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

To: BMcV who wrote (1004)	7/15/1998 7:00:00 PM
From: BMcV	Read Replies (1) \| Respond to of 10280

Here's blast from the past (just last week really), an excerpt from the 1Q report of Labopharm, SEPR's Canadian partner for oral formulations of Levalbuterol. Interesting that they put the SEPR news first in their report (from Businesswire via Yahoo): "Labopharm Announces First Quarter Results: Sepracor Receives FDA Approvable Letter for Inhalation Version of Levalbuterol MONTREAL--(BUSINESS WIRE)--July 8, 1998--Labopharm (TSE:DDS. - news; ME:DDS. - news) With its first quarter results for fiscal 1998-99, Labopharm Inc., announces that its R&D projects are progressing well including its project with Sepracor Inc. [Nasdaq:SEPR - news], the U.S. firm with which it has formed an alliance for the formulation of solid oral dosage forms of levalbuterol. Levalbuterol is the therapeutically active isomer of racemic albuterol, the world's leading bronchodilator for asthma with worldwide sales of US $1.4 billion in 1997. Sepracor Inc. just announced a significant advance with the receipt of an approvable letter from the U.S. Food and Drug Administration (FDA) for the inhalation solution of this drug (levalbuterol HCI or Xopenex(TM)) in multiple dosage strengths. Final approval by the FDA of the Xopenex (levalbuterol HCI) New Drug Application (NDA) is subject to satisfactory completion of the product labeling discussions and certain other conditions. ''The fact that the FDA has just issued an approvable letter for the inhalation solution of levalbuterol is particularly encouraging,'' said Mr. Donald Buxton, President and CEO of Labopharm. ''When an active ingredient is approved in one galenic form, normally the approval processes for other galenic forms progress more quickly,'' he added. Sepracor has indicated that it is on track to launch Xopenex in the fourth quarter of 1998 through its specialty respiratory sales force, pending final approval by the FDA. It 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." Galenic, as far as I can tell from my dictionary, refers to the different formulations without any additional pharmacologically active substances. Heavy volume past two days and finally a close above (well above!) 48 today.