Recently, Alkermes Inc. (ALKS) announced that its pipeline candidate, ALKS33, for addiction and nervous system disorders, gave positive results in two early stage clinical trials. Results from the two studies, ALK33-003 and ALK33-004, demonstrated that the candidate blocked the effects of an opioid with an action duration that supported once daily dosing.
The studies were initiated in May this year. ALK33-003, a randomized, double-blind, placebo-controlled, multi-dose study, evaluated the pharmacokinetics, safety and tolerability of multiple doses of ALKS33 in 30 healthy volunteers. ALK33-004, a randomized, single-blind, placebo-controlled, single-dose study, was designed to examine the ability of ALKS33 to block the effects of an opioid following a single oral dose of ALKS33 in 24 healthy, non-dependent, opioidexperienced subjects.
ALKS33, an oral opioid modulator, was generally well-tolerated in both the studies. The company intends to move the candidate into mid-stage studies by the end of this calendar year. Opioid receptors, which are blocked by ALKS33, are involved in gastrointestinal and immune disorders, pain, addiction, and psychiatric illness.
Other candidates under development at Alkermes include ALKS 27 for chronic obstructive pulmonary disorder (COPD), ALKS 29 for alcohol dependence, ALKS 36, a co-formulation of an opioid analgesic and RDC-1036 for the treatment of pain.
We remind investors that a key action date for Alkermes is coming up in 2010 when the US Food and Drug Administration (FDA) will decide on the company’s type II diabetes candidate, exenatide once-weekly. Exenatide once weekly is an injectable formulation of Amylin Pharmaceuticals’ (AMLN) Byetta (exenatide).
Although the efficacy data on exenatide once-weekly is impressive, we are concerned that the approval of the product could be pushed back beyond the first quarter of 2010, given the current regulatory environment.
Our concern stems from the potential safety of the drug. Fears of pancreatitis and new fears of thyroid cancer associated with the use of glucagon-like peptide-1 (GLP-1) molecules like exenatide lead us to believe that the FDA will want to see additional data before they grant approval. Currently we are Neutral on Alkermes.
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