Activists ‘Demand’ Greater Access to New Fusion Inhibitor

Calling an expanded access program for the new HIV drug T-20 "catastrophically" inadequate, activists Tuesday "demanded" that Roche and its U.S. partner Trimeris expand access to the not-yet-approved drug, Reuters reports. T-20 is the first fusion inhibitor -- a newer class of antiretroviral drugs that blocks the virus from attaching to and invading immune cells -- to move to an expanded access program. Roche and Trimeris have announced plans to offer the drug to 450 people under an expanded access program, in addition to the 550-600 patients receiving the drug as part of a Phase III clinical trial. Maria Vigneau, a Roche spokesperson, said the expansion asked for by the European AIDS Treatment Group is not possible because T-20 is "a very complex drug and requires a novel peptide manufacturing process which has never been performed before at the scale required." A pilot plant in Boulder, Colo., is currently producing the drug for the trials and will not reach full production capacity until the middle of 2002. T-20 and another fusion inhibitor called T-1249 are part of a "radical new approach" to fighting HIV, which is capable of mutating and developing a resistance to many approved medications. Fusion inhibitors hold promise, especially for patients with resistant strains of HIV, because they block the fusion process. However, the drugs have some drawbacks -- they must be administered twice daily by injection, with some patients developing inflammation at the injection site. The global market for the drugs, which have been "fast-tracked" by the FDA, is estimated to be $500 million a year. Roche and Trimeris hope to have FDA approval by late 2002 and will split U.S. and Canadian revenues, with Roche paying Trimeris a "low double-digit" royalty on sales elsewhere in the world (Hirschler, Reuters, 3/20).