Alkermes plc (ALKS) recently announced positive results from a phase I study on its new antipsychotic candidate, ALKS 3831. ALKS 3831 is a combination of ALKS 33, and Eli Lilly and Company’s (LLY) Zyprexa (olanzapine).
Alkermes is developing ALKS 3831 for the treatment of schizophrenia and is designed to reduce the antipsychotic-related metabolic side effect of weight gain. Alkermes enrolled 106 healthy volunteers for the study.
Results from the study showed 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). Alkermes also reported that ALKS 3831 was well tolerated in the study and the safety and tolerability results were almost similar to that of Zyprexa alone.
The company stated in its press release that weight gain is a common side effect in atypical antipsychotic medications and Zyprexa has the highest number of incidences and greatest amount of weight gain in this class of drugs.
Alkermes expects to initiate a phase II study on ALKS 3831 in mid-calendar 2013 after meeting the US Food and Drug Administration (:FDA) on the basis of the positive results from the phase I study.
We remind investors that the schizophrenia market is highly competitive with the presence of players like Eli Lilly and Novartis AG (NVS).
We currently have a Neutral recommendation on Alkermes. The stock carries a Zacks #3 Rank (Hold). Meanwhile, other pharma stocks such as Targacept, Inc. (TRGT) and Repligen Corporation (RGEN) carry a Zacks #1 Rank (Strong Buy).
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