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Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
Date:12/11/2008

pproximately 800 patients and complete in 2010.

"We are confident that the strategy of the DURATION program will yield powerful data to support a strong launch for exenatide once weekly," said James Malone, M.D., global exenatide medical director, Eli Lilly and Company. "We believe the program will demonstrate the value of exenatide once weekly to physicians, patients and payers."

DURATION-3 completed enrollment in the fourth quarter. This approximately 450 patient, open-label, superiority study compares exenatide once weekly with insulin glargine on a background of oral agent therapy. Results are expected in the third quarter of 2009.

DURATION-2 completed enrollment in the third quarter of 2008. This 500 patient, double-blind, superiority study compares exenatide once weekly with TZD and a DPP-4 inhibitor on a background of metformin therapy. Results are expected in the second quarter of 2009.

DURATION is an acronym for the overall exenatide once weekly clinical program. It stands for "Diabetes therapy Utilization: Researching changes in A1C, weight and other factors Through Intervention with exenatide ONce weekly."

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

About Diabetes

Diabetes affects more than 23 million in the United States and an estimated 246 million adults worldwide.(i, ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(iii)

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SOURCE Eli Lilly and Company
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