To: Thomas M. who wrote (2148 ) 3/26/1999 1:14:00 PM From: Don Miller Respond to of 10280
FYI, Reuters Report U.S. regulators approve Sepracor's asthma drug FRIDAY, MARCH 26, 1999 12:07 PM EST - Reuters NEW YORK, March 26 (Reuters) - Sepracor Inc. (NASDAQ:SEPR) said on Friday U.S. regulators approved a new version of a drug for asthma, a breathing disorder that effects 15 million people in the United States. The Massachusetts-based company said the U.S. Food and Drug Administration approved the drug, Xopenex, in two dosage strengths to be launched by April 30. The company expects annual sales of about $250 million, according to David Southwell, Sepracor chief financial officer said in an interview on CNBC. Xopenex is a new version of an existing class of asthma drug called beta agonists, which are used to open lung passageways during severe asthma attacks. Xopenex will compete with racemic albuterol, the prevailing type of beta agonist on the market. This class of drugs can cause tremors and hyperactivity. Xopenex has fewer side effects and is just as effective at 0.63 mg as the standard clinical dose of racemic albuterol, 2.5 mg, a spokeswoman for the company said. Xopenex's higher dose, 1.25 mg, has comparable side effects as the standard clinical dose of racemic albuterol, but the beneficial effects last longer, she said. "It's an extremely major milestone for the company," Chief Executive Tim Barberich told analysts in a conference call after the FDA approval was announced. In addition, the new version can be used for the treatment along with prevention of asthma attacks, the company said. The approved drug will be given to patients in vapor form through a mouthpiece or face mask. Executives from the company, which specializes in making safer versions of existing drugs, declined to forecast the drug's impact on profits. The company, founded in 1984, has yet to turn a profit. The company also hopes to launch a tablet and syrup form of the Xopenex in 2000 and other versions by 2003. Clinical studies are also underway for a version targeted at children under 12. Shares of Sepracor rose $2.69 at $120.94 in midday trading. (( -- David Brinkerhoff, New York Newsroom, 212-859-1700)) //Begin Meta Data// Selector Code: reutr Copyright 1999, Reuters News Service Copyright 1999 Reuters Limited. Click Here for Limitations and Restrictions on Use.