Amylin, partners report exenatide once monthly data

Alkermes Inc. (NASDAQ:ALKS), Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Eli Lilly and Co. (NYSE:LLY) said low-, mid- and high-doses of exenatide once monthly reduced mean HbA1c from baseline to week 20 by 1.3-1.5% vs. 1.5% for Bydureon exenatide once weekly in a Phase II trial to treat Type II diabetes. The open-label, U.S. trial enrolled 121 patients. Amylin and Eli Lilly co-developed both products, which use Medisorb drug delivery technology from Alkermes.

Amylin and Lilly market a twice-daily injectable version of exenatide under the name Byetta. Next half, the companies plan to submit a complete response to FDA for Bydureon. Last year, FDA issued a second complete response letter for the product. ...