taken neuroenhancing drugs in the past year. Many hear of these drugs through friends, others independently. "I read an article in the student press on them," says Lawrence Price, a third-year arts student at Sheffield Hallam University. "It was criticising them, but I thought they sounded great." Perera, similarly, found out about smart drugs through the media. "I read an article in Nature on them," he says. "They seemed a pretty good idea." Students believe the drugs enable them to do more work. "I take them when I need to get through lectures and I have a terrible hangover," says Price. At the other extreme, Lucy Makepeace, a postgraduate student at Cambridge, uses them less from a lack of diligence than an excess of it. Extremely hard working, she takes modafinil once or twice a week. "With study, work and sport I have a very full timetable," she says. "I want to do everything, but I don't want to do any of it at a mediocre level. Taking modafinil helps me to do it all." Perera similarly turned to modafinil from time pressures - which were, in his case, extreme. "Due to difficulty getting my visa last year, I couldn't return at the start of the summer term," he says. "When I eventually got my visa, I arrived back with just a fortnight before my exams, and no revision behind me." All the students are clear on the drug's effects. "Modafinil increases my enthusiasm for studying," says Perera. "It makes me feel that lazing around is the last thing I want to do." Price agrees: "Modafinil gives me the motivation I would otherwise lack." Makepeace, who clearly doesn't lack motivation, instead takes modafinil to stay alert. "Once I've taken a pill I can stay up all night without stopping. It just works so well," she says. "I need it." The way the students obtain the drugs varies. Some get them from friends, but many purchase them from online chemists. "I just Googled them," says Perera. "The cost, including shipping, came to about £2 each." "I bought them from an online pharmacy," says Price. "You just sign a disclaimer saying you won't sue them for selling you prescription drugs without a prescription, then they send you them." Unknown quantity Such a convenient process might please the consumer, but it is not one that impresses Sahakian. "When you get a drug off the internet, you don't know what it is, or whether you have some pre-existing condition that means you shouldn't be taking it," she says. "If you get a drug from your GP, they would check that." Even if the drugs are what they purport to be, they are not risk-free. Such smart drugs have only been developed relatively recently, and, says Sahakian (who has herself researched the effects of modafinil on healthy volunteers), it is therefore too early to feel confident that they are safe. "It's a real worry that students are taking these drugs, as we just don't know whether they are safe in the long term. They're so new. How could we know?" In addition to concerns about the drugs' physical effects, there are also moral issues. "Do we want to solve all our problems in this way?" Sahakian asks. "There are other ways of coping - like exercise, or sleep." Such methods would not only be physiologically better, but also psychologically. "It's nice to feel that what you have achieved is your achievement. Take a pill and you might not feel that," she says. For some, chemically enhanced achievement is reprehensible. "Students who are not taking them, feel (to do so) is cheating," says Sahakian. "They feel that (taking these) could just make the difference between a 2.1 and a first. At that point, students who don't want to take them start to feel coerced into doing so because everyone else is." But the accusation of bending the rules is denied unanimously. "I'm not cheating," says Makepeace. "Taking a pill is no different to having a cup of coffee. It's just more effective." Perera agrees: "I don't think this is cheating. I read a nice analogy, which said that people with a bad memory are no different to people who have bad eyesight. You let people with bad eyesight have glasses; why not let people with a bad memory have these pills?" At present, the actual status of such drug-taking remains undefined by universities, something that Sahakian hopes they will soon address. "Universities need to think about whether they want their students to be on drugs or not when they come into their exams. There needs to be some debate within the universities. Do we care about this? Is this cheating? Is it the way we want our society to be going?" Professor John Rallison, pro vice-chancellor for education at Cambridge University, said the university "does not approve of any non-medicinal drug-taking", and welfare officers at the university's union said that they were concerned about such usage. The view is echoed by Universities UK, the body representing the heads of British universities, which says it has "grave concerns about students taking drugs not prescribed to them", because it "poses health risks to those students". Instead, it advises pressurised students to seek help from university counselling services or the GP. A spokesman for Sheffield Hallam University said: "We are not aware of any student taking this drug and if any students do have difficulties with their studies we encourage them to make use of our support services." Given the habits of academics themselves, the topic is a sensitive one: according to a recent survey by Nature, whose readership tends to be academics and researchers, one in five respondents said that they had used smart drugs. Something of which Sahakian herself has personal experience. "I was at a conference in America recently," she says. "I'd just flown in that day from the UK. I saw I was timetabled to give a lecture that afternoon. I wanted to do a good job of it, but I was just feeling so jetlagged. I mentioned to a colleague how I felt and he immediately said to me, 'Oh, do you want to take some of my modafinil?'" She didn't, for the record, accept. All student names have been changed Captions: Modafinil is one of the new 'smart drugs' being used by students to help them keep going Photograph: Will Boase Staying alert is one reason students give for taking modafinil Alamy LOAD-DATE: April 6, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 Guardian Newspapers Limited All Rights Reserved 157 of 998 DOCUMENTS Indian Patents News April 2, 2010 Friday 6:30 AM EST American Inventors Develop Processes for the Preparation of Modafinil and Analogs Thereof LENGTH: 118 words New Delhi, April 2 -- Liang Sidney, Duchek John R and Schaffer Carl J of Mallinckrodt Inc, St. Louis, USA have developed processes for the preparation of modafinil and analogs thereof.Mallinckrodt Inc filed the patent application on June 9, 2008. The patent application number is 2877/CHENP/2008 A.According to the Controller General of Patents, Designs & Trade Marks, "The present invention generally relates to an improved process for preparing modafinil and analogs thereof. The process minimizes impurities and improves the overall yield by oxidizing a modafinil intermediate compound in a reaction mixture including an alcohol and an organic acid at a ratio of from about 1:1 to about 80:1 (by volume)." LOAD-DATE: May 4, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Indian Patents News, distributed by Contify.com All Rights Reserved 158 of 998 DOCUMENTS PR Newswire March 29, 2010 Monday 4:47 PM EST Cephalon Receives Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder LENGTH: 1058 words DATELINE: FRAZER, Pa., March 29 FRAZER, Pa., March 29 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. As the first company to study a treatment option to improve wakefulness associated with jet lag disorder, Cephalon worked closely with the FDA to design a special protocol assessment (SPA) that would evaluate the experience of a typical eastbound airline traveler. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p=0.044]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, insomnia, diarrhea and palpitations. There were no reports of serious rash observed in the trial participants, and no new safety signals were observed in the clinical trial. "Although we reached statistical significance on both primary endpoints, the Complete Response letter raised questions regarding the robustness of the PGI-S data," said Dr. Lesley Russell, Cephalon's Chief Medical Officer. "We have already reviewed this issue with the FDA and will be scheduling a meeting with the Agency in the near future to discuss it further." About NUVIGIL NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009. It is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults in association with the use of armodafinil and in adults and children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com. About Cephalon, Inc. Cephalon is an international biopharmaceutical company dedicated to discovering, developing and bringing to market medications for difficult to treat and rare conditions. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients around the world in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 3,000 people worldwide. Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. The company's proprietary products in the United States include: NUVIGIL, TREANDA® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], PROVIGIL® (modafinil) Tablets [C-IV], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for and frequency of filing new indications for NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion. Contacts: Media: Investor Relations: Candace Steele Flippin Chip Merritt 610-727-6231 (office) 610-738-6376 (office) csteele@cephalon.com cmerritt@cephalon.com SOURCE Cephalon, Inc. CONTACT:Media: Candace Steele Flippin, +1-610-727-6231 (office), csteele@cephalon.com; Investor Relations: Chip Merritt, +1-610-738-6376 (office), cmerritt@cephalon.com URL: http://www.prnewswire.com LOAD-DATE: March 30, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 PR Newswire Association LLC All Rights Reserved 159 of 998 DOCUMENTS Agence France Presse -- English March 19, 2010 Friday 9:11 PM GMT Cycling: US rider Clinger banned for two years LENGTH: 218 words DATELINE: colorado springs, Colorado, March 19 2010 David Clinger, runner-up in last year's US national road race championships, has been slapped with a two-year ban after testing positive for performance-enhancing drugs. The 32-year-old American tested positive for synthetic testosterone and modafinil in July at the 2009 national championships in Bend, Oregon, the US Anti-Doping Agency announced on Friday. "Synthetic testosterone is prohibited as an anabolic agent and modafinil is prohibited as a stimulant on the World Anti-Doping Agency Prohibited List," USADA said in a news release. This is the latest setback for Clinger, who is a former US Postal teammate of Lance Armstrong and Floyd Landis. He has been in and out of drug rehab facilities. He is also known for an unusual New Zealand Maori-inspired tattoo which covers his entire face like a mask. USADA said the suspension is retroactive to the date Clinger was first notified of the ban by US officials meaning he will be eligible to compete again in 19 months. His has also been stripped of his race results. Clinger told the discipline panel that he was taking the drugs on the advice of his personal doctor in Utah and that he declared the use of testosterone on the forms that accompanied his test sample. The disciplinary panel rejected USADA's request for a longer suspension than two years. gph/dj10 LOAD-DATE: March 20, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Agence France Presse All Rights Reserved 160 of 998 DOCUMENTS Xinhua General News Service March 19, 2010 Friday 9:10 PM EST U.S. rider Clinger banned for two years SECTION: WORLD NEWS; Sports LENGTH: 179 words DATELINE: WASHINGTON March 19 David Clinger, runner-up in last year's U.S. national road race championships, has been banned for two years after testing positive for performance-enhancing drugs. The 32-year-old American tested positive for synthetic testosterone and modafinil in July at the 2009 national championships in Bend, Oregon, the US Anti-Doping Agency announced on Friday. "Synthetic testosterone is prohibited as an anabolic agent and modafinil is prohibited as a stimulant on the World Anti-Doping Agency Prohibited List," USADA said in a news release. USADA said the suspension is retroactive to the date Clinger was first notified of the ban by U.S. officials meaning he will be eligible to compete again in 19 months. He has also been stripped of his race results. Clinger told the discipline panel that he was taking the drugs on the advice of his personal doctor in Utah and that he declared the use of testosterone on the forms that accompanied his test sample. The disciplinary panel rejected USADA's request for a longer suspension than two years. LOAD-DATE: March 20, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Xinhua News Agency 161 of 998 DOCUMENTS Xinhua General News Service March 19, 2010 Friday 1:18 AM EST U.S. rider Clinger banned for two years SECTION: WORLD NEWS; Sports LENGTH: 179 words DATELINE: WASHINGTON March 19 David Clinger, runner-up in last year's U.S. national road race championships, has been banned for two years after testing positive for performance-enhancing drugs. The 32-year-old American tested positive for synthetic testosterone and modafinil in July at the 2009 national championships in Bend, Oregon, the US Anti-Doping Agency announced on Friday. "Synthetic testosterone is prohibited as an anabolic agent and modafinil is prohibited as a stimulant on the World Anti-Doping Agency Prohibited List," USADA said in a news release. USADA said the suspension is retroactive to the date Clinger was first notified of the ban by U.S. officials meaning he will be eligible to compete again in 19 months. He has also been stripped of his race results. Clinger told the discipline panel that he was taking the drugs on the advice of his personal doctor in Utah and that he declared the use of testosterone on the forms that accompanied his test sample. The disciplinary panel rejected USADA's request for a longer suspension than two years. LOAD-DATE: March 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Xinhua News Agency 162 of 998 DOCUMENTS Business Day (South Africa) March 17, 2010 Health News Edition NEUROLOGY. Perpetual motion for the brain BYLINE: Graeme Addison SECTION: HEALTH LENGTH: 1209 words NEUROLOGY Perpetual motion for the brain It may be time to sound a 'subculture alert' that there are people out there who think we should never sleep, but use our lives more productively by remaining awake and ever active. Are they right? investigates ADRUG called modafinil can keep you awake for many days and nights without apparently serious side effects. Considering that we humans spend up to a third of our lives sleeping, it seems only rational - the next step in our evolution - that we should attempt to extend our waking hours and get more done. There are those who believe that we need to sleep less, or not sleep at all. The usual suspects dosing themselves on stimulants such as caffeine and amphetamines include students cramming for exams, executives preparing for that big presentation, emergency workers at disaster scenes, and soldiers in battle. They - and others such as journalists on perpetual deadlines - are prime candidates for modafinil. The drug is a unique wake-promoting stimulant of the central nervous system, approved in the US in 1998 and in SA in 2004 as a treatment for narcolepsy (the tendency to fall asleep). It was discovered in the 1970s by Prof Micheal Jouvet, experimenting with antidepressants at the French firm Lafon. Students of Jouvet who tried the pill showed an "amazing" improvement in their work. It was speculated at the time that it could keep an army on its feet and fighting for three days and nights with no major negative side effects. Modafinil is one of only two drugs in a unique class called eugeroics, which literally means good arousal, and is a sold on prescription as Provigil, Modiodal and Alertec. Some users have been known to stay awake for up to four days and nights, recovering with only a normal eight-hour bout of sleep. In clinical trials the most commonly observed side effects in more than 5% of patients are headache, upper respiratory tract infection, nausea, nervousness, anxiety and insomnia. According to the Biogenesis Laboratories, which sells a variety of life-extension, anti-ageing, anti-depressant and cognitive enhancement drugs over the internet in SA, modafinil increases alertness and concentration, reducing the desire to nap, and yet at the same time displays no addictive or "coming-down" side-effects. It keeps you steadily awake for up to eight hours after swallowing a 100mg tablet. One participant in the online global Drugs Forum reported: "Small euphoria - seems to build when longer in the experience - getting the whole time absorbed into things, which have to be done (almost neurotic behaviour). Sleeplessness. More energy. Impulsive behavior." For that user modafinil lived up to its reputation as a mood-brightening psycho stimulant. The big question is where such stimulation may be taking us. Modafinil is probably not the last "go-pill" that will emerge from modern pharmacology. There is a real prospect of keeping people awake indefinitely. As with research into anti-ageing - promising death's end - the end of sleep would fundamentally change the nature of our species. What would we do with ourselves? For some, this lidless future - making us like snakes with ever-open eyes - is too horrible to contemplate. It would reconstruct our lives around activities lasting all day and night, pausing for rest and recovery only to think (consciously) about the next thing to do. The Swiss psychiatrist Calr Jung would turn in his grave, although he did say "that consciousness acts upon our nightly life just as much as the unconscious overshadows our daily life". Perhaps we could learn more about ourselves by simply staying awake. The fact is that medical science has struggled to explain why we need sleep anyway. According to the journal Science, the function of sleep is one of the 100 or so greatest unsolved mysteries in science. Theories range from brain "maintenance" - including memory consolidation and pruning - to reversing damage from oxidative stress suffered while awake. Dr Jerome Siegel, a University of California, Los Angeles, professor of psychiatry and director of the university's Centre for Sleep Research at the Semel Institute for Neuroscience and Human Behaviour, has studied sleep in a broad range of animals from the platypus to the walrus. In the online journal Nature Reviews Neuroscience last year, he concluded that sleep's primary function is to increase the efficiency of animals and minimise risk. We stay alert and active when we need to and relax our guard when there is less danger or less call for action. "We see sleep as lying on a continuum that ranges from these dormant states like torpor and hibernation, on to periods of continuous activity without any sleep, such as during migration, where birds can fly for days on end without stopping," said Siegel. Airmen, unfortunately, cannot fly for days for days on end. This problem has mightily exercised military researchers. But hopes that modafinil would be the solution have been dashed by a number of studies of its effectiveness. Harvard law student Douglas Kim pulled the findings together in a 2007 paper on "vigilance" as a military priority. "In certain studies, modafinil's efficacy as compared to caffeine and amphetamines were of questionable conclusion," he wrote. "Researchers also noticed modafinil produced unexpected side-effects including an increase in core temperature, an inability to discern when the drug has begun to perform, and an additional 'over-confidence' effect in self-reported questionnaires - all side-effects that are of real concern when superimposed on sustained military operations." If you ask busy people whether they would like to stay awake for long periods, you get some intriguing responses, as I did to my question on Facebook. "I would never give up sleeping, I need it too much," said one South African business executive now working in the US. He might well have quoted Shakespeare, whose nervously overwrought Macbeth feared that he was cursed to sleep no more. "You've got to love the ICU in hospital," wrote another, "it's the only place you actually get intensive nursing care but absolutely NO sleep." And a sportsman friend wrote: "Thankful for sleep... Best time of our lives sometimes." As to getting more done by not sleeping, a rather despairing note sounded in this response: "As an insomniac, I question that assumption." Efficiency and productivity may not be enhanced simply by staying awake, because the body and mind need to regenerate through sleep. Jung believed that in sleep our dreams reconnect us with the collective unconscious of our species, the myths and archetypes that underlie our wakeful reality and shape our lives. If so, we cannot do without it, and any attempt to drug ourselves into a state of perpetual sleeplessness will smash our psyche to pieces. To be cursed with sleep, or with sleeplessness: which is it to be? Birds know the answer, we don't - though perhaps only for now. The fact is that medical science has struggled to explain why we need sleep anyway AIMING EVER HIGHER: Night time is no time to nod off, say those who believe we should be spending more hours awake. Less time sleeping means more opportunity to make optimum use of our time and remain productive, they say. Picture: iSTOCKPHOTO LOAD-DATE: March 18, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 BDFM Publishers PTY Ltd. All Rights Reserved 163 of 998 DOCUMENTS Business Day (South Africa) March 17, 2010 Health News Edition NEUROLOGY. Perpetual motion for the brain BYLINE: Graeme Addison SECTION: HEALTH LENGTH: 1209 words NEUROLOGY Perpetual motion for the brain It may be time to sound a 'subculture alert' that there are people out there who think we should never sleep, but use our lives more productively by remaining awake and ever active. Are they right? investigates ADRUG called modafinil can keep you awake for many days and nights without apparently serious side effects. Considering that we humans spend up to a third of our lives sleeping, it seems only rational - the next step in our evolution - that we should attempt to extend our waking hours and get more done. There are those who believe that we need to sleep less, or not sleep at all. The usual suspects dosing themselves on stimulants such as caffeine and amphetamines include students cramming for exams, executives preparing for that big presentation, emergency workers at disaster scenes, and soldiers in battle. They - and others such as journalists on perpetual deadlines - are prime candidates for modafinil. The drug is a unique wake-promoting stimulant of the central nervous system, approved in the US in 1998 and in SA in 2004 as a treatment for narcolepsy (the tendency to fall asleep). It was discovered in the 1970s by Prof Micheal Jouvet, experimenting with antidepressants at the French firm Lafon. Students of Jouvet who tried the pill showed an "amazing" improvement in their work. It was speculated at the time that it could keep an army on its feet and fighting for three days and nights with no major negative side effects. Modafinil is one of only two drugs in a unique class called eugeroics, which literally means good arousal, and is a sold on prescription as Provigil, Modiodal and Alertec. Some users have been known to stay awake for up to four days and nights, recovering with only a normal eight-hour bout of sleep. In clinical trials the most commonly observed side effects in more than 5% of patients are headache, upper respiratory tract infection, nausea, nervousness, anxiety and insomnia. According to the Biogenesis Laboratories, which sells a variety of life-extension, anti-ageing, anti-depressant and cognitive enhancement drugs over the internet in SA, modafinil increases alertness and concentration, reducing the desire to nap, and yet at the same time displays no addictive or "coming-down" side-effects. It keeps you steadily awake for up to eight hours after swallowing a 100mg tablet. One participant in the online global Drugs Forum reported: "Small euphoria - seems to build when longer in the experience - getting the whole time absorbed into things, which have to be done (almost neurotic behaviour). Sleeplessness. More energy. Impulsive behavior." For that user modafinil lived up to its reputation as a mood-brightening psycho stimulant. The big question is where such stimulation may be taking us. Modafinil is probably not the last "go-pill" that will emerge from modern pharmacology. There is a real prospect of keeping people awake indefinitely. As with research into anti-ageing - promising death's end - the end of sleep would fundamentally change the nature of our species. What would we do with ourselves? For some, this lidless future - making us like snakes with ever-open eyes - is too horrible to contemplate. It would reconstruct our lives around activities lasting all day and night, pausing for rest and recovery only to think (consciously) about the next thing to do. The Swiss psychiatrist Calr Jung would turn in his grave, although he did say "that consciousness acts upon our nightly life just as much as the unconscious overshadows our daily life". Perhaps we could learn more about ourselves by simply staying awake. The fact is that medical science has struggled to explain why we need sleep anyway. According to the journal Science, the function of sleep is one of the 100 or so greatest unsolved mysteries in science. Theories range from brain "maintenance" - including memory consolidation and pruning - to reversing damage from oxidative stress suffered while awake. Dr Jerome Siegel, a University of California, Los Angeles, professor of psychiatry and director of the university's Centre for Sleep Research at the Semel Institute for Neuroscience and Human Behaviour, has studied sleep in a broad range of animals from the platypus to the walrus. In the online journal Nature Reviews Neuroscience last year, he concluded that sleep's primary function is to increase the efficiency of animals and minimise risk. We stay alert and active when we need to and relax our guard when there is less danger or less call for action. "We see sleep as lying on a continuum that ranges from these dormant states like torpor and hibernation, on to periods of continuous activity without any sleep, such as during migration, where birds can fly for days on end without stopping," said Siegel. Airmen, unfortunately, cannot fly for days for days on end. This problem has mightily exercised military researchers. But hopes that modafinil would be the solution have been dashed by a number of studies of its effectiveness. Harvard law student Douglas Kim pulled the findings together in a 2007 paper on "vigilance" as a military priority. "In certain studies, modafinil's efficacy as compared to caffeine and amphetamines were of questionable conclusion," he wrote. "Researchers also noticed modafinil produced unexpected side-effects including an increase in core temperature, an inability to discern when the drug has begun to perform, and an additional 'over-confidence' effect in self-reported questionnaires - all side-effects that are of real concern when superimposed on sustained military operations." If you ask busy people whether they would like to stay awake for long periods, you get some intriguing responses, as I did to my question on Facebook. "I would never give up sleeping, I need it too much," said one South African business executive now working in the US. He might well have quoted Shakespeare, whose nervously overwrought Macbeth feared that he was cursed to sleep no more. "You've got to love the ICU in hospital," wrote another, "it's the only place you actually get intensive nursing care but absolutely NO sleep." And a sportsman friend wrote: "Thankful for sleep... Best time of our lives sometimes." As to getting more done by not sleeping, a rather despairing note sounded in this response: "As an insomniac, I question that assumption." Efficiency and productivity may not be enhanced simply by staying awake, because the body and mind need to regenerate through sleep. Jung believed that in sleep our dreams reconnect us with the collective unconscious of our species, the myths and archetypes that underlie our wakeful reality and shape our lives. If so, we cannot do without it, and any attempt to drug ourselves into a state of perpetual sleeplessness will smash our psyche to pieces. To be cursed with sleep, or with sleeplessness: which is it to be? Birds know the answer, we don't - though perhaps only for now. The fact is that medical science has struggled to explain why we need sleep anyway AIMING EVER HIGHER: Night time is no time to nod off, say those who believe we should be spending more hours awake. Less time sleeping means more opportunity to make optimum use of our time and remain productive, they say. Picture: iSTOCKPHOTO LOAD-DATE: March 19, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 BDFM Publishers PTY Ltd. All Rights Reserved 164 of 998 DOCUMENTS Business Day (South Africa) March 17, 2010 Health News Edition NEUROLOGY. Perpetual motion for the brain BYLINE: Graeme Addison SECTION: HEALTH LENGTH: 1209 words NEUROLOGY Perpetual motion for the brain It may be time to sound a 'subculture alert' that there are people out there who think we should never sleep, but use our lives more productively by remaining awake and ever active. Are they right? investigates ADRUG called modafinil can keep you awake for many days and nights without apparently serious side effects. Considering that we humans spend up to a third of our lives sleeping, it seems only rational - the next step in our evolution - that we should attempt to extend our waking hours and get more done. There are those who believe that we need to sleep less, or not sleep at all. The usual suspects dosing themselves on stimulants such as caffeine and amphetamines include students cramming for exams, executives preparing for that big presentation, emergency workers at disaster scenes, and soldiers in battle. They - and others such as journalists on perpetual deadlines - are prime candidates for modafinil. The drug is a unique wake-promoting stimulant of the central nervous system, approved in the US in 1998 and in SA in 2004 as a treatment for narcolepsy (the tendency to fall asleep). It was discovered in the 1970s by Prof Micheal Jouvet, experimenting with antidepressants at the French firm Lafon. Students of Jouvet who tried the pill showed an "amazing" improvement in their work. It was speculated at the time that it could keep an army on its feet and fighting for three days and nights with no major negative side effects. Modafinil is one of only two drugs in a unique class called eugeroics, which literally means good arousal, and is a sold on prescription as Provigil, Modiodal and Alertec. Some users have been known to stay awake for up to four days and nights, recovering with only a normal eight-hour bout of sleep. In clinical trials the most commonly observed side effects in more than 5% of patients are headache, upper respiratory tract infection, nausea, nervousness, anxiety and insomnia. According to the Biogenesis Laboratories, which sells a variety of life-extension, anti-ageing, anti-depressant and cognitive enhancement drugs over the internet in SA, modafinil increases alertness and concentration, reducing the desire to nap, and yet at the same time displays no addictive or "coming-down" side-effects. It keeps you steadily awake for up to eight hours after swallowing a 100mg tablet. One participant in the online global Drugs Forum reported: "Small euphoria - seems to build when longer in the experience - getting the whole time absorbed into things, which have to be done (almost neurotic behaviour). Sleeplessness. More energy. Impulsive behavior." For that user modafinil lived up to its reputation as a mood-brightening psycho stimulant. The big question is where such stimulation may be taking us. Modafinil is probably not the last "go-pill" that will emerge from modern pharmacology. There is a real prospect of keeping people awake indefinitely. As with research into anti-ageing - promising death's end - the end of sleep would fundamentally change the nature of our species. What would we do with ourselves? For some, this lidless future - making us like snakes with ever-open eyes - is too horrible to contemplate. It would reconstruct our lives around activities lasting all day and night, pausing for rest and recovery only to think (consciously) about the next thing to do. The Swiss psychiatrist Calr Jung would turn in his grave, although he did say "that consciousness acts upon our nightly life just as much as the unconscious overshadows our daily life". Perhaps we could learn more about ourselves by simply staying awake. The fact is that medical science has struggled to explain why we need sleep anyway. According to the journal Science, the function of sleep is one of the 100 or so greatest unsolved mysteries in science. Theories range from brain "maintenance" - including memory consolidation and pruning - to reversing damage from oxidative stress suffered while awake. Dr Jerome Siegel, a University of California, Los Angeles, professor of psychiatry and director of the university's Centre for Sleep Research at the Semel Institute for Neuroscience and Human Behaviour, has studied sleep in a broad range of animals from the platypus to the walrus. In the online journal Nature Reviews Neuroscience last year, he concluded that sleep's primary function is to increase the efficiency of animals and minimise risk. We stay alert and active when we need to and relax our guard when there is less danger or less call for action. "We see sleep as lying on a continuum that ranges from these dormant states like torpor and hibernation, on to periods of continuous activity without any sleep, such as during migration, where birds can fly for days on end without stopping," said Siegel. Airmen, unfortunately, cannot fly for days for days on end. This problem has mightily exercised military researchers. But hopes that modafinil would be the solution have been dashed by a number of studies of its effectiveness. Harvard law student Douglas Kim pulled the findings together in a 2007 paper on "vigilance" as a military priority. "In certain studies, modafinil's efficacy as compared to caffeine and amphetamines were of questionable conclusion," he wrote. "Researchers also noticed modafinil produced unexpected side-effects including an increase in core temperature, an inability to discern when the drug has begun to perform, and an additional 'over-confidence' effect in self-reported questionnaires - all side-effects that are of real concern when superimposed on sustained military operations." If you ask busy people whether they would like to stay awake for long periods, you get some intriguing responses, as I did to my question on Facebook. "I would never give up sleeping, I need it too much," said one South African business executive now working in the US. He might well have quoted Shakespeare, whose nervously overwrought Macbeth feared that he was cursed to sleep no more. "You've got to love the ICU in hospital," wrote another, "it's the only place you actually get intensive nursing care but absolutely NO sleep." And a sportsman friend wrote: "Thankful for sleep... Best time of our lives sometimes." As to getting more done by not sleeping, a rather despairing note sounded in this response: "As an insomniac, I question that assumption." Efficiency and productivity may not be enhanced simply by staying awake, because the body and mind need to regenerate through sleep. Jung believed that in sleep our dreams reconnect us with the collective unconscious of our species, the myths and archetypes that underlie our wakeful reality and shape our lives. If so, we cannot do without it, and any attempt to drug ourselves into a state of perpetual sleeplessness will smash our psyche to pieces. To be cursed with sleep, or with sleeplessness: which is it to be? Birds know the answer, we don't - though perhaps only for now. The fact is that medical science has struggled to explain why we need sleep anyway AIMING EVER HIGHER: Night time is no time to nod off, say those who believe we should be spending more hours awake. Less time sleeping means more opportunity to make optimum use of our time and remain productive, they say. Picture: iSTOCKPHOTO LOAD-DATE: March 20, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 BDFM Publishers PTY Ltd. All Rights Reserved 165 of 998 DOCUMENTS Reuters Health Medical News March 15, 2010 Monday 9:00 PM EST Guideline urges treatment for nonmotor symptoms of Parkinson's disease SECTION: CLINICAL LENGTH: 579 words DATELINE: NEW YORK A new practice parameter from the American Academy of Neurology calls for doctors to identify and treat nonmotor symptoms in patients with Parkinson's disease (PD). Nonmotor symptoms - autonomic dysfunction, sleep disorders, psychological and cognitive problems, and sensory abnormalities - are major, often unrecognized causes of morbidity in PD. In 2006 and 2008, the Academy issued guidelines pertaining to cognitive and mood dysfunction in PD as well as treatment of sialorrhea with botulinum toxin. To evaluate treatment options for other nonmotor PD symptoms, Dr. Theresa A. Zesiewicz from the University of South Florida in Tampa and associates searched MEDLINE, EMBASE, and the Science Citation Index and identified 46 controlled trials published between 1966 and 2008. Most trials supporting specific treatments provided only level C evidence, the researchers report in the March 16th issue of Neurology. The only recommendation backed by level B evidence was the use of levodopa/carbidopa (Atamet, Sinemet) to treat periodic limb movements of sleep. One trial evaluated the efficacy of sildenafil (Viagra) in 12 patients with erectile dysfunction. Sildenafil was more effective than placebo at enabling men to achieve and maintain an erection, with minimal changes in blood pressure. The authors advise a complete medical evaluation to rule out other treatable causes of erectile dysfunction. For excessive daytime sleepiness, modafinil (Provigil) might be useful. However, modafinil might improve patients' perception of wakefulness without improving objective measures of sleepiness, creating a potential safety hazard if patients engage in activities such as driving. Methylphenidate (Ritalin) might help patients with fatigue, but the authors warn of the potential for abuse. They note that PD patients "have a risk for dopamine dysregulation syndrome and impulse control disorders that share many clinical and functional imaging features with addiction." Isosmotic macrogol (polyethylene glycol or Miralax) possibly improved constipation in one study. Increased water and dietary fiber intake have also been helpful. However, for many conditions considered - orthostatic hypotension, urinary incontinence, insomnia, rapid eye movement sleep behavior disorder, and anxiety -- the authors found insufficient evidence to support or refute treatments. Dr. Zesiewicz and associates advise physicians to diagnose nonmotor symptoms in PD using tools such as the NMS Quest study questionnaire and the updated version of the Unified Parkinson's Disease Rating Scale. Concluding, the investigators write, "There are few dedicated controlled trials of drugs to treat nonmotor symptoms in PD. Such trials are urgently required." However, co-author Dr. William J. Weiner commented in an interview with Reuters Health, "The truth is that when we do these very formal surveys of the literature looking for evidence in a rigorous manner, it's quite common that we can't find much evidence." That doesn't mean that many of the measures that physicians commonly use to treat nonmotor PD symptoms aren't helpful, he added. Dr. Weiner, from the University of Maryland Medical Center, Baltimore, continued, "It's also helpful for patients to know that they don't have another disease (when they develop these symptoms), so they don't have to see a cardiologist or a GI specialist or a urologist; that in fact it's part of what is going on with them." SOURCE: Neurology 2010;74:924-931. LOAD-DATE: March 16, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Reuters Health All Rights Reserved 166 of 998 DOCUMENTS DAILY MAIL (London) March 9, 2010 Tuesday TEENAGERS ARE NOW BUYING ILLEGAL 'SMART DRUGS' ONLINE TO BOOST EXAM PERFORMANCE. BUT AS THIS SPECIAL REPORT SHOWS,THE EFFECT ON THEIR HEALTH CAN BE CATASTROPHIC BYLINE: BY STEVE BOGGAN AND TIM STEWART LENGTH: 1799 words JOSH has an exam and, like most of the other boys at his prestigious public school, he's keen to put his best foot forward. He's eaten breakfast and dressed smartly, but before he sets off for class, he reaches for a white pill and pops it into his mouth. He bought 30 of the tablets online for £40 from the U.S., but for all Josh knows they might well have been knocked up in an illegal backstreet 'pharmacy' in India. Still, the drug modafinil -- usually used to treat sleeping disorders -- has worked before for him and if it works again he is sure to get top marks. Welcome to the world of 'smart drugs', otherwise known as cognitive enhancement pharmaceuticals. This is a world where pupils as young as 15 self-medicate, participate in illegal online drug trafficking and swap notes on the best pill cocktails for good grades. Concern over smart drugs has been growing for some time among academics, politicians and pharmacologists, but it has been brought into sharp focus with the announcement that the former health minister, Lord Darzi of Denham, is heading a study at Imperial College, London, into their effects. This might seem odd because most of these drugs have been around for decades for the treatment of conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, and have been found to be safe. But no one has monitored their chaotic use in healthy young people taking inappropriate doses to boost their intellectual prowess. And some experts believe this kind of use in brains that are still developing could cause addiction and permanent damage. Josh is an intelligent, articulate 17-year-old, so you wonder why he needs extra help to feel smart. He has been taking modafinil (sold as the prescription-only drugs Provigil, Alertec, Modavigil and Modalert) since he was 16, but has friends who began using smart pharmaceuticals at 15. He lives in London and his parents are lawyers. 'I read about modafinil in a newspaper and then researched it on the internet and spoke to some of my friends about it,' he says. 'It appealed to me as an inexpensive method for highly concentrated revision, for which I would otherwise depend on coffee, tea or Red Bull. Modafinil gives you heightened alertness, stamina and productivity. I find it helpful for focus and memory. 'I find I can memorise a graph after drawing it once instead of several times. I would say it makes me 40 to 50 per cent more productive in a day, but it does not make me any cleverer. 'While revising for my last set of exams, I was taking 100mg of modafinil a day for six or seven days a week for three weeks. 'Around half-term, I stepped it up to 150mg to 200mg a day and in the last two or three weeks up to the exams I took 200mg to 300mg a day and worked 18-hour days. 'I find you can get by on four to six hours of sleep for up to three weeks and then, at the end, the body needs to rest and catch up. I take a whole day off and sleep for 24 hours. 'Taking it is no different from having other stimulants such as coffee, ProPlus caffeine tablets or Red Bull. It is no different from taking painkillers for a headache. 'I use it specifically for exams and will carry on at university. I would recommend it to anyone who is informed about it and knows what they are doing. 