Forest Files Cariprazine NDA - Analyst Blog
December 04 2012 - 6:00AM
Zacks
Forest Laboratories, Inc., (FRX) 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 market.
Meanwhile, Forest Labs gained US approval for two products in
calendar 2012 - Linzess (linaclotide) and Tudorza (aclidinium).
While Linzess (partnered with Ironwood
Pharmaceuticals (IRWD)) 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
2015.
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
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