Organon Abandons Gepirone Following Second “Not Approvable” Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Company will withdraw NDA for the antidepressant, which it had planned to market as Variza. With Implanon, Organon has one potential 2004 launch remaining; other new products are not expected before 2006-2007
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Organon plans to withdraw its NDA for the antidepressant gepirone ER following receipt of a second "not approvable" letter from FDA, the company announced June 24. The company received the letter June 23, six months after responding to the first not approvable letter with additional data. Organon had planned to market once-daily gepirone under the trade name Variza . FDA's negative response likely relates to efficacy concerns, which derailed the drug during its first review. The original NDA for the serotonin 5-HT1A receptor partial agonist for treatment of major depression and depression with anxiety was submitted in May 2001, and deemed not approvable in April 2002. Organon had been counting on gepirone as one of two potential major launches in 2004 to help offset an anticipated "rough ride" for the Akzo Nobel pharma subsidiary going into 2005 (1 (Also see "Akzo Nobel Pharma In For “Rough Ride” In 2004; Firm Will Rely On Partnering, R&D Investment" - Pink Sheet, 21 Apr, 2004.)). Gepirone was being positioned to help fill in the financial gap created by generic competition to the antidepressant Remeron (mirtazapine) in 2003. Organon's remaining potential 2004 launch is the implantable contraceptive Implanon (etonogestrel), which has an October user fee date. The firm's next set of launches is not anticipated before 2006-2007, when Organon hopes to introduce the antipsychotic asenapine with marketing partner Pfizer, and the low-dose osteoporosis agent Livial (tibolone), which was deemed "approvable" in 2001 and is undergoing additional studies. Organon said it is "disappointed" with FDA's gepirone response, but is "moving forward with our next steps in the development of products for mental health." Although asenapine - a clozapine follow-on in Phase III for schizophrenia and bipolar disorder - could be a big product for the company if its purported improved side effect profile holds out, Organon's other mental health pipeline agents have not yet moved beyond Phase II. According to F-D-C Reports' 2 NDA Pipeline, Organon is conducting Phase II trials with the ampakine compound ORG-24448 for schizophrenia and the hypothalamus-pituitary-adrenal axis modulator ORG-34517/34850 for depression. Organon licensed U.S. and European rights to gepirone ER from Fabre-Kramer, which had acquired exclusive rights to the immediate-release formulation of the drug from Bristol Myers-Squibb in 1993. - Alla Rutstein Bobbitt |