Licensing In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer ups ante on Exubera approval with full license: Pfizer's decision to acquire Sanofi-Aventis' marketing rights to Exubera suggests the company is confident that the inhaled insulin product will receive FDA approval. Exubera's user fee date is Jan. 27, following a three-month extension resulting from an FDA request for additional technical chemistry data. Pfizer announced Jan. 12 that it will acquire worldwide rights for the development, production and commercialization of Exubera for $1.3 bil. - building on the firms' previous co-development alliance. The deal follows a judge's ruling that Sanofi's purchase of Aventis constituted a change-in-control under Pfizer and Aventis' 1998 agreement for Exubera. The NDA was submitted in March (1Pharmaceutical Approvals Monthly March 2005, p. 12)...