BifeprunoxTreatment for Schizophrenia
U.S. Food and Drug Administration Files New Drug Application for Bifeprunox, Submitted in October 2006
BRUSSELS, December 12, 2006 -- Solvay announced today that the New Drug Application (NDA) for bifeprunox submitted to the U.S. Food and Drug Administration (FDA) in October 2006 has been officially filed by the FDA. This means that the formal processing and review period both begin.
This event has triggered a milestone payment of USD 25 million from Wyeth, Solvay's co-development and co-commercialization partner for this candidate schizophrenia treatment in the U.S. The milestone has been booked into Solvay's 4th quarter 2006 figures. The guidance given to the markets on October 27, 2006 concerning Solvay Pharmaceuticals' full year expected results and margins remains basically unchanged, having anticipated this payment.
Bifeprunox is an investigational, new generation atypical antipsychotic for treatment and maintenance of stability of patients with schizophrenia. The NDA file is based on safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in approximately 2,550 patients. Patients were evaluated with acute exacerbations for six weeks, and stable patients were evaluated for six months.
- Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia October 12, 2006
Posted: December 2006
- Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia - August 10, 2007
- Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia - October 12, 2006