Roche Fuzeon (T-20) supply
Executive Summary
Roche and Trimeris are setting up 1,200-patient access program for HIV fusion inhibitor Fuzeon (T-20/enfuvirtide) in anticipation of supply constraints at time of launch. The program will commence in September/October and reach its patient cap by March 2003, Roche said. "In the short-term, we do not have the flexibility to increase production beyond our current capacity to meet a potentially higher than initially anticipated demand," Roche said. The companies will file Fuzeon in the third quarter and will receive a "fast-track" review. One estimate for expanded availability would have the company supplying 40,000 patients by end of 2004..
You may also be interested in...
Roche Fuzeon 2003 Production: 15,000-Patient Supply Plus 6-Month Cushion
Roche/Trimeris' 2003 production cap for Fuzeon includes doses for 12,000 to 15,000 patients, in addition to a six-month "safety supply," the companies said during a Dec. 18 analyst call
Roche Fuzeon (T-20) NDA
Roche and Trimeris file NDA for HIV fusion inhibitor Fuzeon (T-20/enfuvirtide) Sept. 17. The companies are establishing a 1,200-patient access program in anticipation of supply constraints (1"The Pink Sheet" Aug. 5, In Brief)...
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.