Forest Launches Two Products - Analyst Blog
December 19 2012 - 6:10AM
Zacks
Forest Laboratories, Inc. (FRX) and partner
Ironwood Pharmaceuticals, Inc. (IRWD) recently
launched Linzess (linaclotide), which is approved for the treatment
(once-daily) of adults suffering from irritable bowel syndrome with
constipation (IBS-C) or chronic idiopathic constipation (CIC).
The companies had gained FDA approval for the product in August
2012. Linzess’ label carries a boxed warning stating that Linzess
is contraindicated in pediatric patients up to 6 years of age.
Moreover, Linzess’ use in pediatric patients 6 through 17 years of
age should be avoided.
Forest Labs also launched another product, Tudorza, in the US.
Tudorza gained FDA approval in late July 2012 for the long-term
maintenance treatment of bronchospasm associated with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis
and emphysema.
The approval and launch of Linzess and Tudorza is a major
milestone for Forest Labs, which is currently facing generic
competition for depression drug Lexapro. Over the past few years,
Forest Labs has been very active in signing in-licensing and
partnership deals with the intention of expanding its pipeline.
Forest Labs currently has two candidates pending approval.
Besides seeking FDA approval for cariprazine (schizophrenia and
bipolar mania), the company is looking to get levomilnacipran
approved for the treatment of depression. A response from the FDA
regarding levomilnacipran should be out in the third quarter of
calendar 2013. Successful commercialization of the candidate would
build on Forest Labs’ already strong presence in the depression
market.
We currently have a Neutral recommendation on Forest Labs, which
carries a Zacks #3 Rank (Hold). We expect investor focus to remain
on the successful commercialization of new products. Pharma
companies that currently carry a Zacks #1 (Strong Buy) include
Astellas Pharma (ALPMY).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
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