Forest Laboratories, Inc.
) continues to progress with its pipeline. The company and Pierre
Fabre Laboratories recently submitted a new drug application for
levomilnacipran. The companies are looking to get levomilnacipran
approved by the US Food and Drug Administration (FDA) for the
treatment of major depressive disorder (MDD) in adults.
Forest Labs and Pierre Fabre have presented positive results on
levomilnacipran from three phase III studies including two
double-blind, fixed-dose studies and one flexible-dose study.
Levomilnacipran showed a statistically significant improvement
compared to placebo in all three studies. Moreover, levomilnacipran
was generally found to be well tolerated. Successful
commercialization of the candidate would build on Forest Labs'
already strong presence in the depression market.
Forest Labs has a collaboration agreement with Pierre Fabre,
signed in December 2008, for the development and commercialization
of levomilnacipran in the US and Canada. The active pharmaceutical
ingredient (API) for levomilnacipran will be supplied by Pierre
We are pleased with Forest Labs' success with its pipeline. The
levomilnacipran filing comes a few weeks after the company gained
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
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
cariprazine by year end. Cariprazine is being developed for the
treatment of schizophrenia, bipolar mania and other psychiatric
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
To read this article on Zacks.com click here.