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Biotech / Medical : Sepracor-Looks very promising
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To: rkrw who wrote ()10/19/1998 12:48:00 PM
From: David Howe  Read Replies (1) of 10280
 
A little soft this morning, but I don't think it will last long (IMO). Two main reasons:

The bull looks like it is back. Two consecutive rate cuts by the Fed and the market historically moves higher. This isn't just usually -- it is about 90% of the time. CNBC had some stats this morning and one was that "new highs" were just 6 months away on average after the Fed cuts twice in a row.

SEPR will get final (labeling) approval on Xopenex (levalbuterol HCI) in the very near future. I'll guess that we hear back within the next couple of weeks or so. Just a guess, but one based on the normal time frames involved. SEPR will move nicely higher on this news and the following roll out of their sales force. Nothing like actual earnings just around the corner to move a stock. See below an article mentioning the approval announced back in July.

There is a very long list of reasons why SEPR should move higher near term, the two mentioned above are just the tip of the iceberg. (IMO)

Dave

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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."
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