Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes

Amylin Pharmaceuticals, Inc.Jun 11 2012

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.

In the study, being presented at the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia, patients completing four years of BYDUREON treatment experienced clinically significant improvements in A1C (1.7 percentage points) and fasting plasma glucose (-37 mg/dL) from baseline. A1C is a measure of average blood sugar over three months. Although BYDUREON is not indicated for weight loss, patients treated with BYDUREON also lost an average of 5.5 pounds from baseline.

"In this study, patients treated with just one dose per week of BYDUREON for four years experienced sustained improvement in glycemic control and showed reductions in certain cardiometabolic measures. The tolerability of BYDUREON also improved over time with long-term treatment," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "The durability of treatment effectiveness and tolerability of BYDUREON are critically important in managing the chronic and progressive condition of type 2 diabetes."

Patients treated with BYDUREON also experienced statistically significant reductions in certain cardiovascular risk markers, including systolic blood pressure (-1.6 mmHg), total cholesterol (-10.9 mg/dL), LDL cholesterol (-8.0 mg/dL) and triglycerides (-13 percent). No unexpected safety findings were observed with long-term BYDUREON therapy, and incidence of mild nausea, the most common adverse event during the controlled portion of the study, decreased over time (27 percent weeks 1-30; 1.6 percent weeks 180-212).