Pipeline Progress at Alkermes

Alkermes plc (ALKS - Analyst Report) recently announced the commencement of a phase III study (n~690) to evaluate its schizophrenia candidate ALKS 9070. ALKS 9070 is a once-monthly injectable extended release version of Bristol-Myer Squibb’s (BMY - Analyst Report) schizophrenia drug Abilify (aripiprazole).

The double-blind, randomized, multicenter, 12-week study will evaluate the safety, tolerability and effectiveness of ALKS 9070 versus placebo in 2 doses in patients experiencing acute exacerbation of the disease. The study will be followed by an open label phase of 12 months duration. Results from the study are expected in mid-2013.

We note that ALKS 9070 has performed encouragingly so far in clinical trials. Earlier in the year, Alkermes presented positive data from phase Ib study (n=32) of ALKS 9070. Data from the study revealed that the candidate was generally well tolerated across all the evaluated doses and achieved therapeutically relevant plasma concentrations of Abilify. The pharmacokinetic profile backed the once-monthly dosing of ALKS 9070.

Apart from ALKS 9070 Alkermes has other interesting candidates in its pipeline such as ALKS-37 for opioid-induced constipation, ALKS-33 for multiple indications, ALKS-36 for the treatment of pain without the side-effects of constipation and ALKS 5461 (a combination of ALKS 33 and buprenorphine) for treating patients suffering from treatment resistant depression  and cocaine addiction.

The lead candidates added through the purchase of the Elan Drug Technologies unit from Elan Corporation (ELN - Snapshot Report) in September 2011 include pain candidates Meloxicam IV and Zohydro. The successful development and commercialization of these candidates should boost the company’s top-line.

Our Take & Recommendation

Even though positive on the merger  between Alkermes, Inc. and Elan's EDT unit which created Alkermes plc, we believe that it will take some time for the merged entity to start delivering. This uncertainty is reflected by the Zacks #4 Rank (Sell rating) carried by the stock in the short-run. We are however Neutral on Alkermes in the long-run.

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