Forest Labs Will Present Data from Cariprazine and Levomilnacipran Phase 3 Trials at American Psychiatric Association Annual Meeting

Forest Laboratories, Inc. 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