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Salix Asks FDA to Review Colitis Drug



By AP
31 December 2007 @ 11:40 am EST

RALEIGH, N.C. - Salix Pharmaceuticals Ltd. said Monday it submitted an application to the Food and Drug Administration for marketing approval of its product granulated mesalamine to treat a type of colitis.

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The stock fell sharply to a new four-year low Monday after Wall Street learned the drug developer's key product Colazal, also for ulcerative colitis, faces generic competition from three companies.

Salix's new drug application seeks approval for once-a-day dosing of granulated mesalamine to help patients stay in remission from ulcerative colitis. The disease causes ulcers in the lining of the rectum and colon.

The Raleigh, N.C.-based company believes the application will be subject to a 10-month review period by the FDA.

The application is based on results from two studies that showed a statistically significantly greater proportion of patients on granulated mesalamine stayed in remission.

Salix said ulcerative colitis patients dosed once a day with 1.5 grams of the drug remained relapse-free over six months of treatment compared with patients on placebo.

Salix acquired rights to market granulated mesalamine in the U.S. from Dr. Falk Pharma GmbH of Germany. Dr. Falk Pharma sells granulated mesalamine in Germany and other European countries, as well as Australia, under the trade name Salofalk Granu-Stix.

Salix's stock dropped $1.36, or 15.1 percent, to $7.66 in very heavy morning trade, having fallen to a new 52-week low of $7.50 earlier in the day. That's the stock's lowest level since August 2003. Previously, the stock traded between $8.78 and $16.38 over the past 52 weeks.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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