Recently, Alkermes Inc. (ALKS) received a boost when an advisory panel of the US Food and Drug Administration (FDA) recommended the approval of Vivitrol (naltrexone for extended-release injectable suspension) for treating opioid dependence. Opioid dependence refers to a chronic ailment of the brain.
The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-1 in favor of approving Vivitrol for the additional indication. The drug is already available for the treatment of alcohol dependence for which it gained FDA approval in 2006.
A final response from the FDA regarding the approval of Vivitrol for treating opioid dependence is expected to be out in the third quarter of fiscal 2011 (target date: Oct 12, 2010). Even though the regulatory agency is not bound to follow the advice of its advisory committees, the recommendation of the panel is usually considered while deciding the fate of a drug candidate.
We remind investors that the supplemental New Drug Application (sNDA), seeking to expand Vivitrol’s label, was submitted in April 2010. The application was based on positive results from a randomized, multi-center, late-stage six month study which evaluated the efficacy and safety of Vivitrol for opioid dependence. At the time of submitting the application, Alkermes had requested priority review. The request was approved by the FDA in May 2010. The US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months.
We believe that the approval of Vivitrol for the additional indication is essential to boost its sales. Apart from Vivitrol, the FDA is scheduled to decide on another Alkermes drug in October this year. The target date for Bydureon, co-developed by Alkermes, Eli Lilly (LLY) and Amylin Pharmaceuticals Inc. (AMLN) for treating type II diabetes, is October 22, 2010.
Currently, we have a long-term Neutral stance on the stock which is supported by our Zacks#3 Rank (short-term Hold recommendation) on Alkermes.