Fuzeon makers say manufacturing slowdown will result in limited supply

BY Advocate.com Editors

December 21 2002 12:00 AM ET

Officials at pharmaceutical companies Trimeris and Roche on Wednesday announced 40% decreased production estimates for their HIV entry inhibitor Fuzeon, which is currently under review by the Food and Drug Administration. The drugmakers projected that by the end of 2003 they would be able to produce enough Fuzeon for 12,000 to 15,000 patients. By the end of 2004 about 32,000 patients will have access to the drug. The new estimates are down sharply from earlier projections that supplies would be adequate for 25,000 people in 2003 and 40,000 in 2004.

Fuzeon, the first drug in the new category of medications known as HIV entry inhibitors that aim to block HIV from attaching to and infecting T cells, is expected to receive FDA marketing approval in the first quarter of 2003. It will initially be available to patients who have failed other anti-HIV drug regimens.

Roche's manufacturing plant has completed its first commercial batches of Fuzeon, company officials said. The manufacturing process involves 106 separate chemical steps, 10 times the number required for the production of most drugs. Because of its difficult manufacturing process, Fuzeon is expected to cost between $10,000 and $15,000 per patient per year.

Tags: Health