Forest Laboratories, Inc.
Ironwood Pharmaceuticals, Inc.
) recently announced that they received US Food and Drug
Administration (FDA) approval for Linzess (linaclotide). Linzess is
approved for the treatment (once-daily) of adults suffering from
irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC).
The label comes with 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.
The FDA was previously expected to deliver a decision on Linzess
in June 2012. However, the agency had extended its review period by
three months to September following the submission of additional
analysis of existing data.
Linzess' approval 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 has several interesting candidates in its pipeline,
which if developed successfully, should help compensate for a part
of the loss of revenues with the genericization of Lexapro.
Linzess is the second candidate in Forest Labs' portfolio to
gain approval in the last few weeks. In late July 2012, the company
had gained FDA approval for Tudorza for the long-term maintenance
treatment of bronchospasm associated with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and
emphysema. Both Linzess and Tudorza are slated to launch in the
fourth quarter of 2012.
Meanwhile, the company remains on track to file for approval of
two more candidates (levomilnacipran and cariprazine) by year end.
Levomilnacipran is being developed in collaboration with Pierre
Fabre Medicament for the treatment of depression.
Successful commercialization of the candidate would build on
Forest Labs' already strong presence in the depression market.
Cariprazine is being developed for the treatment of schizophrenia,
bipolar mania and other psychiatric conditions.
We currently have a Neutral recommendation on Forest Labs, which
carries a Zacks #3 Rank (short-term Hold rating). We expect
investor focus to remain on the successful commercialization of new
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis
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