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Biotech / Medical : CYPB - Cypress BioScience

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From: kenhott	3/6/2009 10:31:10 AM
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UPDATE 1-Forest, Cypress delay launch of fibromyalgia drug Fri Mar 6, 2009 8:34am EST * Now see mid-2009 launch, delayed from March * Seek "minor" cosmetic change NEW YORK, March 6 (Reuters) - Forest Laboratories Inc (FRX.N) and Cypress Bioscience Inc (CYPB.O) said on Friday that they were pushing back the U.S. launch of their fibromyalgia drug Savella while they seek approval for a minor cosmetic change. The companies said they now expect to ship Savella to pharmacies by mid-2009, after previously saying they expected the drug to be available in March. They are waiting on approval from the U.S. Food and Drug Administration for a "minor post-approval cosmetic formulation change." An FDA response is expected by no later than May, the companies said. Forest and Cypress won approval in January for Savella for treating fibromyalgia, a chronic pain condition. Their shares rose sharply on news of the approval. The drug is set to compete with Eli Lilly's (LLY.N) Cymbalta, which is also prescribed for depression, and Pfizer Inc's (PFE.N) Lyrica, which also treats nerve pain. Forest is counting on Savella as one of the products that can help make up for expected steep revenue declines when its Lexapro antidepressant loses U.S. patent protection in early 2012. (Reporting by Lewis Krauskopf; Editing by Lisa Von Ahn)

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