FDAnews
www.fdanews.com/articles/101430-bms-pierre-fabre-update-vinflunine-development-status

BMS, Pierre Fabre Update Vinflunine Development Status

November 26, 2007

Bristol-Myers Squibb (BMS) and France’s Pierre Fabre Medicament will terminate their agreement for vinflunine, a chemotherapy agent under investigation for the treatment of advanced or metastatic bladder cancer and other tumor types.

Based on a review of the clinical development program and the decision not to file a new drug application for bladder cancer in the U.S., the companies have decided that all rights licensed to BMS for vinflunine will be returned to Pierre Fabre Medicament.

P. Hurteloup, Pierre Fabre Medicament’s general manager of oncology, said the company intends to continue discussions with regulatory authorities and file for the registration of vinflunine for bladder cancer in the first quarter of 2008.