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DURATION-4 Study Results: BYDUREON Efficacy and Tolerability Profile Extended to Monotherapy Treatment
Date:6/15/2010

YDUREON produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.

"The majority of patients in this study reached an optimal A1C goal of less than seven percent, which is the glucose control target recommended by the American Diabetes Association," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "DURATION-4 reinforced that continued presence of exenatide helped these recently diagnosed patients to achieve glycemic control. The combination of efficacy, tolerability, and once weekly dosing in this monotherapy setting further supports the potential role BYDUREON can play in helping patients and physicians manage type 2 diabetes."

More than 80 percent of patients in all treatment arms completed the study. There were no major hypoglycemia events in any treatment group. The most frequently reported adverse events among BYDUREON users were nausea (withdrawal rate less than 1 percent) and diarrhea; metformin, diarrhea and headache; Actos, upper respiratory tract infection, headache, hypertension and peripheral edema; and Januvia, upper respiratory tract infection and headache.

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to
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SOURCE Amylin Pharmaceuticals, Inc.
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