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Analysts and company officials at Alkermes Inc. have been taken by surprise by a U.S. Food and Drug Administration decision not to approve a drug candidate to treat type 2 diabetes, Bydureon. Last week, in an interview, CEO Richard Pops expressed optimism about the impending FDA decision.
The drug candidate is jointly owned by Waltham-based Alkermes, Indianapolis, Ind.-based Eli Lilly and Co. and San Diego, Calif.-based Amylin Pharmaceuticals Inc. The unexpected decision by the FDA, analysts predict, will drag on all three companies’ stock prices and earnings in the near term.
If approved, Bydureon would have been the first type 2 diabetes treatment taken once weekly. The drug candidate is a longer acting form of the already-approved drug, Byetta, which has been associated with acute pancreatitis, which can be fatal.
The FDA has increased scrutiny of metabolic drugs for diabetes and obesity, over concern about the drugs' safety profile.
Alkermes was expected to win two key drug nods in one month, following last week’s approval of its alcohol dependency drug Vivitrol for the additional indication of opioid dependence.
The FDA’s rejection of Bydureon will likely push out the company’s return to profitability, which was expected as soon as next year.
The companies have received a complete response letter outlining the next steps they must perform before re-submitting the drug for approval. The potential drug will likely be re-submitted late next year and then face a six month review. Analysts Steve Yoo and Joshua Schimmer of Boston-based Leerink Swann bank are projecting that U.S. commercial sales of the drug are now unlikely to begin until 2013.
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