) is leaving no stone unturned to develop its pipeline
successfully. The biopharmaceutical company's pipeline expanded
significantly following the purchase of the erstwhile Elan's drug
delivery unit. Elan was acquired by
) last year.
Important pipeline candidates at Alkermes include ALKS 5461 for
treating patients suffering from major depressive disorder (phase
III), aripiprazole lauroxil (phase III), ALKS 3831 (phase II) and a
three-month formulation of Invega sustenna for schizophrenia (U.S.
approval expected to be sought by Dec 31, 2014).
In line with efforts to develop its pipeline, last week Alkermes
announced the commencement of a phase I study (n~125) on ALKS 8700,
a monomethyl fumarate molecule, for treating MS patients. The stock
has gained 2% since the announcement.
Alkermes stated that it will evaluate the safety, tolerability and
pharmacokinetics of several oral versions and doses of ALKS 8700
compared to both placebo and active control cohorts in healthy
volunteers through the randomized, double-blind study. Alkermes
believes that ALKS 8700 offers differentiated dosing and
tolerability compared to
) MS drug Tecfidera.
Though the development of ALKS 8700 is encouraging, we believe that
investor focus will remain primarily on updates regarding
aripiprazole lauroxil. Encouraging phase III results on the
candidate were presented by Alkermes last month at the American
Society of Clinical Psychopharmacology.
Alkermes intends to seek U.S. approval of the schizophrenia
candidate by Sep 30, 2014. The approval would boost Alkermes' top
line since the schizophrenia market offers significant commercial
potential. Alkermes is also evaluating a once every two months
dosing regimen for aripiprazole lauroxil.
Alkermes carries a Zacks Rank #3 (Hold). A better-ranked stock in
the health care sector is
) sporting a Zacks Rank #1 (Strong Buy).
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