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Forest Laboratories, Inc., and Gedeon Richter Plc. recently announced the submission of a new drug application (NDA) for their schizophrenia and bipolar mania candidate, cariprazine.

Forest Labs has made significant progress with its pipeline. With the filing of the cariprazine application, Forest Labs now has two candidates pending approval. Besides cariprazine, the company had filed a new drug application (NDA) for levomilnacipran in September 2012 and expects to hear back from the FDA in the third quarter of calendar 2013.

Levomilnacipran is being developed in collaboration with Pierre Fabre Medicament for the treatment of depression. Successful commercialization of the candidate would build on Forest Lab’s already strong presence in the depression market.

Meanwhile, Forest Labs gained US approval for two products in calendar 2012 - Linzess (linaclotide) and Tudorza (aclidinium). While Linzess (partnered with Ironwood Pharmaceuticals (IRWD - Analyst Report)) gained approval for the treatment of constipation-predominant irritable bowel syndrome and chronic constipation, Tudorza (partnered with Almirall) gained approval for chronic obstructive pulmonary disorder (COPD) in July 2012.

We currently have a Neutral recommendation on Forest Labs, which carries a Zacks #3 Rank (Hold). Forest Labs is facing tough times with Lexapro losing exclusivity. Following the release of second quarter results, Forest Labs once again cut its outlook for fiscal 2013.

More than Lexapro’s genericization, the cut in Namenda’s guidance was disappointing as Namenda is currently the main contributor to the company’s top line. Moreover, the performance of new products, especially Teflaro, has been below expectations. Meanwhile, Namenda will face generic competition from early 2015.

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