Amylin Pharmaceuticals Inc. (AMLN)

[mlkrborn]

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct 19, 2010 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide extended-release for injectable suspension).

In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data.

The companies' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.

"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that BYDUREON can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in BYDUREON based on the extensive exenatide database, 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(R) (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 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 [phone] begin_of_the_skype_highlighting [phone] end_of_the_skype_highlighting (U.S./Canada) or [phone] begin_of_the_skype_highlighting [phone] end_of_the_skype_highlighting (international), conference access code 7487145. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at [phone] begin_of_the_skype_highlighting [phone] end_of_the_skype_highlighting (U.S./Canada) or [phone] begin_of_the_skype_highlighting [phone] end_of_the_skype_highlighting (international).