'I haven't told my parents about using modafinil. They wouldn't know what it is and they wouldn't approve of me using it.' Josh's use of modafinil is not unusual. A quick scan of student web forums uncovers a world where drug advice is swapped. The benefits of Ritalin and Adderall, which are meant to be used to treat ADHD, are compared with Provigil, Modalert and a group of drugs called ampakines -- prescription pharmaceuticals that are showing promise in the treatment of Alzheimer's and Parkinson's. The problem in telling students not to take them is that tests have shown these drugs can help with focus, memory, concentration and alertness by interacting in different ways with neurotransmitters -- chemical messengers -- in the brain. the ADHD treatments contain amphetamines, which can result in addiction, and there are suspicions that sleep disorder treatments such as modafinil could be addictive. Barbara Sahakian, Professor of Clinical Neuropsychology at Cambridge University, says scientists understand how drugs such as Ritalin work by stimulating levels of the neurotransmitters dopamine and noradrenaline in the brain. These affect mood, cognition and memory. 'However, there is an optimal dose for ideal performance,' she says. 'Levels beyond that could cause problems with addiction. With modafinil, no one really knows how exactly the drug acts in the brain to boost cognition.' Evidence is emerging, however, that modafinil -- long thought not to be addictive -- also affects the levels of dopamine. This is significant because dopamine production can lead to addictive behaviour. Sometimes referred to as the 'reward' drug, dopamine is released during experiences such as the enjoyment of sex, food and drugs. We are programmed to repeat rewarding experiences, a cycle that can result in addiction. A study published in the Journal of the American Medical Association last year looked at ten healthy men taking modafinil and found it did increase levels of dopamine. The research was conducted by the National Institute on Drug Abuse (Nida) in the U.S. '[Modafinil] has the signature that it could potentially be addictive,' says Nida's director Dr Nora Volkow. 'Studies have shown consistently that all of the drugs of abuse . . . have a common effect of increasing dopamine in the nucleus accumbens [area of the brain]. 'That is believed to be crucial for their reinforcing effect and ultimately their underlying potential for producing addiction.' The jury is still out on whether modafinil is addictive. Scientists regard tests on just ten people as being far from definitive. Sahakian has called on the Government to hold a public debate on the use of smart drugs. On the one hand, she feels they could be of real benefit to society if proven to be safe. On the other, she wonders whether in some dystopian future people will be pressured into taking them to work longer and harder. Already, there is evidence that students feel pressured into taking smart drugs to compete with highachieving classmates who are using them. And some pushy parents appear to be condoning their use. One third-year student studying computer science at London Metropolitan University told us that taking modafinil is a 'lifesaver' in helping him to complete assignments. 'I am aware of school children who have taken modafinil. They were aged between 16 and 18,' he says. 'Their father [a computer programmer], my friend, used to take it occasionally. The parents had extremely high expectations for their children and they were taking exams. 'My friend's daughter was advised to take modafinil by her classmates. Unfortunately, this was a terrible decision. 'She was taken to hospital after five days of sleep deprivation. She had high blood pressure, was anxious and experienced some kind of hallucinations and psychosis. 'She was taking extremely high doses of modafinil. I was told she had felt some kind of euphoria and kept taking more and more. It is proof that modafinil can be addictive for some people.' If Nida in the U.S. is correct and all these drugs affect dopamine levels in some way, then concern is likely to focus on students self-medicating inappropriate dosages and using them over a long time. Dr Daniel Amen, a psychiatrist and Fellow of the American Psychiatric Association, says that while treating young ADHD patients with carefully controlled doses of Ritalin can improve their lives immeasurably, unmonitored doses taken by healthy youngsters could be damaging. 'A therapeutic dose arrived at by careful monitoring by a physician might be anywhere from 5mg to 60mg a day,' he says. 'We know that can enhance brain function in many people by stimulating levels of dopamine. 'But where you have some of these students taking concentrations of 100mg to 500mg, that could cause some problems. 'The extra dopamine produced constricts blood flow to the brain and, over the long term, that could cause permanent damage. 'The adolescent brain, especially the pre-frontal cortex -- the most thoughtful part of the brain -- is developing rapidly. Anything that disrupts or interferes with this process can cause lasting problems.' There is debate on student forums over whether using smart drugs amounts to cheating. Some say it does, while others argue that those who want to ban them should be prepared to give up commonplace stimulants, such as caffeine and nicotine. Even academics are divided. Dr Anders Sandberg, a philosophy lecturer specialising in bioethics at Oxford University, tried modafinil as part of his research three years ago and now uses it openly. In common with students who take it, Dr Sandberg is on the legal side of an illegal transaction. Under the 1963 Medicines Act, it is an offence to supply a drug without a prescription, but not to buy one. 'When I take it, it is like having a little electric motor in the back of my head running through lists of things I need to do,' he says. 'Then, instead of putting them off until tomorrow, I go ahead and do them. 'I use the drugs only occasionally if I have a paper to write or need to fly long distances to attend a conference or deliver a speech. I find that instead of having jet-lag, I can focus on the job at hand.' But isn't that sending the wrong message to students? 'This is something I have spent a lot of time considering, but in general I believe people should have control over their own bodies,' he says. 'That right is important, but you need to use it appropriately and that's why youngsters shouldn't take responsibility for managing drugs, alcohol or enhancers. 'These drugs are like stepladders. If you need them to attain something that would otherwise be out of your reach, then use them. But if you can reach those heights anyway, then you're just being lazy.' However, health professionals take a dim view of anyone misusing drugs. 'Anyone taking prescription drugs without a prescription obtained through a consultation with a health professional is making a big mistake,' says Neal Patel, a pharmacist and spokesman for the Royal Pharmaceutical Society. 'It's dangerous to experiment with medicines and the sideeffects of cognitive enhancement drugs are significant -- they can cause abdominal pain, nausea, heart problems and changes in blood pressure. 'These side- effects are dose dependent -- the more you take, the greater your risk of being affected and seriously harmed.' Professor Sahakian and Dr Amen say there are other, less risky yet proven remedies for improving brain function: sleep, exercise and a healthy diet. Apparently, they work. LOAD-DATE: March 9, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Papers Copyright 2010 Associated Newspapers Ltd. All Rights Reserved 167 of 998 DOCUMENTS Irish Independent March 6, 2010 Saturday They call it the professional's pill SECTION: FEATURES LENGTH: 1264 words Why more middle-class people are taking a drug they believe will make them smarter Sandra is an air steward. She pops a tab every time she crosses the Atlantic to make sure she's perky on landing. Gerry uses them during exams to give his concentration a boost. Simon, a junior doctor, takes one during the night shift to keep sleep at bay and his brain sharp. You won't find their pill of choice on the shelves of your local head shop but there's growing evidence that high-flying professionals and stressed-out students are relying on brain-boosting drugs to quicken their thinking and keep them awake. This week in Britain, scientists urged the government to bring the closet phenomenon of so-called smart drugs into the open, claiming their use is spreading across all sectors of society from surgeons to soldiers. Researchers from Cambridge University warned that the drugs, which were designed to help people with neurological disorders like attention-deficit hyperactivity disorder, Alzheimer's and brain injury, are now being used for reasons far beyond their original purpose by uptight executives, multi-tasking mothers and exhausted shift-workers who need a chemical pick-me-up. No self-respecting GP would prescribe these powerful brain-changing drugs to a patient suffering from poor concentration or tiredness, so users are turning to the internet, where a multitude of websites offer them for sale. In Ireland, customs officers are at the coalface of this new craze, with increasing quantities of cognitive-enhancement drugs such as Modafinil and Ritalin being shipped into the country illegally every year. In 2008, 1,250 tablets of Modafinil, a sleep inhibitor, were seized at ports and airports, rising to 1,920 last year. In the first two months of this year, 170 tablets were found. Seizures of Ritalin, dubbed 'kiddie cocaine' in the US where it is doled outlike candy to school-going children, have been lower but significant all the same with more than 612 units found since 2007. Here, Modafinil is sold under the trade name Provigil. In November, its manufacturers Cephalon were granted permission by the Irish Medicines Board to market the drug for the treatment of excessive daytime sleepiness associated with sleep apnoea. Taoiseach Brian Cowen is among those who suffer from this condition, which periodically causes breathing to stop during sleep. Originally developed in France, Modafinil, which is also licensed to treat narcolepsy -- a disorder marked by sudden uncontrollable attacks of daytime sleep -- is the first of a new generation of wake-promoting drugs which targets the sleep/wake centres in the brain. It works by activating sleep-suppressing neurons fooling the mind into believing it is time to be alert. This pharmaceutical prototype has the power to keep a person awake and focussed for up to 90 hours running, without the jitteriness or poor concentration that other stimulants like amphetamines or caffeine are known to produce. Proponents say it works without causing a crash after its effects have worn off and does not create any sense of euphoria in the brain thereby limiting its potential for abuse. The use of Modafinil within the American military is well-documented where it has been approved for use on air force missions, allowing troops to stay awake for days at a time and complete operations as quickly as possible. In Britain, the drug was approved for use in 2002, and since then has surged in popularity. The number of prescriptions for stimulants like it has nearly doubled in recent years, rising from 458,000 in 2004 to 751,000 in 2008. A Nature magazine poll of 1,400 respondents, mostly scientists and academics, suggested that one in five had used 'smart drugs'. Fears that stay-awake pills are increasingly being used as 'lifestyle drugs' are strengthening, especially since their long-term effects on the brain are still unknown. Some neuroscientists also worry that drugs like this will turn humans into mechanistic beings who pop a pill when they need a brain boost rather than opting for a brisk walk or a good night's sleep. Pharmaceutical advances like this could make cosmetic neurology as popular as beauty enhancements, they claim. And there are ethical concerns about the unfair advantage such drugs give to users over their peers in academic settings. In the US, surveys show that an estimated 16-20pc of US college students take smart drugs to help their memory and keep them alert. The drugs may especially help in subjects like mathematics and science by aiding students to complete puzzles and remember long chains of digits. Last week, one of Britain's leading psychologists called for an official university-wide strategy to tackle student misuse of prescription drugs like Modafinil. Barbara Sahakian, professor of clinical neuropsychology at Cambridge University, whose work is at the forefront of research into cognitive enhancement drugs, has even raised the prospect of dope testing of exam students as a possible safeguard against their use. "This is something that universities really have to discuss," she says. "It has enormous implications. The coercion aspect is a strong one. Some students say they feel it is cheating and it puts pressure on them to feel they have to use drugs when they don't really want to. "You have to consider there are things that could be beneficial about such drugs because we have an ageing population: people will have to work for longer and their pensions may not be performing. "The big question is, are we all going to be taking drugs in the next 10 years and boosting our brain power in this way? And if we are, will we use them to have a shorter working week, so we can go home, spend more time with our families and have a good work/life balance? Or will we go headlong into a 24/7 society were we work all the time because we can work all the time'" Improving brain power and its ability to stay awake is certainly where drug companies think the future lies as the market for treatments for neurological and psychiatric illnesses continues to outstrip that for painkillers and cardiovascular drugs in the western world. Dozens of neuro-enhancing drugs are currently in the research pipeline and their use in the coming years is expected to soar. Advocates argue that smart drugs will remove disparities in society and give those who are mentally challenged a better chance of self-improvement and success. They also claim it is better for high-risk professionals like surgeons and pilots to take a medically-controlled tablet rather than dosing themselves up on caffeine and ending up with a shaky hand and a twitchy disposition But for those dealing with the downside of chemical consumption, the advent of smart drugs is a worrying prospect. "As with any stimulant that alters the central nervous system, you have to stop and think of the long-term consequences of using these drugs," says Dr Fiona Weldon, clinical director of the Rutland Centre, Dublin's leading addiction therapy centre. "We are unsure about the extent to which these drugs are being used in Ireland but it would be naive to think it isn't happening and it is something we should be very worried about," she says. "I've seen students become reliant on the likes of Ritalin. They claim it makes them work better but before you know it there is a dependency. "There is such a tendency now to seek out a quick chemical fix as the solution to our stresses but if you over-stimulate the brain in a false way, the system will eventually crash and the side effects are incredible." LOAD-DATE: March 6, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 Independent News and Media Ltd. All Rights Reserved 168 of 998 DOCUMENTS The Times (London) February 27, 2010 Saturday Edition 1; National Edition Get smart drugs out of the closet, scientists urge BYLINE: Lucy Bannerman SECTION: NEWS; Pg. 28,29 LENGTH: 574 words Scientists have urged the Government to bring the "closet phenomenon" of so-called smart drugs out into the open, suggesting that regulated use of the stimulants could help groups such as surgeons, soldiers, and jurors to maximise their benefit to society. The calls coincide with a new study, headed by the former health minister and surgeon Lord Darzi of Denham, that will monitor the effects of "cognitive enhancement drugs" on the memory, concentration and decisionmaking skills of healthy adults. There is little data on the long-term safety of the performance-enhancing effects of Ritalin and Modafinil, which are available only on prescription for those diagnosed with conditions such as attention deficit hyperactivity disorder (ADHD) or narcolepsy. Anecdotal evidence suggests, however, that the pills' illicit promise of increased brain power and long bouts of uninterrupted concentration is attracting numbers of healthy high-fliers. Professor Barbara Sahakian, a neuroscientist from the University of Cambridge, is working with Lord Darzi's team at Imperial College London. Making the drugs available over the counter would be one way of prompting the clinical trials, which she believes are needed to explore just how far they can improve the human mind. Until then, Professor Sahakian warns that ambitious executives, multitasking mothers and students under pressure will continue to take risks with drugs procured over the internet, or other people's prescriptions, while the rest of society risks losing out. "This is a closet phenomenon," she told The Times. "We know that people are doing these drugs anyway but we don't know about their long-term safety. The Government has a responsibility to think about what they should do about that. Maybe they should be letting pharmaceutical companies brand these medications via a safe route. Wouldn't that be better?" Government health statistics for England show that the number of prescriptions for stimulants such as Ritalin and Modafinil has nearly doubled in recent years - rising from 458,000 in 2004 to 751,000 in 2008. "I'm rather careful about my brain," said Dr Anders Sandberg, 37, as one might well expect from a philosophy lecturer who specialises in bioethics at the University of Oxford. He first took Modafinil three years ago, after consulting a pharmacologist friend, and procuring about thirty 50mg doses from a website. He now takes it on average once a month - "not chronically, but only on days when I decide, 'OK, I need to get something done'." Days when he has conferences, seminars, papers to write. He also wants to remove the stigma attached to those who seek artificial improvement for their attention span. "When the cellphone first arrived, we weren't sure when to use it. But we learnt to invent rules, so that it's generally not OK to use them in restaurants but it's OK walking outside. We need to achieve the same with enhancement drugs. We need the right culture surrounding it. And the only way we can do that is by being honest about its consumption, and face up to the fact it is going on." A spokeswoman for the Department of Health said a report had been commissioned in 2008 investigating the issue of cognitive-enhancing drugs. She said: "We strongly urge anyone thinking about taking a prescriptiononly medicine, not intended for their personal use, to consult their GP first." Online Health news, features and expert advice timesonline.co. uk/health LOAD-DATE: February 27, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: TIM Copyright 2010 Times Newspapers Limited All Rights Reserved 169 of 998 DOCUMENTS The Times (London) February 27, 2010 Saturday Edition 1; Ireland Get smart drugs out of the closet, scientists urge BYLINE: Lucy Bannerman SECTION: NEWS; Pg. 36,37 LENGTH: 574 words Scientists have urged the Government to bring the "closet phenomenon" of so-called smart drugs out into the open, suggesting that regulated use of the stimulants could help groups such as surgeons, soldiers, and jurors to maximise their benefit to society. The calls coincide with a new study, headed by the former health minister and surgeon Lord Darzi of Denham, that will monitor the effects of "cognitive enhancement drugs" on the memory, concentration and decisionmaking skills of healthy adults. There is little data on the long-term safety of the performance-enhancing effects of Ritalin and Modafinil, which are available only on prescription for those diagnosed with conditions such as attention deficit hyperactivity disorder (ADHD) or narcolepsy. Anecdotal evidence suggests, however, that the pills' illicit promise of increased brain power and long bouts of uninterrupted concentration is attracting numbers of healthy high-fliers. Professor Barbara Sahakian, a neuroscientist from the University of Cambridge, is working with Lord Darzi's team at Imperial College London. Making the drugs available over the counter would be one way of prompting the clinical trials, which she believes are needed to explore just how far they can improve the human mind. Until then, Professor Sahakian warns that ambitious executives, multitasking mothers and students under pressure will continue to take risks with drugs procured over the internet, or other people's prescriptions, while the rest of society risks losing out. "This is a closet phenomenon," she told The Times. "We know that people are doing these drugs anyway but we don't know about their long-term safety. The Government has a responsibility to think about what they should do about that. Maybe they should be letting pharmaceutical companies brand these medications via a safe route. Wouldn't that be better?" Government health statistics for England show that the number of prescriptions for stimulants such as Ritalin and Modafinil has nearly doubled in recent years - rising from 458,000 in 2004 to 751,000 in 2008. "I'm rather careful about my brain," said Dr Anders Sandberg, 37, as one might well expect from a philosophy lecturer who specialises in bioethics at the University of Oxford. He first took Modafinil three years ago, after consulting a pharmacologist friend, and procuring about thirty 50mg doses from a website. He now takes it on average once a month - "not chronically, but only on days when I decide, 'OK, I need to get something done'." Days when he has conferences, seminars, papers to write. He also wants to remove the stigma attached to those who seek artificial improvement for their attention span. "When the cellphone first arrived, we weren't sure when to use it. But we learnt to invent rules, so that it's generally not OK to use them in restaurants but it's OK walking outside. We need to achieve the same with enhancement drugs. We need the right culture surrounding it. And the only way we can do that is by being honest about its consumption, and face up to the fact it is going on." A spokeswoman for the Department of Health said a report had been commissioned in 2008 investigating the issue of cognitive-enhancing drugs. She said: "We strongly urge anyone thinking about taking a prescriptiononly medicine, not intended for their personal use, to consult their GP first." Online Health news, features and expert advice timesonline.co. uk/health LOAD-DATE: February 27, 2010 LANGUAGE: ENGLISH GRAPHIC: The Times writer David Aaronovich said that the Ritalin-type tablets he took brought unexpected benefits PUBLICATION-TYPE: Newspaper JOURNAL-CODE: TIM Copyright 2010 Times Newspapers Limited All Rights Reserved 170 of 998 DOCUMENTS Herald Sun (Australia) February 26, 2010 Friday 1 - FIRST Edition Dangerous increase in prescription drug abuse `Smart pills' alarm BYLINE: Felicity Williams social trends reporter SECTION: NEWS; Pg. 29 LENGTH: 476 words OVERWORKED Melbourne professionals and students are popping speed-like drugs in growing numbers to help them get through the day. The number of prescriptions for modafinil, a treatment for sleep disorders also known to improve alertness and concentration, has almost doubled in Victoria in the past three years. Prescription drug abusers are also engaging in the dangerous practice of using modafinil -- sold here as Modavigil -- without a doctor's authority by buying it on the black market. The Herald Sun can reveal that Melbourne professionals and students have openly discussed the effects, dosage, price and their experiences obtaining the drug without a prescription in an online drugs forum with a Russian domain name. A computer programmer in the discussion thread described the effect of modafinil as ``like amphetamine''. ``Modafinil seems to make me feel sharper . . . I don't know how else to describe it,'' he wrote. ``I usually take it when I feel I should be getting something done.'' Another user admitted he and his colleagues took the drugs before night meetings when he was selling commercial real estate. A student described it as ``the best study aid ever'' despite side-effects such as ``nasty headaches'' and ``feeling scattered''. According to the Pharmaceutical Benefits Scheme website, Victorian pharmacies dispensed 723 items of modafinil last year, up from 370 in 2007. It is also easy to obtain modafinil and other ``smart pills'' such as Ritalin, for hyperactivity, and donepezil, for dementia, without a prescription at online pharmacies. The Herald Sun arranged for the purchase and shipment to Australia of one packet of modafinil tablets but withdrew when the website requested credit card details. Australian Medical Association vice-president Dr Steve Hambleton said illicit use of prescription drugs as smart pills was a major concern. ``There are a range of side-effects, particularly when people aren't taking regular amounts,'' he said. Tweet with Felicity Williams about the latest trends twitter.com/flickwilliams MODAFINIL (Modavigil) Treats sleep disorders such as narcolepsy Used by prescription drug abusers to promote wakefulness Side-effects include dependency, rashes, mania, delusions, hallucinations, suicidal thoughts, high blood pressure, birth defects DONEPEZIL (Aricept) Treats Alzheimer's disease Used by prescription drug abusers to boost mental performance Side-effects include abnormally slow heart rate, fainting, diarrhoea, nausea, vomiting, headaches, insomnia May increase risk of stomach ulcers, seizures, asthma RITALIN Treats attention deficit hyperactivity disorder Used by prescription drug abusers to enhance concentration Side-effects include dependency, psychotic episodes, severe depression, suicidal thoughts, high blood pressure Linked to sudden death in children, teenagers and adults with serious heart problems LOAD-DATE: February 25, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: DHS Copyright 2010 Nationwide News Pty Limited All Rights Reserved 171 of 998 DOCUMENTS Guardian Unlimited February 23, 2010 Tuesday A Pandora's box full of smart drugs BYLINE: Ann Robinsonguardian.co.uk LENGTH: 737 words ABSTRACT Ann Robinson: We should think very carefully before we start routinely taking drugs such as Modafinil to boost cognitive function FULL TEXT Here's a thoroughly modern ethical dilemma to chew over. You go for a job interview but are pipped to the post by another person who seems wholly underwhelming and is less well qualified. The feedback is that she came across as more zappy and focused. Over coffee, she shares that she's popped a tab of before the interview. How does that make you feel? Or here's another one. Senior members of the academic department that you work in share their tip for being able to fly over to the US and deliver a lecture the same day while looking fresh and sounding perky. They regularly take the drug to counter jet lag and enhance their cognitive function. You're not keen, but as a junior member of the team, you want to perform as well as possible. So do you try to get your GP to prescribe some or, like most of your workmates, buy some on line? These challenges aren't theoretical but real. Cognitive-enhancing drugs, also known as "smart" drugs are already being used to help people with Alzheimer's disease, schizophrenia, attention deficit hyperactivity disorder (ADHD) and brain injury. But is there burgeoning use among university students and others wishing to boost their brain power? It is this that's posing the ethical dilemmas. , professor of clinical neuropsychology at Cambridge University, described how the smart drugs fit in to our quest to keep our minds functioning longer and better in our ageing population, in a , organised by Prospect magazine. The three drugs in common use are (Ritalin), (Provigil) and (Strattera). All boost neurotransmitter chemicals (noradrenaline, acetylcholine, dopamine) at the junction between nerves to improve transmission or electrical activity. Even modest improvements in cognitive function can make a big difference to people's lives. It can make the difference between someone with schizophrenia being able to live independently or not. Or a kid with ADHD being able to stop his impulsive behaviour and stay out of trouble at school. And there are huge financial implications in being able to reduce the cost of long-term care for people with Alzheimer's if a drug can slow their cognitive decline by even 1%. Professor Sahakian said that the smart drugs are just one approach to boosting cognitive function. Exercise (three brisk walks a week will do, she said) and learning new things throughout life are most important. And connecting with others, giving of yourself and maintaining your curiosity about life are the other cornerstones of mental wellbeing. She warns against the potential dangers of people under 20, whose brains are still developing, taking smart drugs like Ritalin unless they have a condition such as ADHD. But an estimated 16-20% of US college students take smart drugs and there is reason to believe its spreading to the UK. The field of is developing to look at challenges posed by advances in the neurosciences. Some arguments for smart drugs include removing disparity in society and boosting performance. In a lengthy operation, it is best to have one surgeon do the whole job and a tab of Modafinil may be better than caffeine which, in high doses, can cause tremor. The US army is interested in smart drugs to allow troops to complete military operations as quickly as possible. But the potential harms include the fact that we don't know about long-term effects, especially in developing brains. People may feel coerced into taking them. There's a potential for abuse and you may get unwanted effects like persistent memories. Is it cheating to take the drugs? Will it turn us into mechanistic beings who don't feel we've earned the right to feel proud of our achievements? Will working hard and being motivated become antiquated concepts? Will we become a homogenous society and will we lose creativity? The last concern is practical. There is no licence for prescribing smart drugs unless you have a specified condition. No self-respecting GP is likely to prescribe it. And buying drugs online is fraught with dangers. You have to check you have no contraindications, that it won't interact with any other medication and that what you get in the post is what it says on the box. LOAD-DATE: February 23, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2010 Guardian Unlimited All Rights Reserved 172 of 998 DOCUMENTS Reuters Health Medical News January 28, 2010 Thursday 9:00 PM EST Stimulants better than nonstimulants for adult ADHD: meta-analysis SECTION: CLINICAL LENGTH: 588 words DATELINE: NEW YORK Stimulant medications show greater efficacy than nonstimulants for treating attention-deficit/hyperactivity disorder (ADHD) in adults, according to a new meta-analysis. Study authors Dr. Stephen V. Faraone and Dr. Stephen J. Glatt note that stimulants have been the mainstay of ADHD pharmacotherapy for decades. Several nonstimulant medications have also been shown effective - tricyclic antidepressants, bupropion, modafinil, monoamine oxidase inhibitors, guanfacine, atomoxetine, and clonidine. However, it's been difficult to compare different drugs or drug classes due to the lack of head-to-head trials. Drs. Faraone and Glatt, both from SUNY Upstate Medical University in Syracuse, New York, searched the medical literature for double-blind, placebo-controlled studies of ADHD in adults published after 1979, in which subjects were followed for at least 2 weeks. They identified 18 articles that involved more than 2000 subjects and evaluated 13 drugs. In their report, which appeared online December 29 in the Journal of Clinical Psychiatry, effect size is expressed as the standardized mean difference, in which a 1-point difference is equivalent to 1 standard deviation on the outcome measure. Five trials studied 4 long-acting stimulants (mixed amphetamine salts extended release, osmotic-release oral system methylphenidate, dexmethylphenidate extended release, and lisdexamfetamine dimesylate) in 637 participants. The mean effect size was 0.73. The 3 short-acting stimulants evaluated in 7 trials (n = 459) were mixed amphetamine salts, dextroamphetamine, and methylphenidate. The effect size was 0.96. Nine trials with 968 subjects examined the efficacy of 6 nonstimulants (atomoxetine, bupropion SR, modafinil, bupropion XL, paroxetine, and an investigational drug ABT-418). The mean effect size was 0.39. There was significant heterogeneity among effect sizes, and evidence of publication bias, only in the trials of short-acting stimulants. Correction for publication bias revealed an effect size of 0.86, which did not differ significantly from that of long-acting stimulants. There was also no significant difference between methylphenidate- and amphetamine-based medications. On the other hand, the effect sizes for nonstimulant medications were significantly less than those for long-acting stimulants. After correcting for differences in study design, nonstimulants did not differ from short-acting stimulants. Dr. Faraone and Dr. Glatt note that the effect sizes are robust and similar to those reported for medication treatment studies of children with ADHD. Only one medication, paroxetine, was worse than placebo. Numbers needed to treat (NNT) ranged from 2 to 3 for long-acting stimulants, from 2 to 4 for short-acting stimulants, and from 2 to 5 for nonstimulants. Among nonstimulants, only modafinil had a NNT of less than 3. The authors point out that the response rates are less than those reported in the literature, because the latter are not placebo adjusted. "The NNT results...suggest that most patients will need more than 1 drug trial to achieve a positive outcome that cannot be attributed to a placebo effect." Still, in the absence of head-to-head trials, the researchers urge caution in comparing effects of different medications across studies. The study was funded by a grant from Shire US, whose products include lisdexamfetamine dimesylate (Vyvanse), methylphenidate transdermal (Daytrana), methylphenidate hydrochloride (Equasym), and guanfacine (Intuniv). SOURCE: J Clin Psychiatry 2009. LOAD-DATE: January 29, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Reuters Health All Rights Reserved 173 of 998 DOCUMENTS US Fed News January 20, 2010 Wednesday 10:37 AM EST Patent No. 7,649,020 Issued on Jan. 19, Assigned to Cephalon France for Modafinil Polymorphic Forms (French Inventors) LENGTH: 187 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., Jan. 21 -- Armand Frydman of Verrieres-le-Buisson, France, Veronique Broquaire of Noisy-le-Grand, France, Laurent Courvoisier of Laigneville, France, Franck Mallet of Blangy sur Bresle, France, Gerard Coquerel of Boos, France, and Michel Broquaire of Le Perreux, France, have developed modafinil polymorphic forms. The inventors were issued U.S. Patent No. 7,649,020 on Jan. 19. The patent has been assigned to Cephalon France, Maisons-Alfort, France. According to the abstract released by the U.S. Patent & Trademark Office: "Polymorphic forms of modafinil racemate, methods of preparation thereof, pharmaceutical compositions and methods of therapeutic treatment involving modafinil polymorphic forms." The original application was filed on Dec. 14, 2007. For further information please visit: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetah tml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7649020&OS=7649020&R S=7649020 For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: January 21, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 HT Media Ltd. All Rights Reserved 174 of 998 DOCUMENTS Reuters Health Medical News January 19, 2010 Tuesday 9:00 PM EST No improvements in schizophrenia symptoms seen with modafinil SECTION: CLINICAL LENGTH: 410 words DATELINE: NEW YORK The "wakefulness promoting" agent modafinil does not appear to help schizophrenic patients who don't respond well to clozapine, researchers report in the December issue of the Journal of Clinical Psychiatry. Clozapine "mostly treats positive symptoms," the researchers explain, "with meager efficacy at best" for negative symptoms or cognitive deficits. Furthermore, "clozapine-induced sedation can worsen cognition and impair social and occupational functioning," lead investigator Dr. Oliver Freudenreich of Harvard Medical School, Boston, and colleagues point out. Modafinil, which is sold in the US as Provigil, is approved to treat narcolepsy and shift work sleep disorder. Three previous controlled trials that assessed the safety and efficacy of modafinil add-on therapy in schizophrenia had inconsistent results, according to Dr. Freudenreich and his associates. In a double-blind, placebo-controlled, flexible-dose pilot trial in 35 patients, the researchers evaluated the safety, tolerability, and effect of modafinil on negative symptoms, cognition, and wakefulness/fatigue. All subjects were outpatients with stable schizophrenia, and all were taking clozapine. For the 8-week study, they were randomized to receive up to 300 mg/day of modafinil (n=19) in addition to clozapine, or placebo (n=16). The patients were an average of 45.2 years old and their mean duration of illness was 19.5 years. Adherence was over 75% for most subjects. At the end of treatment, the average dose of modafinil was 250 mg/d. "Modafinil was well-tolerated, with no clear tolerability problem in this small sample," the researchers note. "We did not detect worsening of psychosis, one of the safety concerns that has been raised with modafinil." But, they add, there was no reduction in cognitive deficits, negative symptoms or wakefulness and fatigue with modafinil compared with placebo. "Our power to detect differences between modafinil and placebo was limited by sample size," the authors said, adding that larger trials might show a benefit with modafinil. They also caution that physicians who prescribe this agent on a case-by-case off-label basis should keep in mind that rare instances of psychosis, rashes, and Stevens-Johnson syndrome have been reported with modafinil use. The pilot trial was sponsored by Cephalon Inc, the manufacturer of modafinil. Two of the authors receive grant and research support from Cephalon. SOURCE: J Clin Psychiatry 2009;70:1674-1680. LOAD-DATE: January 20, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2010 Reuters Health All Rights Reserved 175 of 998 DOCUMENTS PR Newswire December 21, 2009 Monday 4:30 PM EST Cephalon Provides Update on Regulatory Review of NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder; Company Expects FDA Decision by End of First Quarter 2010 LENGTH: 1014 words DATELINE: FRAZER, Pa., Dec. 21 FRAZER, Pa., Dec. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date to March 29, 2010, for its review of the supplemental New Drug Application (sNDA) for NUVIGIL® (armodafinil) Tablets [C-IV]. The sNDA is for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. "We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the March 29, 2010, action date," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "We remain excited about this opportunity as there are no medications approved by the FDA to treat excessive sleepiness associated with eastbound jet lag disorder." This sNDA for NUVIGIL was filed with the FDA on June 29, 2009, and given the action date of December 29, 2009, under the Prescription Drug User Fee Act (PDUFA). The company submitted additional information within 90 days of the assigned action date. Subsequently, the FDA informed the company that the agency required more time for a full review of the submission and, therefore, would extend the action date by three months. About NUVIGIL NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009. It is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com. About Cephalon, Inc. Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology. The company's proprietary products in the United States include: NUVIGIL, TREANDA® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), PROVIGIL® (modafinil) Tablets [C-IV] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for and frequency of filing new indications for NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion. Contacts: Media: Investor Relations: Candace Steele Flippin Chip Merritt 610-727-6231 (office) 610-738-6376 (office) csteele@cephalon.com cmerritt@cephalon.com SOURCE Cephalon, Inc. CONTACT:Media, Candace Steele Flippin, +1-610-727-6231, csteele@cephalon.com, or Investor Relations, Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc. URL: http://www.prnewswire.com LOAD-DATE: December 22, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 PR Newswire Association LLC All Rights Reserved 176 of 998 DOCUMENTS The Age (Melbourne, Australia) October 2, 2009 Friday First Edition Call for testing on 'smart drugs' BYLINE: JULIA MEDEW HEALTH REPORTER SECTION: NEWS; Pg. 7 LENGTH: 466 words INCREASING use of "smart drugs" among students aiming to improve their memory and cognitive function could prompt authorities to start drug-testing students before exams, an Australian researcher says. Vince Cakic, a researcher from the University of Sydney's school of psychology, said students were increasingly using psychostimulants â[#x20ac]" drugs usually prescribed for neuropsychiatric disorders and sleep disorders â[#x20ac]" to enhance their academic performance. He said drugs such as selegiline, usually prescribed for Parkinson's disease, were touted as a motivation enhancer, while others, such as modafinil and piracetam, were known for keeping people alert and improving their memory respectively. Collectively, the drugs are known as "nootropics" or "smart drugs", he said, because of the Greek words noo (mind) and troppo (to turn or change). Although research recently published in the US suggested modafinil was addictive, Mr Cakic said it was particularly popular among students because it kept them awake and alert without making them hyperactive. "I would say a lot of students are using that now," he said. "Memory enhancers like piracetam are also very popular." Mr Cakic said the drugs were easily purchased over the internet through online pharmacies in South-East Asia, Mexico and India, but he said amphetamines such as Dexedrine were harder to buy because they were controlled substances. In an article published in the Journal of Medical Ethics today, Mr Cakic said although some of the drugs had well-known side effects, including addictive qualities and the potential to aggravate mental illness, it was unclear how dangerous most of them were for healthy people long term. "It remains to be seen whether nootropics represent a pharmacological 'free lunch' or if the enhancement of some cognitive functions can only be realised at the expense of others," he wrote. Mr Cakic said increasing use among students could prompt people to treat them like performance-enhancing drugs in professional sport. If it was perceived they offered students an unfair advantage, drug tests could follow. Australian Drug Foundation chief executive John Rogerson said anecdotal reports suggested young people were talking more about these drugs, but he said there was no indication it was a big problem in Australia. "We haven't got evidence of this, but there's no doubt that kids are taking stimulants like Ritalin to get a short-term advantage," he said. "We would encourage young people to stay away from it." SO-CALLED SMART DRUGS METHYLPHENIDATE (Ritalin, Concerta) MODAFINIL (Provigil, Modavigil) AMPAKINES PIRACETAM (Nootropil, Avigilen) ERGOLOID (Hydergine, Cicanol) BETA-BLOCKERS (Propranolol) NOTE: THE AGE DOES NOT CONDONE THE USE OF ANY OF THESE DRUGS WITHOUT A PRESCRIPTION AND APPROPRIATE MEDICAL ADVICE. LOAD-DATE: October 1, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 The Age Company Limited All Rights Reserved 177 of 998 DOCUMENTS The Age (Melbourne, Australia) October 2, 2009 Friday Second Edition 'Smart' students could sit drug tests BYLINE: JULIA MEDEW, HEALTH REPORTER SECTION: NEWS; Pg. 3 LENGTH: 454 words INCREASING use of "smart drugs" among students aiming to improve their memory and cognitive function could prompt authorities to drug-test students before exams, an Australian researcher says. Vince Cakic, a researcher from the University of Sydney's school of psychology, said students were increasingly using psychostimulants â[#x20ac]" drugs usually prescribed for neuropsychiatric disorders and sleep disorders â[#x20ac]" to enhance their academic performance. He said drugs such as selegiline, usually prescribed for Parkinson's disease, were touted as a motivation enhancer, while others, such as modafinil and piracetam, were known for keeping people alert and improving their memory respectively. Collectively, the drugs are known as "nootropics" or "smart drugs". Although research recently published in the US suggested modafinil was addictive, Mr Cakic said it was particularly popular among students because it kept them awake and alert without making them hyperactive. "I would say that a lot of students are using that now," he said. "Memory enhancers like piracetam are also very popular." Mr Cakic said the drugs were easily purchased over the internet through online pharmacies in South-East Asia, Mexico and India, but he said amphetamines such as Dexedrine were harder to buy because they were controlled substances. In an article published in the Journal of Medical Ethics today, Mr Cakic said although some of the drugs had well-known side effects, including addictive qualities and the potential to aggravate mental illness, it was unclear how dangerous most of them were for healthy people long term. "It remains to be seen whether nootropics represent a pharmacological 'free lunch' or if the enhancement of some cognitive functions can only be realised at the expense of others," he wrote. Mr Cakic said increasing use among students could prompt people to view this issue in the same light as performance-enhancing drugs in professional sport. If it was perceived that drugs offered students an unfair advantage and were dangerous, drug tests could follow. Australian Drug Foundation chief executive John Rogerson said anecdotal reports suggested young people were talking more about these drugs, but he said there was no indication it was a big problem in Australia. "There's no doubt that kids are taking stimulants like Ritalin to get a short-term advantage," he said. "Some of this stuff is being bought off the internet, which is very risky," he said. SO-CALLED SMART DRUGS *METHYLPHENIDATE (Ritalin, Concerta) *MODAFINIL (Provigil, Modavigil) *AMPAKINES *PIRACETAM (Nootropil, Avigilen) *ERGOLOID (Hydergine, Cicanol) *BETA-BLOCKERS (Propranolol) NOTE: THE AGE DOES NOT CONDONE THE USE OF ANY OF THESE DRUGS WITHOUT A PRESCRIPTION LOAD-DATE: October 2, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 The Age Company Limited All Rights Reserved 178 of 998 DOCUMENTS MX Brisbane (Queensland, Australia) October 2, 2009 Friday 1 - BRIS Edition Sample exams - Call for urine tests to tackle `smart drug' BYLINE: Alex Dickinson SECTION: MX; Pg. 1 LENGTH: 308 words University students using ``smart drugs'' to get an edge in class could soon face sports-style urine tests before exams. Research from the University of Sydney has warned that students are increasingly using ``performance enhancing'' psychostimulants usually prescribed for Alzheimer's, Parkinson's or sleep disorders, to enhance their academic performance. Among those being taken are the ADD drug Ritalin, Aricept used to treat dementia and the ``wide-awake'' drug Modafinil. The drugs are being easily purchased over the internet through pharmacies in South-East Asia, Mexico and India. Researcher Vince Cakic, whose findings have been published in the Journal of Medical Ethics, said purchasing ``smartness in a bottle'' is likely to have broad appeal to students seeking to gain an advantage in an increasingly competitive world. He said the drugs are near-impossible to monitor, but a sports-style urine tests would detect them. ``One conjures to mind the scenario of students taken to one side, cup in hand, and asked to provide a urine sample to test officials,'' Cakic said. He said that Modafinil was very popular among students in the US because it kept them awake without making them hyperactive. ``So far, these drugs offer only a modest perk in performance, but more powerful versions are in the pharmaceutical pipeline and may well have a potent allure,'' Cakic said. But the proposal to set up urine tests before exams has angered student groups. General secretary of the Queensland University of Technology Student Guild, Kat Henderson, said urine tests on students was ``ridiculous''. ``There's nowhere in the world that a guild would allow the university to start drug-testing students,'' Henderson said. ``I've never heard of using drugs for concentration as being a big problem. To test students would be infringing on their basic rights.'' LOAD-DATE: October 2, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: MXB Copyright 2009 Nationwide News Pty Limited All Rights Reserved 179 of 998 DOCUMENTS PR Newswire September 24, 2009 Thursday 8:30 AM EST Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder LENGTH: 957 words DATELINE: FRAZER, Pa., Sept. 24 FRAZER, Pa., Sept. