Good News for Alkermes' Pipeline - Analyst Blog

Preliminary results from the 12-week multi-center, double-blind study revealed that ALKS 33 well tolerated at all 3 dose levels. A significant decline in heavy drinking days in a dose dependent manner was observed across all dose levels compared to placebo. The greatest reduction in heavy drinking days (41%) compared to placebo was witnessed in patients treated with the highest dose of the candidate.

However, the difference in complete abstinence from heavy drinking across the treatment groups failed to meet statistical significance. Alkermes intends to set up a meeting with the US Food and Drug Administration (FDA) to discuss the results of the mid-stage study and the potential endpoints for a late-stage study.

We note that ALKS 33 is also being evaluated for other indications such as binge-eating disorder and as a combination therapy for treating cocaine addiction and other disorders. In October 2010, Alkermes presented encouraging data from an early-stage study of the combination therapy of ALKS 33 and buprenorphine combination for treating patients suffering from cocaine addiction.

Our Take

However, Alkermes suffered a major setback this year with the FDA issuing a second complete response letter for diabetes candidate Bydureon. The setback caused Alkermes to trim its revenue projections and increase the net loss forecast for fiscal 2011.

Currently we have a long-term ‘Neutral' stance on Alkermes which is supported by the Zacks #3 Rank (short-term ‘Hold' rating) carried by the company.



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