ALKS 5461 is one of the most interesting candidates in Alkermes’ (ALKS) pipeline which has expanded significantly following the acquisition of Elan Corporation’s (ELN) Elan Drug Technologies unit. ALKS 5461 is a combination of ALKS 33 and buprenorphine. The candidate is being developed for major depressive disorder (MDD).
Alkermes has progressed well with the development of ALKS 5461. The U.S. Food and Drug Administration (:FDA) has granted fast track status to the candidate for treating MDD patients.
The FDA assigns fast-track status to products that are being developed for the treatment of serious or life-threatening diseases which have an unmet medical need. The designation helps to speed up the review process of the candidate.
Earlier in the month, the company completed its end-of- phase II interactions with the 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. (ALIOF) and Isis Pharmaceuticals, Inc. (ISIS) appear to be better placed with a Zacks Rank #1 (Strong Buy).