Forest Laboratories, Inc.
) and Gedeon Richter Plc. recently announced the submission of a
new drug application (NDA) for their schizophrenia and bipolar
mania candidate, cariprazine.
Forest Labs has made significant progress with its pipeline.
With the filing of the cariprazine application, Forest Labs now
has two candidates pending approval. Besides cariprazine, the
company had filed a new drug application (NDA) for
levomilnacipran in September 2012 and expects to hear back from
the FDA in the third quarter of calendar 2013.
Levomilnacipran is being developed in collaboration with
Pierre Fabre Medicament for the treatment of depression.
Successful commercialization of the candidate would build on
Forest Lab's already strong presence in the depression
Meanwhile, Forest Labs gained US approval for two products in
calendar 2012 - Linzess (linaclotide) and Tudorza (aclidinium).
While Linzess (partnered with
)) gained approval for the treatment of constipation-predominant
irritable bowel syndrome and chronic constipation, Tudorza
(partnered with Almirall) gained approval for chronic obstructive
pulmonary disorder (COPD) in July 2012.
We currently have a Neutral recommendation on Forest Labs,
which carries a Zacks #3 Rank (Hold). Forest Labs is facing tough
times with Lexapro losing exclusivity. Following the release of
second quarter results, Forest Labs once again cut its outlook
for fiscal 2013.
More than Lexapro's genericization, the cut in Namenda's
guidance was disappointing as Namenda is currently the main
contributor to the company's top line. Moreover, the performance
of new products, especially Teflaro, has been below expectations.
Meanwhile, Namenda will face generic competition from early
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