Tibotec said it selected Aspen because of its extensive African distribution network. Aspen and Tibotec will share the responsibility for ensuring prompt and affordable access to patients in the Sub-Saharan region.
The drug Prezista, distributed by Aspen and sold at an ex-factory price that should not exceed $3 a day.
Prezista, co-administered with ritonavir and with other antiretroviral agents (ARVs), is expected to be indicated for treatment-experienced patients, especially those failing an earlier regimen that includes a protease-inhibitor.
Aspen will manage the mechanism for pre-approval access for patients in sub Saharan Africa in urgent need of Prezista where this is permitted by local health authorities. Tibotec is responsible for seeking pre-qualification from the World Health Organization and approval in order to facilitate the funding of Prezista by international organizations. Tibotec has filed the Prezista dossier for regulatory approval in South Africa, Botswana and Namibia.
“Tibotec is pleased to be working with a local partner in sub-Saharan Africa to expedite pre-approval access, registration and the development of sustainable supply-chains to meet patient need,” said Julie McHugh, company group chairman, Virology, Tibotec.