AMLN Amylin Pharmaceuticals, Inc. (MM)

Recently, Alkermes Inc. (ALKS) presented disappointing top line data from a mid-stage study (n=68) of its pipeline candidate ALKS 33 for treating patients suffering from binge eating disorder.

The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ALKS 33, administered orally on a daily basis, versus placebo.

Results from the 12-week study revealed ALKS 33 was not more effective than placebo in reducing weekly episodes of binge eating. The disappointing results prompted Alkermes to decide against developing ALKS 33 further for the indication. Binge eating disorder is a very common eating disorder in the US and often leads to obesity in the affected individuals.

Even though Alkermes has not reached success with ALKS 33 for the indication, it continues to evaluate ALKS 33 for other indications. The candidate is being evaluated for alcohol dependence. Moreover, Alkermes is studying ALKS 33 in combination with buprenorphine (as ALKS 5461) for treating patients suffering from cocaine addiction and treatment-resistant depression.

Apart from ALKS 33, Alkermes has other candidates in its pipeline such as ALKS 37 for opioid-induced constipation, ALKS 6931 for treating rheumatoid arthritis, ALKS 36 for the treatment of pain without the side-effects of constipation, ALKS 9070 and ALKS 7921 for treating schizophrenia.

However, we believe that investor focus will remain on the fate of diabetes drug, Bydureon, in the US rather than on development of the other pipeline candidates at Alkermes. It has co-developed Bydureon, which was approved in the European Union in June 2011, with Amylin Pharmaceuticals (AMLN) and Eli Lilly and Company (LLY).

Our Recommendation

Currently we have a ‘Neutral’ long-term recommendation for Alkermes. The company carries a Zacks #3 Rank (‘Hold’ rating) in the short run.

 
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