Washington Editor

Trimeris Inc. and partner F. Hoffmann-La Roche Ltd. Monday said they will charge European patients participating in certain early access programs upward of $20,000 a year for Fuzeon, a twice-daily HIV drug candidate.

While Fuzeon has not been cleared for marketing by any regulatory authority, about 600 U.S. patients have been getting the subcutaneous injection free of charge since an early access program was initiated in September. Roche, of Basel, Switzerland, will offer Fuzeon as part of the special license sales (SLS) programs in European Union countries.

Prior to European Union approval, Roche will make Fuzeon (enfuvirtide) available for €52 (US$56) a day, or about $20,408 per year.

Early access patients in the U.S. will continue receiving Fuzeon at no cost until the FDA approves it. Trimeris, of Durham, N.C., and Roche filed the Fuzeon new drug application in September, and in accordance with fast-track priority review procedures, the FDA is obligated to issue action on or before March 16. (See BioWorld Today, Sept. 18, 2002.)

Neither company would comment on the planned price of Fuzeon (once known as T-20) in the U.S. However, a prepared statement released by both companies said, "The SLS program price announced today will be indicative of eventual global commercial prices; however, actual retail prices will vary according to individual country conditions."

Early access Europeans must pay for Fuzeon because of diverse laws and government reimbursement programs, Heather Van Ness, Roche's spokeswoman, told BioWorld Today.

Fuzeon is expected to cost more than other HIV drugs, which run anywhere from $3,000 a year to $13,000 a year.

When asked why it is more expensive, Robin Fastenau, Trimeris' manager of corporate communications, told BioWorld Today that Fuzeon is one of the most complex and challenging molecules ever chemically manufactured by the pharmaceutical industry on such a large scale. "There are more than 100 production steps, which is 10 times more than any other antiretroviral drug. It also requires 45 kilograms of raw materials to manufacture 1 kilogram of Fuzeon," she said.

Mike King, managing director of Banc of America Securities in New York, told BioWorld Today the price tag is higher than expected, "but so far there don't seem to be any shrieks of protest."

In previous models, King said Fuzeon was calculated to cost about $15,000 a year in the U.S. and $12,000 a year in Europe. When the new figures came out Monday, King said, "We reduced the assumption of the number of patients who received the drug and increased the price.

"From the standpoint of the market opportunity, I don't think it changes things that much because I think it is going to be targeted at a pretty late-stage audience where the benefits of an expensive drug like this can be more profound."

He estimates peak worldwide sales to total $800 million.

Fuzeon, a fusion inhibitor, was designed to block HIV from entering healthy human cells (most HIV drugs work inside the cell). The product was discovered by Dani Bolognesi, Trimeris' CEO, and his colleague, Tom Matthews, when they were researchers at Duke University. The two founded Trimeris, and in 1999 signed a deal with Roche to develop Fuzeon.

The Fuzeon NDA is based on two 24-week international Phase III trials known as TORO 1 and TORO 2 (T-20 vs. Optimized Regimen Only). Trimeris said data show the combination therapy with Fuzeon reduced HIV to undetectable levels in the blood in at least twice the percentage of patients as those who did not take the drug. (See BioWorld Today, July 9, 2002.)

TORO 1 included 491 patients who had been treated with 12 antiretroviral agents. Fifty-two percent of patients receiving Fuzeon experienced a 1.0 log¹⁰ or greater reduction in HIV levels. TORO 2 enrolled 504 patients who had previously been treated with 11 antiretroviral drugs. Twenty-eight percent of patients who received Fuzeon in combination with an optimized background regimen had undetectable blood levels (less than 400 copies/mL) of HIV at 24 weeks, compared to 14 percent receiving an optimized background regimen alone (p<0.0001).

Trimeris' stock (NASDAQ:TRMS) fell 29 cents Monday to close at $43.25.