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder. The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe. These data were presented earlier this year at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies. About NUVIGIL NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com. About Cephalon, Inc. Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology. The company's proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1-800-896-5855. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, timing of FDA decisions, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.     Contacts:     Media     Sheryl Williams     610-738-6493     swilliam@cephalon.com     Investor Relations     Chip Merritt     (610) 738-6376     cmerritt@cephalon.com     Web Site:     www.cephalon.com SOURCE Cephalon, Inc. CONTACT:Media, Sheryl Williams, +1-610-738-6493, swilliam@cephalon.com, or Investor Relations, Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc. URL: http://www.prnewswire.com LOAD-DATE: September 25, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 PR Newswire Association LLC All Rights Reserved 180 of 998 DOCUMENTS Independent Extra September 22, 2009 Tuesday First Edition The brain buzz you may live to regret; So-called 'smart drugs' have been seized upon by undergraduates as a means to stay alert and improve mental performance. But the long-term effects remain unknown. Rob Sharp investigates - and gets students' verdicts on the effects BYLINE: Rob Sharp SECTION: INDEPENDENT LIFE; Pg. 10 LENGTH: 1501 words Two mates in their mid-to-late 20s are joking around. One of them pulls a silver blister pack from his pocket. It contains a rare drug, two pills of which he pops from the shiny wrapper that he holds in his hand. He gives one pill to his pal. They stand still for a moment, consider what they are about to do, before placing the capsules into their mouths and washing them down with a swig of water. They complete the move with a couple of mock-grimaces. The drug in question is Modafinil, a form of prescription medication normally used to treat narcolepsy, but which is increasingly being abused by students across the US and UK for its stimulating properties: in small doses it can improve your memory, increase your focus and prevent you from falling asleep (proving especially handy in the run-up to exams). It is one of a group of cognitive enhancers or "smart pills" that also includes Ritalin and Adderall, both used to treat ADHD (attention-deficit/hyperactivity disorder), that have similar properties. A study by Cincinnati Children's Hospital published in the British Medical Journal last month indicated that use of these latter two drugs in the US has increased by 75 per cent between 1998 and 2005. What's more, a 2005 survey of more than 10,000 US university students found that 4 to 7 per cent of them had tried ADHD drugs at least once to pull pre-exam all-nighters. At some institutions, more than one in four students said they'd sampled the pills. The subject is relatively unstudied in the UK but the trend is the subject of a forthcoming documentary, Wasted Britain, set to air on Current TV on 28 September. "The problem is you don't know what you're getting," says Barbara Sahakian, professor of clinical neuropsychology at Cambridge University's psychiatry department. "We don't know about the effects of long-term use of drugs like Modafinil. We should wait for the studies to show the effect of it on healthy human beings. There are pressures on people but these quick fixes are not the way forward; education and exercise are both good ways of enhancing cognition, too." Perhaps what is so worrying about the Current TV programme is the means by which its participants, Steve Middleditch and Christian Boyd, first got hold of Modafinil. "When the producers first told me to buy it I had never heard of it," says Middleditch. "So I began doing some research on the internet. I discovered that with a few clicks I could get hold of it by filling in a phoney prescription online. I said I had jet lag." A week later a pack of 30 pills arrived, postmarked Mumbai. To conduct his experiment, Steve woke up one day at 3am to make himself fatigued, and took the pills at midday the following day. He describes the experience of taking the drug as odd, to say the least. "It's difficult to explain," he continues. "You get this massive buzz; it's a bit like drinking five cups of coffee in one go. You get a definite buzz off it. It affects areas of the brain rather than the heart. My hands were moving a bit. I definitely got the jitters. It's the sort of thing that not only keeps you awake, it keeps you blathering on. I certainly felt more focused. It was definitely stronger than I thought it would be." The effects of the drug are well-proven. In 2003, Cambridge University researchers found a single dose helped male university students perform in mental planning tests, accurately complete puzzles and remember long chains of digits; it has also been tested by the US and British forces to allow soldiers to complete all-night operations. Scientists believe Modafinil can give its user 48 hours of continuous wakefulness (though there are some side effects: headaches are the most common, though there are plenty of others). The most remarkable thing, however, is that its users don't have to pay back sleep "debt" - a standard eight hours is enough to compensate for no sleep on the previous night: could this mean a future of 22-hour days? Our bosses may hope so. "I would take Modafinil again because for me the problem is concentration and focus," says Boyd. "It allowed me to get down to what I wanted to do; I never felt like being distracted, so it was great." Philip Harvey, a professor at Emory University in Atlanta, says his work has been helped by Modafinil, which he takes to combat jet lag. Unlike in the UK, American doctors can prescribe the drug to night-shift workers as well as to narcoleptics. "I often fly to Europe to give talks," he says. "I used to travel the day before to give myself time to recover, but with Modafinil I can now give a talk the same day I arrive and feel like I've had a normal night's sleep." Modafinil is not a golden drug, though. Its other side-effects may include insomnia, agitation, anxiety, agitation, and heart problems. And then there are the ethics of taking something that might give you an unfair advantage over your peers. "It's all in your personal preference," concludes Middleditch. "But I don't think it is a good thing. I can see why some people might take them. We've all had a deadline and been knackered and that pill will help you reach that deadline. In some scenarios where people need it I can also agree with it - some troops in combat might use it, or a paramedic might need it to stay focused. Perhaps there's some warrant in that. But personally it's not something I would take again, but that's just my feeling because it doesn't feel right. You become this person that you are kind of not. It's a strange feeling - the day after you still have this strange sensation in your head." Ritalin and Adderall, which are defined by their active ingredients of mixed amphetamine salts and methylphenidate, as well as increasing concentration (in the right doses) can also be taken for the buzz they create. They are often used in combination with other drugs such as alcohol, or cocaine. Research conducted by Harry Sumnall, a psychopharmacologist at the Centre for Public Health at Liverpool's John Moores University, claims that research he has conducted in Merseyside shows that children with prescriptions for ADHD treatments were routinely selling their drugs; in some cases, so were their parents. "At least in the US they're looking out for the problem and routinely including Ritalin misuse in high school drugs surveys, for example," he says. "We might have to do the same here." These drugs are also less effective than Modafinil at enhancing performance. "The biggest issue with these drugs, certainly with the likes of Adderall, is that it is very difficult to know how much to take; very quickly they can go from enhancing your performance to making you of no use whatsoever," says John Marsden, a reader in addiction psychology at the Institute of Psychiatry. "Though the principal issue is that if people were using these drugs it might set in train a process where people were using them more and more and become addicted to them." 'Wasted Britain' is aired on Current TV (Sky channel 183/Virgin channel 155) on Monday 28 September Cognitive enhancers Is it smart to take them? Modafinil Modafinil often comes in the form of the branded Provigil and is a memory-enhancing and mood-brightening stimulant, which enhances wakefulness. It stimulates activity within the brain and spinal cord (central nervous system). It is used to treat narcolepsy and sleep apnoea. It was rejected in 2006 by the Food and Drug Administration in America for prescribing to children with ADHD, but it is prescribed in the UK. Some of the side effects include unstable moods, blurred vision and difficulty sleeping. Ritalin - Tablets of Ritalin, one of the most widely known drug used to treat ADHD in children, contain the active ingredient methylphenidate hydrochloride. This is a stimulant and it is also possible to buy methylphenidate tablets on their own in an unbranded form. As well as calming hyperactive kids, it is used illegally by students to boost concentration and effectiveness at exams. The drug is still illegal without prescription in the UK, and is lawfully rated as class B in this instance. Concerta This is another branded version of methylphenidate hydrochloride, which has very similar effects as Ritalin. It is one of the newer brands on the market used to treat children with ADHD. The side effects seem less pronounced in children than Ritalin but there are still many, such as abdominal pain, nervousness and hostility. It is used less than Ritalin by students but for the same effects. Adderall Contains both amphetamines and dextro-amphetamines (amphetamine salts) and is widely prescribed as a drug to treat ADHD. It has four component salts which are claimed to metabolise at different rates. Manufacturers suggest that this makes the effects smoother. It is also used to treat narcolepsy and sometimes severe depression. The patient or drug user experiences more intense and sustained periods of concentration. It can cause psychotic episodes in those with a history of psychosis, though this is rare. LOAD-DATE: September 21, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: IE Copyright 2009 Independent Print Ltd All Rights Reserved 181 of 998 DOCUMENTS US Fed News August 21, 2009 Friday 1:04 PM EST Patent No. 7,576,133 Issued on Aug. 18 for Modafinil Nasal Administration (Illinois Inventors) LENGTH: 116 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., Aug. 21 -- Carl Henry Lawyer, Matthew Carl Lawyer and Edward Zadok Lawyer, all from Springfield, Ill., have developed a composition for nasal administration of modafinil. The inventors were issued U.S. Patent No. 7,576,133 on Aug. 18. According to the abstract released by the U.S. Patent & Trademark Office: "Systemic delivery of Modafinil to the nasal mucous membrane elicits rapid systemic therapeutic response with reduced side effects compared to current methods of administration." The original application was filed on March 7, 2003. For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: September 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 HT Media Ltd. All Rights Reserved 182 of 998 DOCUMENTS Clinical Advisor August 12, 2009 Agent battles excessive sleepiness SECTION: NEWS; Drug Updates from MPR LENGTH: 619 words HIGHLIGHT: Nuvigil promotes wakefulness in patients with various sleep disorders Product: Nuvigil Company: Cephalon Pharmacologic class: Wakefulness promoter Active ingredient: Armodafinil 50 mg, 150 mg, 250 mg; tabs. Indication: To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift-work sleep disorder (SWSD). Adjunct to standard treatment for underlying airway obstruction in OSAHS. Pharmacology: Armodafinil is the R-enantiomer of modafinil (Provigil). Of the two enantiomers that comprise modafinil, the R-form is longer lasting. Both of these drugs have wakefulness- promoting effects similar to those of sympathomimetics such as amphetamines and methylphenidate. Clinical trials: Two 12-week studies were conducted to establish the safety and efficacy of armodafinil in OSAHS. In the first study, patients were given either armodafinil 150 mg or 250 mg/day, or placebo. The second trial compared the effects of armodafinil 150 mg/day and placebo. Both studies indicated that patients given armodafinil showed improvements in their ability to remain awake and in their overall clinical condition. The results of a 12-week study indicated that armodafinil was effective in improving wakefulness in patients with excessive sleepiness associated with narcolepsy. Patients treated with armodafinil 150 mg or 250 mg/day showed a significantly enhanced ability to remain awake, and more of the patients given armodafinil had an improved overall clinical condition than those given placebo. A 12-week trial was conducted to establish the efficacy of armodafinil in patients with chronic SWSD. Patients were randomized to receive either armodafinil 150 mg/day or placebo. Those given the study drug showed a significant prolongation in the time to sleep onset, as measured by a sleep latency test conducted during a simulated night shift at the final visit, compared with those given placebo. Also, more patients treated with armodafinil experienced an improvement in overall clinical condition, compared with patients given the placebo. Adults: > 17 years: OSAHS, narcolepsy: 150 mg or 250 mg once daily in the am. SWSD: 150 mg one hour before starting shift. Severe hepatic impairment: reduce dose. Children: <17 years: not recommended. Precautions: Discontinue if rash appears (unless clearly not drug-related), or if angioedema, anaphylaxis, or multi- organ hypersensitivity reaction occurs. OSAHS: treat underlying obstruction; maintain continuous positive airway pressure use if indicated. History of left ventricle hypertrophy or mitral valve prolapse syndrome (e.g., ischemic ECG changes, chest pain, arrhythmias associated with central nervous system [CNS] stimulants): not recommended. Recent MI. Unstable angina. Monitor BP. Psychosis. Depression. Mania. Severe hepatic or renal impairment. Re- evaluate periodically. Elderly (may need to reduce dose). Labor and delivery. Pregnancy (Cat. C). Nursing mothers. Interactions: May antagonize hormonal contraceptives; use alternative or additional contraception during and for one month after. Avoid alcohol. Caution with monoamine oxidase inhibitors. Armodafinil levels may be decreased by CYP3A4 inducers (e.g., carbamazepine, phenobarbital, rifampin) and increased by CYP3A4 inhibitors (e.g., ketoconazole, erythromycin). May reduce levels of drugs metabolized by CYP3A4 (e.g., cyclosporine). May increase levels of drugs metabolized by CYP2C9 (e.g., warfarin) or CYP2C19 (e.g., phenytoin, diazepam, propranolol). Adverse reactions: Headache, insomnia, other CNS effects, GI upset; rash (may be serious, e.g., Stevens-Johnson, toxic epidermal necrolysis). How supplied: Tabs-60 For more information, call 800.896.5855 or visit www.Nuvigil.com. LOAD-DATE: November 3, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Magazine JOURNAL-CODE: 6 Copyright 2009 Haymarket Media. All Rights Reserved 183 of 998 DOCUMENTS US Fed News August 3, 2009 Monday 11:07 AM EST Patent No.7,566,805 Issued on July 28, Assigned to Cephalon for Modafinil Compositions (Massachusetts Inventors) LENGTH: 156 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., Aug. 3 -- Magali Bourghol Hickey of Medford, Mass., Matthew Peterson of Hopkinton, Mass., Orn Almarsson of Shrewsbury, Mass., and Mark Oliveira of Framingham, Mass., have developed a modafinil compositions. The inventors were issued U.S. Patent No. 7,566,805 on July 28. The patent has been assigned to Cephalon Inc., Frazer, Pa. According to the abstract released by the U.S. Patent & Trademark Office: "Co-crystals and solvates of racemic, enantiomerically pure, and enantiomerically mixed modafinil are formed and several important physical properties are modulated. The solubility, dissolution, bioavailability, dose response, and stability of modafinil can be modulated to improve efficacy in pharmaceutical compositions." The original application was filed on Sept. 4, 2004.For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: August 3, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 HT Media Ltd. All Rights Reserved 184 of 998 DOCUMENTS Pediatric News August 2009 Editorial Data Needed on Cognition-Enhancing Drugs BYLINE: Richard N. Rosenthal, M.D. SECTION: Pg. 14 Vol. 43 No. 8 ISSN: 0031-398X LENGTH: 853 words     DR. ROSENTHAL is chairman of psychiatry at St. Luke's-Roosevelt Hospital Center and professor of clinical psychiatry at Columbia University, both in New York, and a past president of the American Academy of Addiction Psychiatry. Dr. Rosenthal disclosed that he receives research grants from Titan Pharmaceuticals Inc. and Forest Research Institute. To respond to this editorial, e-mail Dr. Rosenthal at pdnews@elsevier.com    If we had drugs that would make people smarter, wouldn't that benefit society? And would using drugs in this way be a bad thing?    The reality is: We do have such drugs. And, more and more, we are hearing accounts of normal people taking agents to enhance their mental acuity and alertness at work and in school.    The journal Nature did a survey last year that looked at 1,400 of its scientist readers from 60 countries (Nature 2008;456:702-5). The survey found that 20% of them had used cognitive enhancement in the form of modafinil or methylphenidate or had used beta-blockers to calm them and help them focus when they had to give presentations. Interestingly, 80% of them were in favor of being able to obtain the drugs at their own discretion, as opposed to having to go to a doctor or visit the Internet to get a prescription.    Cognition-enhancing drugs give a competitive edge, and in our society the pressure to succeed is huge. Strikingly, one-third of those responding to the Nature survey said they would feel obligated to give cognition-enhancing drugs to their children if the other children in school were taking them.    Some of us may think that the use of such performance-enhancing drugs in "normal" people is wrong. Others see the practice as cheating. The use of a pill to make us smarter somehow goes against the Judeo-Christian ethic, which tells us there is no gain without pain-that gain without pain weakens our character. But does it automatically follow that taking a drug solely to satisfy a person's desires is objectionable?    The notion of improving performance using psychopharmacology is not a new one. Examples include the use of alcohol, caffeine, and herbs, as well as pharmaceutical agents.    In a study of commercial pilots, those who took 5 mg/day of the cholinesterase inhibitor donezepil (Aricept) for 1 month did better in flight simulation tests did than their counterparts who took placebo, especially in emergency situations. Think about that. If you are a passenger, wouldn't you rather have your pilot on donezepil?    Many people use caffeine for its stimulant properties. Caffeine improves concentration and increases the capacity for information processing in the brain. Glucose priming also enhances learning and memory, so coffee with sugar is a powerful combination. Is a sweet espresso an unfair advantage at work? If it reduces accidents in an industrial setting, why wouldn't you want people to consume caffeine?    Methylphenidate (Ritalin) improves concentration, working memory, and attention in people with attention-deficit/hyperactivity disorder. In healthy adults, it improves executive functioning. It's well known on college campuses for use as a study aid, but college students may ignore traditional dosing and snort it at high doses before taking exams or writing papers.    Modafinil (Provigil), approved for narcolepsy and shift-work sleep disorders, reduces attention deficits attributable to sleep deprivation. In normal adults, it significantly improves fatigue levels, motivation, vigilance, performance on digital pattern recognition, memory, and reaction time. Reportedly, modafinil is the entrepreneur's drug of choice in Silicon Valley.    There's a lot of nonmedical use of modafinil out there, and this begs the question about people using it this way-not just people, but also our colleagues.    The pharmaceutical industry is working to develop a drug aimed at inhibiting memory formation to prevent posttraumatic stress disorder after a traumatic event. This is primary prevention, and it is a good idea.    But what about using such a drug simply to prevent an unpleasant memory? Is that okay? How should use of cognition-enhancing drugs be regulated in healthy people? Should their use always be monitored by health care professionals?    These people are not patients; they are healthy members of society. Their rationale for using medication is for self-enhancement, not therapy. But many of these medications are supposed to be available only by prescription.    We need to do scientific work in this area. There may be evils associated with such use, such as increased social inequity. But there may also be real benefits to our society. I fear that if we do not attempt to answer some of these questions and create some guidelines, the government will do so. And when the government does it, the outcome often falls short.    Whatever our views on the matter, society is moving this way. The train has left the station, and there appears to be no conductor on board. Do we want to get on and steer, or do we want to stand by and let someone else deal with this increasingly important issue? LOAD-DATE: August 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: PDNEWS Copyright 2009 Elsevier Inc., International Medical News Group All Rights Reserved 185 of 998 DOCUMENTS Irish Independent July 7, 2009 Tuesday A stimulating debate SECTION: FEATURES LENGTH: 214 words Ritalin A stimulant drug introduced in 1956 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, it has become increasingly widely used, especially in the US. Recent reports have emerged of it being abused by students seeking aids to help them through their exams. Amphetamines The stimulant was first synthesised more than a century ago and has been used and abused to boost energy, increase wakefulness and prolong endurance. Its users have been as diverse as long distance lorry drivers wanting to ward off drowsiness and women trying to lose weight. Today it is prescribed for ADHD and narcolepsy, and has been investigated for its role in helping stroke victims re-learn motor skills. Donepezil Scientists in aviation medicine and in the military have been examining medicines which might increase alertness and concentration to minimise risk of pilot error and maximise endurance. Donepezil, used to treat dementia, has been shown to boost the performance of pilots on flight simulators. Modafinil Modafinil, a drug used to treat the sleep disorder narcolepsy, has also been tested on pilots and other members of the armed forces. Tests on helicopter pilots flying on simulators who had been deprived of sleep showed the drug boosted performance. LOAD-DATE: July 7, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 Independent News and Media Ltd. All Rights Reserved 186 of 998 DOCUMENTS US Fed News July 6, 2009 Monday 1:14 PM EST Patent No. 7,553,646 Issued on June 30, Assigned to University of Iowa Research Foundation for Synthesis Methods (Iowa Inventors) LENGTH: 186 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., July 6 -- Horacio F. Olivo and Antonio Victor Osorio-Lozada, both of Iowa City, Iowa, have developed synthesis methods. The inventors were issued U.S. Patent No. 7,553,646 on June 30. The patent has been assigned to University of Iowa Research Foundation, Iowa City. According to the abstract released by the U.S. Patent & Trademark Office: "The present invention provides novel methods for the synthesis of racemic and enantiomers of modafinil via microbial oxidation-amidation transformation. The methods include the successive oxidation-amidation of benzhydrylsulfanyl carboxylic acid to produce racemic and enantiomers of modafinil using at least one microorganism of yeast, bacteria, or fungus. Also disclosed are pharmaceutical compositions of racemic and enantiomers of modafinil along with their use in the treatment of diseases, including attention deficit hyperactivity disorder and drug addiction." The original application was filed on July 27, 2006.For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: July 6, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 HT Media Ltd. All Rights Reserved 187 of 998 DOCUMENTS PR Newswire June 30, 2009 Tuesday 8:00 AM GMT Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder LENGTH: 1189 words DATELINE: FRAZER, Pa., June 30 FRAZER, Pa., June 30 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights. "This supplemental New Drug Application for a new use of NUVIGIL is another important milestone for Cephalon. We hope that this will be the first of many new indications for NUVIGIL over the next five years," said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. The NUVIGIL sNDA for the treatment of excessive sleepiness associated with jet lag disorder is based on data from a Phase 3 study, recently presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Washington. The data from this novel placebo-controlled pivotal study, which involved overseas air travel, included an evaluation of the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women who all had experienced jet lag symptoms at least once during the previous five years. Clinical efficacy was evaluated using two primary endpoints: an objective assessment -- the Multiple Sleep Latency Test (MSLT), and a subjective assessment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The most common adverse events associated with NUVIGIL treatment (five percent or greater) were headache, nausea, diarrhea, and palpitations. About NUVIGIL NUVIGIL, the longer-lasting form of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy. NUVIGIL is not currently indicated for the treatment of jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S- and R- modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia. Full prescribing information for NUVIGIL is available at www.NUVIGIL.com. About Cephalon, Inc. Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key affiliates are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology. The company's proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855. In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for and frequency of filing new indications for NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.     Contacts:     Media:                         Investor Relations:     Candace Steele                 Chip Merritt     610-727-6231 (office)          610-738-6376 (office)     csteele@cephalon.com           cmerritt@cephalon.com SOURCE Cephalon, Inc. CONTACT:Media, Candace Steele, +1-610-727-6231 (office), csteele@cephalon.com, or Investor Relations, Chip Merritt, +1-610-738-6376 (office), cmerritt@cephalon.com, both of Cephalon URL: http://www.prnewswire.com LOAD-DATE: July 1, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 PR Newswire Association LLC All Rights Reserved 188 of 998 DOCUMENTS US Fed News June 5, 2009 Friday 4:26 PM EST Patent No. 7,541,493 Issued on June 2, Assigned to Cephalon France for Modafinil Preparation Process (French Inventor) LENGTH: 162 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., June 5 -- Sebastien Rose, Arsy, France, has developed a process for preparing modafinil with a defined granulometry. The inventor was issued U.S. Patent No. 7,541,493 on June 2. The patent has been assigned to Cephalon France, Maisons Alfort, France. According to the abstract released by the U.S. Patent & Trademark Office: "The invention relates to a process for preparing modafinil having a defined granulometry which comprises the steps of: a) preparing a solution of methyl diphenylmethylsulphinyl-acetate; b) contacting the solution obtained with NH3 at a predetermined temperature and a predetermined stirring; and c) isolating the modafinil formed, wherein said temperature and said stirring are predetermined in order to obtain said defined granulometry." The original application was filed on May 5, 2004.For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: June 5, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 HT Media Ltd. All Rights Reserved 189 of 998 DOCUMENTS CNS Drug News Pharmaceuticals June 3, 2009 Nuvigil available in US for treatment of excessive sleepiness LENGTH: 449 words Cephalon's Nuvigil (armodafinil) Tablets [C-IV], a longer-lasting formulation of modafinil, is now available in the US. It is indicated to improve wakefulness throughout the day for patients who struggle with excessive sleepiness associated with treated obstructive sleep apnoea, shift work sleep disorder and narcolepsy. Cephalon has finalised the commercialisation plans for the product and any patient with a Nuvigil prescription should now be able to obtain the medication from their pharmacy or have it filled within 24 hours. As part of the launch of Nuvigil, the company is introducing several new programmes designed to expand access for both patients and healthcare providers. To assist insured patients with co-pay costs for the drug, Cephalon will offer the Nuvigil Prescription Savings Program. Through this programme, eligible patients will receive a co-pay savings at the pharmacy to reduce their out-of-pocket costs to fill the prescription. Further, to help patients and healthcare providers navigate the authorisation and reimbursement process, Cephalon established the Nuvigil Reimbursement Hotline. The company is also working with managed care organisations in order to provide greater patient access for Nuvigil through health plans nationwide. In addition, this year Cephalon created the CephalonCares Foundation to provide free medication to eligible patients. Cephalon is also exploring the potential for Nuvigil to treat the symptoms associated with an array of medical disorders. The company recently announced results from a Phase III trial of the drug as a treatment for patients with excessive sleepiness associated with jet lag disorder. Those data are expected to be submitted as part of an sNDA later this year. In addition, the company has an extensive clinical development programme in place to further study the efficacy and safety of Nuvigil in bipolar depression, the negative symptoms of schizophrenia, cancer treatment-related fatigue and excessive sleepiness associated with traumatic brain injury. Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnoea, shift work sleep disorder and narcolepsy. The Nuvigil label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racaemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in Nuvigil). Nuvigil is not approved for use in paediatric patients for any indication. The most common adverse events in controlled clinical trials (>5 per cent) were headache, nausea, dizziness and insomnia. LOAD-DATE: June 3, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 ESPICOM Business Intelligence Ltd. All Rights Reserved 190 of 998 DOCUMENTS CNS Drug News June 3, 2009 Nuvigil available in US for treatment of excessive sleepiness SECTION: NEWS LENGTH: 448 words Cephalon's Nuvigil (armodafinil) Tablets [C-IV], a longer-lasting formulation of modafinil, is now available in the US. It is indicated to improve wakefulness throughout the day for patients who struggle with excessive sleepiness associated with treated obstructive sleep apnoea, shift work sleep disorder and narcolepsy. Cephalon has finalised the commercialisation plans for the product and any patient with a Nuvigil prescription should now be able to obtain the medication from their pharmacy or have it filled within 24 hours. As part of the launch of Nuvigil, the company is introducing several new programmes designed to expand access for both patients and healthcare providers. To assist insured patients with co-pay costs for the drug, Cephalon will offer the Nuvigil Prescription Savings Program. Through this programme, eligible patients will receive a co-pay savings at the pharmacy to reduce their out-of-pocket costs to fill the prescription. Further, to help patients and healthcare providers navigate the authorisation and reimbursement process, Cephalon established the Nuvigil Reimbursement Hotline. The company is also working with managed care organisations in order to provide greater patient access for Nuvigil through health plans nationwide. In addition, this year Cephalon created the CephalonCares Foundation to provide free medication to eligible patients. Cephalon is also exploring the potential for Nuvigil to treat the symptoms associated with an array of medical disorders. The company recently announced results from a Phase III trial of the drug as a treatment for patients with excessive sleepiness associated with jet lag disorder. Those data are expected to be submitted as part of an sNDA later this year. In addition, the company has an extensive clinical development programme in place to further study the efficacy and safety of Nuvigil in bipolar depression, the negative symptoms of schizophrenia, cancer treatment-related fatigue and excessive sleepiness associated with traumatic brain injury. Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnoea, shift work sleep disorder and narcolepsy. The Nuvigil label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racaemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in Nuvigil). Nuvigil is not approved for use in paediatric patients for any indication. The most common adverse events in controlled clinical trials (>5 per cent) were headache, nausea, dizziness and insomnia. LOAD-DATE: December 29, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter JOURNAL-CODE: CNS Drug News Copyright 2009 Espicom Business Intelligence All Rights Reserved 191 of 998 DOCUMENTS Internal Medicine News June 1, 2009 Editorial Data Needed on Cognitive-Enhancing Drugs BYLINE: Richard N. Rosenthal, M.D. SECTION: Pg. 9 Vol. 42 No. 11 ISSN: 1097-8690 LENGTH: 918 words    DR. ROSENTHAL is chairman of psychiatry at St. Luke's-Roosevelt Hospital Center, professor of clinical psychiatry at Columbia University, both in New York, and a past president of the American Academy of Addiction Psychiatry. Dr. Rosenthal disclosed that he receives research grants from Titan Pharmaceuticals Inc. and Forest Research Institute.    If we had drugs that would make people smarter, wouldn't that benefit society? And would using drugs in this way be a bad thing?    The reality is: We do have such drugs. And, more and more, we are hearing accounts of normal people taking agents to enhance their mental acuity and alertness at work and in school.    The journal Nature did a survey last year that looked at 1,400 of its scientist readers from 60 countries (Nature 2008;456:702-5). The survey found that 20% of them had used cognitive enhancement in the form of modafinil or methylphenidate or had used beta-blockers to calm them and help them focus when they had to give presentations. Interestingly, 80% of them were in favor of being able to obtain the drugs at their own discretion, as opposed to having to go to a doctor or through the Internet for a prescription.    Cognitive-enhancing drugs give a competitive edge, and in our society the pressure to succeed is huge. Strikingly, one-third of those responding to the Nature survey said they would feel obligated to give cognition-enhancing drugs to their children if the other children in school were taking them.    Some of us may think that the use of such performance-enhancing drugs in "normal" people is wrong. Others see the practice as cheating. The use of a pill to make us smarter somehow goes against the Judeo-Christian ethic, which tells us there is no gain without pain-that gain without pain weakens our character. But does it automatically follow that taking a drug solely to satisfy a person's desires is objectionable?    The notion of improving performance using psychopharmacology is not a new one. The use of alcohol, caffeine, and herbs, as well as pharmaceutical agents, are examples.    Another is the use of Viagra for erectile dysfunction. Is erectile dysfunction part of the normal male aging process? Is a lower free testosterone level because of decreased sex hormone-binding globulin in aging men pathologic? If erectile dysfunction is tied to normal aging, is it "cheating" to take Viagra? One purpose of medicine is to improve quality of life in addition to alleviating suffering. So, if we have the ability to enhance cognition, should we do it?    In a study of commercial pilots, those who took 5 mg per day of the cholinesterase inhibitor donezepil (Aricept) for 1 month did better in flight simulation tests did than their counterparts who took placebo, especially in emergency situations. Think about that. If you are a passenger, wouldn't you rather have your pilot on donezepil?    Many people use caffeine for its stimulant properties. Caffeine improves concentration and increases capacity for information processing in the brain. Glucose priming also enhances learning and memory, so coffee with sugar is a powerful combination. Is a sweet espresso an unfair advantage at work? If it reduces accidents in an industrial setting, why wouldn't you want people to consume caffeine?    Methylphenidate (Ritalin) improves concentration, working memory, and attention in people with attention-deficit/hyperactivity disorder. In healthy adults, it improves executive functioning. It's well known on college campuses for use as a study aid, but college students may ignore traditional dosing and snort it at high doses before taking exams or writing papers.    Modafinil (Provigil), approved for narcolepsy and shift-work sleep disorders, reduces attention deficits attributable to sleep deprivation. In normal adults, it significantly improves fatigue levels, motivation, vigilance, performance on digital pattern recognition, memory, and reaction time. Reportedly, modafinil is the entrepreneur's drug of choice in Silicon Valley. There's a lot of nonmedical use of modafinil out there, and this begs the question about people using it this way. Not just people, but also our colleagues.    The pharmaceutical industry is working to develop a drug aimed at inhibiting memory formation to prevent posttraumatic stress disorder after a traumatic event. This is primary prevention, and it is a good idea. But what about using such a drug simply to prevent an unpleasant memory? Is that okay?    How should use of cognitive-enhancing drugs be regulated in healthy people? Should their use always be monitored by health care professionals? These people are not patients; they are healthy members of society. Their rationale for using medication is for self-enhancement, not therapy. But many of these medications are supposed to be available only by prescription.    We need to do scientific work in this area. There may be evils associated with such use, such as increased social inequity. But there may also be real benefits to our society.    I fear that if we do not attempt to answer some of these questions and create some guidelines, the government will do so. And when the government does it, the outcome often falls short.    