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


To: Don Miller who wrote (3791)10/21/1999 5:09:00 PM
From: Biomaven  Respond to of 10280
 
Don,

Do you mean at the conference? If so there was no mention - he was too busy hitting the highlights of many of the other ICE's in the portfolio.

Here was the Labopharm release, in case it hasn't been posted aready:

FOLLOWING SUCCESSFUL COMPLETION OF PHASE I STUDY
LABOPHARM ANNOUNCES INITIATION OF
XOPENEX™ PHASE II CLINICAL TRIALS

LAVAL, (Quebec), September 21, 1999 — Labopharm Inc. announced today that an IND was accepted by the Therapeutic Products Directorate of Canada to begin Phase II clinical studies on solid oral dosage forms of XopenexTM *(levalbuterol HCl) using Contramid® technology. This study , which was initiated on September 19, 1999, will form part of the international registration file and follows upon an agreement signed in June, 1997, between Labopharm and Sepracor Inc. of Massachusetts to jointly develop this product. Sepracor has worldwide marketing rights on the Xopenex oral, sustained release dosage forms and will pay Labopharm royalties on product sales.

"The speed with which we have moved to Phase II is a direct reflection of success achieved with the formulation used in the Phase I study reported in July of this year," said Donald Buxton, President and CEO of Labopharm. The results are expected in the first quarter of next year.

Patients who may benefit from an orally-dosed bronchodilator are those who experience chronic obstructive pulmonary disease (COPD) and asthmatics -- primarily children and elderly patients -- who have difficulties using inhalers. In addition, the product may be attractive for patients who do not use existing solid oral forms due to tolerability issues.

Sepracor's Xopenex (levalbuterol HCl) is the therapeutically active isomer of racemic albuterol. Racemic albuterol, marketed as Ventolin® * and Proventil®*, is the world's leading bronchodilator for asthma with worldwide sales of $1.2 billion in 1998. 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.