Diabetes Drug Application May Be New Factor in Amylin Proxy Battle

Xconomy San Diego — 

Amylin Pharmaceuticals (NASDAQ: AMLN), which is engaged in a proxy fight, has submitted a new drug application to the U.S. Food and Drug Administration for exenatide, its once weekly drug for type 2 diabetes. The San Diego biotech made the announcement today with Eli Lilly (NYSE: LLY), its marketing partner, and Cambridge, MA-based drug developing company Alkermes (NASDAQ: ALKS).

Amylin, Lilly, and Alkermes have been working to develop a new version of Byetta, the diabetes drug developed by Amylin, as a once-a-week injection based on Alkermes’ proprietary technology for long-acting medications.

“The clinical data supporting this submission highlight the potential of exenatide once weekly to significantly advance the treatment of type 2 diabetes,” says Amylin’s president and CEO Daniel Bradbury, according to the companies’ joint statement. “If approved, exenatide once weekly would be the first and only once-a-week therapy for the treatment of type 2 diabetes,” says David Vondle, Lilly’s global brand development leader.

Billionaire investor Carl Icahn and Eastbourne Capital Management, who together hold a 22 percent stake in Amylin, have targeted the San Diego biotech’s financial performance (and lagging Byetta sales) in their quest to gain more control on the company’s board. Amylin said yesterday it plans to lay off 200 employees in a restructuring of its sales force.