Whatever our views on the matter, society is moving this way. The train has left the station, and there appears to be no conductor on board. Do we want to get on and steer, or do we want to stand by and let someone else deal with this increasingly important issue? LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: IMNEWS Copyright 2009 Elsevier Inc., International Medical News Group All Rights Reserved 192 of 998 DOCUMENTS US Fed News May 12, 2009 Tuesday 11:39 AM EST Patent No. 7,528,172 Issued on May 5, Assigned to Cooper Health System for Improving Recovery Method (Pennsylvania Inventors) LENGTH: 145 words DATELINE: ALEXANDRIA, Va. ALEXANDRIA, Va., May 12 -- Ghassem E. Larijani of Villanova, Pa., and Michael E. Goldberg of Philadelphia, have developed a method for improving recovery after general anesthesia. The inventors were issued U.S. Patent No. 7,528,172 on May 5. The patent has been assigned to Cooper Health System Inc., Camden, N.J. According to the abstract released by the U.S. Patent & Trademark Office: "Compositions and methods for improving recovery following general anesthesia are provided. The composition comprises an effective dose of modafinil. Modafinil has been shown to reduce the symptoms associated with post-operative general anesthesia, improving the recovery form anesthesia." The original application was filed on Oct. 2, 2003.For more information about US Fed News contract awards please contact: Sarabjit Jagirdar, US Fed News, Email:- htsyndication@hindustantimes.com LOAD-DATE: May 12, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 HT Media Ltd. All Rights Reserved 193 of 998 DOCUMENTS The Sunday Times (London) May 3, 2009 Edition 1 Essay-enhancing drugs; More and more students are taking 'smart pills' to help boost their results in exams - but are they safe, asks Tariq Tahir BYLINE: Tariq Tahir SECTION: NEWS REVIEW;FEATURES; Pg. 9 LENGTH: 1004 words Gemma is a recent Oxford University graduate. As a student of experimental psychology, she wrote three essays a week, in addition to spending 40 hours in lectures and labs. At night she worked for the student newspaper. In her final year things began to pile up but the 22-year-old was reluctant to drop any of her activities. She started taking Modafinil to make possible a life that was fast becoming impossible. Modafinil is a stimulant most commonly prescribed as a prescription drug to treat sleeping disorders, particularly narcolepsy. But increasingly this drug, and two other stimulants, Ritalin and Adderall, are being bought illegally over the internet by high-achieving, overstretched students in British universities to sharpen their focus, concentration and memory. Like many other high-flyers who use so-called "study" or "smart" drugs, Gemma felt a desire to be on top of her game all the time. Modafinil helped her to stay awake long enough to complete her assignments. "I had a few American friends who regularly used Ritalin and sang its praises but I was suspicious of it," she says. "But my friend bought some Modafinil online, said it was fantastic and could keep you awake for ever so I bought some from him. "Taking Modafinil meant that I could just keep working. It didn't make me any more gifted but it meant that my day lasted anything up to 36 hours." The other popular stimulants, Ritalin and Adderall, are legally prescribed for children who have been given a diagnosis of attention-deficit hyperactivity disorder (ADHD). But since it has been demonstrated in scientific trials that these drugs can boost cognitive performance, their unofficial use has rocketed. Yet, even as students pop the pills and brag about their advantages in chat rooms, some experts are asking how much damage they are doing to their bodies. Others are speculating that, if the risks are found to be slight, the use of such drugs could become the norm for the brightest, most competitive young people in our society. Like many users Gemma soon discovered the downsides. She describes feeling shaky, although "this might just have been me not going to sleep. I didn't feel tired and I didn't feel hungry. It stopped my body clock. I lost all track of time and whether I was meant to be eating or not. I would have long bursts of concentration". More worryingly, she also experienced bouts of obsession. "One night I made 10 Facebook photo albums for no good reason other than the fact that I was set on doing it," she says. Tackling the problem is difficult. Figures that reveal who is taking what are not readily available. Last year the scientific journal Nature published the results of an online survey of 1,400 adults. It showed that 20% of readers had taken "smart drugs", but no definitive figures exist on the extent of their use in British universities. Research at the University of Michigan in the United States reveals that 8% of American undergraduates have used such drugs at one time or another to improve alertness. Other studies suggest the figure could be as high as one in six. Emmanuel Akpan-Inwang, a student union welfare officer at the London School of Economics, says that as students approach their exams at the end of the year many are experimenting with "anything that will enhance their performance. "Adderall is the most popular drug at the moment," he reveals. Such people include Claire, a 22-yearold final-year Cambridge University philosophy student. She opted to try Adderall, a drug that is composed of mixed amphetamine salts, in the run-up to her second-year exams last year. She had no difficulty getting hold of it. "I was sitting around in our college rooms with friends and someone mentioned that the engineering students had this drug that they used to help them study," she says. "A friend who was in the year above had a lot of it, which he had bought on the internet, and so he gave me some." She took a capsule the next day before going to the library and was delighted to sail through a highly productive session of study. "I really found my concentration levels went up," she says. "I thought, oh wow, I've been sitting in the library for five hours and haven't been distracted by people walking around like I usually am. It was very helpful." With her finals coming up in a few weeks, she is planning to use Adderall again to keep her concentration at peak levels. Nor are the prices prohibitive: Ritalin costs £290 for 150 10mg pills, Adderall £230 for 120 30mg capsules and Modafinil £75 for 100 200mg doses. Information on the risks of such drugs is highly anecdotal. Users report side effects such as headaches and depression, but no definitive research has been done on the long-term effects of their use on healthy people. This in itself is worrying many, including Barbara Sahakian, professor of neuropsychology at Cambridge University. Sahakian first became interested in the drugs when, arriving jet lagged at a conference in the United States, she was offered Modafinil. After speaking to her colleagues she discovered the extent to which it, and other similar drugs, were in circulation, both among her academic peers and their students. In a paper entitled Professor's Little Helper, she spelt out her concerns. "The trouble is that people in the UK are getting these drugs off the internet," she says. "That's worrying, because you are not really sure what you are getting. And even if the drug is pure, you may have another medical condition that means you shouldn't take it. A person having a bad reaction to one of these drugs is, I think, a horrible accident waiting to happen." For other academics, such as John Harris, professor of bioethics at Manchester University, it is only a matter of time before smart pills are available, without prescription, on the high street. "If these drugs are shown to be safe, I can see a time when bright, competitive people will be able to access them as easily as you can get the morning-after pill now," he says. Some names have been changed LOAD-DATE: May 4, 2009 LANGUAGE: ENGLISH GRAPHIC: Students take the drugs to avoid feeling drowsy TETRA IMAGES PUBLICATION-TYPE: Newspaper JOURNAL-CODE: STS Copyright 2009 Times Newspapers Limited All Rights Reserved 194 of 998 DOCUMENTS The Sunday Times (London) May 3, 2009 Edition 1 Drugs to write essays by; More and more students are taking 'smart pills' to help boost their results in exams - but are they safe, asks Tariq Tahir BYLINE: Tariq Tahir SECTION: ECOSSE;FEATURES; Pg. 12 LENGTH: 963 words Gemma is a recent Oxford University graduate. As a student of experimental psychology, she wrote three essays a week, in addition to spending 40 hours in lectures and labs. At night she worked for the student newspaper. In her final year, things began to pile up, but the 22-year-old was reluctant to drop any of her activities. She started taking Modafinil to make possible a life that was fast becoming impossible. Modafinil is a stimulant most commonly prescribed to treat sleeping disorders. But increasingly this drug, and two other stimulants, Ritalin and Adderall, are being bought illegally over the internet by highachieving, overstretched students in British and American universities to sharpen their focus, concentration and memory. Like many other high-flyers who use study drugs, Gemma felt a desire to be on top of her game all the time. For her, Modafinil helped her stay awake long enough to complete her assignments. "I had a few American friends who regularly used Ritalin and sang its praises but I was suspicious of it," she reveals. "But my friend bought some Modafinil online, said it was fantastic and could keep you awake forever so I bought some from him. "Taking Modafinil meant that I could just keep working. It didn't make me any more gifted but it meant that my working day lasted anything up to 36 hours." The other popular stimulants, Ritalin and Adderall, are legally prescribed for children who have been given a diagnosis of attention-deficit hyperactivity disorder (ADHD). But since it has been demonstrated in scientific trials that these "study" or "smart" drugs, as they have now become known, can boost cognitive performance, their unofficial use for non-medical purposes has rocketed. So as students pop the pills, and brag about their advantages in chat rooms, some experts are asking how much damage they are doing to their bodies. Others are speculating that, if the risks are found to be slight, the use of such drugs could become the norm for the brightest, most competitive young people in our society. Like many users, Gemma soon discovered the downsides. She describes feeling shaky, although "this might just have been me not going to sleep. I just didn't feel tired and I didn't feel hungry. It stopped my body clock. I lost all track of time and whether I was meant to be eating or not. I would have long bursts of concentration." More worryingly, she also experienced bouts of obsession. "One night I made 10 Facebook photo albums for no good reason other than the fact that I was set on doing it," she says. Tackling the problem is, however, difficult. Figures that reveal who is taking what are not readily available. Last year the scientific journal Nature published the results of an online survey of 1,400 adults that revealed that 20% of readers had taken smart drugs to sharpen their concentration or memory, but no definitive figures exist on the extent of smart drug use in British universities. Research at the University of Michigan reveals that 8% of American undergraduates have used such drugs at one time or another to improve alertness. Other studies suggest the figure could be as high as one in six.. Emmanuel Akpan-Inwang, a student union welfare officer at the London School of Economics, is only too aware of the level of use as students approach their exams at the end of the year. "Adderall is the most popular one at the moment," he reveals. "Most people will do anything they can to enhance their performance during the exam period." People such as Claire, a 22-year-old final-year Cambridge University philosophy student. She opted to experiment with Adderall, a drug that is composed of mixed amphetamine salts, in the run-up to her second-year exams last year. She had no difficulty getting hold of it. "I was sitting around in our college rooms with friends, talking about our exams, and someone mentioned that the engineering students had this drug that they used to help them study," she says. "A friend who was in the year above had a lot of it, which he had bought on the internet, and so he gave me some." She took some the next day before going to the library and was delighted to sail through a highly productive session of study. With her finals coming up in a few weeks, she's planning to use it again to keep her concentration at peak levels. Information on the risks of such drugs is equally anecdotal. Users report side effects such as headaches and depression, but no definitive research has been done on the long-term effects of their use on healthy people. This in itself is worrying many, such as Barbara Sahakian, professor of neuropsychology at Cambridge University. She first became interested in the drugs when, arriving jet lagged at a conference in America, she was offered Modafinil. After speaking to her colleagues she discovered the extent to which Modafinil, and other similar drugs, were in circulation among her academic colleagues and their students. In a paper entitled Professor's Little Helper, she spelt out her concerns. "The trouble is that people in the UK are getting these drugs off the internet," she says. "That's worrying, because you are not really sure what you are getting. And even if the drug is pure, you may have another medical condition that means you shouldn't take it. A person having a bad reaction to one of these drugs is, I think, a horrible accident waiting to happen." For other academics, however, such as John Harris, professor of bioethics at Manchester University, it is only a matter of time before smart pills are available on the high street. "If these drugs are shown to be safe, I can see a time when bright, competitive people will be able to access them as easily as you can get the morning-after pill now," he says. Some names have been changed LOAD-DATE: May 4, 2009 LANGUAGE: ENGLISH GRAPHIC: Students take the drugs to avoid feeling drowsy TETRA IMAGES PUBLICATION-TYPE: Newspaper JOURNAL-CODE: STS Copyright 2009 Times Newspapers Limited All Rights Reserved 195 of 998 DOCUMENTS Clinical Psychiatry News May 2009 Modafinil's Mechanism of Action Raises Abuse Risk BYLINE: Mary Ann Moon SECTION: Pg. 18 Vol. 37 No. 5 ISSN: 0270-6644 LENGTH: 213 words    The wake-promoting drug modafinil raises dopamine levels in the brain, data from a pilot study of 10 men show.    Until now, modafinil's mechanism of action has been uncertain, and it was thought to involve several other central nervous system substances but not dopamine. That hypothesis must now be reconsidered, said Dr. Nora D. Volkow of the National Institute on Drug Abuse, Bethesda, Md., and her associates.    More important, the drug's effect on dopamine means that it has a heightened potential for abuse. Given its growing popularity for a variety of uses, clinicians and patients alike must be made aware of the increased risk of addiction, the investigators noted.    The study subjects, who were aged 23-46 years, were given the 200-mg dose that is recommended to treat narcolepsy as well as the 400-mg dose that is thought to be beneficial for attention-deficit/hyperactivity disorder, at different times. They then underwent positron-emission tomography with different radiotracers to measure the effects on extracellular dopamine and dopamine transporters in the brain (JAMA 2009;301:1148-54).    Modafinil was found to increase dopamine in the brain by blocking dopamine transporters, Dr. Volkow and her colleagues said    The investigators had no conflicts. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: CPNEWS Copyright 2009 Elsevier Inc., International Medical News Group All Rights Reserved 196 of 998 DOCUMENTS Clinical Oncology Alert May 1, 2009 Pharmacology Watch LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. Pharmacology Watch In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 197 of 998 DOCUMENTS Critical Care Alert May 1, 2009 Pharmacology Watch: FDA Warning: Pharmaceuticals in "Natural" Products LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Pharmacology Watch Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 198 of 998 DOCUMENTS Emergency Medicine Reports May 1, 2009 Modafinil's abuse potential LENGTH: 213 words Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 199 of 998 DOCUMENTS Infectious Disease Alert May 1, 2009 Pharmacology Watch: FDA Warning: Pharmaceuticals in "Natural" Products LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. Pharmacology Watch In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 200 of 998 DOCUMENTS Neurology Alert May 1, 2009 Pharmacology Watch LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. Pharmacology Watch In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 201 of 998 DOCUMENTS OB/GYN Clinical Alert May 1, 2009 Pharmacology Watch: FDA Warning: Pharmaceuticals in LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. Pharmacology Watch In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 202 of 998 DOCUMENTS Primary Care Reports May 1, 2009 Pharmacology Watch LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Pharmacology Watch Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 203 of 998 DOCUMENTS Travel Medicine Advisor May 1, 2009 Pharmacology Watch: FDA Warning: Pharmaceuticals in "Natural" Products LENGTH: 1371 words FDA Warning: Pharmaceuticals in "Natural" Products In this issue: Aspirin dose and cardioprotection; uncovering modafinil's abuse potential; proton-pump inhibitors and clopidogrel; FDA actions. Finding pharmaceuticals in natural products Some natural products are not so "natural" after all. The FDA has warned consumers for several months that a number of weight-loss products contain undeclared pharmaceutical ingredients. The newest products to join the list are Herbal Xenicol which contains cetilistat (a drug similar to orlistat that is not approved in this country), as well as Slimbionic and Xsvelten, both of which contain sibutramine (the prescription medication also known as Meridia®). The FDA's list of over-the-counter weight-loss agents that contain undeclared active pharmaceutical ingredients now includes 72 products. Some of the other undeclared pharmaceutical ingredients found in these products include fenproporex (an amphetamine derivative no longer available in this country), fluoxetine (Prozac®, an SSRI), furosemide (Lasix®, a loop diuretic), and even phenytoin (Dilantin®, an antiseizure medication). The FDA is seeking recalls on many of these products; however, some are available only on-line and previous recall efforts have proved inadequate. Pharmacology Watch In a related story, the FDA has announced a voluntary recall of Zencore Plus, the heavily marketed product for "natural male enhancement," which has been found to contain benzamidenafil, a new PDE5 inhibitor not yet available in this country. Benzamidenafil is similar in action to sildenafil (Viagra®) and tadalafil (Cialis®). PDE5 inhibitors are noted to have a drug interaction with nitrates, leading to potential life-threatening risk of sudden and profound drop in blood pressure. Zencore Plus is distributed by Hi-Tech Pharmaceuticals in Norcross, GA, and is widely sold in health food stores, by mail order, and by Internet sales. Aspirin dose and cardioprotection What is the best dose of aspirin for patients taking dual therapy with clopidogrel to prevent cardiovascular events? Investigators looked at 15,595 patients with cardiovascular disease or multiple risk factors in an observational analysis from a double-blind, placebo-controlled randomized trial. Patients were randomized to doses of aspirin less than 100 mg (75 mg or 81 mg), 100 mg, or greater than 100 mg (150 mg or 162 mg) with or without clopidogrel. The primary efficacy outcome was the composite of myocardial infarction, stroke, or cardiovascular death and the primary safety endpoint was severe life-threatening bleeding. In patients given aspirin alone, the hazard ratio for the efficacy and safety endpoints were the same regardless of aspirin dose. In patients given aspirin with clopidogrel, there was a statistically nonsignificant associated reduction in efficacy with aspirin doses over 100 mg, and a significantly higher increase in harm (hazard ratio, 1.30 with clopidogrel plus aspirin greater than 100 mg). The authors conclude that daily doses of aspirin greater than 100 mg were not associated with benefit and may be associated with harm in patients also taking clopidogrel. Therefore, daily doses of aspirin 75-81 mg optimize efficacy and safety in patients requiring long-term aspirin therapy, especially in patients receiving dual antiplatelet therapy (Ann Intern Med 2009;150:379-386). This is especially important given the recent U.S. Preventive Services Task Force recommendation that encourages men ages 45-79 years to take aspirin preventively when the potential benefit of a reduction of myocardial infarction outweighs the potential harm of an increase in gastrointestinal hemorrhage. Women ages 55-79 years are also encouraged to use aspirin when the potential benefit of a reduction in ischemic stroke outweighs the potential harm of increased gastrointestinal hemorrhage (Ann Intern Med 2009;150:396-404). PPIs and clopidogrel Increasing evidence suggests that proton pump inhibitors (PPIs) may attenuate the effect of clopidogrel on platelet aggregation. PPIs are often used prophylactically in patients with acute coronary syndrome (ACS), as patients on clopidogrel and aspirin may be at higher risk for GI bleeding. A new study from VA researchers was set up to determine if there are clinical implications from the interaction between PPIs and clopidogrel. In a retrospective cohort study of 8205 patients with ACS taking clopidogrel, 63.9% were also prescribed a PPI at discharge, during follow-up, or both. Death or rehospitalization for ACS occurred in 20.8% of patients taking clopidogrel without a PPI and 29.8% patients taking clopidogrel with a PPI. Use of clopidogrel plus a PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without a PPI (adjusted odds ratio, 1.25; 95% confidence interval, 1.11-1.41). Patients taking a combination of the two drugs were at higher risk for hospitalizations for ACS and revascularization procedures, but not for all-cause mortality. Patients taking a PPI without clopidogrel were not at higher risk for rehospitalization. The authors conclude that concomitant use of clopidogrel and a PPI after hospital discharge for ACS is associated with an increase risk of adverse outcomes, suggesting that PPIs may attenuate the benefits of clopidogrel, and that PPIs should only be used with clopidogrel if there is a clear indication, and not for routine prophylaxis (JAMA 2009;301:937-944). Modafinil's abuse potential Modafinil (Provigil®) is a wake-promoting medication used to treat narcolepsy and other sleep disorders. Recently, the drug has be used off-label to enhance cognition in psychiatric patients and even in healthy patients seeking a memory boost. Modafinil has been touted as having a low abuse potential; however, a new study questions that assumption. Most stimulant medications, such as methylphenidate and amphetamine, increase brain dopamine levels. Modafinil was thought to exert its effect in the brain on pathways other than dopamine, but now there is evidence that dopamine is involved. Researchers from the National Institute on Drug Abuse looked at 10 healthy male volunteers to measure the effects of modafinil at therapeutic dosing of 200 mg and 400 mg given orally. PET scans were used to measure the effect of modafinil on extracellular dopamine and dopamine transporters. Modafinil increased extracellular dopamine and showed evidence of occupancy of dopamine transporters, effects similar to drugs with the potential for abuse. The authors conclude that, considering the increasing use of modafinil, there needs to be heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations (JAMA 2009;301:1148-1154). FDA Actions The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting. A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex[TM]. This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5468. E-mail: LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2009 AHC Media LLC All Rights Reserved 204 of 998 DOCUMENTS Pharmacy News (Australia) April 1, 2009 Sleep disorder drug open to abuse BYLINE: Mark Gertskis SECTION: LENGTH: 336 words A DRUG used to treat sleeping disorders and boost cognitive functions has the potential to be abused as an addictive stimulant. A new study in the Journal of the American Medical Association (JAMA) has revealed that modafinil, marketed as Modavigil in Australia, has the potential to be addictive due to its effect on levels of the dopamine hormone. "Modafinil blocked dopamine transporters and increased dopamine in the human brain (including the nucleus accumbens)," the study's authors wrote. "Because drugs that increase dopamine in the nucleus accumbens have the potential for abuse, and considering the increasing use of modafinil, these results highlight the need for heightened awareness for potential abuse of and dependence on modafinil in vulnerable populations." Modafinil is designed to improve daytime wakefulness in people suffering from narcolepsy, sleep apnoea and shift work sleep disorder. The study's authors noted that it is also being increasingly used as a cognitive enhancer for conditions such as attention deficit hyperactivity disorder. "Although initially launched as distinct from stimulants that increase extracellular dopamine by targeting dopamine transporters, recent preclinical studies suggest otherwise," the authors wrote. Modafinil consumer medicine information states, however, that the drug differs from other stimulants because it does not "overstimulate or produce a 'high' feeling". The drug's US manufacturer, Cephalon, said JAMA's findings were consistent with what was already known about modafinil, marketed as Provigil in the US. "We believe that there is a low relative potential for abuse with modafinil," a Cephalon statement said. "It has some potential for abuse and dependence. "It is important to note that the product label for Provigil advises physicians to follow patients closely, especially those with a history of drug and/or stimulant (e.g. methylphenidate, amphetamine or cocaine) abuse and to observe patients for signs of misuse or abuse or drug-seeking behavior." LOAD-DATE: June 24, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Magazine JOURNAL-CODE: PN Copyright 2009 Reed Business Information Ltd. All Rights Reserved 205 of 998 DOCUMENTS M2 PressWIRE March 30, 2009 Monday visiongain: Visiongain is proud to announce the release of the brand new report "Sleep Disorders: Market Analysis 2008-2018" LENGTH: 1035 words the release of the brand new report "Sleep Disorders: Market Analysis 2008-2018" More than 80 sleep disorders have been identified. They affect over 200 million people worldwide. The report focuses on the market for following sleep disorders: * Insomnia * Restless legs syndrome (RLS) * Narcolepsy and * Obstructive Sleep Apnoea / Hypopnea Syndrome (OSAHS) The market penetration for insomnia drugs has not reached saturation point. Opportunities remain. But with the introduction of several new products the market is set to see changes, but expansion. This expansion is based on increased general awareness physicians better comprehension of the significance of this disease and the positive role that a sleep medication prescription plays. At present time there are several prescription sleeping medications available to treat insomnia. The market-focus has been driven by the production of sleep medications with less side-effects and danger of overdose. Prescription benzodiazepines and newer non-benzodiazepine hypnotics developed in the 1990s, such as Imovane, Ambien and Sonata will continue to be the most prescribed. Benzodiazepines are widely used to treat an underlying neurological disorder which is often the underlying cause of insomnia, e.g. anxiety and depression. Visiongain predicts that market share by volume for insomnia in the US will change significantly from 2008 to 2018. Ambien IR lost its patent protection in April 2007, which opened to generic competition for Zolpidem. Ambien will remain the market leader for the short term, but what will over take it? A generic version of Ambien is expected to achieve strong market share by volume as there is a great demand for zolpidem tartrate for insomnia. The market share for insomnia treatment will gradually rise after 2012, which will be due to: * Market expansion of existing expensive medications into Europe and Japan in particular * Market penetration of new medications currently in pipeline. Other drugs dealt with in this report include: * Modafinil (Provigil) is the first in a new class of wake-promoting drugs and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. * Provigil is quickly replacing Ritalin, and other CNS stimulants, as the medication of choice for treating daytime sleepiness in narcolepsy. The FDA granted modafinil (Provigil) orphan drug status in 1993. * Modafinil was initially launched in the US in 1999 for the treatment of narcolepsy. In 2004, modafinil became FDA-approved prescription medicine for the treatment of excessive sleepiness associated with Obstructive Sleep Apnoea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD). * Requip (ropinirole) became the first and only FDA-approved drug treatment for moderate to severe primary Restless Legs Syndrome (RLS) in 2005. Key findings that will broaden the scope of the sleep disorders market: * Over the next decade, the development and improvement of sleep disorders therapies will primarily depend on the success of burgeoning technology and innovative approaches. * It is possible to purchase prescription medications online without producing a prescription. Purchase of online sleep medications has increased and will continue to evolve over the next years. * The impact of DTC advertising has created an improved awareness of available insomnia treatment. * This is likely to increase as DTC advertising continues to prosper and the culture becomes more accepting towards insomnia treatment. Visiongain expects the market for sleep disorders to increase, driven by a growing awareness of sleep disorders and by campaigns to promote sleep medications, both by DTC advertising and consumer education. The relaxation of DTC marketing restrictions in the 1990s in the US set the stage for a flow for both branded and unbranded advertising and promotional programmes. Those regulations are prompting more responsible DTC advertising on the industry's part. * The FDA has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger warnings concerning potential risks. * The Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) approved Neurim's Circadin a prolonged-release melatonin as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or over. Neurim is actively seeking strategic alliances for the major European markets. What questions does the report answer? * Which current or future therapies will drive the sleep disorders market from 2008 to 2018? * The key companies involved in the market and their analysis? * What is the patient identification rate for each of the therapeutic areas? * What is the present state of the disease awareness? * What R&D opportunities exist for 'new comers'? Why should you buy this report? * This report focuses on the marketed medications and the pipeline development for sleep disorders from 2008 to 2018. It also discusses the strength and weakness of products, along with the opportunities and threats facing the market. * The report describes world market situation for sleep disorders, namely insomnia, narcolepsy, RLS and OSAHS, with forecasts made for all key products. It also describes the insomnia market situation in the seven major world markets for sleep medications: the US, Japan, France, Germany, Italy, Spain and the UK, with forecasts for key products. * The report provides transcripts of visiongain's interviews with experts in the field of sleep disorders, which reviews the future direction of the sleep disorders treatment market. Visiongain ltd. Report.aspx?rid=274 Or http://www.visiongain.com CONTACT: Suvitha Damodaran, Visiongain ltd e-mail: suvitha.damodaran@visiongainglobal.com e-mail: info@visiongainglobal.com Tel: +44 (0)20 7549 9946 Tel: +44 (0)20 7336 6100 Fax: +44 (0) 20 7549 9930 WWW: http://www.visiongain.com ((M2 Communications Ltd disclaims all liability for information provided within Further information on http://www.presswire.net on the world wide web. Inquiries to info@m2.com)). LOAD-DATE: April 4, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire JOURNAL-CODE: M2P Copyright 2009 M2 PressWIRE All Rights Reserved 206 of 998 DOCUMENTS Flesh and Stone March 24, 2009 Tuesday 12:52 PM EST Neuro Scans LENGTH: 958 words Mar. 24, 2009 (Flesh and Stone delivered by Newstex) -- Stem cell ban lifted but researchers must remain vigilant to protect scientific integrity Earlier this month, President Obama through executive order lifted the ban on federal funding for embryonic stem cell research. The ban put in place by President Bush in 2001 limited research funding to approximately two dozen existing embryonic stem cells lines. The ban was viewed as politically motivated by many researchers and the public which overwhelmingly favored increased research that might lead to cures for diabetes, Alzheimers, Parkinsons, spinal cord injuries, and other neurological disorders. Some researchers insist America has lost almost a decade of research time that could have resulted in medical advancements. A possible silver lining to the ban is that many researchers developed new partnerships with colleagues in foreign institutions in order to continue their research. With the lifting of the ban, hundreds of lines developed since 2001 will be eligible for federal funding. Obama science advisor Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York and former head of the National Institutes of Health, recently co-authored an editorial in Science on Obama's stem cell research and scientific integrity policies (registration required). In the editorial Varmus encourages scientists to stay involved in policy discussions because preserving scientific integrity in a highly politicized environment will require vigilance. When lifting the ban, Obama also pledged through a memorandum to appoint only credentialed experts to federal positions that involve evaluating scientific information. Wakefulness drug modafinil may be addictive Modafinil (Provigil), approved by the FDA for the treatment of narcolepsy, has also come into wider use as a cognitive performance enhancer as it was generally believed to be a safer alternative to amphetamines. A recent study by NIH and collaborating institutions published in JAMA, however, found that the drug blocked dopamine transporters and increased dopamine in the brain. These changes in the brains pleasure center could lead to dependence and abuse, say researchers. Using positron emission tomography (PET), researchers measured the effects of 200 mg and 400 mg, common therapeutic dosages given in pill form, on extracellular dopamine and on dopamine transporters in 10 healthy male brains. The study is preliminary, given such a small sample, but the findings warrant further study, especially since modafinil has been approved for use by the U.S. military beginning in 2003. Approved initially for certain Air Force personnel, returning Army and National Guard soldiers have said the drug is readily available to those in combat situations, and clinicians have concerns that returning soldiers may have developed a dependency on the drug. The drug is also increasing in popularity among college students and others who say the drug improves performance, enhances mood and allows better concentration. Citation: JAMA. 2009;301(11):1148-1154. Closer to a consensus on when brain death occurs? The medical community, particularly neurologists, have been grappling with the definition of brain death and striving to reach a consensus on when brain death occurs for decades. JAMA first published a landmark article that quantitatively defined the clinical and laboratory criteria used to measure the presence of brain death in 1968. But different protocols at different institutions left openings for disagreements and legal entanglements. The work took on new urgency in 2005 when the Terry Schiavo case became a national political wedge issue. Not limited to medical experts and ethicists, the case galvanized religious activists, conservative politicians, and celebrities who grandstanded before an eager media. Adding to the high drama, President Bush made a midnight flight from his ranch in Crawford, Texas, to Washington, DC, to sign a law passed by an emotionally charged Congress that forced doctors to re-insert the feeding tube that had kept Schiavo alive in a vegetative state for 15 years. After all Congressional and legal maneuvers were exhausted, Florida judge George Greer ruled that Schiavo could be removed from life support as her legal guardian had requested for seven years. Schiavo died from dehydration on March 30, 2005. After intense study, an ad hoc committee of experts from Harvard Medical School has just issued a new definition on when brain death occurs: Consciousness, Coma, and Brain Death"2009, A Definition of Irreversible Coma: Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death. Will it be the final word? Left: CAT scan of normal brain. Right: Terri Schiavo's 2002 CAT scan provided by Ronald E. Cranford, MD, then assistant chief of neurology at the Hennepin County Medical Center, Minneapolis. (The image is fair use, since the doctor released his image to the public.) Wrapping it up with a bow tie workshop The American Academy of Neurology, known for hosting an intense dawn to dusk (and beyond) annual meeting, is gearing up for its 61st in Seattle, April 25-May 2. While the conference attendees work hard, they also know how to have competitive fun at the wildly popular NeuroBowl quiz show and Neuro Idol talent show. The organization does, on occasion, poke a little fun at itself. This year the AAN is hosting a oebow-tying booth at the meeting in honor of the bowtie which, along with pale blue blazers, is ubiquitous among neurologists. Ill be attending the meeting and filing stories for some free lance clients and doing some news blogging from the meeting here on Flesh & Stone. Newstex ID: FLST-0001-33400535 LOAD-DATE: March 24, 2009 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs on Demand® shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs on Demand®. Reader's comments reflect their individual opinion and their publication within Blogs on Demand® shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2009 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2009 Flesh and Stone 207 of 998 DOCUMENTS The Times & Transcript (New Brunswick) March 23, 2009 Monday 'Smart drug' may be addictive; Study suggests Provigil may be habit- forming SECTION: LIFE; Pg. D2 LENGTH: 339 words A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure centre, very much like potentially habit- forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side-effects." The study, appearing in the Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and it sales topped $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an air force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. LOAD-DATE: March 23, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 CanWest Interactive, a division of CanWest MediaWorks Publications Inc. All Rights Reserved 208 of 998 DOCUMENTS The Philadelphia Inquirer March 18, 2009 Wednesday CITY-D Edition Study says Provigil may be addictive; It affected the brain just as other addictive drugs did, the research found. BYLINE: By Miriam Hill; Inquirer Staff Writer SECTION: BUSINESS; P-com Biz; Pg. C01 LENGTH: 619 words Smart drugs may not be so smart after all. A new federal government study steps up concerns that Cephalon Inc.'s top-selling drug, Provigil, is addictive. The research arrives amid reports that college students and some professionals increasingly pop Provigil, Adderal and Ritalin to improve focus and stay awake. Many people now call these pills "brain boosters" or "smart drugs." The findings, published yesterday in the Journal of the American Medical Association, found that taking Provigil caused changes in the pleasure centers of the brains of 10 men. The changes resembled those caused by other addictive drugs, such as amphetamines, said Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. Cephalon is based in Frazer. A recent article in the journal Nature said people without medical problems should be able to use these drugs to work harder and longer. "The Nature article was cavalier, equating it to dangers of drinking coffee, and that was incorrect," she said. "The implication that these drugs are safe, I think, is very misleading." Provigil is approved to treat excessive drowsiness associated with narcolepsy, obstructive sleep apnea, and shift-work sleep disorder. University of Pennsylvania brain scientist Martha Farah co-authored the Nature paper. Yesterday, she told the Associated Press that the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." She added that "even now, after all the years that [Provigil] has been on the market, we are still learning things about it that are relevant to its safety." The Provigil label has included information about the risk of abuse and addiction since the U.S. Food and Drug Administration approved the drug in 1998, Cephalon's chief scientific officer Jeffry Vaught said. He said the company agreed with Volkow that doctors should not prescribe Provigil to healthy people. Provigil's U.S. sales totaled $943 million last year, according to data provider IMS Health. Analysts have estimated that 80 percent of Provigil prescriptions are for "off-label" treatment of sleepiness and fatigue from illnesses such as depression, Parkinson's disease and multiple sclerosis. The company is developing a longer-acting version of the drug, called Nuvigil. Yesterday, Cephalon shares jumped 9.3 percent, to close at $69.06 each, after the company reported that Nuvigil met key study goals in a Phase II clinical trial involving adults with bipolar disorder. Volkow and her group studied 10 men 23 to 46 years old. They received either a dummy pill or modafinil - the generic name for Provigil. PET scans showed higher levels of dopamine among those who took modafinil. Modafinil also increased dopamine in the nucleus accumbens, a part of the brain believed to be involved with addiction. Volkow said her research was the first evidence that Provigil affects dopamine transporters in human brains. Although the study was small, Volkow said the clear correlation between Provigil and dopamine levels in the scans was good evidence. Earlier research had showed the same results in mice and monkeys. In a September agreement with the Philadelphia office of the U.S. Attorney, Cephalon said it would pay $425 million to settle criminal and civil charges that it illegally marketed three of its drugs, including Provigil, for so-called off-label uses. Doctors can prescribe a drug for any use, but drug companies can market them only for uses approved by the U.S. Food and Drug Administration. Marketing them for other purposes is known as "off-label." Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com. LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 Philadelphia Newspapers, LLC All Rights Reserved 209 of 998 DOCUMENTS Reuters Health Medical News March 18, 2009 Wednesday 9:00 PM EST Modafinil has addictive potential in vulnerable populations SECTION: CLINICAL LENGTH: 273 words DATELINE: NEW YORK Modafinil, a wake-promoting drug initially used to treat narcolepsy, increases extracellular dopamine -- an effect that increases the drug's potential for abuse -- results of a pilot study indicate. "The growing use of modafinil in clinical medicine and as a cognitive enhancing agent and the uncertainties surrounding the mechanisms underlying its pharmacological effects highlight the need to better understand its mechanisms of action," the research team explains in the Journal of the American Medical Association for March 18. Led by Dr. Nora D. Volkow at the National Institute on Drug Abuse in Bethesda, Maryland, the investigators measured the effects of modafinil in 10 healthy men. Positron emission tomography was used to compare the effects of modafinil (therapeutic doses of 200 mg or 400 mg) versus placebo on extracellular dopamine and on dopamine transporters. Results showed that modafinil produces elevations in brain dopamine through blockade of dopamine transporters similar in magnitude to those produced by methylphenidate, which is used to treat attention deficit/hyperactivity disorder. "The dopamine-enhancing effects of modafinil in the nucleus accumbens may help explain reports of its abuse, since this pharmacological effect is considered crucial for drug reinforcement," Dr. Volkow and colleagues write. Despite the fact that "modafinil is much less potent as a reinforcer than stimulant drugs, and reports of modafinil abuse are rare and much less frequent than those for stimulant drugs," the team warns that "risk for addiction in vulnerable persons merits heightened awareness." SOURCE: JAMA 2009;301:1148-1154. LOAD-DATE: March 19, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Reuters Health All Rights Reserved 210 of 998 DOCUMENTS St. Louis Post-Dispatch (Missouri) March 18, 2009 Wednesday THIRD EDITION MEDICAL DIGEST BYLINE: FROM NEWS SERVICES SECTION: NEWS; Pg. A2 LENGTH: 372 words DATELINE: 0 Study questions safety of Modafinil A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in today's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. 