Forest Seeks FDA Nod for MDD Drug

Forest Laboratories, Inc. ( FRX - Analyst Report ) 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 Fabre.

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 constipation (CIC).

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 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 products.