AEGiS-ST: Aspen to market new Aids drug Sunday Times (Johannesburg)Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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Aspen to market new Aids drug

Sunday Times (Johannesburg) - April 10, 2007
Tamar Kahn


Africa's biggest generic drug maker, Aspen Pharmacare, has sealed a deal with Johnson & Johnson subsidiary Tibotec Pharmaceuticals to package, distribute and ultimately manufacture a new AIDS drug called darunavir to subSaharan Africa.

Darunavir, which is expected to reach 30,000-40,000 people in Africa in 2011, is a promising new protease inhibitor used for HIV patients who have developed resistance to other drugs.

About 3% of Africa's HIV patients receiving treatment were resistant to first-line and second-line regimens, and needed these newer and more costly "salvage" medicines, said Aspen's head of strategic trade, Stavros Nicolau.

"As more and more patients go on to treatment in Africa, salvage treatment is going to become more and more important," he said.

Citing United Nations figures, he said about 1,3-million African HIV patients were receiving antiretroviral treatment. The number was expected to rise to 3,4-million within the next three or four years.

Aspen, which manufactures a range of generic Aids drugs, currently supplied medicines to about half-a-million patients, 40% of them in SA, said Nicolau.

In terms of the royalty-free, nonexclusive licence agreement, Aspen would register and sell darunavir at less than $3 a patient a day, possibly as low as $2,60, said Nicolau. The drug will be co-branded by Aspen and Tibotec as Prezista.

"Were it not for this type of arrangement, this type of drug would be inaccessible for African patients. The cost would exorbitant," Nicolau said.

Prezista has been approved by the US Food and Drug Administration, and was given conditional marketing rights by European regulators last month.

An application to register Prezista in SA was lodged with the Medicines Control Council (MCC) three months ago.

Like most Aids drugs, it was given "fast track" status, which theoretically means it could be given the green light within the next six months.


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