Alkermes (ALKS) recently announced encouraging top-line data from a phase II study (n=142) on ALKS 5461. The study evaluated the safety and efficacy of ALKS 5461 across two doses for the treatment of major depressive disorder (MDD) in patients who did not respond satisfactorily to currently available therapies for clinical depression.
Results from the randomized, double-blind, multicenter, placebo-controlled study showed that depressive symptoms were reduced across a range of standard measures. Results also revealed that ALKS 5461 was well tolerated during the study. Alkermes now plans to advance ALKS 5461 into a pivotal development program based on the positive phase II data and previously reported favorable phase I/II results.
We note that the MDD market currently has big players like Eli Lilly and Company (LLY) and Pfizer Inc. (PFE). ALKS 5461 is a combination of ALKS 33 and buprenorphine.
We are encouraged by Alkermes’ efforts to develop its pipeline. Apart from ALKS 5461, Alkermes also has aripiprazole lauroxil (phase III, data expected by the end of calendar 2013) for schizophrenia, in its pipeline.
Alkermes was recently in the news for the approval of a restructuring plan by its board of directors related to a manufacturing facility at Athlone, Ireland. By fiscal 2016 and beyond, annual cost savings from these restructuring initiatives are expected in the range of $15–$20 million. We are positive on the restructuring plan. The company’s fiscal year commences in April.
Alkermes, a biotechnology company, currently carries a Zacks Rank #1 (Strong Buy). Another biotech company WuXi PharmaTech (Cayman) Inc. (WX) also carries a comparable rank.
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