Experimental AIDS Drug Raises Treatment Hopes, Pricing Fears
August 22, 2002
A new experimental drug is raising hopes for people with strains of HIV 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 North Carolina-based Trimeris, Inc., the drug won a priority, six-month review from the FDA. The companies plan to file their application by the end of September so the drug 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 from entering blood cells. It acts on the third stage of that entry process, known as fusion. T-20 is expected to prolong the lives of patients with drug-resistant strains.
Roche, based in Switzerland, and Trimeris, of Durham, N.C., won't discuss specifics of pricing until the drug is approved, but they 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.
Fuzeon was discovered by two researches at Duke University, Dani Bolognesi and Tom Matthews, who then founded Trimeris. They recognized its problems as a commercial drug candidate. Fuzeon is a large, complex peptide that is difficult to manufacture and must be taken by injection twice daily. Most drugs are small molecules that are easier to produce and can be taken orally. The manufacturing process requires 44 ingredients -- about three times the norm -- and there are 106 steps involved, more than four times the average.
08.21.02; Theresa Agovino
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.