) 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
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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
). 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
Alkermes, a biotechnology company, currently carries a Zacks Rank
#1 (Strong Buy). Another biotech company
WuXi PharmaTech (Cayman) Inc.
) also carries a comparable rank.