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Amylin Pharmaceuticals Reports First Quarter Financial Results
Date:4/18/2011

achieve this goal."

Highlights of Amylin's First Quarter and Recent ActivitiesExenatide

  • Initiated a thorough QT study to address questions raised by the U.S. Food and Drug Administration (FDA) in their complete response letter regarding the BYDUREON™ (exenatide extended-release for injectable suspension) New Drug Application.
  • Announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BYDUREON in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies.
  • Communicated top-line results from DURATION-6, the sixth DURATION study that showed weekly BYDUREON significantly improved glucose control from baseline. These results reinforce the important role of GLP-1 receptor agonists in the treatment of type 2 diabetes, although BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to daily Victoza® (liraglutide (rDNA origin) injection) in this study.
  • Announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes. The investigational GLP-1 treatment improved glucose control with just one dose per month. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline. We are proceeding with regulatory interactions to outline the next steps for this important program within the exenatide franchise.
  • Lilly received approval in Mexico for an expanded indication of BYETTA® (exenatide) injection as an add-on therapy to basal insulin.

  • Obesity Program

  • Voluntarily suspended clinical activities in an ongoing phase 2 study of pramlintide/m
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  • SOURCE Amylin Pharmaceuticals, Inc.
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