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Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
Date:10/19/2010

atabase, including more than seven years of clinical experience with BYETTA, the twice-daily form of exenatide that is available in more than 60 countries worldwide."

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection. BYETTA has been available in the U.S. since June 2005 and is used in more than 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

The NDA for BYDUREON was submitted in May 2009 and is based on data that include the DURATION-1 head-to-head clinical study, safety data from DURATION-2 and more than seven years of clinical experience with BYETTA. The agency issued a complete response letter to the companies in March 2010 and in May 2010 classified the companies' first complete response as a Class 2 resubmission with a PDUFA action date of October 22, 2010.

Amylin to Host Investor Conference Call

Amylin will host a conference call to discuss the complete response letter for BYDUREON at 4 p.m. PT on Oct. 19. Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals, will lead the call.

The call will be webcast live through Amylin's corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to www.amylin.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 857-5738 (U.S./Canada) or (415)
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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