Positive News on Forest's Pipeline - Analyst Blog
March 06 2012 - 9:30AM
Zacks
Forest Laboratories, Inc. (FRX) recently
reported back-to-back positive news on the pipeline front. The
company and partner Gedeon Richter Plc. announced that their
late-stage antipsychotic candidate, cariprazine, met its primary
endpoint in two phase III studies.
The studies were conducted to evaluate cariprazine for the
treatment of acute exacerbation of schizophrenia. Results showed
that patients in the cariprazine arm achieved a significant
improvement in symptom compared to patients in the placebo arm.
Statistically significant separation from placebo was observed in
all doses from week 2 and at each subsequent time point. Forest
Labs and Gedeon said that the higher dose showed separation as
early as week 1 of treatment. The results were similar to
data presented earlier from a phase IIb fixed-dose
placebo-controlled study.
Cariprazine is one of the candidates that Forest Labs intends to
file for approval in 2012, the other candidate being
levomilnacipran (treatment of major depressive disorder).
Cariprazine is being studied for other indications as well
including bipolar depression and as an adjunct treatment in major
depressive disorder (MDD).
Earlier, in February 2012, Forest Labs and Gedeon had reported
positive preliminary top-line results on cariprazine from a phase
III study conducted in patients with acute mania associated with
bipolar I disorder.
Forest Labs will most likely file for US approval of cariprazine
in the second half of 2012. However, the antipsychotic market,
while large, is pretty crowded with players like
Bristol-Myers Squibb (BMY) and Eli
Lilly (LLY) among others.
Panel Votes for Aclidinium
Meanwhile, another candidate in Forest Labs’ pipeline,
aclidinium bromide, recently received a positive recommendation
from the US Food and Drug Administration’s (FDA) Pulmonary-Allergy
Drugs Advisory Committee (PADAC). The committee voted 12 to 2 in
favor of approving aclidinium bromide for the maintenance treatment
of chronic obstructive pulmonary disease (COPD). The committee
voted unanimously in favor of the efficacy and 10-3 in favor of the
safety of the 400 ug twice daily dose.
Although the FDA is not bound to follow the advice of its
advisory committees, it usually does so. A response regarding
aclidinium's approval status should be out in the second quarter 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 were pleased to see 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.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
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