Wyeth and Solvay end bifeprunox accord

US drugmaker Wyeth has terminated its collaboration agreement with Belgium's Solvay Pharmaceuticals. The deal covered the atypical antipsychotic bifeprunox, which was the subject of a Food and Drug Administration "non-approvable" letter last year (Marketletter August 10, 2007), as well as the two early-stage psychiatric disorder drug candidates, SLV313 and SLV314.

The FDA said that while bifeprunox, which was originally developed in collaboration with Denmark's H Lundbeck A/S, had demonstrated superiority to placebo in two short-term studies (Marketletters passim), the efficacy data provided was not sufficient to warrant its approval when compared with existing drugs. The agency indicated that a further Phase III trial would be required for approval.

"Insufficient commercial value"