MGI Pharma MOGN New patents, anti cancer Message Board

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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer

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To: Icebrg who wrote (1646)	12/30/2005 3:05:03 PM
From: tuck	of 1826

>>BOSTON, Dec 30 (Reuters) - Valeant Pharmaceuticals International (VRX.N: Quote, Profile, Research) said on Friday that U.S. regulators will not approve the company's request to change information on the package insert for its anti-vomiting drug Cesamet until it provides more safety information. The decision by the U.S. Food and Drug Administration means the company cannot yet launch the drug, which it acquired from Eli Lilly & Co. in 2004. The FDA requested additional information to address concerns over potential safety problems. Valeant said it will meet promptly with the agency to discuss details of the letter. The FDA had asked Valeant to update the labeling when it acquired the drug, and Valeant has been withholding launch of the treatment until the updated label is approved. Valeant currently sells Cesamet, which was approved in 1985 to treat nausea and vomiting associated with chemotherapy, in Canada.<< Prescribing info here: rxmed.com This apparently buys a bit more time for Aloxi versus this competing drug, but this is an old drug with an inferior side effect profile, and I don't see it making much of a dent unless it can be priced like generic Zofran. Which maybe it can. If approved in '85, it's gotta be cheap by now. Lazard reiterated its buy rating today. Supposedly, November scrip data is in fact good, though this is not really news here: finance.messages.yahoo.com Cheers, Tuck

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