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Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009
Date:6/7/2009

Improvements in Systolic Blood Pressure and Triglycerides Also Observed

NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc. (Nasdaq: ALKS) today announced long-term, interim results from the DURATION-1 study that showed sustained glucose control with weight loss, as well as improvements in systolic blood pressure and triglycerides, through two years of treatment with exenatide once weekly, an investigational therapy for type 2 diabetes. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans. A New Drug Application (NDA) for exenatide once weekly was recently submitted to the U.S. Food and Drug Administration.

In the controlled portion of the open-label study, patients received exenatide once weekly or BYETTA(R) (exenatide) injection for 30 weeks, followed by 74 weeks of treatment with exenatide once weekly for all patients during an open-ended assessment period. Significant reductions in A1C of 1.7 percent and fasting plasma glucose (FPG) of 40 mg/dL were maintained after two years of treatment. Sixty-five percent of patients achieved an A1C of 7 percent or less. A1C of less than 7 percent is the target for good glucose control as recommended by the ADA. Body weight was significantly reduced, with patients losing an average of 5.8 pounds. Serum lipid profiles were significantly improved, and there was a significant reduction in systolic blood pressure (SBP).

"These two-year DURATION-1 data showed that maintenance of steady state concentrations of exenatide may res
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SOURCE Amylin Pharmaceuticals, Inc.
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