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Amylin Pharmaceuticals Reports First Quarter Financial Results
Date:4/16/2009

) was similar to initiators of the more traditional therapies metformin or glyburide.
  • Manuscript in Diabetes Care confirmed a significantly increased risk of pancreatitis in patients with type 2 diabetes - approximately three times the rate of those without diabetes.

  • Exenatide Once Weekly

    • Completed analyses to demonstrate manufacturing comparability necessary for regulatory submission. These analyses will be part of the NDA submitted to FDA this quarter.
    • Announced results from the first head-to-head comparative effectiveness study, DURATION-2, that demonstrated exenatide once weekly provided superior glucose control, with weight loss, compared to maximum doses of Januvia or Actos(R) (pioglitazone).
    • Announced decision to initiate a large cardiovascular outcomes trial with superiority design that will evaluate the effects of exenatide once weekly on major cardiovascular events, compared to standard of care with traditional antidiabetes medications.
    • Initiated DURATION-5, a new phase 3b study designed to show superiority of exenatide once weekly compared to BYETTA, support regulatory submissions outside the U.S. and provide additional controlled clinical data on the commercially manufactured product.

    Conference Call

    Amylin will webcast its Quarterly Update Conference Call today at 5:00 p.m. ET/2:00 p.m. PT. Daniel M. Bradbury, Amylin's president and chief executive officer, will lead the call. During the call, the Company plans to provide further details underlying its first quarter financial results, and information regarding assumptions for the remainder of 2009 operations.

    The call will be webcast live through the "Investors" section of Amylin's corporate Web site at

    SOURCE Amylin Pharmaceuticals, Inc.
    Copyright©2009 PR Newswire.
    All rights reserved

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