Gilead Expects E.U. Approval of Antiretroviral Drug Truvada Early Next YearGilead Sciences on Tuesday said it hopes that the European Union within the next three or four months will approve its once-daily, fixed-dose combination antiretroviral drug Truvada, and the company is planning a "product rollout," the Oakland Tribune reports (Simmers, Oakland Tribune, 12/1). FDA in August approved Truvada, which combines Gilead's antiretrovirals Viread and Emtriva, and the company announced later that month that it would offer the drug through its Global Access Program to 68 developing countries at the not-for-profit price of 99 cents per patient daily -- or $29.75 for a 30-day supply (Kaiser Daily HIV/AIDS Report, 8/20). A committee of the European Medicines Agency, which approves drugs for the European Union, has recommended the agency approve the drug for marketing. "We look forward to our continued work to make this combination product available to people living with HIV/AIDS throughout Europe," Gilead CEO John Martin said. The Foster City, Calif.,-based company expects between $870 million and $890 million in sales this year for its HIV-related products (Oakland Tribune, 12/1).
Trimeris, Roche Increase Fuzeon Access
Durham, N.C.-based drug maker Trimeris and Swiss pharmaceutical company Roche on Wednesday announced a program that will provide up to a 60-day supply of the antiretroviral drug Fuzeon at no cost to patients who take the drug in combination with an investigational antiretroviral drug obtained through an expanded access program, according to a Trimeris/Roche release (Trimeris/Roche release, 12/1). Trimeris and Roche jointly developed Fuzeon, which is designed for HIV/AIDS patients who have failed to respond to other medications. The drug has encountered resistance from doctors and patients because of its high cost -- about $20,000 per patient annually -- and injection delivery method (Kaiser Daily HIV/AIDS Report, 10/22). The Accelerated Simultaneous Access Program, or ASAP, will allow patients with already limited treatment options to begin "two active agents to maximize virus suppression and limit further drug resistance," Cal Cohen, research director at the Community Research Initiative of New England, said (Trimeris/Roche release, 12/1).