Agreement for generic license of darunavir in South Africa
On 4 April 2007 Tibotec announced that it has signed a royalty-free, non-exclusive license agreement with Aspen of South Africa. Aspen will register, package and distribute the protease inhibitor darunavir (TMC-114, Prezista) in sub-Saharan Africa.
Aspen and Tibotec will share the responsibility for ensuring prompt and affordable access to patients in the Sub-Saharan region.
Darunavir was submitted to regulatory agencies in South Africa during the Autumn 2006 and in Botswana and Namibia earlier this year.
Tibotec say that the ex-factory cost should not exceed US$3 a day, it will be offered on an FOB basis so there will be additional costs (Free On Board means that the shipper pays freight, taxes and duty costs) although these are beyond the control of Aspen and Tibotec.
Darunavir was licensed in the US in June 2006 and in Europe in February 2007.
Source: Tibotec press release and communication with Tibotec