Alkermes' Pipeline Development Impresses, Key Updates Ahead


Alkermes (ALKS) 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 Perrigo Company (PRGO) 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 Biogen Idec’s (BIIB) 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 Actelion Ltd. (ALIOF) sporting a Zacks Rank #1 (Strong Buy).

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