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April 05, 2007, 07:15
A South African drug manufacturer has signed an agreement with an international company allowing it to distribute an anti-retroviral cheaply in sub-Saharan Africa, the companies said yesterday.
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 (darunavir, DRV) in sub-Saharan Africa," said Shauneen Beukes, the spokesperson for the two companies.
Aspen may also manufacture Prezista later if there is enough demand. Stavros Nicolaou, the Aspen executive, said Prezista was not a generic but the agreement meant it would be as cheap as if it was. In terms of the agreement, the Port Elizabeth-based Aspen will sell Prezista at an ex-factory price of not more than $3 a day. Nicolaou said the final price to consumers was not yet known.
Prices could rise
The companies warned that the retail price could be higher as other costs could be added, including "the logistics fee in South Africa, or the freight, insurance, customs handling, taxes and duties". Nicolaou said protease inhibitors were a particular class of ARVs, were "fairly new", and would become increasingly important. Protease inhibitors are currently used as "salvage treatment" for patients for whom first and second line drugs did 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.
"Prezista, co-administered with ritonavir and with other antiretroviral agents, is expected to be indicated for treatment-experienced patients, especially those failing an earlier regimen that includes a protease-inhibitor," said Beukes.
"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."
The US approved the drug in June
The drug was approved by the US 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 took 12 to 18 months but these were being fast-tracked so could take less than a year.
Beukes said these three countries and another 17 would be the first targets for regulatory approval as they make up about 80% of the need for the drug. They others are Cameroon, Democratic Republic of Congo, Ethiopia, Ghana, Ivory Coast, Kenya, Lesotho, Malawi, Mozambique, Nigeria, Rwanda, Senegal, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. - Sapa
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