Friday, April 15, 2011

Alkermes' diabetes treatment boosted in Europe

By Julie M. Donnelly, Boston Business Journal

Alkermes Inc. (Nasdaq: ALKS) has received a positive opinion from a key European regulatory committee for its experimental diabetes treatment, Bydureon. The recommendation means the drug candidate is very likely to be approved there.

The news is a boost for Waltham-based Alkermes, along with its partners, Indianapolis-based Eli Lilly and Company (NYSE: LLY), and San Diego, Calif.-based Amylin Pharmaceuticals Inc. (Nasdaq: AMLN), following a rejection from the U.S. Food and Drug Administration for the potential drug late last year.

Bydureon is a once weekly injection of an already-approved drug, Byetta. But Byetta has faced safety concerns after post-marketing studies linked the drug to acute pancreatitis and kidney problems, in rare cases.

If approved, Bydureon would be the first once-weekly treatment for diabetes. Supporters of the drug target believe that drug compliance – a major issue in the treatment of chronic conditions such as diabetes – would be improved with a once-weekly option.

The European committee recommended that Bydureon be approved for use in conjunction with other oral therapies.

A final decision from EU regulators is expected in two to three months. The companies said they planned to re-submit the drug candidate for FDA approval, with additional data, in the second half of 2011.