Roche, Ipsen diabetes drug sidelined by PhIII safety issues

After stumbling badly on troubling safety data in June, researchers handling the late-stage diabetes study of taspoglutide have run straight into a brick wall. Ipsen and Roche say they have opted to suspend treatments in a Phase III trial of taspoglutide after tracking a high rate of GI reactions among the patients taking the drug. Once picked as a likely blockbuster, analysts this morning are assessing the drug's chances as "uncertain and bleak."

Taspoglutide had been one of the front-runners among a group of GLP-1--glucagon-like peptide--drugs in the clinic. The therapy is injected weekly, offering an easier dosing regimen. Amylin and Eli Lilly have the GLP-1 drug Bydureon up for an approval. And analysts this morning were shaking their heads over the fate of taspoglutide, which, at a minimum, faces a huge delay that would give its competitors a leg up in the race for market domination.

Side effects registered last June had already forced researchers to delay their schedule for a planned app by 18 months, a move that led some analysts to predict that Roche would hand the drug back to Ipsen. Annie Cheng, an analyst for Bryan, Garnier, had cut her odds on success from 60 percent to 10 percent. Those odds got even worse as of today. Shares of Ipsen slid 3 percent on the news.

- here's the story from Reuters

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