Production of Generic Antiretroviral Drug Combination Could Begin in March, South Africa's Aspen Pharmacare Says

The production of a generic antiretroviral drug combination that was recently approved by FDA could begin as early as March or April, expanding treatment for people living with HIV/AIDS in the 12 African countries covered under the President's Emergency Plan for AIDS Relief, the AP/Long Island Newsday reports (Leonard, AP/Long Island Newsday, 1/26). FDA on Tuesday announced that it has approved a generic version of a widely used co-packaged antiretroviral drug regimen made by South Africa's Aspen Pharmacare. The regimen includes a generic version of GlaxoSmithKline's fixed-dose combination Combivir, which contains the antiretroviral drugs lamivudine and zidovudine, and a version of Boehringer Ingelheim's Viramune, known generically as nevirapine, which Aspen packages together. The FDA approval is expected to expand AIDS treatment in the developing world by allowing PEPFAR to purchase the drugs. PEPFAR is a five-year, $15 billion program that directs funding for HIV/AIDS, tuberculosis and malaria to 15 focus countries, including Botswana, Ethiopia, Cote d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Zambia, Haiti, Guyana and Vietnam (Kaiser Daily HIV/AIDS Report, 1/26).

Registration, Production Details
According to Aspen spokesperson Stavros Nicolao, the first shipments of the regimen likely will arrive in April, depending on how quickly the drugs can be registered in the 12 African countries eligible for assistance under PEPFAR. Aspen currently is working to register the regimen in those countries, Nicolao said, adding that the drugs are "close" to being registered in South Africa, and he expects registration to go "quickly" in countries with established treatment programs, according to the AP/Newsday. Although the drug maker also is working with the William J. Clinton Presidential Foundation to register the drugs in as many of the qualified countries as possible, registration could take longer in countries with newly established programs, Nicolao said, adding that Aspen can begin production of the drugs six to eight weeks after it has received orders from treatment groups. The drugs will be manufactured at a plant in Port Elizabeth, South Africa, with the capacity to produce 5.5 billion capsules annually at a cost of $16.65 to $20 per patient per month -- less than half the $55 some organizations currently pay for the brand-name equivalent, according to Aspen. Nicolao added that the regimen also will be sold to groups receiving aid from the Global Fund to Fight AIDS, Tuberculosis and Malaria (AP/Long Island Newsday, 1/26).

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