Forest Candidate Scores in Study - Analyst Blog
March 13 2012 - 10:45AM
Zacks
Forest Laboratories, Inc. (FRX) and Pierre
Fabre Medicament recently announced positive top-line data on their
phase III candidate, levomilnacipran, which is being developed for
the treatment of adults with major depressive disorder (MDD).
Results from the randomized, double-blind, placebo-controlled,
flexible-dose study showed that patients in the levomilnacipran arm
experienced a significant reduction in depression symptoms compared
to patients on placebo. The reduction was experienced as early as
week one and at each subsequent visit.
Forest Labs and Pierre Fabre are analyzing the data further.
Last year, the companies had reported positive data from another
placebo-controlled phase III study conducted in adults suffering
from MDD.
Another placebo-controlled phase III fixed-dose study is
currently ongoing with results expected in Spring 2012.
Levomilnacipran is one of the candidates that Forest Labs
intends to file for approval in 2012, the other being antipsychotic
candidate cariprazine. Forest Labs will most likely file for US
approval of cariprazine in the second half of 2012.
Neutral on Forest Labs
We currently have a Neutral recommendation on Forest Labs, which
carries a Zacks #3 Rank (short-term “Hold” rating). The company is
facing a major patent cliff with lead product Lexapro losing
exclusivity. Mylan (MYL) launched a generic
version of Lexapro in late February. Moreover, Namenda will face
generic competition in early 2015 putting another $1+ billion at
risk.
In such a scenario, the company is dependent on new products to
make up for a part of the loss of revenues that will take place
with the genericization of Lexapro. We are pleased with the
positive developments on the pipeline front. We are also encouraged
by Forest Labs’ efforts to grow its pipeline through in-licensing
and acquisition activities.
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