Alkermes’ (ALKS - Free Report) product portfolio as well as pipeline have been strengthened following its purchase of Elan Corporation’s Elan Drug Technologies unit. Interesting candidates include aripiprazole lauroxil for treating schizophrenia, ALKS 5461 (a combination of ALKS 33 and buprenorphine) for major depressive disorder, ALKS 3831 and a three-month formulation of Invega sustenna.
We are impressed by Alkermes’ efforts to develop its pipeline. Regarding ALKS 5461, the company completed its end-of- phase II interactions with the U.S. Food and Drug Administration (FDA). Following the successful completion of the interactions, the company intends to start evaluating the candidate in major depressive disorder patients who have responded inadequately to standard treatments for the disease early next year.
As a result of the communications, Alkermes and the U.S. regulatory body agreed on the key elements of the phase III program, including its design. The written communications proved to be sufficient for the 2 parties to come to an agreement. Consequently, a meeting was not necessary.
Aripiprazole lauroxil (formerly known as ALKS 9070) is another interesting candidate in Alkermes’ pipeline. The company has completed enrolling patients in a phase III study on the candidate. The 12-week, multicenter study will be evaluating the efficacy, safety and tolerability of aripiprazole lauroxil in patients who experience acute exacerbation of schizophrenia. Successful development and subsequent commercialization of aripiprazole lauroxil would boost Alkermes’ top line since the schizophrenia market offers significant commercial potential.
Alkermes currently carries a Zacks Rank #3 (Hold). Companies like Actelion Ltd. and Isis Pharmaceuticals, Inc. appear to be better placed with a Zacks Rank #1 (Strong Buy).