Recently, Alkermes Inc. (ALKS) initiated a multidose early-stage study of its candidate of ALKS 37. ALKS 37 is an orally active, peripherally-restricted opioid antagonist, which has the potential to block the effects of opioid agonists on gastrointestinal motility, commonly termed as opioid-induced constipation (OIC).
The randomized, double-blind, placebo-controlled, repeat-dose early-stage trial is designed to assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37. Approximately 24 healthy volunteers will be studied for a period of one week. The study will see two dose levels of ALKS 37 being tested in sequential cohorts.
This study comes after the completion of a previous single dose clinical study in healthy volunteers. In that study ALKS 37 was generally well tolerated and demonstrated low systemic exposure across a wide range of doses. These results will support a mid-stage study of ALKS 37 expected to begin in the first half of calendar 2010. The mid-stage study will assess the safety, tolerability and efficacy of ALKS 37 in individuals suffering from OIC.
We remind investors that the US Food and Drug Administration (FDA) recently issued a complete response letter delaying the approval of the once weekly formulation of Byetta (exenatide). The candidate is being co-developed by Alkermes, Inc., Eli Lilly (LLY) and Amylin Pharmaceuticals, Inc. (AMLN). The companies are seeking to get Byetta once weekly (proposed trade name: Bydureon) approved for the treatment of type II diabetes. However, the agency did not ask the companies to conduct additional clinical or pre-clinical studies. This is encouraging news as additional studies would have delayed approval significantly.
The delay in granting approval does not surprise us. While we were expecting a delay in Byetta once weekly’s approval, we are pleased to see that the companies will not be required to conduct additional studies.
Byetta once weekly should receive approval in the second half of 2010. However, we believe that the final label for Byetta once weekly is likely to contain warnings regarding the risk of pancreatitis and thyroid cancer.
Our Recommendation
We currently have a Neutral outlook on Alkermes in the long-term implying that it will perform in line with the overall U.S. equity market over the next six to twelve months. We advise investors to retain the stock over the time period.
Read the full analyst report on “ALKS”
Read the full analyst report on “AMLN”
Read the full analyst report on “LLY”
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