Alkermes plc (ALKS) recently announced the commencement of a phase II study (n~400) on its schizophrenia candidate ALKS 3831. ALKS 3831 is a combination of ALKS 33, and Eli Lilly and Company’s (LLY) Zyprexa (olanzapine).
The double-blind, active-controlled, dose-ranging study will evaluate the safety and tolerability of the candidate. Alkermes also intends to asses the impact of ALKS 3831 on weight and other metabolic factors compared to Zyprexa alone. Alkermes also intends to confirm the results (involving weight gain) in the phase I study on ALKS 3831. Results from the phase I study were announced in Jan 2013.
Data from the phase I study revealed that weight gain in patients who were administered ALKS 3831 was significantly lower (an average of 2.5 kg) than in patients who took Zyprexa (an average of 3.4 kg).
In a separate development, Alkermes unveiled three more pipeline candidates- a monomethyl fumarate (MMF) prodrug program (multiple sclerosis), ALKS 7106 (pain), and RDB 1419 (oncology). Alkermes intends to commence a phase I study on the MMF prodrugs in mid- 2014. A phase I study on ALKS 7106 is also expected to be initiated in mid-2014 after filing an investigational new drug (IND) application. Alkermes also stated at its R&D day that it intends to conduct IND-enabling activities on the oncology candidate RDB 1419 in 2014.
Alkermes also stated that phase III data on its schizophrenia candidate aripiprazole lauroxil is expected in the first half of 2014. Alkermes intends to submit a new drug application seeking marketing approval for the candidate in 2014. Aripiprazole lauroxil is expected to be launched in 2015.
The company also provided an update on its pipeline candidate, ALKS 5461 (a combination of ALKS 33 and buprenorphine) for major depressive disorder. Alkermes stated at its R&D day that following encouraging phase II results on the candidate, announced earlier in the year, it intends to meet the US Food and Drug Administration officials for an end- of - phase II meeting. The company intends to initiate a pivotal program on the candidate in 2014. The successful development and commercialization of these candidates should boost the company’s top line.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Biopharmaceutical stocks such as Medivation, Inc. (MDVN) and Sarepta Therapeutics, Inc. (SRPT) appear to be well placed with a Zacks Rank #1(Strong Buy).
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