) initiated two of the three core efficacy phase III studies
(FORWARD-3 and FORWARD-4) on ALKS 5461 under its FORWARD (Focused
On Results With A Rethinking of Depression) program. ALKS 5461 is
being developed for the adjunctive treatment of major depressive
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. Four of
the 12 FORWARD studies have already begun. The third core phase III
study, FORWARD-5, is also expected to be initiated soon.
The FORWARD-3 and FORWARD-4 studies will be evaluating the safety
and efficacy of ALKS 5461 in patients who did not respond
satisfactorily to currently available therapies, including
selective serotonin reuptake inhibitors or serotonin-norepinephrine
reuptake inhibitors. The efficacy studies will primarily assess the
change in Montgomery-Åsberg Depression Rating Scale scores from
baseline in these patients.
Results from the FORWARD-3 and FORWARD-4 studies are expected in
2016. Alkermes intends to utilize the data from the FORWARD program
to form the basis of its New Drug Application (NDA) submission for
ALKS 5461 in the MDD indication in the U.S.
We are encouraged by Alkermes' progress with its pipeline. The
company has a series of pipeline events lined up in the quarters to
come. Candidates like aripiprazole lauroxil and ALKS 3831, both for
schizophrenia, hold promise. Positive news on the pipeline will
boost the stock.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks include
Gilead Sciences Inc.
Regeneron Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
). While Gilead and Regeneron carry a Zacks Rank #1 (Strong Buy),
Alexion holds a Zacks Rank #2 (Buy).
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