Based on a review of the clinical development program and the decision not to file a new drug application for bladder cancer in the US, coupled with an analysis of Bristol-Myers Squibb’s Research & Development priorities, the companies have jointly decided that all rights licensed to Bristol-Myers Squibb for vinflunine will be returned to Pierre Fabre Medicament.
Vinflunine was developed by Pierre Fabre Medicament and licensed to Bristol-Myers Squibb in 2004 for specific territories.
Mr. Hurteloup, general manager of medicament oncology division, Pierre Fabre, said: “In Europe, Pierre Fabre Medicament intend to continue discussions with regulatory authorities and plan to file for the registration of vinflunine for bladder cancer in the first quarter of 2008. We also are considering a range of further development options, including pursuing the product on a worldwide basis for the treatment of a number of cancers.”