Merck To Allow South African Firm To Make, Sell Generic Version of Antiretroviral Drug Stocrin

Pharmaceutical company Merck on Wednesday announced that it plans to issue a nonexclusive license to South African drug manufacturer Thembalami Pharmaceuticals to allow it to make and sell a generic version of its antiretroviral drug Stocrin, which is known generically as efavirenz, Reuters reports. Under the terms of Merck's offer, Thembalami -- which is a joint venture between Adcock Ingram and India's Ranbaxy Laboratories -- will provide the drug in the Southern African Development Community, which includes some of the areas most affected by the HIV/AIDS epidemic. MSD, Merck's South African subsidiary, said that the company's offer to license the drug "royalty-free" was done to "complement" the rollout of South Africa's national antiretroviral drug treatment program, according to Reuters (Quinn, Reuters, 4/7). The South African Cabinet in November 2003 approved a plan for the program, which aims to provide antiretroviral drugs to 1.2 million people -- or about 25% of the country's HIV-positive population -- by 2008. Gauteng province this month became the first of the country's nine provinces to begin dispensing drugs under the government's program. Western Cape started its own program earlier this year, and other provinces are expected to begin programs in the coming weeks. Officials expect 50,000 people to be on antiretroviral drugs by the end of the year and 1.4 million people to be on the drugs by 2009, at a total cost of $700 million (Kaiser Daily HIV/AIDS Report, 4/2). Stocrin is one of the "key" antiretroviral drugs that the South African government says it will use in its program, according to Business Day. The drug will be given to approximately 70% to 80% of participants in the program, Business Day reports. Although Thembalami will be unable to market its version of Stocrin until it registers the drug with South Africa's Medicines Control Council, the agreement with Merck will allow the company to bid alongside MSD in the state tender for efavirenz (Business Day, 4/8).

Other Companies
Some AIDS advocates have accused large pharmaceutical manufacturers of maintaining antiretroviral prices that are "unfairly high" for South Africa, which has the largest number of people living with HIV/AIDS in the world, according to Reuters. Drug makers GlaxoSmithKline and Boehringer Ingelheim in December 2003 said they would offer more licenses to South African drug firms to produce generic antiretrovirals. GSK, which already has licensed Aspen Pharmacare to make generic antiretrovirals, is currently in "advanced" talks with Thembalami about licenses for its antiretroviral drugs Retrovir and Epivir, which are known generically as zidovudine and lamivudine, respectively, according to Reuters. Thembalami spokesperson Maureen Stewart said that the company also is in "advanced-stage" negotiations with Boehringer Ingelheim, although no licenses have yet been awarded, Reuters reports (Reuters, 4/7).