Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

Apr 22, 2010 - Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines -Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension). In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the companies with an updated Prescription Drug User Fee Act (PDUFA) target action date within the next two weeks.

The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The FDA's complete response letter did not request new pre-clinical or clinical trials, nor did it contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of these observations have been addressed.

"The companies have worked diligently and quickly over the last few weeks to submit a complete response and are confident we addressed the requests that were outlined by the FDA,"...

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...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(R) (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 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... Alkermes' Press Release - Eli Lilly's Press Release - Amylin's Press Release -

Amylin, Lilly and Alkermes : Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements

June 7, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc. (Nasdaq: ALKS) announced results from a 30-week study that compared the efficacy of exenatide once weekly, a long-acting release formulation of exenatide, to BYETTA® (exenatide) injection.
Type 2 diabetes patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1C (-1.9%+/-0.08 (LS mean+/-SE)) and fasting plasma glucose (FPG -42+/-3 mg/dL) from baseline and compared with BYETTA (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG).
Patients in both treatment groups also reported significant weight loss (average of 8 pounds) and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less.
These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco... Lilly's Press Release - Alkermes' Press Release -

Alkermes, Eli Lilly, Termination of AIR (Inhaled) Insulin Program

March 7, 2008--Alkermes, Inc. (NASDAQ: ALKS) announced that it has received a letter terminating the development and license agreement between Eli Lilly and Company (Lilly) and Alkermes dated April 1, 2001 thereby terminating the AIR(R) Inhaled Insulin (AIR(R) Insulin) program. The termination will become effective in 90 days. The termination of the agreement also results in the termination of the AIR Insulin supply agreement... Alkermes' Press Release - Lilly's Press Rlease -