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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.
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