Good News for Alkermes' Pipeline - Analyst Blog


Alkermes plc ( ALKS ) recently announced that its candidate ALKS 5461 has fared well in a phase I/II study (n=32) in patients suffering from major depressive disorder ( MDD ). The patients evaluated in the study had responded inadequately to treatments under the standard drugs for clinical depression. ALKS 5461 is a combination of buprenorphine and Alkermes' another candidate ALKS 33.

Topline data from the multicenter, randomized, double-blind, placebo-controlled, parallel-group seven day study revealed that there was a significant reduction in depression symptoms in patients treated with ALKS 5461 compared to those in the placebo arm. Moreover, ALKS 5461 was well tolerated in the study.

The encouraging top line data prompted the company to evaluate the candidate in a larger study (phase II: n~130) for the MDD indication. Alkermes expects data from the randomized, double-blind, multicenter, placebo-controlled phase II study in the first half of calendar 2013. We note that Alkermes is also evaluating ALKS 5461 for cocaine addiction.

Apart from ALKS 5461 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 9070 for treating patients suffering from schizophrenia.

The lead candidates added through the purchase of the Elan Drug Technologies unit from Elan Corporation ( ELN ) 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

Despite being positive on the merger  of 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. Consequently, we are Neutral on Alkermes in the long-run. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

ALKERMES INC ( ALKS ): Free Stock Analysis Report
ELAN CP PLC ADR ( ELN ): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: ALKS , ELN , MDD

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