After Amylin Pharmaceuticals lost more than 50% in stock value an investigation on behalf of investors in Amylin Pharmaceuticals (NASDAQ: AMLN) shares concerning potential violations of Federal Securities laws in connection with the New Drug Application for Amylins diabetes drug BYDUREON was announced.

The investigation by a law firm on behalf of investors in AMLN shares concerns whether Amylin Pharmaceuticals, certain of its officers, directors, or insiders potentially violated any Securities laws in connection with the recent developments surrounding the diabetes drug BYDUREON (TM) (exenatide extended-release for injectable suspension.

San Diego, California based Amylin Pharmaceuticals, Inc. is a biopharmaceutical company engaged in discovery, development and commercialization of medicines. Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes, Inc. are currently working together to develop BYDUREON, which is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide, the active ingredient in BYETTA(R) (exenatide) injection, in a single weekly dose. BYETTA has been available in the U.S. since June 2005 and is used in more than 60 countries worldwide by adults with type 2 diabetes.

Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes, Inc. submitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BYDUREON in May 2009 based on data that included the DURATION-1 head-to-head clinical study, safety data from DURATION-2 and more than seven years of clinical experience with BYETTA.

Shares of Amylin Pharmaceuticals, Inc. increased from May 2009 from $11 per share to as high as almost $24 per share in April 2010.

FDA issued a complete response letter to the companies in March 2010 and in May 2010. AMLN shares dropped from almost $24 per share in April to under $16 in May 2010.

AMLN shares regained value over the next months and traded at roughly $21 per share during October before AMLN shares dropped more than 50% on Wednesday October 20, 2010.
The evening before the more than 50% decline Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes announced after the market closed that the FDA has issued a complete response letter regarding their NDA for BYDUREON. In the complete response letter the FDA requested a thorough QT study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. 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.

It is expected that the companies will submit their reply to the complete response letter by the end of 2011, meaning the FDA is unlikely to make a decision until mid-2012, thus representing a potential delay of more than 18 months.

The investigation by a law firm on behalf of investors of Amylin Pharmaceuticals, Inc. seeks to determine when Amylin Pharmaceuticals, Inc. , certain of its officers and directors, and certain insiders knew about the potential delay and/or knew about any other material information in regards to the BYDUREON matter in violations to Federal Securities Laws.