AMLN Amylin Pharmaceuticals, Inc. (MM)

Alkermes plc (ALKS) recently announced the commencement of an open-label pilot study (n=30) of Vivitrol in adult prisoners who have a history of pre-incarceration of opioid dependence, a chronic brain disorder. The study is designed to evaluate the impact of Vivitrol in bringing down the incidence of re-arrest among the prisoners having a history of opioid dependence and currently seeking treatment. Alkermes intends to disclose data from the study in mid-calendar 2013.

The incidence of re-incarceration, drug abuse treatment program entry, treatment retention in the community, incidence of opioid use and opioid overdose in addition to life quality and HIV risk behaviors comprise the secondary endpoints of the trial.

Alkermes intends to treat the prisoners with Vivitrol for approximately 7 days prior to their release. Following their release, they will be treated for an additional six months with a once monthly dose of the drug with a follow-up period (post-treatment) of one month.

We note that Vivitrol is already approved in the US for the prevention of relapse to opioid dependence, after opioid detoxification. The drug is also approved for treating alchohol dependence.

The commencement of the pivotal trial of Vivitrol in prisoners comes close on the heels of a couple of other pipeline related developments for Alkermes. In early January 2012, Alkermes announced that its candidate ALKS 5461 has fared well in a phase I/II study (n=32) in patients suffering from major depressive disorder (MDD). In December 2011, the company announced the commencement of a phase III study (n~690) to evaluate its candidate ALKS 9070 for treating patients suffering from schizophrenia.

However, the best news for Alkermes, as it prepares to release its third quarter of fiscal 2012 financial results on February 2, came in the form of the US approval for type II diabetes treatment Bydureon. Alkermes initially co-developed the drug with Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly & Company (LLY). However, in November 2011, Amylin and Eli Lilly terminated their agreement.

Our Recommendation

We are positive on the merger between Alkermes, Inc. and Elan Corporation's (ELN) unit, Elan Drug technologies, which created Alkermes plc in September 2011.  However, we believe that it will take some time for the merged entity to start delivering.  Hence, we are Neutral on Alkermes in the long-run. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.

 
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