News

Fabre-Kramer Re-Acquires Gepirone ER Rights From Organon

HOUSTON, June 15, 2005 PRNewswire
-- Fabre-Kramer Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, and Organon, the human healthcare business unit of Akzo Nobel (Nasdaq: AKZOY), announced today that they have reached an agreement under which Fabre-Kramer is re-acquiring all rights related to Gepirone ER, a once-daily product being developed for the treatment of depression.

Under the agreement, Organon 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 pediatric 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.

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 5HTIA 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."

About Fabre-Kramer
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas is engaged in acquiring, developing and commercializing psychotropic drugs that have significant market potential. In addition to Gepirone ER, Fabre-Kramer has 10 other compounds in various stages of development for indications including depression, anxiety, schizophrenia, Parkinson's disease and insomnia.


 
 
 
 
 
 
Fabre Kramer Pharmaceuticals, Inc.• 5847 San Felipe, Suite 2000• Houston, TX 77057
(713) 975-6900 • Fax (713) 977-1574
Email contact: info@fabrekramer.com
© 2005 Fabre Kramer Pharmaceuticals, Inc.