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Analysis Shows BYDUREON™ Was Not Associated with Clinically Relevant QT Prolongation in Patients with Type 2 Diabetes: Results Presented at ADA 2011
Date:6/24/2011

SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from an analysis of the DURATION-1 study that showed the investigational type 2 diabetes medication BYDUREON™ (exenatide extended-release for injectable suspension) was not associated with clinically relevant QT prolongation in patients with type 2 diabetes. These findings will be presented in a poster session at the 71st Scientific Sessions of the American Diabetes Association in San Diego on Saturday, June 25 from 11:30 a.m. to 1:30 p.m. PDT.

The QT interval represents the amount of time the heart's electrical system takes to repolarize, or recharge, after each beat.(i) Drugs that substantially prolong the QT interval have been associated with cardiac arrhythmias.

This analysis used data from the DURATION-1 study to evaluate changes in the QT interval associated with BYDUREON, correcting for heart rate with Fridericia's formula (QTcF). The change in QTcF from baseline was small and clinically insignificant at 14 weeks (1.7 milliseconds) and 30 weeks (3.0 milliseconds). There was no correlation between change in QTcF and exenatide blood plasma concentrations or renal status.

"These results suggest BYDUREON does not produce clinically relevant QT prolongation," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "To further characterize the QT-related safety of BYDUREON, we are currently conducting a thorough QT study according to guidelines set by the FDA. We believe that BYDUREON could be an important treatment option for patients with type 2 diabetes, and we continue to
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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