'Observation stay' being questioned Hospitals are using a little-known category of medical care called the "observation stay" more than ever, and patients are reporting that they weren't aware that many standard hospital services are not covered by insurance when a patient is admitted on this basis. Paula Biever filed a complaint with Medicare and the Minnesota attorney general's office when her father, 79, was billed $17,820 over an observation stay. Experts say hospitals are turning to "observation stays" when they believe a patient is too sick to go home but not sick enough to meet guidelines for admittance. Medicare officials said observation care is supposed to be for a day, but that longer stays are happening. Medicare is looking into it. Briefly - Obesity problems: Being obese can take years off your life and in some cases may be as dangerous as smoking, according to a study being published today in the medical journal Lancet that was paid for by Britain's Medical Research Council, the British Heart Foundation, Cancer Research UK and others. - Brain waves: Brain waves generated when trying to hear were sharply reduced in people with schizophrenia, suggesting a connection, according to a study by researchers at Harvard-affiliated McLean Hospital published in the Schizophrenia Bulletin. LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH NOTES: medical Digest DOCUMENT-TYPE: BRIEF PUBLICATION-TYPE: Newspaper Copyright 2009 St. Louis Post-Dispatch, Inc. All Rights Reserved 211 of 998 DOCUMENTS USA TODAY March 18, 2009 Wednesday FINAL EDITION A warning on off-label use of sleep-disorder drug; Modafinil meant for snoozing, not for 'smarts' BYLINE: Rita Rubin SECTION: LIFE; Pg. 6D LENGTH: 454 words A drug approved to help people with sleep disorders stay awake during the day is also being used off-label by healthy people who think it helps them perform better on the job or at school. But new research into how the medication affects the brain suggests the risk of abuse or addiction, while low, might be greater than previously thought. The conventional wisdom has been that modafinil is different from other stimulant drugs, such as amphetamines or methylphenidate -- marketed as Ritalin for attention deficit hyperactivity disorder -- in that it doesn't increase dopamine in the brain, researchers write in the Journal of the American Medical Association. Dopamine is a neurotransmitter that carries messages from nerve cell to nerve cell or other tissues. Drugs that increase dopamine have the potential for abuse. Modafinil, marketed as Provigil, has been available in the USA since 1999. Like benzodiazipines such as Valium, it is a Schedule IV controlled substance, with relatively low abuse potential. In the new study, scientists used positron emission tomography, or PET, to scan the brains of 10 healthy men given 200 milligrams of modafinil, the recommended daily dose for treating sleep disorders, or 400 milligrams. Both doses raise dopamine levels as much as methylphenidate does, but not as much as amphetamines do. Lead author Nora Volkow, director of the National Institute on Drug Abuse, says she hopes the pilot study will lead to more research. Volkow says no one knows how many people are using modafinil off-label as a "cognitive enhancer" to improve their thinking ability and work for hours on end. "It's not like anyone has done a proper survey to actually document that," Volkow says. The potential for abuse isn't the only reason healthy people shouldn't take modafinil or other "smart drugs," she says. They can have serious effects, such as brief psychotic episodes, she says, and there's little evidence they improve cognition. Jeffry Vaught, chief scientific officer for the medication's maker, Cephalon, calls modafinil "a very serious medication for serious medical disease. This is for pathological sleep disruption, not for people who've stayed awake for 24 hours." Animal studies have long suggested that modafinil raises dopamine in humans' brains, Vaught says, but "to date, we've just not seen any signals that there's a problem" with abuse or addiction. Although Volkow says no cases of modafinil addiction have been reported in the scientific literature, psychiatrist Stefan Kruszewski of Harrisburg, Pa., says he is treating his third case. "I had two doctors back-to-back who were addicted to modafinil, so I became alarmed," Kruszewski says. Both of them also were alcoholics, he says. LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH GRAPHIC: PHOTO, B/W, National Institute on Drug Abuse PUBLICATION-TYPE: NEWSPAPER Copyright 2009 Gannett Company, Inc. All Rights Reserved 212 of 998 DOCUMENTS Associated Press Online March 18, 2009 Wednesday 12:05 AM GMT Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: DOMESTIC NEWS LENGTH: 577 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org (This version CORRECTS that Provigil's sales "approached" $1 billion.)) LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 213 of 998 DOCUMENTS The Associated Press State & Local Wire March 18, 2009 Wednesday 7:28 AM GMT Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: STATE AND REGIONAL LENGTH: 565 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org LOAD-DATE: March 19, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 214 of 998 DOCUMENTS Associated Press Financial Wire March 17, 2009 Tuesday 8:08 PM GMT Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: BUSINESS NEWS LENGTH: 565 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 215 of 998 DOCUMENTS The Associated Press March 17, 2009 Tuesday Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: BUSINESS NEWS LENGTH: 565 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 216 of 998 DOCUMENTS Elsevier Global Medical News March 17, 2009 Tuesday 05:25 PM GMT Modafinil Boosts Brain Dopamine, Raising Addiction Risk BYLINE: By Mary Ann Moon, Elsevier Global Medical News LENGTH: 378 words The wake-promoting drug modafinil, often used off-label to boost cognitive performance in attention-deficit/hyperactivity disorder and even in healthy individuals, was found to raise dopamine levels in the brain, according to a report in the March 18 issue of JAMA. Until now, modafinil's mechanism of action has been uncertain, and it was thought to involve several other central nervous system substances but not dopamine. That hypothesis must now be reconsidered, said Dr. Nora D. Volkow of the National Institute on Drug Abuse, Bethesda, Md., and her associates. More important, the drug's effect on dopamine means that it has a heightened potential for abuse. Given its growing popularity for a variety of uses, clinicians and patients alike must be made aware of the increased risk of addiction, the investigators noted. They assessed modafinil's effects on the brain in a pilot study of 10 healthy men aged 23-46 years. The study subjects were given the 200-mg dose that is recommended to treat narcolepsy as well as the 400-mg dose that is thought to be beneficial for attention-deficit/hyperactivity disorder, at different times. They then underwent positron emission tomography with different radiotracers to measure the effects on extracellular dopamine and dopamine transporters in the brain. Modafinil was found to increase dopamine in the brain by blocking dopamine transporters. The elevations in dopamine were comparable with those produced by therapeutic doses of methylphenidate, Dr. Volkow and her colleagues said (JAMA 2009;301:1148-54). Modafinil was developed as a drug that "could have a nondopaminergic target for its wake-promoting effects." However, these findings, together with preclinical study results, document that modafinil has clear dopamine-enhancing effects, they added. Modafinil appears to be "much less potent as a reinforcer" than stimulant drugs are, making its abuse less common. "Nevertheless, considering the broadening use of modafinil and the results in this study showing that it increases dopamine in the nucleus accumbens at therapeutic doses, its potential for abuse should not be disregarded," the investigators noted. Dr. Volkow and her associates had no financial disclosures to make in relation to the study. Nora D. Volkow LOAD-DATE: June 10, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: NewsWire Copyright 2009 Elsevier Inc., International Medical News Group All Rights Reserved 217 of 998 DOCUMENTS States News Service March 17, 2009 Tuesday NARCOLEPSY DRUG BEING USED TO IMPROVE COGNITIVE PERFORMANCE AFFECTS BRAIN DOPAMINE ACTIVITY BYLINE: States News Service LENGTH: 642 words DATELINE: CHICAGO The following information was released by Brookhaven National Laboratory: Preliminary research in healthy men suggests that the narcolepsy drug modafinil, increasingly being used to enhance cognitive abilities, affects the activity of dopamine in the brain in a way that may create the potential for abuse and dependence, according to a study in the March 18 issue of JAMA. Brookhaven senior chemist Joanna Fowler: "Like cocaine and methylphenidate, Modafinil blocks dopamine transporters thereby increasing dopamine levels in the brain. This study raises awareness about Modafinil's potential for abuse and addiction in vulnerable populations and signals the need to monitor its use." Modafinil, a wake-promoting drug used in the treatment of sleep disorders, may enhance cognition and is used off-label for the treatment of cognitive dysfunction in some psychiatric disorders (i.e., schizophrenia, attention-deficit/hyperactivity disorder [ADHD]). The Physicians' Desk Reference cautions that it can produce psychoactive and euphoric effects typical of central nervous system stimulant drugs, and there is debate surrounding its potential for abuse, according to background information in the article. The mechanisms of action of modafinil are not well understood but are believed to differ from those of stimulant medications (such as methylphenidate and amphetamine), which increase dopamine (a neurotransmitter in the brain essential for the normal functioning of the central nervous system) in the brain by targeting the dopamine transporters, a mechanism that underlies the abuse potential of these drugs. However, there is growing evidence that dopamine may also play a role in the mode of action of modafinil. Nora D. Volkow, M.D., of the National Institute on Alcohol Abuse and Alcoholism, Bethesda, Md., and colleagues at Brookhaven National Laboratory conducted a study to test whether modafinil, at therapeutic doses, would elevate extracellular (located or occurring outside of cells) dopamine in the brain by blocking the dopamine transporter. The study included 10 healthy men, between the ages of 23-46 years, who received either placebo or modafinil: 200 mg, the dose recommended for narcolepsy; or 400 mg, a dose shown to be beneficial for the treatment of ADHD. The effects of modafinil on extracellular dopamine and on dopamine transporters were measured by positron emission tomography (a radiographic technique used to examine biochemical activity in tissue). The researchers found: In this pilot study, modafinil acutely increased dopamine levels and blocked dopamine transporters in the human brain. Because drugs that increase dopamine have the potential for abuse, and considering the increasing use of modafinil for multiple purposes, these results suggest that risk for addiction in vulnerable persons merits heightened awareness. PET images of the brain show that subjects given modafinil had lower levels of the radiotracer [11C]raclopride bound to dopamine receptors than subjects given a placebo. Red represents the highest amount of binding. This signal indicates higher levels of dopamine release in the modafinil subjects. (Dopamine competes with the radiotracer so higher levels of dopamine "push" the tracers out.) Modafinil also increased dopamine in the nucleus accumbens, a brain region critical for the rewarding effects of drugs of abuse. Modafinil was developed with an expectation that a medication could have a non-dopaminergic target for its wake-promoting effects. However, the current findings in humans, along with preclinical studies, documenting the indispensable role of dopamine in the wake-promoting effects of modafinil, support modafinil's dopamine-enhancing effects as a mechanism for its therapeutic actions. (JAMA. 2009;301[11]:1148-1154. Available pre-embargo to the media at http://www.jamamedia.org) LOAD-DATE: April 29, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 States News Service 218 of 998 DOCUMENTS Associated Press Worldstream March 17, 2009 Tuesday 8:16 PM GMT Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: DOMESTIC NEWS LENGTH: 566 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pennsylvania, and it sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 219 of 998 DOCUMENTS The Associated Press State & Local Wire March 17, 2009 Tuesday 8:26 PM GMT Study: 'Smart drug' Provigil may be habit-forming BYLINE: By CARLA K. JOHNSON, AP Medical Writer SECTION: STATE AND REGIONAL LENGTH: 565 words DATELINE: CHICAGO A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students. "It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects." The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said. Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil. Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying. Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry." "But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said. The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise. The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence. Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said. Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused. "If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes." Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer. "There's no substitute for sleep," Vaught said. On the Net: JAMA: http://jama.ama-assn.org LOAD-DATE: March 18, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2009 Associated Press All Rights Reserved 220 of 998 DOCUMENTS Business Wire February 10, 2009 Tuesday 2:40 PM GMT Research and Markets: Narcolepsy - Entry-Point to a Lucrative Fatigue-Associated Market - Provigil (Modafinil), Expected To Launch In 2012 LENGTH: 484 words DATELINE: DUBLIN, Ireland Research and Markets( http://www.researchandmarkets.com/research/30c8d6/stakeholder_opinio ) has announced the addition of the " Stakeholder Opinions: Narcolepsy - Entry-point to a Lucrative Fatigue-Associated Market " report to their offering. Introduction Narcolepsy is a chronic sleep disorder, which affects fewer than 500,000 sufferers across the seven major markets (7MM). The narcolepsy market value has grown considerably since 2004 to reach $230m in 2007 driven largely by the significant penetration of Provigil (modafinil; Cephalon) and Xyrem (sodium oxybate; Jazz Pharma) and the associated increase in the awareness of the disorder. Scope · Patient potential including disease definition, etiology, prevalence, diagnosis, and treatment guideline review. · Review of the key unmet needs in the treatment of narcolepsy as identified by key opinion leaders interviewed for the report. · Analysis of narcolepsy market IMS sales data from 2004 to 2007 for major marketed narcolepsy drugs: Provigil and Xyrem. · Pipeline analysis with detailed profile for Nuvigil (armodafinil, Cephalon) and the theory behind potential label expansions beyond narcolepsy. Highlights Although generic versions of Cephalons market leading treatment, Provigil ( modafinil), are expected to launch in 2012, Cephalon is expected to retain a significant position in the narcolepsy market by switching patients over from Provigil to its follow-up product, Nuvigil (armodafinil). Despite Xyrems (sodium oxybate) proven efficacy and its broader narcolepsy coverage than Provigil, Xyrems sales continue to be limited because of its black box warning, restricted distribution and comparatively high price. Targeting narcolepsy as a primary indication and then expanding Provigils label coverage to other sleep disorders has proven commercially successful for Cephalon. Datamonitor believes companies could take this strategy a step further by using narcolepsy as an entry point to access the broader fatigue- or sleepiness-associated market. Reasons to Purchase · Quantify the narcolepsy market value in the US, 5EU and Japan and identify the drivers and resistors in this market. · Understand key opinion leader (KOL) views on topical issues in the current and future treatment of narcolepsy and associated disorders. · Appreciate the potential of off-label prescribing and indication expansions for treatments possessing narcolepsy as the primary indication. Key Topics Covered: · CHAPTER 1 EXECUTIVE SUMMARY · CHAPTER 2 MARKET DEFINITION AND OVERVIEW · CHAPTER 3 DISEASE OVERVIEW · CHAPTER 4 UNMET NEEDS · CHAPTER 5 BRAND DYNAMICS · CHAPTER 6 PIPELINE ANALYSIS · BIBLIOGRAPHY · APPENDIX · List of Tables · List of Figures For more information visit http://www.researchandmarkets.com/research/30c8d6/stakeholder_opinio . Source: Datamonitor CONTACT: Research and Markets Laura Wood Senior Manager press@researchandmarkets.com Fax from USA: 646-607-1907 Fax from rest of the world: +353-1-481-1716 URL: http://www.businesswire.com LOAD-DATE: February 11, 2009 LANGUAGE: ENGLISH DISTRIBUTION: Business Editors PUBLICATION-TYPE: Newswire Copyright 2009 Business Wire, Inc. 221 of 998 DOCUMENTS M2 PressWIRE February 10, 2009 Tuesday Research and Markets: Narcolepsy - Entry-Point to a Lucrative Fatigue-Associated Market - Provigil (Modafinil), Expected To Launch In 2012 LENGTH: 540 words Entry-Point to a Lucrative Fatigue-Associated Market - Provigil (Modafinil), Expected To Launch In 2012 Dublin - Research and Markets(http://www.researchandmarkets.com/research/f49f45/stakeholder_op inio) has announced the addition of the "Stakeholder Opinions: Narcolepsy - Entry-point to a Lucrative Fatigue-Associated Market" report to their offering. Introduction Narcolepsy is a chronic sleep disorder, which affects fewer than 500,000 sufferers across the seven major markets (7MM). The narcolepsy market value has grown considerably since 2004 to reach $ 230m in 2007 driven largely by the significant penetration of Provigil (modafinil; Cephalon) and Xyrem (sodium oxybate; Jazz Pharma) and the associated increase in the awareness of the disorder. Scope - Patient Patient potential including disease definition, etiology, prevalence, diagnosis, and treatment guideline review. - Review of the key unmet needs in the treatment of narcolepsy as identified by key opinion leaders interviewed for the report. - Analysis of narcolepsy market IMS sales data from 2004 to 2007 for major marketed narcolepsy drugs: Provigil and Xyrem. - Pipeline analysis with detailed profile for Nuvigil (armodafinil, Cephalon) and the theory behind potential label expansions beyond narcolepsy. Highlights Although generic versions of Cephalons market leading treatment, Provigil (modafinil), are expected to launch in 2012, Cephalon is expected to retain a significant position in the narcolepsy market by switching patients over from Provigil to its follow-up product, Nuvigil (armodafinil). Despite Xyrems (sodium oxybate) proven efficacy and its broader narcolepsy coverage than Provigil, Xyrems sales continue to be limited because of its black box warning, restricted distribution and comparatively high price. Targeting narcolepsy as a primary indication and then expanding Provigils label coverage to other sleep disorders has proven commercially successful for Cephalon. Datamonitor believes companies could take this strategy a step further by using narcolepsy as an entry point to access the broader fatigue- or sleepiness-associated market. Reasons to Purchase - Quantify the narcolepsy market value in the US, 5EU and Japan and identify the drivers and resistors in this market. - Understand key opinion leader (KOL) views on topical issues in the current and future treatment of narcolepsy and associated disorders. - Appreciate the potential of off-label prescribing and indication expansions for treatments possessing narcolepsy as the primary indication. Key Topics Covered: - CHAPTER 1 EXECUTIVE SUMMARY - CHAPTER 2 MARKET DEFINITION AND OVERVIEW - CHAPTER 3 DISEASE OVERVIEW - CHAPTER 4 UNMET NEEDS - CHAPTER 5 BRAND DYNAMICS - CHAPTER 6 PIPELINE ANALYSIS - BIBLIOGRAPHY - APPENDIX - List of Tables - List of Figures For more information visit http://www.researchandmarkets.com/research/f49f45/stakeholder_opinio Source: Datamonitor CONTACT: Laura Wood, Senior Manager, Research and Markets Fax: +1 646 607 1907 (US) Fax: +353 1 481 1716 (Rest of World) e-mail: press@researchandmarkets.com ((M2 Communications Ltd disclaims all liability for information provided within Further information on http://www.presswire.net on the world wide web. Inquiries to info@m2.com)). LOAD-DATE: February 12, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire JOURNAL-CODE: M2P Copyright 2009 M2 PressWIRE All Rights Reserved 222 of 998 DOCUMENTS Guardian Unlimited January 13, 2009 The not-so-clever pills LENGTH: 494 words HIGHLIGHT: Robert Fox: Cognitive-enhancement pills are nothing new - and neither is their power to disappoint us The generalised use of Modafinil, the "clever pill" advocated in Nature magazine last month and by its online editor Adam Rutherford on this website, may not be quite so clever as it appears. In the Nature article, Professor Henry Greely marshals a distinguished panel of experts and co-writers to argue that cognitive-enhancement drugs are so generally used by students in the US, occasionally illegally, that it is time to put them on a sensible footing. If need be, the authors suggest, there should be licensing or regulation. The article claims that some 7% of all US college students now use Ritalin, a drug prescribed for attention-deficiency hyperactivity disorder (ADHD), to help them concentrate and stay alert while studying for exams. Another favourite is the pharmaceutical psychostimulant sold under the commercial name of Adderall, also prescribed for ADHD cases. It is suggested that on some campuses up to 25% of all students are using one of these two stimulants. Greely and Rutherford argue that a wider use of Modafinil, commonly sold as Provigil for narcolepsy and similar cases, can only be beneficial to concentration, learning and study. There seem to be few side-effects, if any, and such use should be for self-improvement and the better education of humanity in general. After all, he rightly suggests, humanity has always tried to master and adapt nature for its own benefit. Greely, the Director of Stanford Law School's Center for Law and Biosciences, suggests that dishing out cognitive-enhancing drugs to students isn't necessarily tipping the level playing field of competition in the same way as giving performance-enhancing drugs to athletes. After all, he suggests, differences in schooling and previous learning experience, also make for inequality between examinees. Fair enough, but from a little research I'm not entirely convinced about the invidious comparison with performance-enhancers, for different reasons. Of course, we have been through the arguments about the liberal and libertarian approaches to recreational and mind-expanding drugs since the priestesses got stoned at the shrine of Apollo at Delphi and da Quincy and Coleridge got high on opium. In our own day we have a cult of psychotropic drugs. Aldous Huxley cautiously suggested that mescaline might open the doors of perception to greater spiritual awareness and unity with creation - and gave the name to Jim Morrison's visionaries The Doors. Hunter S Thompson took on a load of pills to fuel his quest for the American dream in Fear and Loathing in Las Vegas. All of them thought the drugs made them better and powerful performers and thinkers. Coleridge was doing fine as he sketched his path through Xanadu, Alph the sacred river and the sunless sea, until the man from Porlock broke in on the spell. The muse fled and Kubla Khan remains a fragmented, broken spell. The problem is that the man from Porlock is always lurking in the corner to be a spoil-sport. LOAD-DATE: January 13, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2009 Guardian Unlimited (© Guardian Newspapers Limited) All rights reserved 223 of 998 DOCUMENTS Daily Mail (London) January 6, 2009 Tuesday 1ST Edition CAN A PILL MAKE YOU BRAINIER?; Students and the military are using drugs to boost their brainpower. But do they work -- and are they safe? This intrepid writer decided to find out BYLINE: ANGUS WATSON SECTION: Pg. 45 LENGTH: 1423 words A PILL that makes you more intelligent, boosts your memory, improves your concentration and reduces tiredness? It sounds like the stuff of science fiction. In fact, it is already available, and academics in America and Britain have apparently been taking it for years. Last week, John Harris, a professor of bioethics at the University of Manchester, said students should be allowed to take 'smart' drugs (or 'Viagra for the brain', as they've been dubbed) to boost their academic performance. He claimed a sizeable body of evidence showed that pills such as Ritalin, which is prescribed for ADHD (Attention- Deficit/Hyperactivity Disorder), Adderall, another ADHD drug, and Modafinil significantly improved concentration and should be available without prescription. Modafinil -- better known as Provigil -- is the pill the academics have been taking. Officially, it's used to treat conditions that cause daytime sleepiness, such as narcolepsy. But off-prescription, it's being used, not only by academics and students, but reportedly by the U.S. and UK military, to improve mental energy. There are no figures on the numbers of people using Modafinil as an off-prescription stimulant (it can be obtained through the internet). However, according to my sources, and judging by the large chunk of the internet devoted to the subject, the use -- or abuse -- of Modafinil is widespread. 'Plenty of people use Modafinil,' agrees Barbara Sahakian, professor of Clinical Neuropsychology at the University of Cambridge. 'I know an Oxford University professor who takes it fortnightly for one day of really hard work and a colleague at Cambridge who takes it at parties, while another takes it for jet-lag.' Nobody is certain how Modafinil works, according to Sahakian. It does seem clear, however, that it specifically tackles drowsiness without affecting other parts of the brain. This sets it apart from other stimulants such as amphetamines, which make you less tired, but can also compel you to talk too much. Working at home as a freelance writer, I'm OK in the mornings, but my afternoon work ethic would shame a siesta-loving Spaniard. A pill to increase my post-lunch productivity would be marvellous. I decided to see for myself if Modafinil worked. THE fact that it definitely does something to one's brain, but nobody's quite sure what, was a niggling worry. It didn't help when I talked to Baroness Susan Greenfield, the neuroscientist, about my plans to take it. 'You're taking a risk,' she said firmly. 'Our brains are hugely delicate and responsive to drugs. If you take too much vitamin C, it's excreted in your urine. That's not the case with brain-altering drugs. Any influence -- especially the direct chemical manipulation that you're suggesting -- could have a long-term, negative effect on brain cells. You're risking your life.' So trying Modafinil might damage my brain for ever. And there were other potential, and more immediate side-effects. I read of a vast range of possible nasties, including headaches, nausea, nervousness, diarrhoea, back pain, reduced appetite and abnormal ejaculation. It was all pretty frightening. But a reckless part of me wondered if it was all worthwhile if the pills did make me branier. First there was the problem of getting prescription-only drugs without being ill. I asked a doctor friend if she'd write me a prescription. She said I was an idiot. So I ordered them online, but they never came. Finally, I tried a randomly picked doctor. Fortunately, his standards weren't as high as my friend's, and he gave me a prescription for a £5 'admin fee'. The guilt of using an ill-gained prescription wore off when the chemist charged me £75 for 30 100mg tablets. He explained, that's how much privately-prescribed drugs cost. The label gave no dosage advice, but the internet suggested 200mg daily. I'd told the doctor this was my plan, and he agreed that it seemed reasonable. I decided to start with a 100mg pill at 9am. Given all those potential sideeffects I reasoned it would be best to be wary. I popped the pill and began a big writing project I'd been putting off. An hour later I wasn't dead -- I was perfectly happy, although I had no appetite for breakfast. Perhaps I was working harder -- it was difficult to tell since I usually work well in the morning. By 10am, I was still alive and sane, and, apart from my lack of appetite, all seemed normal. So I took a second 100mg pill. Half an hour later I was lightheaded and euphoric. I began singing along to the radio and my computer keyboard felt oddly fizzy, as if I had pins and needles in my fingertips. At 10am, alone in my flat, it felt like I'd downed four glasses of champagne. Modafinil was meant to improve my work ethic and focus, but there was no way I could concentrate. My mind was rushing, so much so that I got a little scared. I worried that I might have a heart attack, or perhaps my head might explode. So I went for a walk by the Thames. I've always found that watching ducks can allay pretty much any affliction, and this was no exception. I calmed down, came home, forced myself to eat and felt better. My mind was still on overdrive but it was my most productive working afternoon -- ever. That evening, I had dinner with a friend. I was conscious of being chatty, but also witty and incisive. Before we parted, I told her about the Modafinil trial. 'You were a little more obnoxious than usual,' she commented. Back home, I found myself standing in the bathroom doing a sudoku puzzle at 1.30am, and didn't get to sleep until 2am. Next morning I took 200mg in one go. Soon I felt a bit sick, muddle-headed, panicky and sweaty. But I calmed down, and did a good morning's work. A night later, I met my new girlfriend's friends for the first time in a trendy restaurant. I was extremely talkative as I knocked back gallons of wine, and became astonishingly extrovert, dancing with people and coercing a group of reluctant revellers to sing Under Pressure by Queen. I remember nothing of the taxi ride home. The next morning, I had a horrendous hangover but was cheered by reports from my girlfriend, who said her friends thought I was the life and soul of the party. Was that a euphemism for loudmouth buffoon, I asked? 'No, really, you were fun', she insisted. I recovered by Sunday and, settling into the Modafinil, my work took off. Panic disappeared, I felt absolutely fine. Concentration and output sky-rocketed and I felt fantastic. In fact, during my two weeks of Modafinil-enhanced life I did tons of good work, gained two new regular slots in newspapers, lost 4lb in weight and cleared an Augean stable of admin. But I'm not sure Modafinil really increases your memory or makes you more intelligent. It makes you think you're more intelligent. I took part in a pub quiz -- we won -- but despite, rather than because of me. I was convinced I was right every time, but was consistently wrong. WHAT'S the driest place in the world? 'Atacama Desert!' I cried, full of confidence. 'Isn't it Antarctica?', asked someone. 'No, no, Atacama,' I insisted patronisingly. Of course, the answer was Antarctica. And then there are those lingering health doubts. It's said that Turkish leader Kemal Ataturk only functioned after he overcame his crushing shyness with vast quantities of the spirit of Raki. And he defeated every major European power and founded modern Turkey. So it worked for him. But he did die of cirrhosis at the age of 58. Another danger comes with buying the Modafinil online. As with all illegally supplied drugs, you have no control over what you're getting. You could be sold something useless or, worse, dangerous. And then there's that fundamental question: is false brain enhancement morally acceptable? And if it is, could it also ever be made safe? Neuroscientist Greenfield thinks not. 'Drugs will always have sideeffects. If you want to improve your output, you should look at your lifestyle and goals. Not take drugs.' Professor Sahakian treads a middle ground. 'There are better ways to enhance ourselves, such as education and exercise. If there are clean drugs that could make work easier and improve our lives, that would be great, but we'd have to be careful not to push ourselves to unpleasant limits.' Cephalon, who manufacture Provigil, said it only supported approved uses for the drug. It is 'naturally opposed to all forms of purchases which are not under the control of physicians such as online sales,' their spokesman added. So -- expensive, 'illegal' and a potential health risk. Think I'll stick to early nights instead.. LOAD-DATE: January 6, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Papers Copyright 2009 Associated Newspapers Ltd. All Rights Reserved 224 of 998 DOCUMENTS The International Herald Tribune November 3, 2008 Monday Narcoleptic allowed to race again; Cycling BYLINE: Samuel Abt - The New York Times Media Group SECTION: SPORT; Pg. 20 LENGTH: 609 words Rise and shine, up and at 'em: After four years of legal and medical battles, Franck Bouyer can return to work. ''I can dream again,'' he said with no hint of irony. Bouyer's problem has been that of course he can dream - anywhere, at any time - since he is a victim of narcolepsy, or sleeping sickness. The genetic disease, which is marked by unpredictable episodes of sleep during normal waking hours and disturbed sleep at night, afflicts about one in 200,000 people. Except for Bouyer, none of them is a professional bicycle racer. That job is impossible for a narcoleptic without medical treatment since Bouyer works amid a pack of other men on bicycles. Let the sandman call and Bouyer swerve, the result can be a mass crash. Although that has not happened yet, he has been known to fall asleep during a training ride and wake up sprawled in the courtyard of a farm. Once or twice, feeling himself nodding off, he has had to pull to the side of the road during a race. ''With medicine, no problem,'' he said in a telephone interview this week from his home in western France. ''Without medicine, lots of problems.'' But the medicine that is commonly used to treat narcolepsy is modafinil, which is on the list of drugs prohibited by the International Cycling Union because they enhance performance. So Bouyer has been caught between two arguments: For safety's sake, doctors for the French Cycling Federation refused to issue him a license unless he was using modafinil, but the highest governors of the sport refused to let him race if he did use the drug. Back and forth the legal battle went, with the International Cycling Union barring Bouyer, the World Anti-Doping Agency first ruling against him and then for him and the Court of Arbitration for Sport turning down his appeal. ''It went on so long,'' he said this week. ''So much time, so much money. It killed my career.'' Now 34 years old, Bouyer has long been a solid midlevel rider. Since he turned professional in 1995 and joined the first of six French teams, he has finished, albeit far back, five Tours de France. He has had his share of victories, though. In 2001, he won the Tour of the Limousin and in 2002, the Tour of the Vendée, both French races. His best year was 2004, when he won Paris-Camembert and a stage in the Circuit of the Sarthe. That was also the year, however, that he learned he had narcolepsy. Since then, he has raced only briefly late in 2005 and early in 2006 while the legal battles were in abeyance. His breakthrough occurred early this year when a doctor prescribed another medicine, Xyrem, to treat his disease. It worked as well as modafinil and was not on the list of prohibited drugs, according to the International Cycling Union when Bouyer phoned its doctors. ''So that was that,'' he said. ''I applied for my racing license in July and got it. Since August, I've been training constantly.'' Why did nobody prescribe the legal drug years ago? Good question, said Bouyer, unable to answer it. He will join his Bouygues Télécom teammates this week at a training camp and will be a paid rider for the first time in two years. ''It's really strange,'' Bouyer said, ''I thought it was all over and now I'll be back. Such a long wait.'' He has no great hopes for immediate success, not after years away from the sport. ''Lance Armstrong might be able to do that,'' he said, ''but I don't have his motor. I hope to be riding at a correct level, mostly for the pleasure of it all. Yes, for the satisfaction of competing again.'' As for the races he will enter next year, it's too early to decide, but he will give it a lot of thought, he said. In other words, he'll sleep on it. LOAD-DATE: November 3, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2008 International Herald Tribune All Rights Reserved 225 of 998 DOCUMENTS The Times (South Africa) October 20, 2008 Monday Stay wired awake BYLINE: Caspar Greeff SECTION: LIFESTYLE & LEISURE; Pg. 20 LENGTH: 422 words POKER is not yet an Olympic sport, which means that players are not monitored by the World Anti-Doping Agency, nor are they subject to the rules of the World Anti-Doping Code. This is a pity because I am sure that two of the more senior members of our Thursday night poker school (both of them are 87- years- old) are on performance-enhancing drugs. How else do they win all my money week after week? One poker player who openly admits his use of stimulants is former computer programmer Paul "Dot Com" Phillips, who has career winnings of more than $2.3-million. Phillips told Slate magazine: "I've long been an enthusiastic believer in better living through chemistry. That's why, when I was diagnosed with attention-deficit hyperactive disorder two years ago, I didn't hesitate to fill a prescription for Adderall. A few months later, I won almost $500000 in a World Poker Tour event, then another $1.1-million in another WPT event soon after." "With Adderall in my system, I am like an information sponge, able to process data from several players at once while considering my next action. It improved my patience. "This year, I have a new chemical weapon: Modafinil. It stimulates wakefulness and enhances focus but without the side effects of an amphetamine - for me, reduced appetite and insomnia. With Modafinil, I feel well-rested even on limited sleep. Through judicious use of both I can operate at my full potential for days on end." Modafinil, also called Provigil, is a nootropic or cognitive enhancer used in the treatment of narcolepsy, shift work sleep disorder and obstructive sleep apnea. It is also described as a "memory-improving and mood-brightening psychostimulant". The US military has given Modafinil to its air force pilots in the Gulf War and Iraq, and the French government admits that the Foreign Legion has used it during " covert operations". Modafinil expert Trevor Robbins, professor of cognitive neuroscience at Cambridge University, says: "It works like a mental manager. It's great on tasks requiring reflection and planning, plus it inhibits impulsiveness - and blurting out the wrong thing." What are the side effects? The website provigil.com warns: "If you experience chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide, aggression, or other mental problems, stop taking Provigil [Modafinil] and call your doctor or get emergency treatment." Funny, I get all those symptoms every time I lose money at poker, and that's without any performance-enhancing stimulant. LOAD-DATE: June 2, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: The Times Copyright 2008 AVUSA Media LTD All Rights Reserved 226 of 998 DOCUMENTS US Fed News September 19, 2008 Friday 6:05 AM EST French Inventors Develop Therapeutic Treatment Method BYLINE: US Fed News LENGTH: 192 words DATELINE: Alexandria, Va. ALEXANDRIA, Va., Sept. 19 -- Veronique Broquaire of Noisy-le-Grand, France, Ludovic Broquaire of Frejus, France, Laurent Courvoisier of Laigneville, France, Gerard Coquerel of Boos, France, Franck Mallet of Blangy sur Bresle, France, and Michel Broquaire of Le Perreux, France, have developed a therapeutic treatment system. According to the abstract released by the U.S. Patent & Trademark Office: " Modafinil polymorphic forms of modafinil racemate, methods of preparation thereof, pharmaceutical compositions and methods of therapeutic treatment involving modafinil polymorphic forms." The inventors were issued U.S. Patent No. on July 29. The patent has been assigned to Cephalon France, Maisons Alfort, France. The original application was filed on Oct. 12, 2005, and is available at: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=% 2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,405,323.PN.&OS=PN/7,405,323&RS= PN/7,405,323. For more information about US Fed News federal patent awards please contact: Myron Struck, Managing Editor/US Bureau, US Fed News, Direct: 703/866-4708, Cell: 703/304-1897, Myron@targetednews.com LOAD-DATE: September 19, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 HT Media Ltd. All Rights Reserved 227 of 998 DOCUMENTS US Fed News September 19, 2008 Friday 6:05 AM EST French Inventors Develop Therapeutic Treatment Method BYLINE: US Fed News LENGTH: 193 words DATELINE: Alexandria, Va. ALEXANDRIA, Va., Sept. 19 -- Veronique Broquaire of Noisy-le-Grand, France, Ludovic Broquaire of Frejus, France, Laurent Courvoisier of Laigneville, France, Gerard Coquerel of Boos, France, Franck Mallet of Blangy sur Bresle, France, and Michel Broquaire of Le Perreux, France, have developed a therapeutic treatment system. According to the abstract released by the U.S. Patent & Trademark Office: " Modafinil polymorphic forms of modafinil racemate, methods of preparation thereof, pharmaceutical compositions and methods of therapeutic treatment involving modafinil polymorphic forms." The inventors were issued U.S. Patent No. 7,405,323 on July 29. The patent has been assigned to Cephalon France, Maisons Alfort, France. The original application was filed on Oct. 12, 2005, and is available at: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=% 2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,405,323.PN.