Forest Laboratories, Inc. and Pierre Fabre Medicament have entered into a definitive collaboration agreement to develop and commercialize F2695 in the U.S. and Canada. F2695 is a selective norepinephrine and serotonin reuptake inhibitor being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.
Under the terms of the agreement, Pierre Fabre will receive an upfront payment of $75 million and is eligible to receive milestone payments and royalties on sales. Forest will be responsible for the clinical development and commercialization of F2695 in the U.S. 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 Phase II study in more than 550 patients with major depressive disorder, F2695 demonstrated statistically significant improvement compared to placebo 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.