South African Generic Drug Maker to Produce Country's First Generic Antiretroviral Drug

, southern Africa's largest generic drug manufacturer, yesterday announced that it will develop and produce the continent's first generic antiretroviral drug, called Aspen-Stavudine, South Africa's Mail & Guardian reports (Mail & Guardian, 8/6). The drug, manufactured under voluntary license from Bristol-Myers Squibb, which markets stavudine as Zerit, "marks a breakthrough" in the fight against AIDS in Africa, according to Reuters (Chege, Reuters, 8/5). Under the terms of its voluntary license, the company will be allowed to sell the drug to both the public and private sector, according to Aspen CEO Stephen Saad. The drug will cost between $3 and $4 per month per person, depending on dosing, compared with about $5 per person for a month's supply of Zerit in South Africa, the Associated Press reports (Nessman, Associated Press, 8/6). The cost of the drug is within the range recommended by the World Health Organization and will be competitive with the pricing of generic drugs produced by Asian generic drug makers (Reuters, 8/6). The company has also submitted registration applications to the country's Medicines Control Council for its generic versions of Combivir, zidovudine, lamivudine, didanosine and nevirapine, Saad said (Mail & Guardian, 8/6). Once the generic drugs are registered, Aspen plans to sell a three-drug combination regimen for less than $1 a day, according to Saad. Unlike Aspen-Stavudine, however, the licenses obtained for the production of the other antiretrovirals will allow the company to sell the drugs only to the public health system (Associated Press, 8/6). Current three-drug combinations using generics from Asian manufacturers cost about $1.40 per patient per day.

Government Action
Aspen's announcement puts pressure on the South African government to roll out a national antiretroviral treatment plan, according to health industry officials, Reuters reports. The government's AIDS policies came under fire yesterday at the close of the South African AIDS Conference 2003 in Durban and health industry officials said that Aspen's announcement leaves the government with "little room for excuses," according to Reuters. "We are at a point when the government has sufficient options in place to consider rolling out an antiretroviral treatment program," an unnamed pharmaceutical industry official said (Reuters, 8/6). Trade and Industry Minister Alec Irwin said that he could not determine whether the government would make use of the new drug, adding that the rollout of the antiretroviral treatment plan would "continue as planned," according to the SAPA/Independent Online. "The advantage we now have is that a generic is available from a South African company, so it certainly gives certain cost advantages in the roll-out program," he said (SAPA/Independent Online, 8/6). South African AIDS advocacy group Treatment Action Campaign "cautiously welcomed" the announcement but criticized the exclusive license BMS granted Aspen, saying that only free competition among generic companies would make the prices of drugs fall as low as possible, according to the Associated Press. "While this is an excellent development, and it does move us forward, it is not ideal," Eduard Grebe, TAC's treatment project coordinator, said, adding, "It's in fact a transfer of monopoly and not generic competition" (Associated Press, 8/6).

Webcasts of selected sessions of the conference are available online through kaisernetwork.org's HealthCast.

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