&OS=PN/7,405,323&RS= PN/7,405,323. For more information about US Fed News federal patent awards please contact: Myron Struck, Managing Editor/US Bureau, US Fed News, Direct: 703/866-4708, Cell: 703/304-1897, Myron@targetednews.com LOAD-DATE: September 19, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 HT Media Ltd. All Rights Reserved 228 of 998 DOCUMENTS Daily Mail (London) August 19, 2008 Tuesday 1ST Edition Fears for 'smart pill' generation BYLINE: Sarah Harris SECTION: Pg. 60 LENGTH: 761 words THE A-level and GCSE exam season is over for another year. Pupils -- and parents -- will be relieved that the stress, last-minute cramming and hard work is behind them. Last week saw record A-level results. The pattern is expected to be repeated this Thursday when hundreds of thousands of GCSE pupils discover how well they did. But experts are questioning how far pupils and their families are prepared to go to get the best results. Rising numbers of stressed students are feared to be popping so-called 'smart pills' to boost their exam performance. They are taking drugs used to treat hyperactive children and people with sleep problems to improve their brain power, despite being healthy. Doctors have warned that parents may be tempted to condone or even encourage this risky practice to give their youngsters a competitive edge. The British Medical Association claims that despite a lack of information about the possible long-term side-effects, 'there is already evidence of demand' for these cognitive enhancers in the UK. The problem is thought to be spreading due to the growth of online pharmacies selling Ritalin and Modafinil -- the most popular cognitive enhancers -- from 60p per pill without prescription. Experts believe parents are also duping doctors into giving them Ritalin for their children on prescription when there is no medical justification for using the drug. The number of prescriptions given to pupils for behaviour-altering drugs such as Ritalin and Modafinil has risen tenfold in the past decade, from around 48,000 in 1996-7 to more than 450,000 last year. Ritalin is used to calm and focus children with attention deficit hyperactivity disorder (ADHD). It increases alertness and improves concentration and memory. Modafinil is sold to treat narcolepsy (characterised by sudden attacks of sleepiness), but it can also stave off tiredness in those without a diagnosed sleep disorder. The BMA has warned that - cognitive enhancers are already being used 'surreptitiously' by students in the States as study aids. In a recent report, it says: 'Modern-day UK society is highly competitive. Children are judged from a young age on the basis of success in examinations, competition for university places, for openings in prestigious and highly paid professions, and pressure to succeed in one's chosen pursuits. ' In such an environment, it is perhaps not surprising that anything that gives an individual a competitive edge over his or her peers is seen as beneficial.' AND THE BMA says there is a 'strong advantage' for parents in trying to ensure their child, rather than somebody else's, gains an in-demand university place. 'So, those who could afford the interventions for their children would have a competitive advantage,' the report says. 'The result may well be pressure on parents to choose cognitive enhancers, and those who abstain risk holding their children back.' It asks 'whether we want to live in a society in which the use of cognitive enhancements are routine'. The use of brain-boosting drugs is rife among students in the U.S. Research by the National Institute on Drug Abuse found 2.5 per cent of eighth graders (13- to 14-year-olds) and 5.1per cent of 12th graders (17- to 18-year-olds) took 'smart pills' either for the 'rush' or as a study aid. Other studies show that on some U.S. campuses, 16 per cent of students are taking the drugs. Experts say that a similar problem is 'almost certainly happening here' among the student population. Barbara Sahakian, a professor of clinical neuropsychology at Cambridge University and author of studies into cognitive enhancers, says that prescriptions of Ritalin are increasing in the UK. She explains: 'When doctors see children, it's only for a short period of time. They're taking information provided by the parent about how they behave at school and home. It's self-reporting and it is open to abuse. For those children with ADHD it is a very effective form of treatment, but it shouldn't be used for all children.' Paul Cooper, professor of education at Leicester University, says teachers have told him that parents are buying Ritalin for their children off the internet. This is a 'dangerous risk' as they do not know if the drug is genuine or has been adulterated. They may also administer the wrong dose or mix it with other medicines. 'I think it's likely that parents are using Ritalin to try to improve their children's performance,' he says. 'If you think about the pressures that students and their parents are under -- short of outright cheating, I think they will go to extreme lengths.' LOAD-DATE: August 26, 2008 LANGUAGE: ENGLISH GRAPHIC: Under pressure: The use of brain-boosting drugs is on the increase PUBLICATION-TYPE: Papers Copyright 2008 Associated Newspapers Ltd. All Rights Reserved 229 of 998 DOCUMENTS Clinical Psychiatry News August 2008 Modafinil Reduces Severe Cancer Fatigue BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 52 Vol. 36 No. 8 ISSN: 0270-6644 LENGTH: 362 words    CHICAGO - The wakefulness-promoting drug modafinil reduced self-reported severe fatigue, according to a study of more than 600 cancer patients undergoing chemotherapy that was presented at the annual meeting of the American Society of Clinical Oncology.    Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil (Provigil) daily or placebo.    Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.    Participants were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle. They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10).    A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively..    Among patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant. This was not surprising, Dr. Morrow said during a press briefing. "With side effects, quite often the potency of the effect is somewhat dependent on where you began," he said.    Modafinil-a nonamphetamine stimulant-is currently indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work sleep disorder, and narcolepsy. Last year, researchers also at the University of Rochester reported success with modafinil in treating "chemo brain," a reduction in cognitive function that has been associated with chemotherapy.    There may be some overlap between chemo brain and fatigue, Dr. Morrow said in an interview. Problems with executive function are commonly described in chemo brain. Cancer-related fatigue appears to particularly affect tasks associated with executive function. Cancer patients complain of not being able to "get around" to doing things they know they should do.    Cephalon Inc. provided modafinil and placebo for the trial. Dr. Morrow reported that he has no relevant financial relationships. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: CPNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 230 of 998 DOCUMENTS Internal Medicine News August 1, 2008 Modafinil Helps Reduce Severe Cancer-Related Fatigue BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 33 Vol. 41 No. 15 ISSN: 1097-8690 LENGTH: 361 words    CHICAGO - The wakefulness-promoting drug modafinil (Provigil) reduced self-reported severe fatigue, according to a study of more than 600 cancer patients undergoing chemotherapy that was presented at the annual meeting of the American Society of Clinical Oncology.    Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil daily or placebo. Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.    The participants were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle. They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10). A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively.    Among patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant. This was not surprising, Dr. Morrow said during a press briefing. "With side effects, quite often the potency of the effect is somewhat dependent on where you began," he said.    Modafinil-a nonamphetamine stimulant-is currently indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work sleep disorder, and narcolepsy. Last year, researchers also at the University of Rochester reported success with modafinil in treating "chemo brain," a reduction in cognitive function that has been associated with chemotherapy.    There may be some overlap between chemo brain and fatigue, Dr. Morrow said in an interview. Problems with executive function are commonly described in chemo brain. Cancer-related fatigue appears to particularly affect tasks associated with executive function. Cancer patients complain of not being able to "get around" to doing things they know they should do.    Cephalon Inc. provided modafinil and placebo for the trial. Dr. Morrow reported that he has no relevant financial relationships. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: IMNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 231 of 998 DOCUMENTS The Sunday Times (London) July 20, 2008 There's a buzz about Modafinil BYLINE: Fleur Britten SECTION: FEATURES; Style; Pg.36 LENGTH: 1335 words There's a buzz about Modafinil, the 'smart' drug that is meant to make you sharper, brighter and more energised, but the idea of popping a pill to boost your brain - without any nasty side effects - is a little hard to swallow. Fleur Britten plays guinea pig Is your memory so perforated that you fear early-onset Alzheimer's? Your attention so centrifugal that you've self-diagnosed attention deficit hyperactivity disorder (ADHD)? Perhaps you don't have time to sleep, or maybe you would just like to function as a super-you. The sci-fi solution we have all been waiting for is already here, and it's circulating in student unions and school. These days, the kids are all on "smart drugs". A group of pharmaceuticals designed for sufferers of narcolepsy, Alzheimer's and ADHD, smart drugs are increasingly being used "off label" (unsupervised, as a lifestyle choice) by healthy people, who procure them from online pharmacies, friendly physicians and illicit prescription sales. "This stuff is being passed around all the time," says one male A-level student with something of a smart-drug habit - "this stuff" largely being Ritalin, usually prescribed for children with ADHD, and Modafinil, which is used to treat narcolepsy. Students are rejoicing and cramming for exams with smart-drug- fuelled all-nighters. One told me that he buys his from a mate who sells on his larger-than-necessary prescription; another offered to put me in touch with her "very kind doctor". The government, meanwhile, is sweating. It recently commissioned a report on brain science that concluded more work is needed. What students and the government both know is that in Ritalin improves attention, memory and cognitive flexibility in healthy subjects; Modafinil improves attention, memory, planning and decision- making and leaves you in a state of wakefulness without the wired bit, liability of addiction or "obvious toxic effects". So what's not to like? Imbued with visions of a new, improved me, I visit that conveniently unregulated online pharmacy. Ritalin costs £ 58 for 10 pills; Modafinil, £ 10 for 10. No questions asked, no electrocardiograph tests required. I plump for cheapo Modafinil. My sister, a doctor, phones with a warning: "I've been discussing your drugs trial with a colleague, and we don't think it's safe to experiment with your brain like this." I fall silent as she explains there are scant statistics on Modafinil's long-term effects, even fewer on the effects on healthy subjects. Plus, as with all neurological drugs, there can be atypical side effects. And a new report claims three in five medicines bought online are fake, some dangerously so. A dodgy package arrives in the post. Wrapped in low-grade manila, wonkily stamped "Mumbai - India", is a loose strip of 10 x 200mg legit-looking Modafinil pills (the website was recommended by a genuine American pharmacy that refused to ship to the UK). There are no instructions, no warnings of harmful contraindications, only this: "Dosage: as directed by the neurologist/ psychiatrist/specialist." I turn to my old friend the internet to check the dose (one or two pills) and side effects (insomnia, decreased appetite, anxiety, headache and rapid heartbeat). Some, of course, may see these cons as pros. First thing the next morning, down it goes, and I await the "eureka!" moment. It never comes, but an hour later, I feel undoubtedly alert. Actually, I feel pretty normal (no cleverer, no less hungry), if a little edgy. A persistent, dry headache develops, like I have drunk one too many coffees (after all, caffeine and Modafinil both stimulate the central nervous system), but where my attention usually drifts, today it can't. Streams of consciousness babble endlessly; I feel spirited and industrious. The steady energy endures with no 4pm fogs, and I fantasise about Thatcher-style productivity. Perhaps this is the key to the mythological 25-hour day? There are stories of off-label users finally conquering their intellectual Everests (lifelong battles with War and Peace); the American poker player Paul Phillips claimed that when he was prescribed Modafinil, it helped him win more than £ 1.7m. One A-level student told me: "On Ritalin and Modafinil, no matter what you're doing, you're interested. I studied politics, which usually I couldn't give a toss about. Four hours in, you have the choice to work or not, and you prefer to work. I screwed around all year and then worked really hard for my exams - on drugs. Some say it's cheating, but it's not like in sport, where you can be banned for taking steroids." According to the Department of Health, buying these drugs from illegal organisations is not against the law, as they are legal. It is time to find out what is going on in my head, so I call the Modafinil expert, Trevor Robbins, professor of cognitive neuroscience at Cambridge University and one of the academics behind the government's recent brain science report. He is unambiguously excited. "It works like a mental manager, optimising the performance of several different faculties," he says. "It's great on tasks requiring reflection and planning, plus it inhibits impulsiveness - and blurting out the wrong thing." Does he see it as cheating? "Coffee is a cognition enhancer," he argues. "People don't think of them as the same, but they're both chemicals. It's like taking a vitamin pill." Except that Modafinil is much more sophisticated and active. But where was super-me? "Modafinil operates on an inverted U-shaped curve," Robbins says. "If you're already functioning at the top of it, you can only go down." Depressing. He adds that some may not be genetically optimal for enhancement. Has Robbins tried Modafinil? "Never. I perform optimally already." Disturbingly, nobody knows exactly how Modafinil works, although it's generally considered safe (provided, of course, you're not taking the fakes). Made by Cephalon, it's been licensed for narcolepsy (as Provigil) for 10 years in the UK. In America, where the licensing regulations are more lenient, plenty of academics have it on repeat prescription. Cephalon refuses to answer my questions about off-label use, saying it has no direct involvement with tests on healthy volunteers, nor any plans for over-the-counter sales. It was after dark that Modafinil's potential for 48-hour wakefulness appeared - annoyingly. (I was only after the "smart" bit.) Wide-eyed at 2am, I reached for a sleeping pill. And another. Predisposed to poor sleep, I ended up taking three times the normal dose, yet getting barely two hours' kip. Many claim to sleep fine and that there is no sleep debt after all-nighters, provided you get eight hours' kip the following night. I'm not convinced. The next day, I'm still alert, but I need an extra jolt of caffeine. By 6pm, I'm broken. I see that upper- downer cycle winking at me: Exhausted? Take this little pill. Can't sleep? Try this. And I did, a few days later, this time on a hangover. With the stuffing already knocked out of me, I wondered whether Modafinil could be the ultimate hangover cure. But no - I had the same sleep issues (none, all night) and a whole new hangover to deal with. The day after, I felt heavy, woolly and strung out, with a stubborn, brittle headache - not dissimilar to the aftermath of a drugs bender. Unsurprisingly. According to the US military, sequential dosing has diminishing returns: Modafinil can work for 48 hours, but then people need sleep. After all, people eventually die from sleep deprivation. As far as I can work out, it doesn't do to mess with your circadian cycle: power pills are no substitute for real sleep. But in these time-obsessed days, off-label use is predicted to rise, and more cognition-enhancing drugs are in development. I haven't touched my stash since, but if I were a truckie or on the eve of exams, I could be tempted. But you would be foolish to treat smart drugs like the new coffee. 1 FOTOFIT LOAD-DATE: July 25, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: sb Copyright 2008 Times Newspapers Limited All Rights Reserved 232 of 998 DOCUMENTS Pallimed July 2, 2008 Wednesday 2:03 PM EST 2008 ASCO: methadone, genetics, modafinil BYLINE: Drew Rosielle MD LENGTH: 289 words Jul. 2, 2008 (Pallimed delivered by Newstex) -- The 2008 American Society of Clinical Oncology meeting was last month. Every year the palliative care, supportive care, and end-of-life care abstracts are worth browsing (abstracts here).I wanted to particularly point out 3:First is a case series about one center's experience with initiating and rotating to methadone in outpatients. Very little has been published about rotating to methadone in the outpatient setting despite it being a relatively common practice (that's my sense at least) - most of the publications about methadone rotations have been in inpatients. The data presented here suggest it's safe (no one falling over dead from torsades) and has salutary effects on pain.Second is one looking at genetic polymorphisms (of cytokine genes) and their associations with pain and opioid dose (certain polymorphisms in this lung cancer population were associated both with pain and opioid dose). I'm probably prematurely excited about the growing trickle of research (in actual real live humans in pain) into the genetic basis of the variable response to opioids, but there you go.Third, outcome data from a randomized, placebo controlled trial of modafinil for cancer-related fatigue was presented. Patients were all initiating chemotherapy, and those who reported severe fatigue (but not mild or moderate) seemed to benefit from modafinil over placebo. The magnitude of the benefit, while statistically significant, is unclear from the abstract. I've used modafinil occasionally, with (of course) mixed results; these are the first placebo controlled data I've seen on it in our population. I'm curious as to readers' experience with it. Newstex ID: PALL-0001-26407116 LOAD-DATE: July 3, 2008 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs on Demand®") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs on Demand® are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs on Demand® is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs on Demand® shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs on Demand®. Reader's comments reflect their individual opinion and their publication within Blogs on Demand® shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2008 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2008 Pallimed 233 of 998 DOCUMENTS Family Practice News July 1, 2008 Modafinil Reduces Severe Cancer-Related Fatigue BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 45 Vol. 38 No. 13 ISSN: 0300-7073 LENGTH: 307 words    CHICAGO - The wakefulness-promoting drug modafinil (Provigil) reduced self-reported severe fatigue, according to a study presented at the annual meeting of the American Society of Clinical Oncology.    Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil daily or placebo. Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.    The subjects were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle. They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10). A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively.    In patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant.    Modafinil, a nonamphetamine stimulant, is indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work, and narcolepsy. Last year, researchers also at the University of Rochester reported success with modafinil in treating "chemo brain," a reduction in cognitive function associated with chemotherapy.    There may be some overlap between chemo brain and fatigue. Problems with executive function are commonly described in chemo brain. Cancer-related fatigue appears to particularly affect tasks associated with executive function. Cancer patients often complain of not being able to do things they know they should do, Dr. Morrow said.    Cephalon Inc. provided modafinil and placebo for the trial. Dr. Morrow said he has no relevant financial relationships. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: FPNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 234 of 998 DOCUMENTS Ob/Gyn. News June 15, 2008 Modafinil May Cut Fatigue In Patients During Chemo BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 14 Vol. 43 No. 12 ISSN: 0029-7437 LENGTH: 361 words    CHICAGO - The wakefulness-promoting drug modafinil (Provigil) reduced self-reported severe fatigue, according to a study of more than 600 cancer patients undergoing chemotherapy that was presented at the annual meeting of the American Society of Clinical Oncology.    Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil daily or placebo. Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.    Participants were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle. They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10). A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively.    Among patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant. This was not surprising, Dr. Morrow said during a press briefing. "With side effects, quite often the potency of the effect is somewhat dependent on where you began," he said.    Modafinil-a nonamphetamine stimulant-is currently indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work sleep disorder, and narcolepsy.    Last year, researchers also at the University of Rochester reported success with modafinil in treating "chemo brain," a reduction in cognitive function that has been associated with chemotherapy.    There may be some overlap between chemo brain and fatigue, Dr. Morrow said in an interview. Problems with executive function are commonly described in chemo brain. Cancer-related fatigue appears to particularly affect tasks associated with executive function. Cancer patients complain of not being able to "get around" to doing things they know they should do.    Cephalon Inc. provided modafinil and placebo for the trial. Dr. Morrow reported that he has no relevant financial relationships. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: OBNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 235 of 998 DOCUMENTS The Age (Melbourne, Australia) June 6, 2008 Friday First Edition 'Smart drugs' need smarter risk-handling; 'What if you could go into Starbucks and ask for your latte with a shot of (smart drug) modafinil?' BYLINE: Nick Miller, Health Editor SECTION: NEWS; Pg. 3 LENGTH: 844 words "SMART drugs" could be the fluoride of the new millennium, says a visiting expert. But they could also be a social scourge as we dope ourselves and our children to work harder and longer, warned Cambridge University professor Barbara Sahakian, who is visiting Melbourne for the 2008 Alfred Deakin Lectures. Academics, students and high-octane executives are already seeking a new generation of pills that improve cognition, planning skills and memory, with minimal side effects. "This could be the way of the future," Professor Sahakian said. "What if you could go into Starbucks and ask for your latte with a shot of (smart drug) modafinil?" Other experts have even suggested cognitive enhancers be put in the water alongside fluoride, she said. Developed to treat disorders such as narcolepsy or Alzheimer's, some new drugs were found to improve cognition in normal, healthy people. Those in the know are buying drugs such as modafinil through under-regulated internet pharmacies, or friendly doctors who bend strict prescription rules. They are handed around at conferences and swapped before exams. A recent Nature magazine survey found one-fifth of its readers had used smart drugs to boost their concentration or memory. "We're not always working at our best - young mothers with babies, people travelling all the time," Professor Sahakian said. "I went to a meeting in Florida and I said to a colleague 'I'm suffering from jetlag', and he said to me 'would you like some of my modafinil?' A lot of my colleagues (are) using it." Newer smart drugs are proving safer than predecessors such as Ritalin. "New drugs such as modafinil have a much lower side effects profile and don't seem to have a substance abuse potential. It really is something a healthy human might be tempted to try." But that temptation can lead to danger. Many people are sourcing smart drugs from internet pharmacies, unsure what they are getting and without advice about their effect on existing conditions and medication. "I'm keen to have some kind of governmental regulatory approach, so people are getting safe and effective cognitive drugs," Professor Sahakian said. Beyond medical safety, society might be hurt by smart drugs. "What if some people can afford cognitive-enhancing drugs, but other people can't?" she said. "What happens to the work-life balance . . . are we going to improve that using these drugs, to get a good day's work and come home early? Or are we just going to work more?" Professor Sahakian also worries that the focus on "quick fix" pills ignores the cognitive benefits of exercise and education. On the other hand, these drugs could keep an ageing population mentally active. There are at least 40 new cognitive drugs in development, such as "ampakines" that seem to boost memory. Modafinil is available on Australia's Pharmaceutical Benefits Scheme when prescribed for severe sleep disorders. The makers warn it has been associated with severe rashes in children. There may also be unknown side effects. "We don't know about the long-term effects (of modafinil) in the developing brain," Professor Sahakian said. If smart drugs became popular parents would feel pressure to give them to children, especially if schoolmates used them. Drug educator Paul Dillon said in the past 12 to 18 months he had noticed a sharp increase in interest from high school students in drugs that could help them study. "I have had quite a substantial number of questions from year 11s and 12s asking about Ritalin and its effects," he said. "They say 'a friend is using it to study'. Ritalin has always been used in non-medical ways, to get a 'buzz', but this is something new. You have to ask why - is it because of greater pressure to achieve?" There was a risk, especially with young people, if they didn't get the desired effect from one pill they would take 10 the next time, he said. Professor Sahakian delivers tonight's Deakin lecture: www.deakinlectures.net SMART DRUGS METHYLPHENIDATE (Drug names Ritalin, Concerta) A stimulant commonly used to treat attention deficit disorders and chronic fatigue. Healthy users believe it helps them focus on tasks and stay awake. MODAFINIL (Drug names Provigil, Modavigil) Another stimulant with less severe side-effects than Ritalin. Prescribed to treat severe sleep problems. Some studies suggest it improves short-term memory, concentration and pattern recognition. AMPAKINES Still experimental, drugs such as CX717 are believed to affect the neurotransmitter glutamate, possibly improving cognitive function and memory. PIRACETAM (Drug names Nootropil, Avigilen) Normally used to treat alcoholism, dementia or stroke. May improve memory and learning in healthy people. ERGOLOID (Drug names Hydergine, Cicanol) An anti-dementia treatment believed to promote alertness, memory and cognitive abilities. BETA-BLOCKERS (Propranolol, for example) An old treatment for high blood pressure, sometimes used to prevent anxiety in public speakers and musicians. NOTE: The Age does not condone the use of any of these drugs without a prescription and appropriate medical advice. LOAD-DATE: June 5, 2008 LANGUAGE: ENGLISH GRAPHIC: PHOTO: Cambridge University Professor Barbara Sahakian, who says emerging "smart" drugs could be the new fluoride or a scourge if misused. PICTURE: JASON SOUTH PUBLICATION-TYPE: Newspaper Copyright 2008 The Age Company Limited All Rights Reserved 236 of 998 DOCUMENTS The Age (Melbourne, Australia) June 6, 2008 Friday Second Edition 'Smart drugs' need smarter risk-handling; 'What if you could go into Starbucks and ask for your latte with a shot of (smart drug) modafinil?' BYLINE: Nick Miller, Health Editor SECTION: NEWS; Pg. 3 LENGTH: 839 words "SMART drugs" could be the fluoride of the new millennium, says a visiting expert. But they could also be a social scourge as we dope ourselves and our children to work harder and longer, warned Cambridge University professor Barbara Sahakian, who is visiting Melbourne for the 2008 Alfred Deakin Lectures. Academics, students and high-octane executives are already seeking a new generation of pills that improve cognition, planning skills and memory, with minimal side effects. "This could be the way of the future," Professor Sahakian said. "What if you could go into Starbucks and ask for your latte with a shot of (smart drug) modafinil?" Other experts have even suggested cognitive enhancers be put in the water alongside fluoride, she said. Developed to treat disorders such as narcolepsy or Alzheimer's, some new drugs were found to improve cognition in healthy people. Those in the know are buying drugs such as modafinil through under-regulated internet pharmacies, or friendly doctors who bend strict prescription rules. They are handed around at conferences and swapped before exams. A recent Nature magazine survey found one-fifth of its readers had used smart drugs to boost their concentration or memory. "We're not always working at our best - young mothers with babies, people travelling all the time," Professor Sahakian said. "I went to a meeting in Florida and I said to a colleague 'I'm suffering from jetlag', and he said to me 'would you like some of my modafinil?' A lot of my colleagues (are) using it." Newer smart drugs are proving safer than predecessors such as Ritalin. "New drugs such as modafinil have a much lower side effects profile and don't seem to have a substance abuse potential. It really is something a healthy human might be tempted to try." But that temptation can lead to danger. Many people are sourcing smart drugs from internet pharmacies, unsure what they are getting and without advice about their effect on existing conditions and medication. "I'm keen to have some kind of governmental regulatory approach, so people are getting safe and effective cognitive drugs," Professor Sahakian said. Beyond medical safety, society might be hurt by smart drugs. "What if some people can afford cognitive-enhancing drugs, but other people can't?" she said. "What happens to the work-life balance . . . are we going to improve that using these drugs, to get a good day's work and come home early? Or are we just going to work more?" Professor Sahakian also worries that the focus on "quick fix" pills ignores the cognitive benefits of exercise and education. On the other hand, these drugs could keep an ageing population mentally active. There are at least 40 new cognitive drugs in development, such as "ampakines" that seem to boost memory. Modafinil is available on Australia's Pharmaceutical Benefits Scheme when prescribed for severe sleep disorders. The makers warn it has been associated with severe rashes in children. There may also be unknown side effects. "We don't know about the long-term effects (of modafinil) in the developing brain," Professor Sahakian said. If smart drugs became popular parents would feel pressure to give them to children, especially if schoolmates used them. Drug educator Paul Dillon said in the past 12 to 18 months he had noticed a sharp increase in interest from high school students in drugs that could help them study. "I have had quite a substantial number of questions from year 11s and 12s asking about Ritalin and its effects," he said. "They say 'a friend is using it to study'. Ritalin has always been used in non-medical ways, to get a 'buzz', but this is something new. You have to ask why - is it because of greater pressure to achieve?" There was a risk, especially with young people, if they didn't get the desired effect from one pill they would take 10 the next time, he said. Professor Sahakian delivers tonight's Deakin lecture: www.deakinlectures.net SMART DRUGS METHYLPHENIDATE (Drug names Ritalin, Concerta) A stimulant commonly used to treat attention deficit disorders and chronic fatigue. Healthy users believe it helps them focus on tasks and stay awake. MODAFINIL (Drug names Provigil, Modavigil) Another stimulant with less severe side-effects than Ritalin. Prescribed to treat severe sleep problems. Some studies suggest it improves short-term memory, concentration and pattern recognition. AMPAKINES Still experimental, drugs such as CX717 are believed to affect the neurotransmitter glutamate, possibly improving cognitive function and memory. PIRACETAM (Drug names Nootropil, Avigilen) Normally used to treat alcoholism, dementia or stroke. May improve memory and learning in healthy people. ERGOLOID (Drug names Hydergine, Cicanol) An anti-dementia treatment believed to promote alertness, memory and cognitive abilities. BETA-BLOCKERS (Propranolol, for example) An old treatment for high blood pressure, sometimes used to prevent anxiety in public speakers and musicians. NOTE: These drugs should not be used without a prescription and appropriate medical advice. LOAD-DATE: June 5, 2008 LANGUAGE: ENGLISH GRAPHIC: PHOTO: Cambridge University Professor Barbara Sahakian, who says emerging "smart" drugs could be the new fluoride or a scourge if misused. PICTURE: JASON SOUTH PUBLICATION-TYPE: Newspaper Copyright 2008 The Age Company Limited All Rights Reserved 237 of 998 DOCUMENTS Clinical Psychiatry News June 2008 APA Meeting News Modafinil May Keep Weight Gain From Olanzapine to Minimum BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 20 Vol. 36 No. 6 ISSN: 0270-6644 LENGTH: 435 words    WASHINGTON - The wakefulness drug modafinil appears to reduce weight gain associated with the use of the atypical antipsychotic olanzapine, based on a study of healthy subjects presented at the annual meeting of the American Psychiatric Association.    Participants concurrently on olanzapine (Zyprexa) and modafinil (Provigil) gained roughly half the weight of those on olanzapine and placebo, reported James Roerig, Pharm.D., of the University of North Dakota, Grand Forks. Dr. Roerig reported that this study was supported through an investigator-initiated trial grant from Eli Lilly & Co., maker of olanzapine.    The etiology behind atypical antipsychotic-associated weight gain is unclear. Olanzapine is known to block the histamine H1 receptor. A significant increase in AMP-activated protein kinase (AMPK) has been associated with the antagonism of H1 receptors by olanzapine. AMPK is associated with the control of appetite and mediation of the effects of leptin and insulin. Modafinil is approved for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The mechanism of action for modafinil is unclear, but research suggests that it acts on receptors that in turn act on histamine receptors.    For this study, the researchers recruited 50 healthy control volunteers. At baseline, their weight was recorded and they underwent a feeding laboratory assessment. All participants were titrated up to 10 mg/day olanzapine over 5 days. They were also randomized to receive placebo or modafinil, titrated to 200 mg/day over 5 days.    Because of adverse events, 10 patients dropped out-which left 20 patients in each study arm. At the end of 3 weeks, the participants were weighed and underwent another feeding laboratory assessment.    During the feeding laboratory assessment, participants were given a 550-kcal breakfast and a 600-kcal lunch. For dinner, they were given a choice of unlimited amounts of three food items; they were told to eat until they were not hungry. During the dinner session, patients were assessed for energy intake, sleepiness, hunger/satiety, and adverse events.    The placebo group showed a significantly greater increase in body mass index than did the modafinil group, Dr. Roerig said. This difference was significant at week 1 and until the end of the trial. Likewise, the placebo group gained more weight (2.67 kg on average) than the modafinil group (1.33 kg on average). This difference was significant at weeks 1 and 2 but only approached significance at week 3. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: CPNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 238 of 998 DOCUMENTS Clinical Neurology News June 2008 Modafinil Reduced Severe Fatigue in Cancer Patients BYLINE: Kerri Wachter, Senior Writer SECTION: Pg. 11 Vol. 4 No. 6 ISSN: 1553-3212 LENGTH: 381 words    CHICAGO - The wakefulness-promoting drug modafinil (marketed as Provigil) reduced self-reported severe fatigue, according to a recent study of more than 600 cancer patients who were undergoing chemotherapy.    Gary R. Morrow, Ph.D., of the University of Rochester (N.Y.) and his colleagues randomized 631 patients undergoing four cycles of chemotherapy to receive either 200 mg modafinil daily or placebo. Among those with severe fatigue at baseline, patients on modafinil had significantly greater reductions in fatigue, compared with those on placebo.    Dr. Morrow presented his study's findings at the annual meeting of the American Society of Clinical Oncology.    Study participants were asked to rate their level of fatigue at baseline (during the second cycle of chemotherapy) and during the final cycle.    They rated fatigue on a 10-point scale: mild (1-4), moderate (5-6), and severe (7-10).    A total of 67 patients reported mild fatigue at baseline; 106 and 458 reported moderate and severe fatigue, respectively.    Among patients with mild and moderate fatigue, modafinil also reduced fatigue, compared with placebo, but the differences were not significant.    This was not surprising, Dr. Morrow commented during a press briefing.    "With side effects, quite often the potency of the effect is somewhat dependent on where you began," he said.    Modafinil-a nonamphetamine stimulant-is currently indicated for the treatment of excessive sleepiness resulting from obstructive sleep apnea, shift-work sleep disorder, and narcolepsy. Last year, researchers also at the University of Rochester reported success with modafinil in treating "chemobrain," a reduction in cognitive function that has been associated with chemotherapy.    There may be some overlap between chemobrain and fatigue, Dr. Morrow said in an interview. Problems with executive function are commonly described in chemobrain.    Cancer-related fatigue appears to particularly affect tasks associated with executive function.    Cancer patients complain of not being able to "get around" to doing things they know they should do.    The pharmaceutical company Cephalon Inc. provided modafinil and placebo for the trial.    Dr. Morrow reported that he has no relevant financial relationships to disclose. