NEW YORK and PARIS, Dec. 22, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) and Pierre Fabre Medicament today announced that they have entered into a definitive collaboration agreement to develop and commercialize F2695 in the United States and Canada. F2695 is a proprietary selective norepinephrine and serotonin reuptake inhibitor that is being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.
Under the terms of the agreement, Forest will make an upfront payment to Pierre Fabre of $75 million and will pay future, undisclosed milestone payments. In addition, Pierre Fabre will receive royalty payments based on F2695 sales. Forest will assume responsibility for the clinical development and commercialization of F2695 in the United States and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide.
"We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004," commented Howard Solomon, Chairman and Chief Executive Officer of Forest. "We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market."
"Pierre Fabre is looking forward to working with Forest on this exciting product opportunity," said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre Medicament. "Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695."
In a recently completed European placebo-controlled, double-blind Phase II study of F2695 in over 550 patients with major depressive disorder, the compound demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale ("MADRS"). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale ("HAMD-17") and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment initiation.
F2695 is an isomer of milnacipran and is protected by a method of use patent that extends through June 2023. F2695 exerts its effects by selectively inhibiting the reuptake of both norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating mood. Forest, in partnership with Cypress Bioscience, Inc. and Pierre Fabre, is currently developing milnacipran; a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia. The New Drug Application is under FDA review and we continue to plan for a first quarter 2009 product launch meeting
About Pierre Fabre Medicament
The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.7 billion euros in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 30% of its annual sales to R&D during 2008, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. To learn more about Pierre Fabre, visit www.pierre-fabre.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX - News) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, 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 Report on Form 10-Q, and any subsequent SEC filings.
Source: Forest Laboratories, Inc.