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Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
Date:9/30/2008

NEW YORK and BUDAPEST, Hungary, Sept. 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today announced preliminary top-line results from a phase II clinical trial of cariprazine (RGH-188), an investigational antipsychotic, in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that patients with acute manic episodes treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied. Further analyses of the data will be completed in the coming weeks. Cariprazine is also currently being investigated in clinical studies in schizophrenia.

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"These exciting preliminary results in patients with bipolar mania demonstrate the potential of cariprazine as a novel antipsychotic agent," stated Marco Taglietti, M.D., Executive Vice President and Chief Medical Officer, Forest Laboratories, Inc. "Therefore, we will continue to investigate and characterize the therapeutic benefits of cariprazine, a unique molecule with high selectivity for the D3 versus the D2 dopamine receptors.

"Dopamine system stabilizer cariprazine clearly proved its effect in this study," commented Zsolt Szombathelyi, M.D., Research Director of Gedeon Richter Plc. "The result confirms Richter's CNS research concept and the clinical opportunity of a dual acting D3/D2 compound."

About the Study

The phase II double-blind, placebo-controlled, flexible-dose study evaluated the
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SOURCE Gedeon Richter Plc; Forest Laboratories, Inc.
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