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: CNNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 239 of 998 DOCUMENTS The Sunday Times (London) May 25, 2008 Dopers in the dock BYLINE: David Walsh, Chief Sports Writer SECTION: SPORT; Sport; Pg.21 LENGTH: 1148 words The trial of coach Trevor Graham is revealing just how widespread drugs in athletics were How did Michael Johnson feel as he read reports of Antonio Pettigrew's testimony in a San Francisco courtroom last week? Pettigrew was a witness in the case against athletics coach Trevor Graham, who is accused of lying to federal investigators. During his testimony, Pettigrew explained he had been put in touch with a drug supplier, Angel "Memo" Heredia, by Graham and that he continued receiving banned substances from Heredia until 2001. Johnson would have paid attention to Pettigrew's evidence because not only were they rivals on the track, they raced together on US relay teams. Regarded as the greatest of all 400m runners, Johnson's final race was the 4x400m relay in Sydney on September 30, 2000, where he anchored the US team to a clear victory. Pettigrew ran the second leg in that final and played his part in Johnson receiving the baton with an insurmountable lead. By his own admission, Pettigrew was doping at the time. One wonders if Johnson now feels that the last medal is tainted and unworthy of a place among his collection of 19 championship golds. The other two members of that 400m relay team in Sydney were the twins, Calvin and Alvin Harrison, who were given doping bans in 2004 for offences committed after the 2000 Olympics. Calvin tested positive for modafinil, a stimulant once used by athletes connected to the Balco laboratory run by Victor Conte, while Alvin was shown to have used EPO, the steroid tetrahydro-gestrinone (THG), testosterone, human growth hormone, insulin and modafinil. Alvin was given a four-year ban and became the first male athlete to be sanctioned without having failed a drug test. Johnson will know how this story is likely to unfold. Jim Scherr, chief executive of the United States Olympic Committee, weighed up Pettigrew's evidence. "If an athlete who ran in the finals knowingly and purposefully engaged in cheating, the medals won by the entire team are tarnished and, in our view, should be returned." There is a precedent for this sorry episode. At the same 2000 Olympics in Sydney, the women's 4x400m relay was won by a US team containing Marion Jones, who has since admitted she doped before the Games. Last month the International Olympic Committee (IOC) stripped that US team of its medals. They must now do the same with the US men's team and declare second-placed Nigeria as the gold medallists. Johnson never tested positive for doping, nor has he been implicated in any doping controversy, and since his retirement in 2000 he has been consistently critical of those who use drugs. What does he now think about the gold he won in that Sydney relay? At least one of his teammates was cheating at the time and given how well the Harrisons were running in Sydney, he may wonder if they started down the doping road before the 2000 Olympics. The bottom line is clear: that 4x400m gold medal is tarnished and worthless. The only good that can come from this is that by returning it, Johnson can say he wants nothing to do with any award or victory achieved with the help of drugs. It would be nice, too, if the 400m world record-holder returned that medal voluntarily, before the IOC order him to. Of course, the International Association of Athletics Federations (IAAF) and the IOC dislike talk of medals being returned and history being rewritten because there is no end to the problem. If all doping-affected results were re-evaluated and the cheats removed, there would be no time to organise the Games. When the IOC decided to strip the US women of their medals in the 4x100m and 4x400m relays (Jones was also in the 4x100m relay team) from the Sydney Olympics, they took a decision that involved more than 30 athletes in a process that would see some lose their medals, others change the colour of theirs and still others receive medals more than seven years after they had missed out. Three months before the start of the Beijing Olympics, the Graham trial is the last thing sports officials wanted. The Balco investigation is continuing to do significant damage to sport's battered image. It is not just athletics that has suffered in the fallout to the Balco investigation but also baseball and American football. Such was the cynicism that underpinned Conte's operation and the sheer scale of his doping programme that the investigation was always going to have serious consequences, but the situation has been exacerbated by athletes and their coaches believing they could tell the same lies to federal investigators that for years they have been telling to the public. That is why Jones ended up in prison, why the US cyclist Tammy Thomas awaits sentencing after her perjury conviction, why Graham is facing perjury charges. Graham's case is typical. He has been one of America's most successful track coaches and when it was discovered he was the person who tipped off US anti doping authorities about Conte's operation in San Francisco, he was praised for what seemed a strong anti-doping statement. But during the course of the Balco investigation, federal agents received information that suggested Graham was helping his athletes to dope. They interviewed him and agreed to his request for immunity from prosecution provided he was truthful. According to his testimony, Graham was never involved in doping. After speaking with other witnesses, in particular the Mexican-born steroid dealer Heredia, the investigators concluded that Graham had lied and charged him with perjury. For the first four days of last week, a jury in San Francisco heard the case against Graham and it was substantial. He had told the government investigators he had never met Heredia and had not spoken to him on the phone since 1997. A photograph showed Heredia and Graham together in Heredia's apartment in 1996, and phone records indicated Graham had spoken more than 100 times to the supplier since 1997. If the prosecution's case against Graham rested solely on Heredia's evidence, it would be difficult to prove because Heredia supplied drugs to many athletes and was not truthful in his initial interview with federal officers. The case against Graham, however, rests as much on the testimony of his former athletes. Pettigrew testified that Graham suggested he should consider using EPO and human growth hormone and that he would introduce him to a supplier Heredia), while Jerome Young, also a member of America's tarnished 4x400m team at the 2000 Olympics, told the court Graham introduced him to EPO. Dennis Mitchell, who won 4x100m gold for America at the 1992 Olympics, testified that Graham injected him with human growth hormone and Duane Ross, a retired American hurdler, said he fell out with Graham because he refused to use performance-enhancing drugs. The case resumes on Tuesday. LOAD-DATE: May 26, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: st Copyright 2008 Times Newspapers Limited All Rights Reserved 240 of 998 DOCUMENTS Canadian Corporate Newswire May 12, 2008 Monday 11:13 PM EST Get a Deep Insight into the Sleep Disorders Market Analysis 2008-2018 LENGTH: 2262 words LONDON, UNITED KINGDOM--(Marketwire - May 12, 2008) - Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue. Sleep Disorders Market Analysis 2008-2018 http://www.reportlinker.com/p089492/Sleep-Disorders-Market-Analysis-2008-201 8.html More than 80 sleep disorders have been identified. They affect over 200 million people worldwide. The report focuses on the market for following sleep disorders: - Insomnia - Restless legs syndrome (RLS) - Narcolepsy and - Obstructive Sleep Apnoea / Hypopnea Syndrome (OSAHS) The market penetration for insomnia drugs has not reached saturation point. Opportunities remain. But with the introduction of several new products the market is set to see changes, but expansion. This expansion is based on increased general awareness physicians better comprehension of the significance of this disease and the positive role that a sleep medication prescription plays. At present time there are several prescription sleeping medications available to treat insomnia. The market-focus has been driven by the production of sleep medications with less side-effects and danger of overdose. Prescription benzodiazepines and newer non-benzodiazepine hypnotics developed in the 1990s, such as Imovane, Ambien and Sonata will continue to be the most prescribed. Benzodiazepines are widely used to treat an underlying neurological disorder which is often the underlying cause of insomnia, e.g. anxiety and depression. Visiongain predicts that market share by volume for insomnia in the US will change significantly from 2008 to 2018. Ambien IR lost its patent protection in April 2007, which opened to generic competition for Zolpidem. Ambien will remain the market leader for the short term, but what will over take it? A generic version of Ambien is expected to achieve strong market share by volume as there is a great demand for zolpidem tartrate for insomnia. The market share for insomnia treatment will gradually rise after 2012, which will be due to: - Market expansion of existing expensive medications into Europe and Japan in particular - Market penetration of new medications currently in pipeline. Other drugs dealt with in this report include: - Modafinil (Provigil) is the first in a new class of wake-promoting drugs and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. Provigil is quickly replacing Ritalin, and other CNS stimulants, as the medication of choice for treating daytime sleepiness in narcolepsy. The FDA granted modafinil (Provigil) orphan drug status in 1993. Modafinil was initially launched in the US in 1999 for the treatment of narcolepsy. In 2004, modafinil became FDA-approved prescription medicine for the treatment of excessive sleepiness associated with Obstructive Sleep Apnoea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD). - Requip (ropinirole) became the first and only FDA-approved drug treatment for moderate to severe primary Restless Legs Syndrome (RLS) in 2005. Key findings that will broaden the scope of the sleep disorders market: - Over the next decade, the development and improvement of sleep disorders therapies will primarily depend on the success of burgeoning technology and innovative approaches. - It is possible to purchase prescription medications online without producing a prescription. Purchase of online sleep medications has increased and will continue to evolve over the next years. - The impact of DTC advertising has created an improved awareness of available insomnia treatment. This is likely to increase as DTC advertising continues to prosper and the culture becomes more accepting towards insomnia treatment. Visiongain expects the market for sleep disorders to increase, driven by a growing awareness of sleep disorders and by campaigns to promote sleep medications, both by DTC advertising and consumer education. The relaxation of DTC marketing restrictions in the 1990s in the US set the stage for a flow for both branded and unbranded advertising and promotional programmes. Those regulations are prompting more responsible DTC advertising on the industry's part. - The FDA has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger warnings concerning potential risks. - The Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) approved Neurim's Circadin a prolonged-release melatonin as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or over. Neurim is actively seeking strategic alliances for the major European markets. What questions does the report answer? - Which current or future therapies will drive the sleep disorders market from 2008 to 2018? - The key companies involved in the market and their analysis? - What is the patient identification rate for each of the therapeutic areas? - What is the present state of the disease awareness? - What R&D opportunities exist for 'new comers'? Why should you buy this report? - This report focuses on the marketed medications and the pipeline development for sleep disorders from 2008 to 2018. It also discusses the strength and weakness of products, along with the opportunities and threats facing the market. - The report describes world market situation for sleep disorders, namely insomnia, narcolepsy, RLS and OSAHS, with forecasts made for all key products. It also describes the insomnia market situation in the seven major world markets for sleep medications: the US, Japan, France, Germany, Italy, Spain and the UK, with forecasts for key products. - The report provides transcripts of visiongain's interviews with experts in the field of sleep disorders, which reviews the future direction of the sleep disorders treatment market. Unique benefits to you when you order this report - You can access your report whichever country you are in without using harddrive space - Primary research throughout. You will not find this information anywhere else - Full searchable report when you buy the company or corporate editions - Copies can be printed off for offline reading - Packed with charts, analysis, figures, graphs and table Please Note: Reports are sold based on the user licenses indicated. The Publisher delivers the report in Flash format via the publisher website, allowing viewing and printing capabilities only. Within one to two business days after placing the order, the Publisher will email the client with information on accessing their purchase. Prior to initiating fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher. 1 Executive Summary: Pharmaceutical Treatment of Sleep Disorders 2008-2018 1.1 Current Prospects of Sleep Disorders Market 1.1.1 Market Growth Estimate 1.1.2 Generic Pharmaceutical Market 1.1.3 Market Expansion 1.1.4 Market Demand for Short Elimination Half-Life 1.1.5 Medications Targeting M1 and M2 Receptors 1.1.6 Medications Targeting 5HT2A Receptor Receptors 1.1.7 Product Line Extension Activities 1.1.8 Effect of Direct-To-Consumer Advertising (DTCA) 1.1.9 Safety Measures for Online Consumers 1.2 Aim, Scope, and Format Of This Report 2 Introduction to Sleep Disorders and their Pharmaceutical Treatment 2.1 Introduction to Sleep Disorders 2.2 Overview of Chapter 2.3 Introduction to Insomnia 2.4 Discovery of Barbiturates 2.5 Market Entry for Non-Barbiturates 2.6 Arrival of Benzodiazepines 2.7 Non-benzodiazepines the Revolutionary Compound 2.7.1 Prescription Medicines and OTCs 2.8 Pharmacodynamics of Hypnotics 2.9 Introducing New Scope for Insomnia 2.10 Many Forms of Sleep Disturbances 2.10.1 Sleep Deprivation 2.11 Shift Workers Sleep Disorder (SWSD) 2.11.1 Melatonin 2.11.2 Valerian 2.12 Treatment for insomnia in Depression 2.13 Restless Legs Syndrome 2.13.1 Off-label Prescription for Restless Legs Syndrome 2.14 Other Medical Conditions 2.15 Narcolepsy 2.15.1 Xyrem for Cataplexy 2.15.2 Orphan Disease Status 2.15.3 Other Medications for Cataplexy 2.16 Obstructive Sleep Apnea / Hypopnea Syndrome (OSAHS) 2.17 Insomnia - A Common Disease 2.18 Patient Identification Rate 3 Analysis of Current Market for Insomnia 3.1 Market Share for World Insomnia Market 3.2 Market Dominance Continues for Ambien 3.3 Lunesta as Ambien's Contender 3.4 Sonata Continues to Form Niche Market 3.5 Imovane / Amoban Go Down in Insomnia Market 3.6 Benzodiazepines Survived as Low Priced Sleep Aid 3.6.1 Lendormin (brotizolam) 3.6.2 Halcion (triazolam) 3.6.3 Noctamid (Lormetazepam) 3.6.4 Doral (quazepam) 3.6.5 Dalmane (flurazepam) 3.6.6 Rohypnol (flunitrazepam) 3.6.7 Restoril (temazepam) 3.6.8 Eurodin or ProSom (estazolam) 3.6.9 Rhythmy (rilmazafone) 3.6.10 Rhythmy (rilmazafone) 3.6.10 Valium (diazepam) 3.7 Rozerem Market Up-and-Coming 4 Insomnia Market Analysis by World Regions 4.1 US has the Highest Market Share for Insomnia Treatments 4.2 Europe as a Significant Market for Insomnia Treatments 4.3 The Japanese Market for Insomnia is Expanding 5 Market Developments for Narcolepsy, Shift Work Sleep Disorder, and  Restless Legs Syndrome 5.1 Provigil Wins Label Extension 5.2 Adrafinil is a Isomer of Provigil 5.3 Ritalin/ Ritalin SR 5.4 Concerta is an Extension Version of Ritalin 5.5 Adderall as Stimulant 5.6 Xyrem for Cataplexy and Excessive Daytime Sleepiness 5.7 Recent FDA Activities for Restless Legs Syndrome 6 Products in Development for Sleep Disorders 6.1 FDA Approves Generic Ambien 6.2 Circadin a Prolonged-Release Melatonin 6.3 GHB analogue Generally Regarded as Safe 6.4 Clinical Trial Product List for Insomnia 6.5 Indiplon for Insomnia in Pre-Registration Stage 6.6 Caraco's Prospect in Narcolepsy Market 6.7 Lundbeck Faces Setback in Insomnia Market 6.8 Phase III Trial Begins on Posidorm for Insomnia 6.9 Hope for Physiological Sleep with Almorexant 6.10 5HT2A Antagonist for Insomnia 6.11 Agonist at the Serotonin 5-HT1A Receptor 6.12 VEC-162 Future Contender for Rozerem 6.13 Zolpidem as Oral Spray 6.14 Cephalon Adds Nuvigil Alongside Provigil 6.15 Dopamine Patch for RLS 6.16 Transported Prodrug of Gabapentin 7 Recommendations for Ideal Pharmaceutical Treatment for Sleep Disorders 7.1 Firsthand Interview for Expert Opinion 1 7.1.1 Prospect for Sleep Disorders Market 7.1.2 Prospect for Generic Market 7.1.3 Product Line Extension 7.1.4 Prospect for Niche Market 7.1.5 Future of Benzodiazepines Market 7.1.6 Future of Controlled Drug Market 7.1.7 Effect of Direct-to-Consumer Market 7.1.8 Future of Non-Hypnotics Medications 7.1.9 Future Medications for Sleep Apnoea 7.1.10 Prospect for Hypnotics as OTCs 7.1.12 Unmet Needs for Sleep Disorders Market 7.2 Firsthand Interview for Expert Opinion 2 7.2.1 Drug Therapies for the Future 7.2.2 Technological Advance in Sleep Disorders Treatment 7.2.3 New Effective Sleep Medications 7.2.4 Future of Sleep Disorders Market in the Developed Nations 7.2.5 Unmet Needs for Sleep Disorders Treatment 7.2.6 Favourable Medication for the Coming Decade 7.2.7 Side-Effect Profile for Future Drug Development 7.2.8 Sleep Disorders Market in Developing Nations 8 Market Force and Limitation of Sleep Disorders Market 8.1 Table for SWOT Analysis of Sleep Disorders Market 8.2 Market Analysis of Products Unapproved for Sleep Disorders by Regulatory Bodies and Niche Market 8.2.1 Unapproved Insomnia Medications: Benadryl, Unisom, Tylenol PM, Nytol 8.2.3 Purchase of Prescription Medications Online 8.3 Drug Safety Issues and Side-Effects of Drugs 8.3.1 Hypnotics are not Without Side-Effects 8.3.2 Labelling to include Potential Risks 8.3.3 Rohypnol and Xyrem have Potential for Abuse 8.4.4 Consumer Led Campaign 8.4 Unmet needs of Pharmaceutical Treatment for Sleep Disorders 8.5 Non-product Related Drivers and Restraints 8.5.1 National Policies Recommendations 8.5.2 National Policies Advising Prescription of Particular Drugs 8.5.3 Agreed Guidelines 8.5.4 Market Status Quo 8.6 Success of Direct-to-Consumer Advertising 9 Conclusions 9.1 Insomnia Market Will Show High Growth 9.2 Other Sleep Disorders of Interest 9.3 Life-Cycle Management 9.4 New Markets More Details Organisations mentioned in the report Abbott Actelion Alliance American Insomnia Association Andx Apotex Arena Astellas Avant Aventis Bayer Boehringer Ingelheim Caraco Carlsbad Cephalon Dr. Reddy's Elan Eli Lilly Drug Enforcement Administration (DEA) European Patent Office FDA Genpharm GlaxoSmithKline Hoffman-Roche Hypnion Ipsen Johnson & Johnson King Lek Lundbeck Mallinckrodt Merck Mutual MHRA Mylan National Sleep Foundation NCSDR Neurim Neurocrine Neurogen NHLBI NICE NIH NovaDel Novartis Orphan Pfizer Pharmaceutical Researchers and Manufacturers of America (PhRMA) Questcor Ranbaxy Roche Rhone-Poulenc Rorer Roxane Royal Pharmaceutical Society of Great Britain (RPSGB) Sanofi-Aventis Schering-Plough Sepracor Shionogi Shire Skye Synthon Takeda Teva Tikvah UCB Valeant Vanda Watson Wyeth XenoPort To order this report: Sleep Disorders Market Analysis 2008-2018 http://www.reportlinker.com/p089492/Sleep-Disorders-Market-Analysis-2008-201 8.html More market research reports here! FOR FURTHER INFORMATION PLEASE CONTACT: Reportlinker.com Nicolas (718) 887-3024 Email: nbo@reportlinker.com Healthcare - Healthcare, Medical and Healthcare - Surgery and Treatments LOAD-DATE: May 12, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 PIMS Canada, Inc., doing business as CCNMatthews All Rights Reserved 241 of 998 DOCUMENTS Market Wire May 12, 2008 Monday 8:12 PM GMT Get a Deep Insight into the Sleep Disorders Market Analysis 2008-2018 LENGTH: 2222 words DATELINE: LONDON, UNITED KINGDOM; May 12, 2008 Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue. Sleep Disorders Market Analysis 2008-2018 http://www.reportlinker.com/p089492/Sleep-Disorders-Market-Analysis-2008-2018.ht ml More than 80 sleep disorders have been identified. They affect over 200 million people worldwide. The report focuses on the market for following sleep disorders: - Insomnia - Restless legs syndrome (RLS) - Narcolepsy and - Obstructive Sleep Apnoea / Hypopnea Syndrome (OSAHS) The market penetration for insomnia drugs has not reached saturation point. Opportunities remain. But with the introduction of several new products the market is set to see changes, but expansion. This expansion is based on increased general awareness physicians better comprehension of the significance of this disease and the positive role that a sleep medication prescription plays. At present time there are several prescription sleeping medications available to treat insomnia. The market-focus has been driven by the production of sleep medications with less side-effects and danger of overdose. Prescription benzodiazepines and newer non-benzodiazepine hypnotics developed in the 1990s, such as Imovane, Ambien and Sonata will continue to be the most prescribed. Benzodiazepines are widely used to treat an underlying neurological disorder which is often the underlying cause of insomnia, e.g. anxiety and depression. Visiongain predicts that market share by volume for insomnia in the US will change significantly from 2008 to 2018. Ambien IR lost its patent protection in April 2007, which opened to generic competition for Zolpidem. Ambien will remain the market leader for the short term, but what will over take it? A generic version of Ambien is expected to achieve strong market share by volume as there is a great demand for zolpidem tartrate for insomnia. The market share for insomnia treatment will gradually rise after 2012, which will be due to: - Market expansion of existing expensive medications into Europe and Japan in particular - Market penetration of new medications currently in pipeline. Other drugs dealt with in this report include: - Modafinil (Provigil) is the first in a new class of wake-promoting drugs and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. Provigil is quickly replacing Ritalin, and other CNS stimulants, as the medication of choice for treating daytime sleepiness in narcolepsy. The FDA granted modafinil (Provigil) orphan drug status in 1993. Modafinil was initially launched in the US in 1999 for the treatment of narcolepsy. In 2004, modafinil became FDA-approved prescription medicine for the treatment of excessive sleepiness associated with Obstructive Sleep Apnoea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD). - Requip (ropinirole) became the first and only FDA-approved drug treatment for moderate to severe primary Restless Legs Syndrome (RLS) in 2005. Key findings that will broaden the scope of the sleep disorders market: - Over the next decade, the development and improvement of sleep disorders therapies will primarily depend on the success of burgeoning technology and innovative approaches. - It is possible to purchase prescription medications online without producing a prescription. Purchase of online sleep medications has increased and will continue to evolve over the next years. - The impact of DTC advertising has created an improved awareness of available insomnia treatment. This is likely to increase as DTC advertising continues to prosper and the culture becomes more accepting towards insomnia treatment. Visiongain expects the market for sleep disorders to increase, driven by a growing awareness of sleep disorders and by campaigns to promote sleep medications, both by DTC advertising and consumer education. The relaxation of DTC marketing restrictions in the 1990s in the US set the stage for a flow for both branded and unbranded advertising and promotional programmes. Those regulations are prompting more responsible DTC advertising on the industry's part. - The FDA has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger warnings concerning potential risks. - The Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) approved Neurim's Circadin a prolonged-release melatonin as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or over. Neurim is actively seeking strategic alliances for the major European markets. What questions does the report answer? - Which current or future therapies will drive the sleep disorders market from 2008 to 2018? - The key companies involved in the market and their analysis? - What is the patient identification rate for each of the therapeutic areas? - What is the present state of the disease awareness? - What R&D opportunities exist for 'new comers'? Why should you buy this report? - This report focuses on the marketed medications and the pipeline development for sleep disorders from 2008 to 2018. It also discusses the strength and weakness of products, along with the opportunities and threats facing the market. - The report describes world market situation for sleep disorders, namely insomnia, narcolepsy, RLS and OSAHS, with forecasts made for all key products. It also describes the insomnia market situation in the seven major world markets for sleep medications: the US, Japan, France, Germany, Italy, Spain and the UK, with forecasts for key products. - The report provides transcripts of visiongain's interviews with experts in the field of sleep disorders, which reviews the future direction of the sleep disorders treatment market. Unique benefits to you when you order this report - You can access your report whichever country you are in without using harddrive space - Primary research throughout. You will not find this information anywhere else - Full searchable report when you buy the company or corporate editions - Copies can be printed off for offline reading - Packed with charts, analysis, figures, graphs and table Please Note: Reports are sold based on the user licenses indicated. The Publisher delivers the report in Flash format via the publisher website, allowing viewing and printing capabilities only. Within one to two business days after placing the order, the Publisher will email the client with information on accessing their purchase. Prior to initiating fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.  1 Executive Summary: Pharmaceutical Treatment of Sleep Disorders 2008-2018  1.1 Current Prospects of Sleep Disorders Market  1.1.1 Market Growth Estimate  1.1.2 Generic Pharmaceutical Market  1.1.3 Market Expansion  1.1.4 Market Demand for Short Elimination Half-Life  1.1.5 Medications Targeting M1 and M2 Receptors  1.1.6 Medications Targeting 5HT2A Receptor Receptors  1.1.7 Product Line Extension Activities  1.1.8 Effect of Direct-To-Consumer Advertising (DTCA)  1.1.9 Safety Measures for Online Consumers  1.2 Aim, Scope, and Format Of This Report  2 Introduction to Sleep Disorders and their Pharmaceutical Treatment  2.1 Introduction to Sleep Disorders  2.2 Overview of Chapter  2.3 Introduction to Insomnia  2.4 Discovery of Barbiturates  2.5 Market Entry for Non-Barbiturates  2.6 Arrival of Benzodiazepines  2.7 Non-benzodiazepines the Revolutionary Compound  2.7.1 Prescription Medicines and OTCs  2.8 Pharmacodynamics of Hypnotics  2.9 Introducing New Scope for Insomnia  2.10 Many Forms of Sleep Disturbances  2.10.1 Sleep Deprivation  2.11 Shift Workers Sleep Disorder (SWSD)  2.11.1 Melatonin  2.11.2 Valerian  2.12 Treatment for insomnia in Depression  2.13 Restless Legs Syndrome  2.13.1 Off-label Prescription for Restless Legs Syndrome  2.14 Other Medical Conditions  2.15 Narcolepsy  2.15.1 Xyrem for Cataplexy  2.15.2 Orphan Disease Status  2.15.3 Other Medications for Cataplexy  2.16 Obstructive Sleep Apnea / Hypopnea Syndrome (OSAHS)  2.17 Insomnia - A Common Disease  2.18 Patient Identification Rate  3 Analysis of Current Market for Insomnia  3.1 Market Share for World Insomnia Market  3.2 Market Dominance Continues for Ambien  3.3 Lunesta as Ambien's Contender  3.4 Sonata Continues to Form Niche Market  3.5 Imovane / Amoban Go Down in Insomnia Market  3.6 Benzodiazepines Survived as Low Priced Sleep Aid  3.6.1 Lendormin (brotizolam)  3.6.2 Halcion (triazolam)  3.6.3 Noctamid (Lormetazepam)  3.6.4 Doral (quazepam)  3.6.5 Dalmane (flurazepam)  3.6.6 Rohypnol (flunitrazepam)  3.6.7 Restoril (temazepam)  3.6.8 Eurodin or ProSom (estazolam)  3.6.9 Rhythmy (rilmazafone)  3.6.10 Rhythmy (rilmazafone)  3.6.10 Valium (diazepam)  3.7 Rozerem Market Up-and-Coming  4 Insomnia Market Analysis by World Regions  4.1 US has the Highest Market Share for Insomnia Treatments  4.2 Europe as a Significant Market for Insomnia Treatments  4.3 The Japanese Market for Insomnia is Expanding  5 Market Developments for Narcolepsy, Shift Work Sleep Disorder, and   Restless Legs Syndrome  5.1 Provigil Wins Label Extension  5.2 Adrafinil is a Isomer of Provigil  5.3 Ritalin/ Ritalin SR  5.4 Concerta is an Extension Version of Ritalin  5.5 Adderall as Stimulant  5.6 Xyrem for Cataplexy and Excessive Daytime Sleepiness  5.7 Recent FDA Activities for Restless Legs Syndrome  6 Products in Development for Sleep Disorders  6.1 FDA Approves Generic Ambien6.2 Circadin a Prolonged-Release Melatonin  6.3 GHB analogue Generally Regarded as Safe  6.4 Clinical Trial Product List for Insomnia  6.5 Indiplon for Insomnia in Pre-Registration Stage  6.6 Caraco's Prospect in Narcolepsy Market  6.7 Lundbeck Faces Setback in Insomnia Market  6.8 Phase III Trial Begins on Posidorm for Insomnia  6.9 Hope for Physiological Sleep with Almorexant  6.10 5HT2A Antagonist for Insomnia  6.11 Agonist at the Serotonin 5-HT1A Receptor  6.12 VEC-162 Future Contender for Rozerem  6.13 Zolpidem as Oral Spray  6.14 Cephalon Adds Nuvigil Alongside Provigil  6.15 Dopamine Patch for RLS  6.16 Transported Prodrug of Gabapentin  7 Recommendations for Ideal Pharmaceutical Treatment for Sleep Disorders  7.1 Firsthand Interview for Expert Opinion 1  7.1.1 Prospect for Sleep Disorders Market  7.1.2 Prospect for Generic Market  7.1.3 Product Line Extension  7.1.4 Prospect for Niche Market  7.1.5 Future of Benzodiazepines Market  7.1.6 Future of Controlled Drug Market  7.1.7 Effect of Direct-to-Consumer Market  7.1.8 Future of Non-Hypnotics Medications  7.1.9 Future Medications for Sleep Apnoea  7.1.10 Prospect for Hypnotics as OTCs  7.1.12 Unmet Needs for Sleep Disorders Market  7.2 Firsthand Interview for Expert Opinion 2  7.2.1 Drug Therapies for the Future  7.2.2 Technological Advance in Sleep Disorders Treatment  7.2.3 New Effective Sleep Medications  7.2.4 Future of Sleep Disorders Market in the Developed Nations  7.2.5 Unmet Needs for Sleep Disorders Treatment  7.2.6 Favourable Medication for the Coming Decade  7.2.7 Side-Effect Profile for Future Drug Development  7.2.8 Sleep Disorders Market in Developing Nations  8 Market Force and Limitation of Sleep Disorders Market  8.1 Table for SWOT Analysis of Sleep Disorders Market  8.2 Market Analysis of Products Unapproved for Sleep Disorders by  Regulatory Bodies and Niche Market  8.2.1 Unapproved Insomnia Medications: Benadryl,  Unisom, Tylenol PM, Nytol  8.2.3 Purchase of Prescription Medications Online  8.3 Drug Safety Issues and Side-Effects of Drugs  8.3.1 Hypnotics are not Without Side-Effects  8.3.2 Labelling to include Potential Risks  8.3.3 Rohypnol and Xyrem have Potential for Abuse  8.4.4 Consumer Led Campaign  8.4 Unmet needs of Pharmaceutical Treatment for Sleep Disorders  8.5 Non-product Related Drivers and Restraints  8.5.1 National Policies Recommendations  8.5.2 National Policies Advising Prescription of Particular Drugs  8.5.3 Agreed Guidelines  8.5.4 Market Status Quo  8.6 Success of Direct-to-Consumer Advertising  9 Conclusions  9.1 Insomnia Market Will Show High Growth  9.2 Other Sleep Disorders of Interest  9.3 Life-Cycle Management  9.4 New Markets  More Details  Organisations mentioned in the report  Abbott  Actelion  Alliance  American Insomnia Association  Andx  Apotex  Arena  Astellas  Avant  Aventis  Bayer  Boehringer Ingelheim  Caraco  Carlsbad  Cephalon  Dr. Reddy's  Elan  Eli Lilly  Drug Enforcement Administration (DEA)  European Patent Office  FDA  Genpharm  GlaxoSmithKline  Hoffman-Roche  Hypnion  Ipsen  Johnson & Johnson  King  Lek  Lundbeck  Mallinckrodt  Merck  Mutual  MHRA  Mylan  National Sleep Foundation  NCSDR  Neurim  Neurocrine  Neurogen  NHLBI  NICE  NIH  NovaDel  Novartis  Orphan  Pfizer  Pharmaceutical Researchers and Manufacturers of America (PhRMA)  Questcor  Ranbaxy  Roche  Rhone-Poulenc Rorer  Roxane  Royal Pharmaceutical Society of Great Britain (RPSGB)  Sanofi-Aventis  Schering-Plough  Sepracor  Shionogi  Shire  Skye  Synthon  Takeda  Teva  Tikvah  UCB  Valeant  Vanda  Watson  Wyeth  XenoPort To order this report: Sleep Disorders Market Analysis 2008-2018 http://www.reportlinker.com/p089492/Sleep-Disorders-Market-Analysis-2008-2018.ht ml More market research reports here!  Contacts:  Reportlinker.com  Nicolas  (718) 887-3024  Email: nbo@reportlinker.com SOURCE: Reportlinker.com LOAD-DATE: May 13, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 Market Wire, Incorporated All Rights Reserved 242 of 998 DOCUMENTS The Evening Standard (London) May 6, 2008 Tuesday Can a pill boost your brain?; They call it Viagra for the mind. Modafinil is a drug designed for narcoleptics that's now being abused by students to improve their memories - and their IQs. This is what happened when our writer took it for a fortnight ... BYLINE: JOHANN HARI SECTION: A; Pg. 22 LENGTH: 1572 words SOME time in March, in the drizzle, I realised my brain was burned out. Like a rusty engine, I could hear it chug-chug and splutter but it would never quite run at top speed. I had just come back from a month-long worktrip to Bangladesh, and I had an Everest of work in front of me. It was all fascinating and urgent but I was plodding though it at half my normal speed. I needed to be performing at my best; instead, I was at my worst. I stared at the London rain and slogged on. That's when I stumbled across a small story in an American scientific magazine. It said there was a spiky debate across America's universities about the increasing use by students of a drug called modafinil. It was, they said, Viagra for the brain. Originally designed for narcoleptics in the Seventies, clinical trials had uncovered something odd: if you give it to non-narcoleptics, they just become smarter. Their memory and concentration improve, as does their IQ. It's not an amphetamine or a stimulant, the article explained. It doesn't make you high, or wired. It seems to work by restricting the parts of your brain that make you sluggish or sleepy. No significant negative effects have been discovered. Now students are using it in the run-up to exams as a "smart drug" a steroid for the mind. It sounded perfect. A few clicks online and I found I could order it from a foreign pharmacy, for just £30 for a month's supply. I called a friend who is a GP; she'd heard of people using the drug, and went away and looked up the details. "I think it's a stupid thing to do because you shouldn't ever take drugs you don't need," she said when she called back. "Do I think it'll seriously harm you? No, I don't. But you'd be much better off taking a long holiday than narcolepsy pills." Then she warned me: "There is one known side-effect." Oh damn, I thought. A downside. "It often causes people to lose weight." Are you mad? You become cleverer and thinner? I whipped out my Visa card immediately. A week later, the little white pills arrived in the post. I sat down and took one 200mg tablet with a glass of water. It didn't seem odd: for years, I took an antidepressant. Then I pottered about the flat for an hour before sitting down on the settee. I picked up a book about quantum physics and super-string theory I had been meaning to read for ages, for a column I was thinking of writing. Five hours later, I realised I had hit the last page. I looked up. It was getting dark. I was hungry. I hadn't noticed anything, except the words I was reading, and they came in cool, clear passages; I didn't stop or stumble once. PERPLEXED, I got up, made a sandwich and was overcome with the urge to write an article that had been kicking around my subconscious for months. It rushed out of me in a few hours, and was better than usual. My mood wasn't any different; I wasn't high. My heart wasn't beating any faster. I was just able to glide into a state of deep, cool, effortless concentration. It was as if I had opened a window in my brain and all the stuffy air had seeped out, to be replaced by a calm breeze. Once that article was finished, I wanted to do more. I wrote another piece, all of it springing out of my mind effortlessly. Then I went to dinner with friends. At the end, my mate Jess turned to me and said, "You seem very thoughtful tonight." That night, I couldn't sleep. I wasn't restless but I kept thinking very clearly, and I wanted to write it all down. I remembered there's a long history of people in high-pressure jobs using stimulants when their brains lost their sponginess: Anthony Eden was taking Benzedrine all through the Suez Crisis, and Jean-Paul Sartre wrote several of his novels while pumped on mescaline. Admittedly, these precedents aren't encouraging: Eden had a breakdown, and Sartre's brain was so cooked that for the rest of his life, he had the recurring fear he was being followed by a giant lobster. Am I making a stupid mistake? The next morning I woke up and felt immediately alert. Normally it takes a coffee and an hour to kick-start my brain; today I'm ready to go from the second I rise. And so it continues like this, for five days: I inhale books and exhale articles effortlessly. My friends all say I seem more contemplative, less rushed which is odd, because I'm doing more than normal. I keep waiting for an exhausted crash, and it doesn't seem to come. When the American journalist David Plotz took modafinil, he said it should be given a slogan. Just as Valium was marketed as "the housewife's little helper", he said this should be sold as "the boss's little helper". It makes you work better and harder than before. It's hard to explain modafinil's effects beyond that. Normally, one day out of seven I have a day when I'm working at my best I've slept really well, and everything comes easily and fast. modafinil makes every day into that kind of day. It's as if I have been upgraded to a new operating system: Johann 3.0. On discussion boards, I talk to American student doctors taking the drug, who say they feel the same way. "I keep thinking where's the catch?" one says. It turns out it is being given to US soldiers, too. It was then that I noticed I wasn't very hungry. I am normally porcine; my ex once seriously considered having a trough made for me. But on modafinil, I was filled up by a bowl of soup and a piece of bread. I would feel stuffed halfway through my normal meals. A friend howled: "Who are you, and what have you done with the real Johann?" Is all this just the placebo effect: I expect it to do this to me, so it does? Perhaps. But in the clinical trials, it worked much better than the placebo. But then I began to worry again. We don't know the long-term effects of this drug. What if it causes your brain to deplete its resources and wear out? My wonderful grandmother has dementia, her life and personality dissolving in lost memories; no short-term concentration is worth that. A friend says to me, "Why do you always feel like you're not good enough, and you need some kind of chemical enhancement?" It makes me wonder. So after five days on, I decided to take three days off, to see what would happen. It was easy. I sagged back to my former somewhat-depleted state, as though the modafinil had never happened. I worked in my usual stop-start bursts. I ate my usual portions-and-a-half. I stared sadly at the pack of pills, and every time I hit a mental stumbling block, I had to discipline myself not to crack out a modafinil. As soon as my three days were up and I started again, my brain revved back into super-speed and my stomach began to shrivel. But this time I began to worry about the ethics of it all. If this drug had been available during my A-levels or finals, I would have been the first to guzzle it down. But isn't that cheating? What's the difference between modafinil for students and steroids for athletes? And if this drug becomes as popular as, say, antidepressants or Ritalin, won't there be a social pressure for workers to take it, and for parents to drug away their child's disobedience? Professor Anjan Chatterjee says: "This age of cosmetic neurology is coming, and we need to know it's coming." The use of modafinil and its progeny will be mainstream and mainlined in just a few years, he argues, and this made me feel excited and anxious. As the end of my final five days approached, I had to decide what to do. Do I order another pack? Do I think all my thoughts at a faster pace from here on in with the power of modafinil? I finally concluded that taking narcolepsy drugs when you don't have narcolepsy is just stupid. Our lack of knowledge about what it does to your brain was, in the end, a dealbreaker for me. So I have made a pact with myself. I am keeping a pack for the days when I am really knackered and have to work fast and fluently but I won't take more than two or three a month. As I put the tablets aside, I look out over my flat. My desk is piled high with the vast quantities of work I have pumped out. My cupboards are full of uneaten food. The whole place is freakishly clean. Ah, modafinil, you are a gorgeous temptress. With a sad sigh, I close the bathroom cabinet and stumble back to my slow, patchy life, with my slow, patchy brain. ¡ Johann Hari writes for The Independent.. A DOCTOR'S WARNING "MODAFINIL (trade name Provigil) is a brain stimulant drug and the accepted first-line treatment for narcolepsy, a rare condition where the chemical 'switch' that turns sleep on and off is not working properly. Narcoleptics fall asleep in the daytime but also wake frequently at night. "No one knows precisely how modafinil works, not even the company (Cephalon) that developed it. It probably keeps people awake by acting on deep-seated parts of the brain. "Side-effects from modafinil are few although there have been some reports of liver dysfunction. But buying prescription drugs over the internet with no medical control is fraught with hazards. Cognitive ability may be impaired and an untoward event could occur. A case is bound to pop up sooner or later when something awful happens because of someone staying awake too long using stimulants. " Restricted sleep is part of the 24/7 society and there is lots of research beginning to look at the effects on the immune system. But for now the message is 'you mess with these drugs at your peril'." Dr Peter Venn, director of sleep studies at Queen Victoria Hospital, West Sussex.. LOAD-DATE: May 6, 2008 LANGUAGE: ENGLISH GRAPHIC: Cleverer by half: with Progivil, Hari could read fast and absorb ideas effortlessly PUBLICATION-TYPE: Newspaper Copyright 2008 Associated Newspapers Ltd. All Rights Reserved 243 of 998 DOCUMENTS The Pharmaceutical Journal May 2, 2008 Caution in use alert / SPC changes / Prescription products BYLINE: Old_manager LENGTH: 622 words HIGHLIGHT: Prescription Products Meningitec Meningitec (meningococcal serogroup C oligosaccharide conjugate vaccine [adsorbed]; Wyeth) is now available in prefilled syringes. The 10 x 0.5ml vials are no longer available. Childhood immunisation programme supplies are available from Movianto UK on 0870 871 1891. Prescription Products Meningitec Meningitec (meningococcal serogroup C oligosaccharide conjugate vaccine [adsorbed]; Wyeth) is now available in prefilled syringes. The 10 x 0.5ml vials are no longer available. Childhood immunisation programme supplies are available from Movianto UK on 0870 871 1891. Net price: 10 x 0.5ml prefilled syringe, £75 Legal category: POM Pentasa Pentasa 2g sachets (mesalazine prolonged release granules) are now available from Ferring Pharmaceuticals. Net price: 60 x 2g sachets, £72.05 Legal category: POM SPC changes Accessing SPCs The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online Corticosteroids The summaries of product characteristics for Medrone (methylprednisolone; Pharmacia) tablets, Solu-Medrone (methylprednisolone sodium succinate; Pharmacia) injections and Solu-Cortef (hydrocortisone sodium succinate; Pharmacia) injection have been updated to include a warning about potential psychiatric side effects occurring with systemic steroids. Hepsera In lamivudine-resistant patients, Hepsera (adefovir dipivoxil; Gilead) should be used in combination with lamivudine, not as monotherapy, to reduce the risk of resistance, the summary of product characteristics for Hepsera now states. It adds: "In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ml at or beyond one year of treatment." The SPC also warns that resistance to Hepsera can result in viral load rebound, which could result in exacerbation of hepatitis B and, if hepatic function is reduced, lead to liver decompensation and mortality. Virological response should be monitored closely and if viral rebound occurs resistance testing should be performed. Renal failure, Fanconi syndrome, hypophosphatemia, proximal renal tubulopathy and associated myopathy and osteomalacia have been added to the list of undesirable effects (frequency not known) from post-marketing surveillance. Provigil Serious rash requiring admission to hospital and discontinuation of treatment has been reported with the use of Provigil (modafinil; Cephalon), occurring one to five weeks after treatment initiation, the summary of product characteristics for Provigil now states. Isolated cases of serious rash have been reported after prolonged treatment (eg, three months), the SPC adds. It also says that patients with major anxiety should only receive treatment with Provigil in a specialist unit. Psychiatric adverse experiences, including suicidal ideation, have been reported in patients treated with modafinil. In such circumstances, modafinil should be discontinued and not restarted. Caution should be exercised in administering modafinil to patients with a history of psychosis, depression or mania, the SPC says. Sandimmun Patients on Sandimmun (ciclosporin; Novartis) concentrate for infusion should be warned to avoid excess ultraviolet light exposure in view of the potential risk of skin malignancy, the product's summary of product characteristics now says. The SPC also now states that renal function should be monitored with particular care in elderly patients and that caution should be exercised when co-administering lercanidipine with ciclosporin. LOAD-DATE: November 10, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Journal Copyright 2008 PJ Online All Rights Reserved 244 of 998 DOCUMENTS Clinical Psychiatry News May 2008 Options Expanding For Bipolar Disorder BYLINE: Bruce Jancin, Denver Bureau SECTION: Pg. 10 Vol. 36 No. 5 ISSN: 0270-6644 LENGTH: 775 words    VIENNA - A growing list of innovative therapies with novel mechanisms of action in bipolar disorder is available for tough-to-treat cases, Dr. Benedikt L. Amann said at the annual congress of the European College of Neuropsychopharmacology.    All of these candidates have demonstrated promise in open-label or small, controlled, proof-of-concept studies, but they all clearly require larger confirmatory trials. In the interim, psychiatrists are likely to find some of these agents beneficial for off-label use in the many patients with bipolar disorder who respond inadequately to current guideline-directed treatments, said Dr. Amann of the University of Barcelona.    Although he discussed promising new therapies for mania, he gave greater emphasis to progress in the treatment of bipolar depressive episodes because the need is more pressing.    "We do very well with our manic patients on a symptomatic level, but we still do very badly with depressive patients," he observed. Options for Bipolar Depression    The wakefulness drug modafinil (Provigil) improved symptoms of bipolar depression in a recent randomized, placebo-controlled, 85-patient, multicenter study.    All enrollees were inadequately responsive to a mood stabilizer. By week 2, the modafinil-treated group, on a mean dosage of 177 mg/day, showed significantly greater improvement than did controls on the clinician-rated Inventory of Depressive Symptomatology. The remission rate at the end of the 6-week trial was 39% in the modafinil group, compared with 18% with placebo. There was no difference between the two groups in treatment-emergent mania or hypomania (Am. J. Psychiatry 2007;164:1242-9).    In Dr. Amann's 2-year, open-label study of 30 patients with refractory severe bipolar depression, the nutritional supplement chromium was associated with a mean 40% decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) scores (J. Clin. Psychopharmacol. 2007;27:104-6). Like the modafinil trial, the chromium study was funded by the Stanley Medical Research Institute.    In the first double-blind, placebo-controlled trial conducted of a potential treatment for acute bipolar II depression, pramipexole (Mirapex) showed significant benefit, with 60% of patients treated to a target dosage of 1-3 mg/day demonstrating a greater than 50% reduction in MADRS scores after 6 weeks, compared with 9% of those on placebo. One patient on pramipexole and two on placebo developed hypomanic symptoms (Biol. Psychiatry 2004;56:54-60).    