Forest Laboratories, Inc.
) and partner
Ironwood Pharmaceuticals, Inc.
) 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
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
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
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)
FOREST LABS A (FRX): Free Stock Analysis
IRONWOOD PHARMA (IRWD): Free Stock Analysis
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