Wyeth bags bifeprunox
Executive Summary
Six months after receiving a "not approvable" letter for the atypical antipsychotic bifeprunox, Wyeth announces Feb. 29 it is backing out of a development and commercialization deal for the schizophrenia drug with Solvay Pharmaceuticals. "We met with FDA, and while they did talk about there being a path forward [for bifeprunox], Wyeth conducted an assessment, and at the end of the day, decided there wouldn't be enough commercial value for both companies to share," the firm tells "The Pink Sheet." Wyeth initially said it likely would pursue development of bifeprunox for the maintenance of stable adult patients with schizophrenia but would not pursue an acute treatment indication after receiving the not approvable letter in August (1"The Pink Sheet," Aug. 13, 2007, In Brief)
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Wyeth’s bifeprunox “not approvable”
Wyeth and Solvay will pursue approval of the atypical antipsychotic bifeprunox for the maintenance of stable adult patients with schizophrenia despite receiving a "not approvable" letter for the drug, Wyeth announces Aug. 10. The companies appear less likely to pursue an indication for the acute treatment of schizophrenia in the near-term, however. "FDA makes it clear that absent a compelling reason, the lower efficacy in the acute use does not support approval," Senior VP Joseph Mahady states during a same-day conference call. The action letter acknowledges the efficacy of bifeprunox in the maintenance setting and outlines a path forward for its approval, which will include completion of a second maintenance study. Approval in that setting could be set back one to two years, the firm said. It is the second regulatory set back for Wyeth in recent days; the firm's menopause therapy Pristiq was deemed "approvable" in July (1"The Pink Sheet," July 30, 2007, p. 11)...
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