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Forest Laboratories, Inc. : to Present Data from Cariprazine and Levomilnacipran Phase 3 Trials at American Psychiatric Association Annual Meeting

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05/16/2013 | 02:00pm CEST

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 18-22, 2013, in San Francisco, CA. Data on cariprazine, an investigational antipsychotic agent, provides details from Phase 3 trials for schizophrenia and acute mania in bipolar I disorder, as well as a long-term safety and tolerability open-label study in patients with bipolar I disorder. Separately, data on levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD), includes additional analyses of phase 3 trial results. Forest anticipates decisions from the FDA on both cariprazine and levomilnacipran within the calendar year.

The cariprazine results will be announced in six poster presentations:

Clinical Posters

Monday, May 20 from 11:30 am - 1:00 pm PDT

  • Efficacy and Safety of Low- and High-Dose Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder (NR8-03), authored by Joseph R. Calabrese, MD
  • Long-Term Safety and Tolerability of Open-Label Cariprazine in Patients With Bipolar I Disorder (NR8-26), authored by Terence A. Ketter, MD
  • Cariprazine Effects on YMRS Items: Results of a Pooled Analysis of 3 Randomized, Double-Blind, Placebo-Controlled Trials in Bipolar Mania (NR8-13), authored by Paul E. Keck, Jr., MD

Tuesday, May 21 from 9:00 am - 10:30 am PDT

  • Cariprazine in Acute Exacerbation of Schizophrenia: A Fixed-Dose Phase III, Randomized, Double-Blind, Placebo- and Active-Controlled Trial (NR10-11), authored by Andrew J. Cutler, MD
  • Efficacy of Cariprazine on PANSS Items and Marder Factors: Post Hoc Analysis of a Phase III, Double-Blind, Placebo-Controlled Trial in Schizophrenia (NR10-22), authored by John Kane, MD

Preclinical Poster

Tuesday, May 21 from 11:30 am - 1:00 pm PDT

  • At Antipsychotic-Like Effective Doses, Cariprazine Displays Potent Dopamine D3 and D2 Receptor Occupancy In Vivo and Efficacy Across Animal Models (NR11-10), authored by Nika Adham, PhD

The levomilnacipran results will be announced in eight poster presentations:

Clinical Posters

Monday, May 20 from 2:00 pm - 4:00 pm PDT

  • Effects of Levomilnacipran SR 40, 80, and 120 mg on Functional Outcomes in Major Depressive Disorder: Post Hoc Analyses of a Phase III Trial (NR9-19), authored by Carl Gommoll, MS
  • Levomilnacipran SR Efficacy in Major Depressive Disorder Across Patient Subgroups: Pooled Analyses of 5 Double-Blind, Placebo-Controlled Trials (NR9-29), authored by Stuart Montgomery, MD
  • Safety and Tolerability of Levomilnacipran SR in Major Depressive Disorder: Results From An Open-Label, 48-week Extension Study (NR9-43), authored by Rajnish Mago, MD
  • Cardiovascular Safety Profile of Levomilnacipran SR in the Treatment of Major Depressive Disorder (NR9-12), authored by Robert Palmer, MD
  • Drug-Drug Interactions of Levomilnacipran Sustained-Release Capsule With Ketoconazole, Carbamazepine, or Alprazolam in Healthy Subjects (NR9-16), authored by Laishun Chen
  • Pharmacokinetic Characteristics of Levomilnacipran Sustained-Released Capsule Following Single- and Multiple-Dose Administration (NR9-37), authored by Laishun Chen

Tuesday, May 21 from 9:00 am - 10:30 am PDT

  • Safety and Tolerability of Levomilnacipran SR in Major Depressive Disorder: Analysis of 5 Short-Term Double-Blind, Placebo-Controlled Trials (NR10-56), authored by Michael E. Thase, MD

Preclinical Poster

Saturday, May 18 from 2:00 pm - 4:00 pm PDT

  • Levomilnacipran (F2695), a norepinephrine-preferring SNRI, improves working memory in the rat delayed non-matching to position (DNMTP) assay (NR3-035), authored by Ronan Depoortère, PhD

About Cariprazine

Forest has filed New Drug Applications (NDAs) with the U.S. Food and Drug Administration (FDA) for cariprazine for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. Cariprazine is an orally active and potent dopamine D3-preferring D3 /D2 receptor partial agonist. Cariprazine has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic which have been associated with adverse events. Cariprazine is also under development as an adjunctive treatment for MDD and for the treatment of bipolar depression. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada.

About Levomilnacipran

Forest has filed a NDA with the FDA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults. 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. An SNRI, levomilnacipran 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 has been developed 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 supplier.

About Forest Laboratories, Inc.

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, respiratory, gastrointestinal and pain management medicine. Forest'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 Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.

Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President, Investor Relations
[email protected]

© Business Wire 2013
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