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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: David Howe who wrote (2132)	3/26/1999 1:29:00 AM
From: M. Ramle	Read Replies (2) \| Respond to of 10280

David: Just fresh from Bloomberg News: <<<From Bloomberg -- Sepracor Wins U.S. Approval for Asthma Drug Xopenex (Update1). Sepracor Wins U.S. Approval for Asthma Drug Xopenex (Update1) (Adds background on Sepracor, development of Xopenex.) Washington, March 25 (Bloomberg) -- Sepracor Inc., a developer of improved versions of widely used drugs, won U.S. regulatory approval to market the asthma treatment Xopenex, which will be the first product the company markets on its own. Sepracor Executive Vice President and Chief Financial Officer David P. Southwell said the company won the approval. He declined to elaborate, saying the Marlborough, Massachusetts - based company will issue a press release early tomorrow. Xopenex is a form of racemic albuterol, a widely used asthma treatment. Sepracor was able to strip out a chemical compound of albuterol, creating a treatment that the company said is safer than existing versions. The approval will give the company a foothold in the market for asthma drugs, and could bring in annual sales of more than $100 million, analysts said. Asthma, an inflammation of the airways, affects 15 million Americans. ''This is a big event for Sepracor. It gives them credibility,'' said Lance Willsey, a partner with DCF Capital, which holds some 100,000 Sepracor shares. ''It shows they are capable of brining a drug through the clinical trials process and winning regulatory approval.'' Sepracor shares rose $4 7/8 to $118 1/4 amid hopes the drug would be approved. Southwell disclosed the approval late today after U.S. markets had closed. The company has built its business by taking advantage of the fact that drugs like Eli Lilly & Co.'s blockbuster antidepressant Prozac are made of mirror-image compounds called isomers. While the active isomer fits like a key into a molecular lock to produce a drug's benefit, the other isomer can cause side effects. Sepracor strips away the extra isomer, leaving a more pure drug that can be more potent, versatile or carry fewer side effects. The company is developing a successor to Prozac, for which Lilly agreed to pay Sepracor as much as $90 million. The company is also working to develop new versions of blockbusters including BASF AG's Meridia, Pfizer Inc.'s Norvasc and Abbott Laboratories Prevacid. Albuterol Market: The albuterol market is now dominated by Glaxo Wellcome Plc's Ventolin and Schering-Plough Corp.'s Proventil. Generic versions are also available. Today was the deadline for the company to hear from the FDA. The agency in July told Sepracor that Xopenex met standards for approval once the two sides resolved several issues, including the wording of the label that describes how the drug should be used as well as potential side effects.>>> Good Luck to all. Mazen