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Positive Data on Forest Labs/Gedeon's Cariprazine

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Forest Laboratories, Inc. and partner, Gedeon Richter plc, said that their antipsychotic candidate, cariprazine met the primary endpoint in a phase IIb study (n=584). The study was conducted to evaluate the efficacy and safety of the candidate for the treatment of adults (aged between 18 and 65 years) suffering from bipolar depression.

The study comprised four patients groups with cariprazine administered in three groups at dosages of 0.75 mg/day, 1.5 mg/day and 3.0 mg/day, while the last group received placebo. The 1.5 mg/day treatment group showed statistically significant improvements in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to placebo at 6 weeks.

We note that this is the second set of positive data presented by Forest Labs on cariprazine this year. Last month, the company had announced positive topline results on cariprazine from a phase IIb study for the treatment of adults suffering from major depressive disorder (MDD).

The positive results are encouraging. According to the The National Alliance on Mental Illness (NAMI), 2.6% of adults in the U.S. suffer from bipolar disorder. Some of the approved treatments for bipolar depression include Sunovion Pharmaceuticals’ Latuda (treatment of adult patients with major depressive episodes associated with bipolar I disorder) and Forest Labs’ Saphris (schizophrenia and manic or mixed episodes associated with bipolar I disorder).

Meanwhile, Forest Labs is also looking to get cariprazine approved for the treatment of adults suffering from schizophrenia and bipolar mania. However, in November last year, the company had received a complete response letter (CRL) in the U.S. for these two indications.

We remind investors that Actavis plc announced its intention to acquire Forest Labs for a cash and equity transaction valued at about $25 billion. The deal is expected to close in mid-2014.

Forest Labs carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Questcor Pharmaceuticals, Inc. and Shire plc (SHPG - Free Report) carrying a Zacks Rank #1 (Strong Buy). Actavis carries a Zacks Rank #2 (Buy).

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