Pramipexole, a neurotrophic dopamine agonist with selectivity for the D2 receptor subfamily, is approved by the Food and Drug Administration for the treatment of Parkinson's disease. Results of the 21-patient bipolar depression study, led by investigators at the National Institute of Mental Health, implicate the dopaminergic system in the pathophysiology of bipolar depression. Novel Mania Treatments    What do lithium and valproate share besides an antimanic effect? The two structurally dissimilar agents inhibit protein kinase C, an enzyme which regulates pre- and postsynaptic neurotransmission. So does tamoxifen, the estrogen receptor modifier used by huge numbers of women for primary or secondary prevention of breast cancer. Indeed, tamoxifen is also the only selective protein kinase C inhibitor that crosses the blood-brain barrier.    That insight prompted NIMH investigators to conduct a double-blind, placebo-controlled, 3-week pilot study in 16 bipolar patients with acute mania or a mixed state. The response rates, as assessed by the Young Mania Rating Scale, were 63% with tamoxifen at 20-140 mg/day and 13% for placebo (Bipolar Disord. 2007;9:561-70).    "Protein kinase C will probably become an important enzyme in the future in bipolar disorder," Dr. Amann predicted. "Its activation impairs cognition. ... And inhibitors of protein kinase C in the limbic system appear to be relevant to the treatment of mania."    The atypical antipsychotic zotepine, which is marketed in Europe and elsewhere but not in the United States, showed a rapid therapeutic effect in Dr. Amann's open-label pilot study of 12 patients with severe acute mania. Two patients dropped out after 2 days, but 9 of the remaining 10 were classified as responders, with 5 patients experiencing at least a 50% reduction in the Young Mania Rating Scale score within 4 days (Bipolar Disord. 2005;7:471-6).    With regard to mood stabilizers, he asserted that, despite intensive studies of anticonvulsants and atypical antipsychotics in the last decade, nothing has been shown to be more effective than lithium.    "The real mood stabilizer is waiting to be found," he observed. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: CPNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 245 of 998 DOCUMENTS Family Practice News May 1, 2008 Modafinil Improves ADHD Symptoms in Different Subtypes BYLINE: Heidi Splete, Senior Writer SECTION: Pg. 29 Vol. 38 No. 9 ISSN: 0300-7073 LENGTH: 568 words    Modafinil significantly improved symptoms in children with inattentive and combined subtypes of attention-deficit/hyperactivity disorder, based on data from 638 children aged 6-17 years.    Pooled results from one 7-week study and two 9-week studies showed that modafinil was well tolerated and improved attention-deficit hyperactivity disorder (ADHD) symptoms both at home and in school. The studies were funded by Cephalon Inc., which markets modafinil as Provigil in the United States.    Dr. Joseph Biederman of Massachusetts General Hospital, Boston, and Dr. Steven R. Pliszka of the University of Texas Health Science Center, San Antonio, reviewed the pooled data to analyze the effectiveness of modafinil on three ADHD subtypes: inattentive, combined, and hyperactive impulsive (J. Pediatr. 2008;152:394-9). Few studies have examined the effectiveness of drug treatments for ADHD by subtype.    In the 7-week study, children were randomized to receive 340 mg or 425 mg of modafinil or a placebo daily. In the 9-week studies, children were randomized to receive a flexible dose from 170 mg to 425 mg or a placebo daily. A total of 423 children received modafinil and 215 received a placebo.    The researchers used the ADHD-RS-IV School Version, which includes teacher and investigator ratings to assess symptoms.    Children in the inattentive and combined subgroups who received modafinil showed significant improvements in the ADHD-RS-IV School Version total scores, compared with placebo patients. Children in the hyperactive-impulsive subgroup who received modafinil showed a greater improvement in total scores (demonstrated by lower numbers) than placebo patients, but this difference was not statistically significant.    The average score for modafinil patients across all subgroups was 57 at the study's end versus 73 for placebo patients. Results were similar for scores on the ADHD-RS-IV Home Version, which were detailed in a separate analysis.    Forty-eight percent of the inattentive subgroup who received modafinil versus 15% of those who were given a placebo received "much improved" or "very much improved" ratings from investigators. Similarly, 44% of the combined subgroup who received modafinil versus 18% of those who received placebo were rated "much improved" or "very much improved" by the investigators.    Children in the inattentive and combined subtype groups who received modafinil showed significant improvements in subscale scores for cognitive problems/inattention, hyperactivity, and the ADHD index, compared with placebo patients.    The combined subtype of ADHD is the most commonly diagnosed and is most often associated with psychiatric comorbidity and other behavioral, social, and academic problems, the researchers noted. A total of 65% of the children met criteria for the combined ADHD subtype, and this group had the largest percentage (18%) of children who were ranked "severely ill" or "extremely ill" at baseline.    Dr. Biederman receives research support from multiple drug companies, including this study's sponsor, Cephalon (for whom he also serves as a speaker and a member of the advisory board). He also serves as a speaker and advisory board member for many other pharmaceutical companies.    Dr. Pliszka receives research support from Cephalon and Eli Lilly & Co., and serves on speakers bureaus sponsored by Shire Pharmaceuticals and McNeil. LOAD-DATE: July 31, 2009 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: FPNEWS Copyright 2008 Elsevier Inc., International Medical News Group All Rights Reserved 246 of 998 DOCUMENTS US Fed News April 14, 2008 Monday 2:41 AM EST Missouri Inventor Develops Benzhydrylthioacetamide Preparation Process BYLINE: US Fed News LENGTH: 234 words DATELINE: Alexandria, Va. ALEXANDRIA, Va., April 14 -- Sidney Liang of Olivette, Mo., has developed a benzhydrylthioacetamide preparation process. According to the U.S. Patent & Trademark Office: "The present invention is directed to an improved process for preparing modafinil wherein benzhydrylthioacetate is prepared in high yield and purity by the reaction of a haloacetate with the reaction product of thiourea and benzhydrol." An abstract of the invention, released by the Patent Office, said: "The reaction employing the haloacetate is conducted in a solvent comprising an organic solvent such as methanol having dissolved therein an organic base or an inorganic basic salt such as sodium bicarbonate. The resulting benzhydrylthioacetate can be amidated and then oxidized to provide the pharmaceutical grade modafinil in high yield and purity." The inventor was issued U.S. Patent No. 7,345,188 on March 18. The patent has been assigned to Mallinckrodt Inc., Hazelwood, Mo. The original application was filed on Oct. 22, 2004, and is available at: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=% 2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,345,188.PN.&OS=PN/7,345,188&RS= PN/7,345,188. For more information about US Fed News federal patent awards please contact: Myron Struck, Managing Editor/US Bureau, US Fed News, Direct: 703/866-4708, Cell: 703/304-1897, Myron@targetednews.com LOAD-DATE: April 14, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 HT Media Ltd. All Rights Reserved 247 of 998 DOCUMENTS Irish Independent April 9, 2008 Wednesday Just like Viagra for your brain... SECTION: FEATURES LENGTH: 987 words Professionals use them for jet lag, students to pass exams, soldiers to stay alert. Brain-enhancing drugs are the latest fix -- and they're legal. By Simon Usborne Do you face a mid-afternoon lull that even a double espresso cannot break? Is jetlag the bane of your life, or does that pile of revision seem insurmountable? Or perhaps you're just fed up yawning your way out of the pub at 9.30pm. Whether modern life leaves you struggling to keep up or just totally exhausted, the answer could be as simple as popping a pill. Using drugs to improve performance in sport is nothing new -- expect doping to be a hot topic at this summer's Beijing Olympics -- but what about pills that do nothing to enhance biceps, glutes or abs, and instead target the body's most powerful 'muscle' -- the brain? The idea that pills could boost memory or allow weary workers to put in 24-hour shifts evokes the dystopia of Aldous Huxley's 1932 science-fiction novel Brave New World, in which humanity depends on a government-prescribed "happy" drug called Soma. Some scientists are warning that a generation of artificially enhanced thinkers could soon become science-fact, as an increasing number of people, from stockbrokers and soldiers to students and shelf-stackers, look for something moreeffective than caffeine to boost performance. The medicines they use are called cognitive- or brain-enhancing drugs. But you won't find a dedicated shelf in your local pharmacy. Instead, healthy people are popping prescription pills designed to treat conditions such as attention deficit hyperactivitydisorder (ADHD), narcolepsy or even Alzheimer's. The drugs of choice are Ritalin and Modafinil. Prescribed to ADHD sufferers to help calm them down, Ritalin, dubbed 'kiddie coke' by some, can boost concentration and alertness in healthy people. Modafinil, meanwhile, is designed to combat narcolepsy, but it can also stave off tiredness in those without a diagnosed sleep disorder. A 2005 survey of more than 10,000 US university students found that 4pc-7pc of them had tried ADHD drugs at least once to pull pre-exam all-nighters. At some institutions, more than one in four students said they'd sampled the pills. Anecdotal evidence suggests as many as three in four classical musicians in the US take beta blockers such as Inderal, which block adrenaline receptors in the brain, helping to control conditions such as high blood pressureor stage fright in jitterymusicians. Philip Harvey, a professor at Emory University in Atlanta, says his work has been transformed by Modafinil, which he takes to combat jet lag. Unlike here, American doctors can prescribe the drug to night-shift workers as well as to narcoleptics. "I often fly to Europe to give talks," Harvey says. "I used to travel the day before to give myself time to recover, but with Modafinil I can now give a talk the same day I arrive and feel like I've had a normal night's sleep." Harvey says he has no urge to take the drug more frequently, but many do. And it's easy to understand why. In 2003, scientists at Cambridge University found a single dose of Modafinil helped healthy male university students perform better at mental planning tests, complete puzzles more accurately and remember longer chains of digits. The drug has also been tested by British and American armed forces, where it has been shown to help soldiers stay alert during night-time operations. Scientists say that the drug allows 48 hours of continuous wakefulness with few side effects, mild headaches being the most common. Perhaps the most remarkable thing about Modafinil is that users don't have to pay back sleep 'debt' -- a standard eight hours is apparently enough to make up for no sleep the night before. Such impressive results have led some scientists to predict a world with little or no need for sleep, where drugs will allow us to put in 22-hour days. Little wonder, then, that the drugs companies are reportedly racing to develop the world's first marketed brain-enhancing drugs. If, or when, they do, they could make the launch of the impotence drug Viagra look like a damp squib. "It could change society as we know it," says Barbara Sahakian, a psychiatrist at Cambridge University, who has studied cognitive-enhancing drugs. "The drive for the self-enhancement of brain power is likely to be as strong, if not stronger, as in the realms of enhancement of beauty or sexual function." But that is not necessarily a good thing, Sahakian warns. "One concern I have is the lack of regulation when people buy these drugs on the internet, where they can't be absolutely certain what they are getting, or whether they should be taking them. More seriously, we have to ask how this might affect society. We control drug-use in sport, so will we do the same for students who take drugs before exams, forexample? "And if some students or workers take them, will theothers feel pressure to do the same to keep up? "We also have to ask what this says about us -- why is it that we are always looking for the quickest way around the problem? And why do we so often look to the answer in drugs rather than trying psychological therapies -- or just making more time to sleep?" Whether or not these questions can be answered, brain enhancers look set to challenge caffeine as the pick-me-up of choice in the world's offices, classrooms and war zones. Last year Foresight, a British government think-tank, said drugs such as Modafinil could be "as common as coffee" within a decade or two. That will delight hard-working professionals such as Philip Harvey, who want to improve their work-life balance.But Barbara Sahakian's parting words are cautionary: "One person might say cognitive enhancing drugs are good because they allow us to get home early because we finish our work sooner, but others worry that we are working towards a 24-hours-a-day society pushed to the limits of human endurance." LOAD-DATE: April 9, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2008 Independent News and Media Ltd. All Rights Reserved 248 of 998 DOCUMENTS Reuters Health Medical News April 9, 2008 Wednesday 9:00 PM EST Use of cognition-enhancing drugs common among academics SECTION: HUMAN INTEREST LENGTH: 503 words DATELINE: NEW YORK An informal survey of individuals who read the journal Nature reveals that roughly one in five use prescription agents to improve their focus, concentration, or memory. As reported in the April 10th issue of the journal, 1400 people from 60 countries responded to the online survey. The subjects were asked specifically about the use of three drugs: 1.) methylphenidate (Ritalin), which is used to treat ADHD, but is considered on college campuses as a "study aid"; 2.) modafinil (Provigil), which is prescribed for sleep disorders, but is used off-label to fight general fatigue or jet lag; 3.) beta blockers, anti-arrhythmic agents that are also known for their anti-anxiety effect. Brendan Maher, a feature and commentary editor with Nature, analyzed the results and found that among those "who choose to use," methylphenidate was the most popular agent: 62% of users reported taking it. Modafinil was taken by 44% of users and beta blockers by 15%. Thus, many of the subjects were using more than one agent. When asked about use of other agents, many of the subjects reported taking Adderall, an amphetamine similar to methylphenidate. Other drugs used included centrophenoxine, piractem, Dexedrine, and alternative medicines, including ginkgo and omega-3 fatty acids. Use of cognition-enhancing drugs did not vary by age group, the report indicates. Maher said this may be surprising to some people since prior research has suggested increased usage in 18- to 25-years-olds. Improving concentration was the main reason cited for using these drugs with enhancing focus on a specific task being a close second. Usage patterns were evenly split between daily, weekly, monthly, or no more than once a year. Unpleasant side effects, including headache and jitteriness, among others, were reported by roughly half of users. The emergence of side effects did not correlate with decreased frequency of use, however. Four-fifths of respondents believed that healthy adults should be permitted to take cognition-enhancing agents if they want to and 69% said they would risk mild adverse effects to take the drugs themselves. Eighty-six percent of respondents said that children under 16 years should be restricted from using these drugs, yet one-third of respondents said they would feel pressured to give their child these agents if other children were taking them. In a related commentary, Dr. Barbara Sahakian and Dr. Sharon Morein-Zamir, UK researchers whose 2007 study of cognition-enhancing drug use prompted the current survey, caution that "although the appeal of pharmaceutical cognitive enhancers...is understandable, potential users, both healthy and diseased, must consider the pros and cons of their choices." Drs. Sahakian and Morein-Zamir, neuroscientists with the University of Cambridge, add that "scientists, doctors, and policy-makers should provide easy access to information about the advantages and dangers of using cognitive-enhancing drugs and set out clear guidelines for their future use." LOAD-DATE: April 10, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newswire Copyright 2008 Reuters Health All Rights Reserved 249 of 998 DOCUMENTS Independent Extra April 8, 2008 Tuesday First Edition Like Viagra for your brain; Professionals use them for jet lag, students to pass exams, soldiers to stay alert. Brain-enhancing drugs are the latest fix - and they're legal. By Simon Usborne BYLINE: Simon Usborne SECTION: EXTRA; Pg. 12 LENGTH: 1014 words Do you face a mid-afternoon lull that even a double espresso cannot break? Is jet lag the bane of your life, or does that pile of revision seem insurmountable? Or perhaps you're just fed up yawning your way out of the pub at 9.30pm. Whether modern life leaves you struggling to keep up or just totally exhausted, the answer could be as simple as popping a pill. Using drugs to improve performance in sport is nothing new - expect doping to be a hot topic at this summer's Beijing Olympics - but what about pills that do nothing to enhance biceps, glutes, or abs, and instead target the body's most powerful "muscle" - the brain? The idea that pills could boost memory or allow weary workers to put in 24-hour shifts evokes the dystopia of Aldous Huxley's 1932 science-fiction novel Brave New World, in which humanity depends on a government-prescribed "happy" drug called Soma. Some scientists are warning that a generation of artificially enhanced thinkers could soon become science-fact, as an increasing number of people, from stockbrokers and soldiers to students and shelf-stackers, look for something more effective than caffeine to boost performance. The medicines they use are called cognitive- or brain-enhancing drugs. But you won't find a dedicated shelf in your local chemist's. Instead, healthy people are popping prescription pills designed to treat conditions such as attention deficit hyperactivity disorder (ADHD), narcolepsy or even Alzheimer's. The drugs of choice are Ritalin and Modafinil. Prescribed to ADHD sufferers to help calm them down, Ritalin, dubbed "kiddie coke" by some, can boost concentration and alertness in healthy people. Modafinil, meanwhile, is designed to combat narcolepsy, but it can also stave off tiredness in those without a diagnosed sleep disorder. The British Medical Association believes this kind of drug abuse is growing rapidly, as healthy pill-poppers dupe doctors into writing prescriptions, or buy medicines from unlicensed online pharmacies, usually based abroad. The true scale of the problem in the UK is unknown but studies in America suggest brain-boosting drug use is rife. A 2005 survey of more than 10,000 US university students found that 4-7 per cent of them had tried ADHD drugs at least once to pull pre-exam all-nighters. At some institutions, more than one in four students said they'd sampled the pills. Anecdotal evidence suggests as many as three in four classical musicians in the US take beta blockers such as Inderal, which block adrenalin receptors in the brain, helping to control conditions such as high blood pressure, or stage fright in jittery musicians. Philip Harvey, a professor at Emory University in Atlanta, says his work has been transformed by Modafinil, which he takes to combat jet lag. Unlike in the UK, American doctors can prescribe the drug to night-shift workers as well as to narcoleptics. "I often fly to Europe to give talks," Harvey says. "I used to travel the day before to give myself time to recover, but with Modafinil I can now give a talk the same day I arrive and feel like I've had a normal night's sleep." Harvey says he has no urge to take the drug more frequently, but many do. And it's not difficult to understand why. In 2003, scientists at Cambridge University found a single dose of Modafinil helped healthy male university students perform better at mental planning tests, complete puzzles more accurately and remember longer chains of digits. The drug has also been tested by British and American armed forces, where it has been shown to help soldiers stay alert during night-time operations. Scientists say that the drug allows 48 hours of continuous wakefulness with few side effects, mild headaches being the most common. Perhaps the most remarkable thing about Modafinil is that users don't have to pay back sleep "debt"; a standard eight hours is apparently enough to make up for no sleep the night before. Such impressive results have led some scientists to predict a world with little or no need for sleep, where drugs will allow us to put in 22-hour days. Little wonder, then, that the drugs companies are reportedly racing to develop the world's first marketed brain- enhancing drugs. If, or when, they do, they could make the launch of the impotence drug Viagra look like a damp squib. "It could change society as we know it," says Barbara Sahakian, a psychiatrist at Cambridge University, who has studied cognitive-enhancing drugs. "The drive for the self-enhancement of brain power is likely to be as strong if not stronger as in the realms of enhancement of beauty or sexual function." But that is not necessarily a good thing, Sahakian warns. "One concern I have is the lack of regulation when people buy these drugs on the internet, where they can't be absolutely certain what they are getting, or whether they should be taking them. More seriously, we have to ask how this might affect society. We control drug use in sport, so will we do the same for students who take drugs before exams, for example? And if some students or workers take them, will the others feel pressure to do the same to keep up? "We also have to ask what this says about us - why is it that we are always looking for the quickest way around the problem? And why do we so often look to the answer in drugs rather than trying psychological therapies - or just making more time to sleep?" Whether or not these questions can be answered, brain enhancers look set to challenge caffeine as the pick-me-up of choice in the world's offices, classrooms and war zones. Last year, Foresight, a Government think tank, said drugs such as Modafinil could be "as common as coffee" within a decade or two. That will delight hard-working professionals like Philip Harvey, who want to improve their work-life balance. But Barbara Sahakian's parting words are cautionary: "One person might say cognitive enhancing drugs are good because they allow us to get home early because we finish our work sooner, but others worry that we are working towards a 24-hours-a-day society pushed to the limits of human endurance." LOAD-DATE: April 8, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper JOURNAL-CODE: IE Copyright 2008 Independent Print Ltd All Rights Reserved 250 of 998 DOCUMENTS Drug Formulary Review April 1, 2008 Drug Criteria & Outcomes: An Awakening to Narcolepsy LENGTH: 871 words Drug Criteria & Outcomes An Awakening to Narcolepsy By Lori Lawson, PharmD Candidate, Harrison School of Pharmacy, Auburn University Narcolepsy is a chronic neurological disorder, mistakenly thought to occur only rarely. However, approximately 5% of patients seen at the American Academy of Sleep Medicine in the United States have this disease and it is estimated that as many as one in 2,000 Americans have narcolepsy.1,2 Narcolepsy is characterized by uncontrollable sleepiness and intermittent manifestations of REM sleep at periods when a person should normally be awake. Most patients also experience cataplexy, which is partial or generalized loss of skeletal muscle tone and power in response to emotion, especially amusement, anger, and elation. Other common symptoms include: sleep paralysis, hypnagogic hallucinations (vivid, dream-like experiences at the start of sleep), disturbed nocturnal sleep, and automatic behavior.3 This disease has many clinical facets. Sleep attacks can occur at any time and can be very disabling. Patients may involuntarily fall asleep while driving, eating, working, or talking. Hence, this is a dangerous disease that could lead to accidents and loss of employment. Researchers have identified a potential biochemical basis of narcolepsy. In humans, hypocretin, a neurotransmitter, is reduced or undetectable in many but not all patients with narcolepsy associated with cataplexy. Research data on hypocretin continue to be accumulate and in the future hypocretin therapy may be an option. Treatment options Treatment can make a significant difference in these patients' lives. The excessive daytime sleepiness is most commonly treated with stimulants. In 1999, the FDA approved modafinil (Provigil®), a novel stimulant with an unclear mechanism of action that may increase hypocretin activity. Apart from modafinil, all stimulants are centrally acting sympathomimetic agents that increase the release of monoamines in the synaptic cleft and block their reuptake.4 Modafinil is now considered first-line treatment for narcolepsy.2 Modafinil is not a psychostimulant and it does not cause psychomotor agitation, disruption of night-time sleep, inappropriate mood shifts, or the potential for addiction. In June 2007, the FDA approved the active isomer of modafinil, armodafinil (Nuvigil ®), also indicated for narcolepsy. Armodafinil has very similar pharmacokinetics, dosing, and adverse effects as compared to modafinil, and at this time, armodafinil appears to have no clinical advantages over modafinil.5,6 Other stimulants used to treat excessive daytime sleepiness include amphetamine, methamphetamine, dextroamphetmaine, and methylphenidate.1 These drugs can cause insomnia, hypertension, palpitations, and irritability. However, many patients tolerate these drugs without significant side effects. Tolerance to these medications may also occur, necessitating an increase in dose to achieve the same control of symptoms.2 The goal of stimulant therapy is to treat to near normal alertness with minimal adverse effects. Dosages should be started out low and increased as needed and as tolerated. Many physicians are weary of increasing the dose for fear of inducing tolerance or dependence. While tolerance does occur in some patients, abuse is rare in patients who do not have a history.4 Selegiline, a monoamine oxidase inhibitor, is an effective treatment for all narcoleptic symptoms. However, experience with the high doses needed for narcolepsy is limited and diet-induced hypertension is a danger at effective doses.1 Unfortunately, stimulants do not treat cataplexy effectively. Common drug therapies include tricyclic antidepressants such as protriptyline, imipramine, and clomipramine, and selective serotonin reuptake inhibitors such as fluoxetine and paroxetine. Sodium oxybate or gammahydroxybutyrate (GHB) was granted FDA approval in 2002 for the treatment of cataplexy and daytime sleepiness in patients with narcolepsy. It is an old sedative drug with considerable abuse potential, and is available only from one national specialty pharmacy on a named-patient basis. Sodium oxybate is a neurotransmitter found in the brain, and research demonstrates that nightly administration of sodium oxybate helps produce sleep patterns more closely resembling normal sleep patterns.2 Nonpharmacological therapies include maintaining regular sleep and wake times, avoiding shift work, and working in a stimulating environment. It is often said that naps throughout the day are helpful, but objective data are contradictory.1 References · Littner M, Johnson S, McCall V, et al. Practice parameters for the treatment of narcolepsy: An update for 2000. Sleep 2001;24:451-466. · Feldman N. Narcolepsy. South Med J 2003;96:277-282. · Zeman A, Britton T, Douglas N, et al. Narcolepsy and excessive daytime sleepiness. BMJ 2004;329:724-728. · Krahn L, Black J, Silber H. Narcolepsy: New understanding of irresistible sleep. Mayo Clin Proc 2001;76:185-194. · Lexi-Drugs. Hudson, OH: Lexi-Comp, Inc.; 2007. · Harsh J, Hyaduk R, Wesnes K, et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin 2006;22:761-774. LOAD-DATE: May 28, 2010 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2008 AHC Media LLC All Rights Reserved 251 of 998 DOCUMENTS io9 March 25, 2008 Tuesday 5:28 PM EST Provigil is the Cocaine of the Twenty-First Century [Pharmaceuticals] LENGTH: 367 words Mar. 25, 2008 (io9 delivered by Newstex) -- Provigil (AKA modafinil) has been called a wonder drug: it can keep you awake and alert for hours without side-effects, and it's even recommended as "the professor's little helper" by neuroscience researchers writing in the prestigious journal Nature. Provigil, approved by the US food and drug administration for the treatment of narcolepsy, is often prescribed "off label" for ailments like severe jet lag, ADHD, and even problems with sleep cycles. But this drug, which is supposed to be a non-addictive stimulant because it doesn't get you high, turns out to be potentially as euphoria-inducing and addictive as cocaine. In March 2006, researcher Stefan Kruszewski wrote in The American Journal of Psychiatry: Modanifil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. And back in 2002, an article published in Behavioral Pharmacology states: Modafinil and cocaine dose-dependently increased heart rate and blood pressure. The results of the present study suggest that modafinil has minimal abuse potential, but should be viewed cautiously because of the relatively small sample size. Future studies should further characterize the abuse potential of modafinil using other behavioral arrangements, such as drug discrimination or drug self-administration. A full characterization of the abuse potential of modafinil will become important as the use of this drug increases. Other reports suggest that Provigil isn't addictive at all, and would in fact work well as a cure for methamphetamine addiction. Here's a snippet from a 2006 article from Current Psychiatry Reports: In early trials, several candidate medications--bupropion, modafinil, and, to a lesser extent, baclofen--have shown promise in treating aspects of methamphetamine dependence, including aiding memory function necessary to more effectively participate in and benefit from behavioral therapies. With more and more people getting prescriptions for Provigil, and the drug fast catching up with Viagra for most spammy ads online, shouldn't someone be investigating just how addictive it is? Newstex ID: GAWK-0015-24015631 LOAD-DATE: March 25, 2008 LANGUAGE: ENGLISH NOTES: The views expressed on blogs distributed by Newstex and its re-distributors ("Blogs via Newstex") are solely the author's and not necessarily the views of Newstex or its re-distributors. Posts from such authors are provided "AS IS", with no warranties, and confer no rights. The material and information provided in Blogs via Newstex are for general information only and should not, in any respect, be relied on as professional advice. No content on such Blogs via Newstex is "read and approved" before it is posted. Accordingly, neither Newstex nor its re-distributors make any claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained therein or linked to from such blogs, nor take responsibility for any aspect of such blog content. All content on Blogs via Newstex shall be construed as author-based content and commentary. Accordingly, no warranties or other guarantees will be offered as to the quality of the opinions, commentary or anything else offered on such Blogs via Newstex. Reader's comments reflect their individual opinion and their publication within Blogs via Newstex shall not infer or connote an endorsement by Newstex or its re-distributors of such reader's comments or views. Newstex and its re-distributors expressly reserve the right to delete posts and comments at its and their sole discretion. PUBLICATION-TYPE: Web Blog Copyright 2008 Newstex LLC All Rights Reserved Newstex Web Blogs Copyright 2008 io9 252 of 998 DOCUMENTS World Generic Markets Pharmaceuticals February 22, 2008 FTC files complaint against Cephalon charging unlawful blockage of generic modafinil LENGTH: 327 words The FTC has filed a complaint against Cephalon in the US District Court for the District of Columbia, alleging that the company has undertaken a course of anticompetitive conduct to prevent competition against its proprietary drug, Provigil (modafinil), thus denying patients access to generic equivalents. The complaint challenges the validity of certain agreements entered into by the company in late 2005 and early 2006 to settle modafinil patent infringement litigation; it seeks to permanently enjoin the company from maintaining or enforcing these agreements. According to the complaint, Cephalon entered into agreements with four generic drug manufacturers that each planned to sell a generic version of Provigil: Teva Pharmaceutical Industries, Ranbaxy Laboratories, Mylan Pharmaceuticals and Barr Laboratories. These companies had challenged the only remaining patent covering modafinil, which related to the size of particles used in the product. The complaint charges that Cephalon was able to induce each of the generic companies to abandon its patent challenge and agree to refrain from selling a generic version of the drug until 2012, by agreeing to pay the companies a total amount in excess of $200US million. The FTC is seeking a permanent injunction against Cephalon that would allow generic modafinil entry before 2012. Furthermore, it is seeking a final court judgement against the company, declaring that its course of conduct, including its agreements, violates Section 5(a) of the FTC Act and barring Cephalon from engaging in similar or related conduct in the future. In response, Cephalon has stated that it stands by the strength and validity of its modafinil patents and the legal basis for the settlements; the company clarified that it is prepared to vigorously defend itself in this matter. Modafinil is approved to treat excessive sleepiness in patients with sleep apnoea, narcolepsy and shift-work sleep disorder. 13th February 2008 LOAD-DATE: February 22, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newsletter Copyright 2008 ESPICOM Business Intelligence Ltd. All Rights Reserved 253 of 998 DOCUMENTS The Sun (England) February 21, 2008 Thursday Would you trust a pill to make you smart? BYLINE: Pat Hagan SECTION: SUN HEALTH LENGTH: 1121 words DRUGS WITH DESIGNS ON YOUR MIND FORGET morning caffeine boosts. In future, we could all be popping brain-boosting "smart" pills to give us the edge in school and at work. In fact, thousands of people are already using powerful prescription medicines to sharpen their minds. But experts are warning too little is known about the long-term effects of the new generation of smart pills. Oxford University students swotting through the night for exams confess to downing Ritalin, the drug used to treat hyperactivity in kids. They say it boosts concentration and attention span. Some education experts say they know parents who buy the drug on the internet and feed it to their kids to try to beef up exam results. Meanwhile, pilots, soldiers and shift workers are turning to a pill called modafinil (Provigil) to stay awake. The drug was originally developed to treat narcolepsy, a condition where people suddenly fall asleep dozens of times a day. Tests show that, as well as keeping the brain awake for up to 40 hours at a time, it can actually BOOST short-term memory and the ability to plan properly. Battle Even jet-lagged scientists attending conferences are reported to use the drug to pep up their presentations. Psychiatrist Professor Philip Harvey takes modafinil to ward off jet lag. He says: "It makes me feel alert, like I had more sleep." The medic, from Emory University in Atlanta, Georgia, claims the drug doesn't create a high like other stimulants but does focus the mind. The Ministry of Defence is said to have given it to soldiers exhausted by battle. Other drugs that perk up brain cells include amphetamines and ampakines, a new class of medicines that bolster memory. However, thousands of users are thought to be buying them on the internet without getting clearance from their GPs. The British Medical Association believes a growing number of healthy people are using brain-boosting drugs that should only be taken on prescription, buying stimulants like Ritalin for as little as 67p a pill. Apart from potential long-term side-effects, this raises the risk of dangerous interactions with other medicines. A report last year by Government think-tank Foresight said brain boosters like modafinil could be "as common as coffee" within 20 years. The Government has asked the Academy of Medical Sciences to investigate the use of so-called "intelligence drugs". Professor Barbara Sahakian, from Cambridge University, says if studies prove drugs like modafinil are safe, adults could one day buy them over the counter to help them cope with long hours. That would be safer than buying them from unknown suppliers on the internet. Party She says: "I know scientists who buy modafinil on the internet and take it a few hours before a presentation. But some then start to use it when they are busy. One even took it to stay up late for a party. It may be that one day you could go into Boots and buy these pills. "As we get more effective drugs, people will definitely want to use them. But it may be that you have to be over 16 to get them because we have to be careful about the long-term effects on the developing brain." In the US, research at the University of Michigan shows just over eight per cent of undergraduates have used prescription stimulants. And the National Institute On Drug Abuse found one in twenty 17 and 18-year olds had used amphetamines. But how exactly do "smart pills" increase brain power and what are the risks in taking them? Sun Health investigates, and looks at other mind-boosting solutions. HOW TO BOOST YOUR BRAIN SMART DRUGS Amphetamines: Used for: Little medical use these days, apart from Dexedrine, a drug given to help people with narcolepsy. Affect on brain: Stimulates the brain through increased heart rate, promoting alertness. An estimated 72million amphetamine tablets were issued to British Forces during the Second World War. Side-effects: Long-term use can lead to delusions, panic attacks and paranoia. Ritalin: Used for: Hyper- activity in children. Affect on brain: Increases activity of chemicals in parts of the brain that control attention and behaviour. Studies also show just one pill boosts mental performance in healthy, young male students. Side-effects: Although generally safe, some people can suffer severe liver problems. Cost: About 67p a pill on the internet. Modafinil: Used for: Narcolepsy, the sudden onset of sleep. Affect on brain: Keeps the brain awake for up to 40 hours at a time with high levels of concentration. Side-effects: Very few but can cause dizziness and blurred vision. Cost: About £ 1.43 per pill on the internet. Ampakines: Used for: Experimental drugs that could treat Alzheimer's and jet lag. Affect on brain: They boost the activity of glutamate, a chemical that helps the brain store and retrieve memories. Even a small dose can protect the brain against sleep loss. Side-effects: Not yet known Cost: Not yet available. NATURAL BRAIN BOOSTERS Smart pills may be one way to give your brain cells a lift. But there are other reliable methods that don't rely on a chemical cocktail found in a pill. Fish oils: Oils rich in Omega-3 are thought to aid learning and concentration by keeping nerve connections in the brain healthy. A major trial involving 1,000 young offenders is about to launch in the UK to see if fish oil capsules and other supplements will improve behaviour by bolstering brain activity. Caffeine: Strong coffee and caffeine-rich drinks like Red Bull can give the brain a short-term boost. Israeli scientists found caffeine makes existing brain cells swell and new ones grow. It may also protect the female brain against dementia. French researchers found that women over 65 who drank more than three coffees a day suffered less memory loss. Vitamins: Certain vitamins may be crucial in keeping the brain healthy. Scientists at Johns Hopkins University in the US found taking vitamins C and E together seemed to have the most powerful effect, protecting brain cells against damage by highly destructive molecules called free radicals. Folic acid: A daily dose of folic acid boosts the ageing brain, according to a study last year in The Lancet. Men and women aged 50 to 70 who took daily supplements had similar mental abilities to people five years younger. COMPUTER GAMES Kids who play on computer games before lessons do better in exams. Scottish pupils as young as nine who spent 20 minutes each day on the Nintendo Dr Kawashima Brain Training games made dramatic improvements in maths tests. EXERCISE Children who exercise regularly get better exam results. Exeter University researchers found that 79 per cent of 11-year-olds with better than average English results exercised at least three times a week. Among below average pupils, only 38 per cent exercised. LOAD-DATE: February 21, 2008 LANGUAGE: ENGLISH PUBLICATION-TYPE: Newspaper Copyright 2008 NEWS GROUP NEWSPAPERS LTD All Rights Reserved 254 of 998 DOCUMENTS Generic Line February 20, 2008 Wednesday FTC Accuses Cephalon of Buying Off Generic Competition SECTION: Vol. 25 No. 4 LENGTH: 1225 words Cephalon's "anticompetitive conduct" aimed at protecting sales of its top-selling product, which involved paying four firms to refrain from selling generic Provigil until 2012, extended the company's monopoly on the drug beyond the scope of its patent protection and cost patients and payers millions of dollars a year, the FTC alleged in a complaint against the company. But the FTC hasn't filed suit against any of the generic companies involved in the agreements -- Teva Pharmaceuticals, Ranbaxy Pharmaceuticals, Mylan and Barr Laboratories -- because the allegations focus more on the monopolistic actions of Cephalon, rather than the nature of the deals, an FTC staffer told Generic Line. However, FTC Commissioner Jon Leibowitz issued a statement dissenting in part with the 5-0 vote approving the Feb. 13 complaint, saying he would have initiated action against the generic firms as well unless they chose to relinquish their 180-day exclusivity on generic Provigil (modafinil), allowing other companies to receive final approval and launch before 2012. Provigil, originally approved in 1998, is indicated for improving wakefulness in adults who experience excessive sleepiness due to obstructive sleep apnea, shift work sleep disorder or narcolepsy. The drug is unique among wakefulness treatments and is considered the gold standard for treating excessive sleepiness, according to the FTC's complaint, filed in the U.S. District Court for the District of Columbia. Cephalon's recent earnings announcement showed that Provigil had U.S. sales of more than $800 million in 2007. Because Cephalon's compound patent for modafinil expired in 2001, Provigil is only protected by the '516 formulation patent relating to particle size that generic companies could easily design around, the FTC said. In 2002, Teva, Ranbaxy, Mylan and Barr simultaneously submitted abbreviated new drug applications (ANDAs) for generic Provigil with Paragraph IV certifications that the '516 patent was invalid or that their products would not infringe on the patent, which expires in 2015. As first filers, the four companies would share 180-day exclusivity for generic Provigil, and under the Hatch-Waxman Act, the FDA would not be able to approve any other generic versions of the drug until the exclusivity ended. Cephalon filed separate patent infringement suits against the generic drugmakers in 2003, triggering a 30-month s