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

To: John R. Sashko who wrote (952)	7/2/1998 12:57:00 PM
From: Ed Ajootian	Read Replies (1) \| Respond to of 10280

FDA Issues Approvable Letter for Xopenex(TM)levalbuterol HCl) MARLBOROUGH, Mass., July 2 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR) today announced that it has received an approvable letter for Xopenex(TM) (levalbuterol HCl) inhalation solution, in multiple dosage strengths, from the U.S. Food and Drug Administration (FDA). Xopenex (levalbuterol HCl) is the therapeutically active isomer of racemic albuterol. Racemic albuterol, an equal mixture of (R) and (S) isomers, is the world's leading bronchodilator for asthma, with worldwide sales of $1.4 billion in 1997. Final approval by the FDA of the Xopenex (levalbuterol HCl) New Drug Application (NDA) is subject to satisfactory completion of the product labeling discussions and certain other conditions. Subject to final approval by the FDA, Xopenex (levalbuterol HCl) would be the first marketed single-isomer beta-agonist to treat asthma. Asthma is a chronic inflammatory disorder characterized by acute bronchial constriction of the airways that affects about 15 million Americans, including 5 million children. Between 1982 and 1994, the overall prevalence rate for asthma has increased 61 percent. Short-acting and long-acting bronchodilators prescribed for the treatment of asthma had worldwide sales of over $2.5 billion in 1997. "This approvable letter is a significant milestone for Sepracor as we become a fully integrated pharmaceutical company," said Timothy J. Barberich, President and Chief Executive Officer of Sepracor. "The company is on track to launch Xopenex in the fourth quarter of 1998 through our specialty respiratory sales force, pending final approval by the FDA." "Xopenex is the first in a new generation of isomerically pure beta- agonists. Its predecessor, racemic albuterol, was introduced nearly 20 years ago," said David S. Barlow, President of Pharmaceuticals at Sepracor. "Sepracor will continue to work closely with the FDA to expedite the final approval process." Sepracor is a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely-prescribed drugs. Referred to as Improved Chemical Entities ("ICE"), Sepracor's ICE(TM) Pharmaceuticals are being developed as proprietary, single-isomer or active-metabolite versions of these leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases the opportunity for additional indications. This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential clinical and commercial benefits, and timing of the development of the company's ICE Pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of the company's clinical trials with respect to its products under development; the scope of the company's patent protection with respect to such product candidates; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Xopenex is a trademark of Sepracor Inc. SOURCE Sepracor Inc. CO: Sepracor Inc. ST: Massachussetts IN: HEA MTD SU: PDT 07/02/98 06:57 EDT prnewswire.com ******************************************************************************* Just gettin' this baby up on the board here. Always great to see a biotech company actually stick to its schedule --- even for events that are somewhat out of its control! If memory serves correctly this is just a day later than one year since they delivered the NDA to the FDA. Can't believe labelling discussions could take more than a month or two, even considering the fact that we're in vacation season.