Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced positive top-line results in 2 Phase III clinical trials of cariprazine (RGH-188) for the treatment of acute exacerbation of schizophrenia.

For the primary endpoint in each study, the Positive And Negative Syndrome Scale (PANSS), the data showed that cariprazine-treated patients experienced significant symptom improvement compared to placebo-treated patients. All doses showed statistically significant separation from placebo starting at week 2 and at each subsequent time point with the higher dose showing separation as early as week 1 of treatment. Further analyses of the data in each study will be completed in the coming weeks. The results of these 2 studies were consistent with the results of the previously completed placebo-controlled Phase IIb fixed-dose study in this population.

Cariprazine is also currently being investigated in clinical studies for patients with bipolar depression, and as an adjunct treatment for Major Depressive Disorder (MDD). Recently, results were disclosed for a third positive trial in bipolar mania.

“By successfully meeting the primary endpoint in each of these studies, we now have 3 positive schizophrenia trials and 3 positive bipolar mania trials,” said Dr. Marco Taglietti, President of Forest Research Institute. “We look forward to filing the NDA for both indications in 2012.”

“We are pleased with these results which demonstrate that cariprazine provided significant improvement in symptoms for patients suffering from schizophrenia,” said Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter Plc. “It is indeed very encouraging that following successful Phase III trials in bipolar mania and positive Phase III trials in schizophrenia, we may offer promising treatment options for both conditions.”

About the Fixed-Dose Study

This Phase III, multinational, multicenter, double-blind, placebo controlled, parallel-group study evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia. Eligible patients were those that met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia and had a PANSS total score between 80 and 120 at screening and baseline.

Following a washout period of no antipsychotic therapy for up to 7 days, a total of 617 patients between 18 and 60 years old were randomized to one of the following treatment arms: 3 mg/d cariprazine, 6 mg/d cariprazine, 10 mg/d aripiprazole or placebo given once daily for 6 weeks followed by an additional 2-week safety follow-up period, where no drug was administered. Patients were hospitalized during the washout period and for the first 4 weeks of the double-blind treatment. Thereafter, patients were followed either as inpatients or outpatients, as determined by the site investigator and based on patient status.

The protocol-specified primary endpoint was the change from baseline to Week 6 in the PANSS total score for the individual cariprazine treatment groups compared to placebo treatment using a mixed-effects model for repeated measures (MMRM) analysis. The PANSS is a well accepted scale used to evaluate symptom severity in schizophrenia. Statistically significant improvement in PANSS total score was observed in each of the cariprazine dose groups relative to the placebo treatment group (3 mg/day: -6.0, p=0.0044 and 6 mg/day: -8.8, p

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