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Biotech / Medical : Theravance - THRX

THRX 9.810

+0.4%

Jan 8 4:00 PM EST

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From: tnsaf	11/30/2009 10:02:17 PM
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UPDATE 1-FDA denies approval for Theravance's pneumonia drug Fri Nov 27, 2009 2:53pm EST * Gets complete response letter on Telavancin for pneumonia * FDA asks for additional data * Co says already collected data asked by FDA Nov 27 (Reuters) - Drug developer Theravance Inc (THRX.O) said U.S. health regulators did not approve its drug Telavancin for treatment of nosocomial pneumonia. The U.S. Food and Drug Administration issued a complete response letter and asked for additional data, the company said. The company said it has already collected the information and completed the analyses required to respond to the FDA. Theravance also said the FDA's review of the drug was likely to extend into 2010. Telavancin, a once-daily injectable antibiotic, is already approved for the treatment of complicated skin and skin structure infections. Theravance and Japan's Astellas Pharma Inc (4503.T) have agreed to collaborate on U.S. marketing of Telavancin for the first three years. Shares of Theravance closed at $13.13 Friday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Ratul Ray Chaudhuri) ((krishnakali.sengupta@thomsonreuters.com; within U.S +1 646 223 8780; outside U.S +91 80 4135 5800; Reuters Messaging: krishnakali.sengupta.reuters.com@reuters.net)) © Thomson Reuters 2009 All rights reserved

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