) product portfolio as well as pipeline have been strengthened
following its purchase of
) 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
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
Isis Pharmaceuticals, Inc.
) appear to be better placed with a Zacks Rank #1 (Strong
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