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Biotech / Medical : Biotech News

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From: tom pope	9/11/2010 8:50:24 PM
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Amln relevant. Seems important, I may be late picking this up. Roche suspends dosing in diabetes drug trials NEW YORK (Reuters) – Roche Holding has stopped giving patients its experimental diabetes treatment taspoglutide in late stage clinical trials due to a high rate of adverse reactions, marking a major blow to drug once seen to have $2 billion a year potential. The Swiss drugmaker said on Friday that the decision was based on a higher-than-expected rate of discontinuations due to gastrointestinal (GI) intolerability, and due to serious hypersensitivity reactions experienced by some patients, according to 52-week data from the trials. "These discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients," Roche said in a statement. Leerink Swann analyst Joshua Schimmer said in a research note that if Phase III dosing has been suspended "we believe that this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association (meeting) this year." The drug, given once weekly by injection, suffered a serious setback in June after reports surfaced that there were cases of patients suffering hypersensitivity reactions to the medicine in clinical trials. The latest blow to Roche is seen as a boon to Amylin Pharmaceuticals Inc and Eli Lilly and Co, which are awaiting a U.S. approval decision for their once-weekly injectable diabetes drug Bydureon. Amylin shares closed up 1.9 percent, while Lilly shares finished up 0.8 percent.<snip>

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