Aspen Pharmacare, Tibotec Enter Agreement To Distribute Protease Inhibitor Prezista in Sub-Saharan Africa

South Africa-based Aspen Pharmacare has entered an agreement with Johnson & Johnson subsidiary Tibotec Pharmaceuticals to package and distribute Tibotec's antiretroviral drug Prezista, which is sold under the generic name darunavir, in sub-Saharan Africa, South Africa's Business Day reports (Kahn, Business Day, 4/5). Prezista is in a class of antiretrovirals known as protease inhibitors, which work by blocking the action of an enzyme that cuts HIV proteins into the shorter sections that the virus needs to create copies of itself. FDA in June 2006 gave accelerated approval to Tibotec's application for sale and marketing of Prezista for use by HIV-positive people who are resistant to first-line drugs (Kaiser Daily HIV/AIDS Report, 4/5). Under the agreement, Aspen will register and sell Prezista at less than $3 per person daily, and possibly as low as $2.60 per person daily, according to Stavros Nicolaou, Aspen's head of strategic trade (Business Day, 4/5). According to Aspen and Tibotec, Prezista's price might increase slightly because other costs -- such as the "logistics fee in South Africa, or the freight, insurance, customs handling, taxes and duties" -- could be added, according to SAPA/SABC News. Shauneen Beukes, a spokesperson for the two companies, said that 20 African countries will be the first targets for regulatory approval of the drug. Nicolaou said that Botswana, Namibia and South Africa two months ago filed for regulatory approval, which typically takes 12 to 18 months but could take less than 12 months because the applications are being fast-tracked (SAPA/SABC News, 4/4). The drug is expected to reach between 30,000 and 40,000 HIV-positive people in Africa by 2011. Prezista will be prescribed in combination with the antiretroviral ritonavir, according to Business Day (Business Day, 4/5). A study published last week in the online edition of the Lancet found that Prezista decreased HIV viral loads after 48 weeks of use among people who have developed drug resistance (Kaiser Daily HIV/AIDS Report, 4/5). According to Beukes, the World Health Organization estimates that about 4% of people taking antiretrovirals in low- and middle-income countries need other treatment options because they have developed drug resistance (SAPA/SABC News, 4/4).