Positive Results on Forest/Gedeon Drug - Analyst Blog
February 09 2012 - 1:33PM
Zacks
Forest Laboratories, Inc. (FRX) and partner
Gedeon Richter recently presented positive top-line results on
their antipsychotic candidate, cariprazine (RGH-188). Preliminary
top-line results were presented from a phase III study that was
conducted in patients with acute mania associated with bipolar I
disorder.
Results from the five-week multi-center, double-blind,
placebo-controlled, parallel-group study showed that patients in
the cariprazine arm experienced significant symptom improvement
compared to patients in the placebo arm. The improvement was
observed as early as the fifth day of treatment and at each
subsequent time point studied.
Cariprazine, a novel, orally active D2/D3 antagonist, was
generally well tolerated. However, discontinuations due to adverse
events were higher in the cariprazine arms compared to placebo.
Forest Labs intends to analyze the data further. Results from this
study were similar to those reported by the company from two other
studies conducted with cariprazine.
Cariprazine is being studied for other indications as well,
including schizophrenia, bipolar depression, and as an adjunct
treatment in major depressive disorder (MDD). Forest Labs plans to
file for approval of cariprazine in the second half of 2012.
Cariprazine became a part of Forest Labs' pipeline with its 2004
collaboration and licensing agreement with Gedeon Richter. Forest
Labs gained development and exclusive US rights to cariprazine and
related compounds. Other players in the antipsychotic market
include Bristol-Myers Squibb (BMY) and Eli
Lilly (LLY) among others.
We are pleased to see Forest Labs' progress with its pipeline.
The pipeline needs to deliver given the patent cliff being faced by
the company. Depression product, Lexapro, is slated to lose patent
protection in March 2012 - this will place roughly half the
company's top-line at risk to generic competition.
We believe that combined sales of Bystolic, Savella and newly
launched products will not be enough to compensate for the loss of
Lexapro sales. Namenda will face generic competition in early 2015
-- this puts another $1+ billion at risk.
Given the situation, we believe that Forest Labs will continue
to seek in-licensing and acquisition activities to grow its
pipeline. We currently have a Neutral recommendation on Forest
Labs, which carries a Zacks #3 Rank (short-term Hold rating).
BRISTOL-MYERS (BMY): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
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