Generic Drug Firm Thembalami Withdraws Antiretroviral Drug Bid in South Africa; Short List Reduced to Seven Companies
South African generic drug firm Thembalami Pharmaceuticals has withdrawn a bid to supply the South African government with antiretroviral drugs, leaving seven companies on the government's "short list" to supply drugs for millions of HIV-positive people in the country, Business Day reports. Thembalami was created as a joint venture between the South Africa-based pharmaceutical group Adcock Ingram and India-based generic drug firm Ranbaxy to produce generic antiretroviral drugs for South Africa. However, Ranbaxy has voluntarily recalled all of its HIV/AIDS drugs in South Africa because of problems with a research company that conducted studies to determine if the generic drugs offered the same "therapeutic value" as the brand-name versions, according to Business Day. A company report to the World Health Organization in September highlighted problems with the bioequivalence studies for tablets of the antiretroviral drug Avocomb -- which contains the antiretrovirals zidovudine and lamivudine -- and subsequent investigations revealed similar problems with other products. Deloise Raubenheimer, a doctor for Ranbaxy, said she did not know how many people would be affected by the recall but said the number was "small." The company "strongly urged" people taking its drugs to continue with their current therapy "until an equivalent alternative can be substituted," Business Day reports. Ranbaxy CEO Desmond Brothers said that the recall would not affect distribution in other countries (Kahn, Business Day, 10/26).
Antiretroviral Drug Program
The South African government earlier this year launched a national antiretroviral drug treatment program that aims to provide antiretroviral drugs to 1.2 million people -- or about 25% of the country's HIV-positive population -- by 2008. Officials expect 50,000 HIV-positive 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, 10/27). The remaining bidders for the government contract are Abbott, Boehringer Ingelheim, Bristol Meyers Squibb, GlaxoSmithKline, Merck's South African subsidiary MSD and generic manufacturers Aspen Pharmacare and Cipla-Medpro (Business Day, 10/26). Thembalami was expecting to produce a generic of Boehringer's nevirapine that would have cost 30% to 40% less than the brand-name product (Moodley, Business Report, 10/26).