Trimeris, Roche Cite Manufacturing Slowdown in Reduced Production Estimate for Experimental AIDS Drug Fuzeon
U.S. drug maker Trimeris and its corporate partner Roche on Wednesday announced 40% decreased production estimates for their fusion inhibitor Fuzeon, which is designed to be used for HIV-positive patients who have built up a resistance to other antiretroviral drugs, the Raleigh News & Observer reports. The drug makers yesterday projected that by the end of 2003 they could produce enough Fuzeon for 12,000 to 15,000 patients plus a six-month "safety supply" to ensure that all patients taking Fuzeon have a continuous supply of the drug. Roche estimates that they could produce enough of the drug for 32,000 patients by the end of 2004 (Ranii, Raleigh News & Observer, 12/19). Those numbers are down from an August prediction, in which officials said their Boulder, Colo., plant would be able to produce enough of the drug for 25,000 patients by the end of 2003 and 40,000 patients in 2004. Following August's estimates, observers predicted demand could exceed supply because of the rising numbers of HIV-positive people experiencing drug resistance (Kaiser Daily HIV/AIDS Report 8/22). Roche's manufacturing plant has completed its first commercial batches of Fuzeon, according to Roche (Reuters, 12/18). According to Roche, the production of Fuzeon involves 106 chemical steps -- ten times more than those required for the production of most drugs -- and one of the steps is taking longer than expected. According to the News & Observer, the installation of duplicate equipment in the plant should put production capacity "back on track" in 2004 (Raleigh News & Observer, 12/19). Formerly known as T-20, Fuzeon must be injected twice a day, and will cost between $10,000 to $15,000 per patient per year. The FDA granted the drug priority review status in October, and will likely review it by March (Kaiser Daily HIV/AIDS Report, 10/15).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.