AMLN Amylin Pharmaceuticals, Inc. (MM)

Alkermes, Inc. (ALKS), Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Company (LLY) recently announced new analyses of data from the DURATION 3 and DURATION 4 trials which evaluated their type II diabetes candidate, Bydureon (exenatide once-weekly). The co-developers intend to present the data at the 47th European Association for the Study of Diabetes Annual Meeting in Portugal.

Data revealed that patients treated with Bydureon experienced a significant improvement in cardiovascular risk factors like high blood pressure as against those treated with commonly available therapies for diabetes.

Data from the DURATION 3 study demonstrated that patients treated with Bydureon experienced reduction in body weight and cholesterol levels compared to those treated with Sanofi-Aventis’ (SNY) Lantus. The DURATION 4 study compared the efficacy of Bydureon, as a monotherapy treatment against  Merck’s (MRK) Januvia (sitagliptin), Takeda’s Actos and metformin.

We note that Bydureon was approved in the EU in June 2011 and subsequently launched in the UK. The drug is expected to launch in other major European countries soon. Bydureon is under review in the US. A final decision from the US Food and Drug Administration (FDA) regarding Bydureon’s approvability should be out by January 28, 2012 (action date).

We remind investors that the regulatory path for Bydureon has not been smooth in the US where it has already received two CRLs from the FDA. Alkermes 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, Alkermes 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). The response to the second CRL for Bydureon was submitted in late July 2011. The response is being treated as a Class 2 submission and an action date of January 28, 2012 was assigned by the FDA.

We note that even if Bydureon manages to clear the regulatory hurdles in the US, it will face tough competition. The drug will compete with Novo Nordisk’s (NVO) Victoza, a once-daily injection that was launched earlier in 2010. Other glucagon-like peptide-1 (GLP-1) molecules under development include GlaxoSmithKline’s (GSK) Syncria (albiglutide), also a once-weekly injection.

Neutral on Alkermes

Currently, we have a Neutral recommendation for Alkermes for the long run. The stock carries a Zacks #2 Rank (Buy rating) for the short run.

 
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