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Sunovion
Sunovion Pharmaceuticals, Inc. ( former NASDAQ: SEPR ), known until October 12, 2010 as Sepracor, Inc. prior to its acquisition by Dainippon Sumitomo Pharma of Japan,〔(Company press release )〕 is a pharmaceutical company founded in 1984 by Timothy J. Barberich, Steve Matson, and Bob Bratzler. It was originally located in Princeton, New Jersey and then re-located to Marlborough, Massachusetts.〔(SEPR: Profile for SEPRACOR INC - Yahoo! Finance )〕
==Company history==
The company's initial focus was on the development of single isomers and active metabolites. This concept allowed Barberich and Doug Reedich to generate a patent estate that served the company well for many years. Therapeutically, Sepracor's products were focused on the treatment of central nervous system and respiratory disorders, under the direction of Gunnar Aberg, and John McCullough. The primary source of its revenue is the approximately $600 million annually from its Xopenex franchise of drugs, launched under the marketing leadership of John Simon, with the direct involvement of Medical Communications, under Dean Handley. It is available as a multi-dose inhaler (MDI) or nebulized (UDV) form. However, the insomnia drug Lunesta (eszopiclone), which was discovered by Tom Jerussi, approved by the US Food and Drug Administration (FDA) in December 2004 and launched in April 2005 under the marketing leadership of Tim Healy, is on pace to exceed $1 billion in annual sales. On February 13, 2006, Sepracor filed a new drug application for Brovana, patented by Gunnar Aberg and John Morley, (also launched under John Simon) to treat chronic obstructive pulmonary disease. All of the launch drugs were manufactured under the leadership of Walter Piskorski.
Sepracor has broad exposure to generic competition, as both Xopenex inhalation solution and Lunesta brands will face expiring patents at nearly the same time in March 2012, leaving Omnaris, Alvesco, Brovana and Stedesa to fill in the revenue gaps. Sepracor suffered five recent setbacks. The first was the announcement that it had completed the analysis and validation of the preliminary results of a Phase II study evaluating the efficacy and safety of SEP-225289 for the treatment of Major Depressive Disorder where Sepracor determined that SEP-225289 did not meet the primary efficacy endpoint (a reduction in symptoms of depression following eight weeks of treatment). However, the positive control in the study (venlafaxine extended-release) did achieve separation from placebo that was statistically significant on the primary endpoint. Dr Corrigan, responsible for the study, could not explain why clinical study of his design has failed. Secondly, Sepracor has announced patent interference between Sepracor and Wyeth.〔()〕 The interference seeks to determine the priority of invention claims directed to racemic O-desmethylvenlafaxine (ODMV) succinate. Wyeth markets racemic ODMV succinate (the active racemic metabolites of venlafaxine) in the US under the brand name PRISTIQ for the treatment of major depressive disorder in adults. Thirdly, the FDA has notified Sepracor that two clinical studies on eszopiclone in children have been put on clinical hold due the FDAs concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children.〔()〕 Fourthly, the European Medicines Agency, the European Union’s version of the U.S. Food and Drug Administration, has approved Lunesta for sale, but didn’t grant the request by Sepracor to designate it as a new active substance. Because of the EMA decision, Sepracor and GSK are terminating completely their plan to market the drug in the EU.〔()〕 Lastly, Sepracor recently announced it has reached a licensing agreement and settled litigation with a division of Teva Pharmaceuticals USA to make a generic version of Sepracor’s inhaled asthma drug Xopenex.〔()〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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