A while ago I wrote about Glaxo’s latest, greatest anti-depressant – Gepirone ER – the first-in-class 5HT1a agonist.
Fabre-Kramer Pharmaceuticals have ‘sold’ the drug to Glaxo. It only needs approval from the FDA and then Glaxo will be marketing it. I guess that means we’ll be seeing the results of ‘new’ drug trials which will be used for both purposes.
Wow – another new wonder drug… hold on there, maybe not quite so new.
The FDA have turned down this particular drug once already – it was under a different name and it was a different company that tried to get it approved.
On October 10, 2002, the New York times wrote:
Akzo Nobel announced today that it was forced to delay for at least another year the release of an anti-depressant drug it is testing.
The company said its pharmaceutical division, Organon, was having a hard time recruiting patients for clinical trials of the drug, gepirone ER, formerly called Ariza. Akzo had hoped to release the drug next year for the treatment of severe depression but has now put off plans to do so until at least 2004.
”It’s going slower than we anticipated,” said Ian Cressie, a company spokesman.
“Slower than we anticipated“ was an understatement! By 2004, The NARSAD research newsletter noted:
A pyridinyl piperazine (5-HT1A) receptor agonist for the treatment of depression, gepirone (Ariza) has been awaiting FDA’s approval since May 2001. In June 2004, after asking for more clarification, the FDA announced that it has found Organon’s gepirone “Not Approvable.” Organon is planning to withdraw its application for this compound as a treatment for depressive disorder.
Then on June 15 2005 we learned: Fabre-Kramer Re-Acquires Gepirone ER Rights From Organon
HOUSTON, TX–June 15, 2005 –Fabre-Kramer Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, and Organon, the human healthcare business unit of Akzo Nobel, 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 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.”
By ‘continuing the development’ of Gepirone ER it looks like he meant finding another buyer for it – and so we arrive back in February 2007 and happily we find Stephen J Kramer excited once again, now that Glaxo has bought Gepirone ER and is going to try and get it approved by the FDA:
Stephen J. Kramer, M.D., CEO of FKP, commented, “We are excited about this alliance because we are confident that GSK, through its outstanding experience in the depression market will, once approved, successfully commercialise and further develop gepirone ER to help the many depressed patients for whom existing therapies are simply not satisfactory.”