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..