Production of a generic version of the most widely used combination of AIDS drugs could begin as early as March or April and expand treatment for patients in 13 African countries, the company said Wednesday.
Aspen Pharmacare (search), South Africa's largest drug manufacturer, received tentative approval Tuesday from the U.S. Food and Drug Administration to produce a generic version of the AIDS triple cocktail of drugs.
That means the generic drugs will be allowed to be purchased by relief organizations in Africa funded by U.S. President George W. Bush's five-year, $15 billion Emergency Plan for AIDS Relief (search).
Aspen spokesman Stavros Nicolao said Wednesday the drug will be produced at a plant in Port Elizabeth that can produce 5.5 billion capsules a year, which he said is more than three times greater than the demand from the 13 African countries that have qualified for assistance under the Bush plan.
Nicolao said the two-pill cocktail of three drugs also would be sold to aid groups funded by the U.N. Global Fund.
The company estimates the price of the drug at 100 to 120 rands per month $16.65 to $20_ less than half the monthly price of $55 per patient paid by some relief groups now.
"You can't buy candy for that price on a daily basis," said Nicolao.
Sub-Saharan Africa (search) is the region of the world hardest hit by AIDS. U.N. officials said in Davos, Switzerland, on Wednesday that the number of people using HIV/AIDS drugs in the developing world had nearly doubled last year. But they said more work is needed to meet the ambitious goal of having 3 million getting treatment by the end of 2005.
One way to ensure that figure was met was to provide better access to cheaper drugs, they said.
The FDA's decision to fast-track approval of generic AIDS drugs is seen as a way to quickly widen the availability of the anti-retroviral treatment.
"I think it is good news and we would call on the U.S. government not to stop there. We want them to open up access to proven generic drugs and combinations, especially ones that have been preapproved by the World Health Organization," said Liza Kimbo, a leading campaigner in Kenya for access to essential AIDS drugs.
Aspen's product combines one pill that contains a generic equivalent of two drugs made by GlaxoSmithKline PLC of the United Kingdom and a second pill that is a generic version of the Nevirapine drug made by Boehringer Ingelheim GmbH of Germany. The two drugmakers earlier licensed Aspen to produce the drugs.
The company said it had spent $30 million on improvements at the plant that will manufacture the drug.
Nicolao predicted the first shipments of the Aspen product would come in April, but that the timing depended partly on how fast the drug can be registered in the 13 countries. He said Aspen is moving to register the drug in the 13 eligible countries and said it can start manufacturing the cocktail six to eight weeks after receiving orders from relief groups.
Aspen's product is close to being registered in South Africa and Nicolao said he expects the registration to go quickly in countries with relatively advanced anti-retroviral programs for Africa such as Mozambique, Uganda and Tanzania. He said it could take longer in countries such as Burundi that are just getting started with anti-retrovirals.
Aspen, he said, would also work closely with the William Jefferson Clinton Foundation, which has people working on getting HIV therapies registered in many of the 13 African countries that qualify for the Bush program.
Aspen shares rose nearly 5 percent Wednesday to close at $3.49.