Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
South African Press Association - April 4, 2007
The "royalty-free, non-exclusive" agreement between Aspen of South Africa and Tibotec Pharmaceuticals, based in Ireland, allows Aspen to register, package and distribute the protease inhibitor Prezista in sub-Saharan Africa, said spokesperson for the two companies Shauneen Beukes.
Aspen may also manufacture Prezista later if there is enough demand.
Aspen executive Stavros Nicolaou said Prezista is not a generic, but the agreement means it will be as cheap as if it were.
In terms of the agreement, the Port Elizabeth-based Aspen will sell Prezista at an ex-factory price of not more than $3 (about R22) a day. Nicolaou said the final price to consumers is not yet known.
The companies warned that the retail price could be higher as other costs may be added, including "the logistics fee in South Africa, or the freight, insurance, customs handling, taxes and duties".
Nicolaou said protease inhibitors are a particular class of ARVs, are "fairly new" and will become increasingly important. Protease inhibitors are currently used as "salvage treatment" for patients for whom first- and second-line drugs do not work.
"There are very few generic options for salvage treatment ... this would in effect be the first," said Nicolaou.
ARVs are usually administered in a cocktail of three drugs from two different classes.
"The World Health Organisation estimates that approximately 4% of people receiving antiretroviral treatment in low- and middle-income countries today need advanced treatment options because of HIV drug resistance," said Beukes.
The drug was approved by the United States in June last year and the European Commission in February this year.
Nicolaou said applications for South Africa, Botswana and Namibia were filed two months ago. Such applications routinely take 12 to 18 months, but these are being fast-tracked. Beukes said these three countries and another 17 will be the first targets for regulatory approval as they make up about 80% of the need for the drug.
The others are Cameroon, the Democratic Republic of Congo, Ethiopia, Ghana, Cote d'Ivoire, Kenya, Lesotho, Malawi, Mozambique, Nigeria, Rwanda, Senegal, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.
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