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news.Solvay has said that the FDA has officially filed the new drug application for bifeprunox that was submitted in October 2006.
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According to Solvay, this means that the formal processing and review period both begin.
This event has triggered a milestone payment of $25 million from Wyeth, Solvay's co-development and co-commercialization partner for this candidate schizophrenia treatment in the US.
The guidance given to the markets in October concerning Solvay Pharmaceuticals' full year expected results and margins remain basically unchanged, the company said.
Bifeprunox is an investigational, new generation atypical antipsychotic for treatment and maintenance of stability of patients with schizophrenia. The new drug application 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.