Fabre-Kramer Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, and Organon, have reached an agreement to re-acquire all rights related to Gepirone ER, a once-daily product being developed for the treatment of depression.
Under the agreement, Organon, the human healthcare business unit of Akzo Nobel, is returning all rights and know-how related to Gepirone ER to Fabre-Kramer, including sponsorship of NDA 21-164 for Major Depressive Disorder, which was determined by the FDA in June 2004 as not approvable. Fabre-Kramer is assuming certain obligations of Organon for ongoing paediatric trials. In the event of FDA approval of Gepirone ER, Organon will receive a milestone payment and will also receive royalties based on future sales of Gepirone ER, a company release said.
Stephen J. Kramer, M.D., CEO of Fabre-Kramer, commented, "We are excited about the opportunity to continue the development of Gepirone ER. Gepirone ER represents a novel mechanism of action as a 5HT1A partial agonist, with the potential to effectively treat depression with minimal side effects. We look forward to reporting the results of two multi-center placebo-controlled Phase III clinical trials that Fabre-Kramer recently conducted. Our team has worked hard to bring safe and effective alternatives to depressed patients for whom existing therapies are not satisfactory, and Gepirone ER, if approved by the FDA, may be one such alternative."