Alkermes (ALKS - Free Report) announced that it has initiated a pivotal program to evaluate its major depressive disorder (MDD) candidate, ALKS 5461. The pivotal program, FORWARD (Focused On Results With A Rethinking of Depression) will evaluate ALKS 5461 in patients who did not respond satisfactorily to currently available therapies.
FORWARD comprises three core phase III efficacy studies and nine supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and abuse potential of ALKS 5461. The company has already commenced the first FORWARD study (n = 60) to evaluate the onset of action, safety and tolerability profile of the candidate. The three core efficacy studies are expected to be initiated in mid 2014.
Alkermes plans to submit a New Drug Application (NDA) for ALKS 5461 to the U.S. Food and Drug Administration (FDA) based on efficacy and safety data from the FORWARD program.
Earlier, in Apr 2013, Alkermes had reported encouraging top-line data from a phase II study (n=142) on ALKS 5461. The study evaluated the safety and efficacy of ALKS 5461 across two doses for the treatment of MDD in patients who show inadequate response to currently available therapies. Results from the study revealed that depressive symptoms were reduced across a range of standard measures. ALKS 5461 was well tolerated during the study.
We note that the candidate enjoys a Fast Track designation in the U.S.
We are encouraged by Alkermes’ efforts to develop its pipeline. However, we note that the MDD market currently has big players like Eli Lilly and Company (LLY - Free Report) . We believe investors focus will remain Alkermes’ pipeline development efforts. 2014 is expected to be a data rich year for Alkermes with multiple pipeline related events lined up (aripiprazole lauroxil for schizophrenia – phase III data expected by Jun 30, 2014). Positive news on the pipeline will boost the stock.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #1 (Strong Buy). Biopharma stocks Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Amgen Inc. (AMGN - Free Report) carry the same Zacks Rank as Alkermes.