NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) today announced it will be presenting data on two late-stage development products, cariprazine and levomilnacipran, at the American Psychiatric Association (APA) Annual Meeting scheduled May 5-9, 2012 in Philadelphia, PA. Data on cariprazine, an investigational antipsychotic agent, includes additional details from a Phase III trial for acute mania in bipolar I disorder and results from an open-label extension study in schizophrenia. Separately, data on levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD), includes additional analyses of Phase III trial results.
The cariprazine results will be announced in 2 poster presentations:
- Safety and Tolerability of Cariprazine in the Long-Term Treatment of Schizophrenia: Results From a 48-Week Extension Study (Poster NR6-50: Monday, May 7 from 11:00 am - 12:30 pm EDT)
- Cariprazine in the Treatment of Acute Mania in Bipolar Disorder: A Double-Blind, Placebo-Controlled, Phase III Trial (Poster NR9-42: Tuesday, May 8 from 11:00 am - 12:30 pm EDT)
The levomilnacipran results will be announced in 4 poster presentations:
- Levomilnacipran in the Treatment of Major Depressive Disorder: Functional Health and Well-Being Efficacy Results From a Phase III Clinical Trial (Poster NR4-51: Sunday, May 6 from 1:00 pm - 3:00 pm EDT)
- Levomilnacipran in the Treatment of Major Depressive Disorder: An Analysis of Efficacy Data From 2 Phase III Studies (Poster NR9-33: Tuesday, May 8 from 11:00 am - 12:30 pm EDT)
- Levomilnacipran in the Treatment of Major Depressive Disorder: An Analysis of Safety and Tolerability Data From 2 Randomized Placebo-Controlled Trials (Poster NR9-36: Tuesday, May 8 from 11:00 am - 12:30 pm EDT)
- The Efficacy of Levomilnacipran in the Treatment of Major Depressive Disorder: Results From a Phase III Clinical Trial (Poster NR9-48: Tuesday, May 8 from 11:00 am - 12:30 pm EDT)
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.
Forest Laboratories Inc. and Gedeon Richter Ltd. are parties to a collaboration agreement for Cariprazine. Forest has exclusive rights to cariprazine in the US. and Canada and Gedeon Richter has rights in the rest of the world.
About Levomilnacipran
Levomilnacipran (1S, 2R-milnacipran), an enantiomer of racemic milnacipran, is protected by a method of use patent that extends through June 2023, without patent term extension. Levomilnacipran is an SNRI that has greater potency for norepinephrine reuptake inhibition than for serotonin reuptake inhibition in vitro without directly affecting the uptake of dopamine or other neurotransmitters. Levomilnacipran is given as a sustained-release formulation dosed once daily.
Levomilnacipran was discovered by Pierre Fabre and is licensed to Forest Laboratories, Inc., in the U.S. and Canada. Pierre Fabre will be the active pharmaceutical ingredient (API) supplier.
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 Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.