NEW YORK -- A new, experimental drug is raising hopes for AIDS sufferers with strains of the virus that are resistant to existing treatments, but the complex manufacturing process is expected to mean high prices and limited quantities.
Dubbed Fuzeon by its developers, Roche Group and Trimeris Inc., the drug won a priority, six-month review from the Food and Drug Administration. The companies plan to file their application by the end of September so it can be approved by March and on the market next spring.
The drug, called T-20 in early testing, is the first in a class known as fusion inhibitors, which are designed to block HIV, the virus that causes AIDS, from entering blood cells. It acts on the third stage of that entry process, known as fusion.
It is expected to prolong the lives of patients with drug-resistant strains.
"Everyone is so pleased about the drug itself," said Martin Delaney, founding director of Project Inform, an advocacy organization. "It is such a significant development. But we are terribly apprehensive about the cost."
Roche, based in Switzerland, and Trimeris, of Durham, N.C., won't discuss specifics of pricing until the drug is approved, but say Fuzeon is complicated to produce and will be expensive. Experts predict a cost of between $10,000 and $15,000 a year per patient.
The most expensive AIDS drugs now available cost about $7,500 a year, although some combination treatments approach $15,000 in annual costs.
Fuzeon's cost should be kept in perspective, said Dr. James Thommes, the drug's medical director at Roche, saying that it keeps people from expensive hospital stays and prolongs their lives.
"No one wants drug companies to stop looking at ways to treat AIDS" because of expense issues, he said.
Too much demand
Cash-strapped AIDS assistance programs are already worried they might not be able to afford Fuzeon, but there is another issue: Roche and Trimeris have said they may not be able to make enough Fuzeon to meet initial demand.
Fuzeon's journey to the marketplace exemplifies the challenges of transforming innovative science into a drug that fits into a complex web of production, pricing and patient demands.
Roche began outfitting a plant to produce Fuzeon two years ago, when only one 28-patient study on its effectiveness was completed. The companies knew Fuzeon had promise but couldn't know how it would perform in large trials.
The plant was set up to produce enough Fuzeon for 25,000 patients by the end of 2003 and 40,000 patients by 2004. It looks like demand will be greater.
"Now people come into treatment for the first time and are already drug resistant," said Thommes. "We are just trying to get a handle on how much we will need and how we can ramp up."
It is unclear how many of the 850,000 to 950,000 Americans infected with the virus have a drug-resistant form.
However, clinical tests showed that when Fuzeon was added to the regime of patients with drug resistance, they were twice as likely to have virus concentrations decrease below detectable levels than those who didn't add the medicine.