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Forest Laboratories, Inc. (FRX), Gedeon Richter Ltd. Schizophrenia Drug Meet Phase III Trial Goals



2/28/2012 7:06:24 AM

NEW YORK & BUDAPEST, Hungary--(BUSINESS WIRE)--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<0.0001) by MMRM analysis. The change from baseline in PANSS total score was statistically significant at every time point starting at week 1 for the cariprazine 6 mg/d group and week 3 onwards for the cariprazine 3 mg/d group. Statistically significant improvements were also seen in the aripiprazole group relative to placebo in the PANSS total score at each week.

Overall, 67% of patients completed the study. The premature discontinuation rates (all causes, including adverse-event related) were 33% for cariprazine 3 mg/day, 38% for cariprazine 6 mg/day, 25% for 10mg/day aripiprazole and 38% for placebo. Cariprazine was generally well tolerated; the most common adverse events (=10%) observed in any treatment group being akathisia, insomnia, and headache.

About the Fixed-Flexible 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. Patients enrolled in the study met the 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 446 patients between 18 and 60 years old were randomized to one of the following treatment arms: 3-6 mg/d cariprazine, 6-9 mg/d cariprazine, 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 each cariprazine treatment group compared to placebo treatment using the MMRM analysis. Statistically significant improvement in PANSS total score was observed in each of the cariprazine dose groups relative to the placebo treatment group (3-6 mg/day: -6.8, p=0.0029 and 6-9 mg/day: -9.9, p< 0.0001) by MMRM analysis. The change from baseline was statistically significant at every time point starting at week 1 for the cariprazine 6-9 mg/d group and week 2 onward for the cariprazine 3-6 mg/d group.

Overall 61% of patients completed the study. The premature discontinuation rates (all causes, including adverse-event related) were 36% for cariprazine 3-6 mg/day, 42% for cariprazine 6-9 mg/day, and 40% for placebo. Cariprazine was generally well tolerated with the most common adverse events (=10%) observed in any treatment group being akathisia, headache, insomnia, restlessness, and extrapyramidal disorder.

About Cariprazine

Cariprazine, discovered by researchers at Gedeon Richter, is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist. Cariprazine has a low potency at other receptor sites such as 5-HT2C, histamine H1, muscarinic, and adrenergic receptor sites which have been associated with adverse events. Cariprazine is also under development for the treatment of bipolar depression, and as an adjunct treatment for MDD.

About Gedeon Richter Plc.

Gedeon Richter Plc. (www.richter.hu) headquartered in Budapest/Hungary, is a major pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with an expanding direct presence in Western Europe in the field of gynaecology. Richter’s consolidated sales were approximately EUR 1.1 billion (USD 1.5 billion) while its market capitalization amounted to EUR 2.1 billion (USD 2.7 billion) in 2011. The product portfolio of the Company covers almost all important therapeutic areas, including gynaecology, central nervous system and cardiovascular. The Company has the largest R&D unit in Central Eastern Europe. Original research activity focuses on CNS disorders with main clinical targets being schizophrenia, anxiety, chronic pain and depression. With its widely acknowledged steroid chemistry expertise Richter is also a significant player in the female healthcare field worldwide.

About Forest Laboratories

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

Contacts

Forest Laboratories, Inc.

Frank J. Murdolo, 1-212-224-6714

Vice President - Investor Relations

Frank.Murdolo@frx.com




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