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FDA Approves Fetzima

Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of Fetzima for the Treatment of Major Depressive Disorder in Adults

NEW YORK & CASTRES, France--(BUSINESS WIRE)--Forest Laboratories, Inc. and Pierre Fabre Laboratories announced today that Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Major Depressive Disorder (MDD) in adults.

Major Depressive Disorder, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. MDD affects almost 16 million adults in the United States every year, with a range of severity from mild to severe.

In the placebo-controlled, pivotal Phase III studies of adult patients with MDD, statistically significant and clinically meaningful improvement in depressive symptoms (primary endpoint) was demonstrated across three Fetzima dosage strengths of 40, 80, and 120 mg once daily compared with placebo as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) total score (primary endpoint). Fetzima also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score (secondary endpoint).

“Because people respond differently to different medications, Forest Laboratories is dedicated to bringing a range of treatment possibilities to adults living with MDD, as part of our growing mental health portfolio,” said Howard Solomon, Chairman, Chief Executive Officer and President of Forest Laboratories. “The approval of Fetzima fulfills that commitment to the millions of people living with MDD.”

"We are proud that another product stemming from Pierre Fabre’s research has received approval in the United States. This marketing authorisation represents a key milestone for our laboratory, and it confirms our choice to make neuropsychiatry a strategic axis of our R&D efforts, next to oncology and dermatology ", said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Laboratories.

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in the placebo-controlled trials were nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations. Rates of adverse events were generally consistent across doses (40-120 mg); the only dose-related adverse events (greater than 2% overall incidence) were urinary hesitation and erectile dysfunction.

“As many people with MDD struggle to find a treatment that works for them, Fetzima provides patients and physicians with an additional option for treating this serious disease,” said Michael Liebowitz, MD, Professor of Clinical Psychiatry at Columbia University.

Forest Laboratories Inc. expects Fetzima to be available to wholesalers in the 4th calendar quarter 2013.

Data Highlights

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

Primary Endpoint MADRS (Reduction in depressive symptoms)

In all three studies, Fetzima demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the change from baseline to Week 8 in the MADRS total score. MADRS is a widely used, clinician-rated scale to assess the severity of 10 depressive symptoms. A total MADRS score of 35 or greater is suggestive of severe depression. The primary efficacy endpoint in the pivotal trials was change from baseline to week 8 in the total MADRS score. A 2-point difference between drug effect and placebo is generally considered to represent a clinically meaningful improvement in depressive symptoms.

For study 1, the mean baseline MADRS total score was 36 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at all three Fetzima doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2, the mean baseline MADRS total score was 31 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant at both Fetzima doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total score was 35 for all treatment groups. The LS mean difference from placebo in change from baseline was statistically significant for the Fetzima dosing range studied (-3.1 at 40-120 mg/day).

Secondary Endpoint SDS (Improvement in functional impairment)

Fetzima also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score. SDS is a validated scale that measures the extent that emotional symptoms disrupt patient functioning in 3 life domains: work/school, social life, and family life with each item scored from 0 (unimpaired) to 10 (highly impaired).

About Major Depressive Disorder

MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person’s ability to work, sleep, study, eat, and 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 Fetzima

Fetzima is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD). The recommended therapeutic dose range for Fetzima is 40 mg to 120 mg once daily and can be taken with or without food.

While the exact mechanism is unknown, it is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that Fetzima is a potent and selective serotonin and norepinephrine reuptake inhibitor.

Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre Fabre, in the U.S. and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier.

Visit Fetzima.com for more information on this once-daily option for the treatment of MDD in adults.

About Pierre Fabre

Pierre Fabre Laboratories, the second largest independent pharmaceutical group in France, achieved a turnover of 1.98 billion Euros in 2012, with international sales accounting for 54%. Pierre Fabre has branches in 42 countries and its products are distributed in over 130 countries.

Through the holding company Pierre Fabre Participations, 65% of Pierre Fabre SA is held by the Pierre Fabre Foundation, recognized as a public utility since 1999. In addition, thanks to an employee shareholding program set up in 2005, 90% of the company’s employees collectively have a 7 % shareholding interest. This original governance program ensures the independence and sustainability of the company.

Their activities cover all aspects of healthcare, from prescription drugs and family health products to dermo-cosmetics. Pierre Fabre Laboratories employ some 10,000 people worldwide, 1,400 of whom are dedicated to R&D. Every year, the group allocates 20% of its drug revenues to R&D, focusing on three main areas: oncology, dermatology and neuropsychiatry.

With brands including Avène, Glytone, A-Derma, Ducray, Galénic, Klorane, Naturactive, René Furterer or Pierre Fabre Oral Care, Pierre Fabre Laboratories are France’s market leaders when it comes to skin, hair and oral care products sold in the pharmacy channel. Avène is marketed in over 100 countries, and is the leading dermo-cosmetics brand in Europe, Japan and China. In prescription drugs, Pierre Fabre focuses on four therapeutic areas: oncology, dermatology, neuropsychiatry and women’s health. In oncology, Pierre Fabre achieves about 90% of its turnover outside its home country.

In 2012, Pierre Fabre Laboratories was audited by the French certification group AFNOR at advanced level for its corporate social responsibility (CSR) performance. To learn more, visit www.pierre-fabre.com.

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.

 

 

 

Contact:

 

 

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

Posted: July 2013

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