Trimeris’ new anti-HIV drug Fuzeon has been given a crucial approval for sale in Europe, just a week after the US Federal Drug Administration formally accepted Fuzeon.
The Committee for Proprietary Medicinal Products (CPMP) for Europe endorsed Fuzeon on Thursday. Its recommendation still requires formal acceptance by the European Union, but that is expected within the next 90 days.
Also Thursday, Trimeris and its partner Roche, which is manufacturing the complex compound in Colorado and will help market and sell the drug, said the cost of Fuzeon would be around $20,000 a year. That’s much more expensive than other AIDS drugs, but the companies defended the price, noting the cost and complexity of producing it.
In a statement, Trimeris and Fuzeon said that “significant progress” had been made in manufacturing Fuzeon, but added that “production is still not at full capacity. It is expected that demand will exceed the initial available supply.”
Because of demand, the companies set up a “Progressive Distribution program,” and pointed out that prescriptions will be filled on a “first-come, first-served basis as they are received from physicians.”
The price of Fuzeon alarmed some AIDS groups. For example, Reuters reported that the AIDS Healthcare Foundation in California urged that the drug not be included in the state’s Medicaid and AIDS Drug Assistance program until the price was lowered.
The European committee granted approval of Fuzeon after reviewing results of a 48-week test that showed patients using Fuzeon “in combination with an individualized regimen of anti-HIV drugs continue to show a significantly greater reduction in HIV.”
Trimeris (Nasdaq: TRMS) closed at $41.94, down 27 cents, on Thursday.