Alkermes Inc. (ALKS) announced initiation of an early-stage study of pipeline candidate ALKS-5461 for treating patients suffering from treatment-resistant depression (TRD). ALKS-5461 is a combination of Alkermes’ another pipeline candidate ALKS-33 (an oral opioid modulator) and buprenorphine.
The multicenter, randomized, double-blind, placebo-controlled trial (n=32) will evaluate the safety and efficacy of ALKS-5461 in patients with major depressive disorder who did not respond adequately to previous antidepressant therapy. Topline data from the trial is expected to be presented in the second half of calendar 2011.
Depression is a chronic and serious disease which affects more than 20 million adults in the US annually. TRD is also known as refractory depression. It is characterized by episodes of depression that are not adequately controlled by standard antidepressant therapy.
Alkermes is also developing ALKS-5461 for treating patients suffering from cocaine addiction. The early stage study is being funded by the National Institute on Drug Abuse (NIDA). In October 2010, Alkermes presented encouraging data from the study.
ALKS-33, a component of ALKS-5461, is currently being studied in mid-stage trials for the treatment of alcohol dependence and other central nervous system disorders. Encouraging data from a trial in alcohol dependent patients was released last year.
A major recent development for Alkermes involves a deal entered into with Elan Corporation (ELN) in May 2011 to buy the latter’s drug delivery unit (EDT) for $960 million in cash and stock. The deal is expected to close in the third quarter of calendar year 2011. The combined company will be known as Alkermes plc and will be headquartered in Ireland. The merged entity will primarily focus on developing therapies for treating deficiencies of central nervous system. We believe that the transaction is a positive for Alkermes. The deal is expected to boost Alkermes’ cash earnings immediately following its closure. The product portfolio at Alkermes will be strengthened following the merger.
Our Recommendation
Currently we have a ‘Neutral’ long-term recommendation for Alkermes. The company carries a Zacks #3 Rank (‘Hold’ rating) in the short run.
ALKERMES INC (ALKS): Free Stock Analysis Report
Be the first to comment