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Fetzima

Generic name: levomilnacipran
Treatment for: Depression

Update: Fetzima (levomilnacipran) Now FDA Approved - July 25, 2013

Forest Laboratories Submits New Drug Application for Levomilnacipran for the Treatment of Major Depressive Disorder

NEW YORK & CASTRES, France--(BUSINESS WIRE)--Sep 27, 2012 - Forest Laboratories, Inc. and Pierre Fabre Laboratories today announced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran was discovered by Pierre Fabre and jointly developed by Forest Laboratories and Pierre Fabre, under a licensing agreement in the U.S. and Canada. Pierre Fabre will be the active pharmaceutical ingredient (API) supplier.

The application includes results from three positive Phase III studies comprising two double-blind, fixed-dose studies and one flexible-dose study evaluating the efficacy of levomilnacipran compared with placebo in adults with MDD. A total of more than 1,600 adult patients received a once-daily dose of either levomilnacipran (40, 80, 120mg) or placebo in the three studies. In each of the three studies, statistically significant improvement was seen for the levomilnacipran group compared with placebo in the primary and secondary endpoints (change from baseline to endpoint in the Montgomery-Åsberg Depression Rating Scale total score and Sheehan Disability Scale total score, respectively) using the mixed-effects model for repeated measures and last-observation-carried-forward analyses.

Additionally, safety data collected from the Phase III program demonstrated that levomilnacipran 40, 80, 120mg once daily was generally well tolerated, with an incidence of adverse reactions that was consistent across the study treatment arms. The most commonly reported adverse reaction (≥10% and twice the rate of placebo) observed in the levomilnacipran group was nausea.

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. 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.

About MDD

MDD is a serious medical condition requiring treatment, affecting more than 15 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. People diagnosed with MDD may have a combination of symptoms that can interfere with their ability to work, sleep, study, eat, or enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.

About Pierre Fabre Laboratories

Pierre Fabre, the second largest independent pharmaceutical group in France, achieved a turnover of 1.9 billion Euros in 2011, with international sales accounting for 52%. Pierre Fabre has branches in 42 countries and markets its products in over 130 countries. Their activities cover all aspects of healthcare, from prescription drugs and family health products to dermo-cosmetics. The Pierre Fabre Laboratories employ some 10,000 people worldwide, 1,300 of whom are dedicated to R&D. In 2011, the group allocated 20% of its Pharmaceuticals business revenues to R&D, focusing on four main areas: oncology, dermatology, neuropsychiatry and women's health. With brands including Avène, A-Derma, Ducray, Glytone, Klorane, René Furterer, Pierre Fabre Dermatology or Pierre Fabre Oral Care, Pierre Fabre is market leader in France when it comes to cosmetics, hair care, oral products and dermatological products sold in pharmacies. Avène is marketed in over 100 countries, and is the leading dermo-cosmetics brand sold in Europe, Japan and China. In the oncology area, 85% of Pierre Fabre's sales are achieved outside France. Levomilnacipran was discovered by Pierre Fabre and is licensed to Forest Laboratories Inc. in the US and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier. To find out more, go to www.pierre-fabre.com.

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, 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. Forest 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. Forest assumes no obligation to update forward looking statements contained in this release to reflect new information or future events or developments.

Contact: Forest Laboratories, Inc
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
media.relations@frx.com

Posted: September 2012

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