AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) recently announced that the US Food and Drug Administration (FDA) has fixed an action date for their type II diabetes candidate, Bydureon (exenatide once-weekly).

Amylin and its partners had submitted a response to the second complete response letter (CRL) for Bydureon in late July 2011. The response is being treated as a Class 2 submission, which means a final decision from the FDA regarding Bydureon’s approvability should be out by Jan 28, 2012.

The regulatory path for Bydureon has not been smooth in the US where it has already received two CRLs from the FDA. Amylin and its partners had initially submitted the new drug application for the candidate in May 2009. The FDA issued two CRLs – one in March 2010 and the other in October 2010.

In the second CRL, Amylin and its partners were asked to conduct a thorough QT (tQT) study with Bydureon and submit data from the DURATION-5 study which was conducted to compare the safety and efficacy of Bydureon versus Byetta (exenatide).

We note that Bydureon gained approval in the EU in June 2011. Bydureon is already available in the UK and is expected to launch in other major European countries in the near future.

Neutral on Amylin

We currently have a Neutral recommendation on Amylin, which carries a Zacks #3 Rank (short term Hold rating). Going forward, we expect investor focus to remain on Byetta’s performance and updates on the FDA approval process for Bydureon.

 
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