Alkermes Inc.’s (ALKS) pipeline received a shot in the arm with its candidate ALKS 37 faring well in a mid-stage study (n=87) in patients suffering from opioid induced constipation.
Results revealed that treatment with ALKS 37 reduced constipation arising out of the intake of opioid pain therapies without compromising on the efficacy of the drugs. Alkermes intends to present complete results from the study at an upcoming medical conference.
The multi-center, randomized, double-blind, placebo-controlled study evaluated the safety, efficacy and tolerability of the candidate in patients suffering from opioid-induced bowel dysfunction (OBD) while undergoing opioid treatment for chronic, non-cancer pain. The patients were treated with either ALKS 37 (once daily) or placebo for 14 days.
Preliminary results from the multi-dose study revealed a significant increase in the weekly number of bowel movements in patients treated with 30 mg and 100 mg (the two highest doses evaluated) of the candidate compared those treated with placebo. ALKS 37 was well tolerated.
The study was characterized by the absence of serious side-effects, the most common being abdominal pain and diarrhea. The positive results have encouraged the company to plan a pivotal study of the candidate in mid calendar 2011.
Alkermes has many pipeline events lined up. The company intends to present data regarding another pipeline candidate, ALKS 33, in multiple indications during the course of calendar 2011. Alkermes has many other candidates in development.
Alkermes has two approved products on the market. The lead product is Risperdal Consta approved for the treatment of schizophrenia and bipolar disorder. The drug is marketed worldwide by Johnson & Johnson (JNJ) and manufactured by Alkermes.
The other approved product is Vivitrol for the treatment of alcohol dependence. The label of the product was expanded in October 2010 when the US Food and Drug Administration (FDA) approved the drug for the prevention of relapse to opioid dependence after opioid detoxification.
The drug is expected to be launched for the additional indication during calendar 2011. We believe that the approval of Vivitrol for the additional indication will bring in additional revenues at Alkermes.
Even though October 2010 saw the FDA clearing Vivitrol for an additional indication, the same month brought distress to Alkermes. The FDA issued a second complete response letter (CRL) for its lead pipeline candidate, Bydureon, for treating type II diabetes. Bydureon has been co-developed by Eli Lilly and Company (LLY), Alkermes and Amylin Pharmaceuticals, Inc. (AMLN).
A response to the CRL will be submitted in the second half of 2011. We note that Bydureon is currently under review in Europe with a decision expected during the course of 2011.
Our View
Going forward, we expect investor focus to remain on the approval process for Bydureon and see limited upside potential from current levels. Consequently, we retain our Neutral stance on the stock which is supported by the Zacks #3 Rank (Hold rating) carried by Alkermes in the short run.
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