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 (ALPMF).
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