Salix submits new drug application to FDA for granulated mesalamine; shares down |
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Published
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Mon, 31 Dec 2007 16:37
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BOSTON (Thomson Financial) - Salix Pharmaceuticals Ltd. Monday said it has submitted a new drug application to the Food and Drug Administration seeking approval to market granulated mesalamine.Granulated mesalamine is used in the treatment of ulcerative colitis.The Morrisville, N.C.-based drug developer said its application is based upon results from two studies that demonstrated a statistically 'significantly greater' proportion of ulcerative colitis patients dosed once-a-day with 1.5 grams of granulated mesalamine remained relapse-free over six months of treatment than patients dosed with placebo.Salix said it believes the application will be subject to a 10-month review period.Separetly, Piper Jaffray downgraded Salix to sell from neutral, citing concerns over the company's inflammatory bowel disease (IBD) franchise and potential problems with its Xifaxan products. Piper Jaffray also cut its 12-month stock price target to $5 from $13.Shares of Salix touched a new low of $7.50 and last traded at $7.74, down 13.8% on volume of 6.5 million. The issue's 30-day average volume is about 1.4 million shares.Casey Logancl/pcCOPYRIGHTCopyright Thomson Financial News Limited 2007. All rights reserved.The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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