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Amylin Pharmaceuticals Reports 2010 Financial Results
Date:1/26/2011

ll focus on our highest corporate priority – responding to the recent complete response letter for BYDUREON – so that we can make this important therapy available to patients in the U.S. as soon as possible. While we advance this and other value drivers, we will continue to aggressively manage expenses to position Amylin for sustainable growth in the years ahead."

Fourth Quarter Highlights Highlights of Amylin's fourth quarter and recent activities include:

BYDUREON

  • Received written feedback from the U.S. Food and Drug Administration (FDA) indicating approval of the study design for the required thorough QT (tQT) study to support the regulatory application for BYDUREON™ (exenatide extended-release for injectable suspension).  The study is expected to begin in February.

  • BYETTA

  • Received $10 million milestone payment upon launch of BYETTA® (exenatide) injection by partner Eli Lilly and Company in Japan for the treatment of type 2 diabetes in patients who have not achieved adequate glycemic control while taking certain oral anti-diabetes therapies in addition to diet and exercise.
  • Announced results from a retrospective study of nearly 375,000 type 2 diabetes patients evaluating the incidence of events related to cardiovascular disease (CVD) and all-cause hospitalizations among initiators of BYETTA compared to initiators of other commonly used diabetes medications. In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin). BYETTA was also associated with a lower incidence of all-cause hospitalizations than insulin, TZDs and sulfonylureas; a comparable incidence versus metformin and a higher incidence than Januvia.
  • Submitted a supplemental New Drug Application (sNDA) to the FDA for the expanded use of BYETTA as an ad
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  • SOURCE Amylin Pharmaceuticals, Inc.
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