First Quarter 2008 Highlights
Highlights of Amylin's first quarter include:
-- Submitted a supplemental New Drug Application, or sNDA, to the Food and
Drug Administration, or FDA, to seek approval for expanded use of
BYETTA as monotherapy, or stand-alone therapy, in people with type 2
diabetes who are not achieving acceptable blood sugar control.
Approval for this expanded indication is expected in the second
half of 2008.
-- Commercially launched the SymlinPen(TM) 120 and the SymlinPen(TM) 60
pen-injector devices for administering SYMLIN in the United States in
January 2008. These new pre-filled pen-injector devices feature
simple, fixed dosing to improve mealtime glucose control.
Exenatide once weekly
-- Initiated the first of three planned superiority clinical trials of
exenatide once weekly. The study compares exenatide once weekly to a
thiazolidinedione, or TZD, and a DPP-4 inhibitor in patients on
background metformin therapy. Results from this study are expected in
the first half of 2009.
-- Continued progress at the Company's exenatide once weekly manufacturing
facility in Ohio, including the manufacture of exenatide once weekly at
commercial scale. The Company plans to supply material from the
facility to support ongoing and planned clinical programs by the third
quarter of 2008
Amylin will webcast its Quarterly Update Conference Call today at 8:30 a.m. ET/5:30 a.m. PT. The call will be webcast live through Amylin's corporate website, http://www.amylin.com, and a recording will be made available following the close of the call.
Daniel M. Bradbury, Amylin's President and Chief Executive Officer,
|SOURCE Amylin Pharmaceuticals, Inc.|
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