Successful registration after shortest ever review by the FDA of Eloxatin, anti-cancer drug developed by Debio.Eloxatin™ (oxaliplatin) was approved by the American FDA on the 9th August, after a review of only seven weeks, the shortest ever for a cancer drug! Full details can be found in the press release sent out by Debio’s partner Sanofi-Synthélabo SA.
Lausanne-based Debiopharm, who now has 3 drugs (Trelstar LA™, Trelstar Depot™, Eloxatin™) approved by the FDA in the last 2 years. Between April 2000 and August 2002, the FDA has only approved 3 drugs to treat advanced colorectal cancer; EloxatinTM is the most recent. Among the anti-cancer drugs registered by the FDA in the last two years, EloxatinTM is the only one not developed by the two largest Swiss pharmaceutical companies. Debio obtained the marketing approval of oxaliplatin for treatment of advanced colorectal cancer (ACRC) in France in 1996 and, two years later, received wider European marketing approval through the Mutual Recognition Procedure. That was the first time in over twenty years that a cytotoxic drug was registered for ACRC.
Sanofi-Synthelabo SA is Debio’s licensee and long-term partner.
For further information on Debio, please contact:
Kim Bill, VP Business Development & Licensing, firstname.lastname@example.org
Tel: +41 21 321 0111 Fax: +41 21 321 01 69