LONDON - The newly formed Celltech Chiroscience plc last week was celebrating FDA approval for its lead compound, Chirocaine, a long-lasting local anaesthetic.
This is also the first FDA approval of a drug from a UK biotech. Peter Fellner, CEO, said, "The approval of Chirocaine is a great achievement for the management and staff of Chiroscience, and a milestone for the UK biopharmaceutical sector as a whole."
Chirocaine was originally licensed to Zeneca plc, of London, but the rights were handed back after its merger with Astra AB of Sweden. U.S. rights subsequently were licensed to Purdue Pharma LP, of Norwalk, Conn., in return for an equal share in the profits.
Michael Friedman, group vice president of Purdue, said sales force training and product launch plans are being implemented. "We plan to launch Chirocaine in the near future," he said.
Outside the U.S. and Japan rights have gone to Abbott International, of Abbott Park, Ill., and Celltech Chiroscience said approval is proceeding in line with plans in Europe.
Chirocaine is a single-isomer version of the existing anaesthetic bupivacaine. The FDA approval came shortly after the merger of Celltech plc and Chiroscience plc was declared wholly unconditional on Aug. 3. Celltech Chiroscience, based in Slough, is one of the largest biopharmaceutical companies in Europe, with 400 research and development employees and a combined annual R&D expenditure of #51 million (US$81.3 million). On May 31, it had #88 million cash.