Aspen to Market New HIV Drug in Sub-Saharan Africa

Aspen Pharmacare and Tibotec Pharmaceuticals announced they have signed a royalty-free, nonexclusive license agreement under which Aspen will develop and distribute the HIV drug Prezista in Sub-Saharan Africa.

Aspen is the largest drugmaker in Africa. The agreement covers Sub-Saharan Africa, which includes roughly 20 countries. The drug will be sold for not more than $3 a day.

When approved by African regulatory authorities, Prezista (darunavir), co-administered with ritonavir and with other antiretroviral drugs, is expected to be indicated for treatment-experienced patients, especially those failing on an earlier regimen that includes a protease inhibitor.

Aspen will be in charge of seeking regulatory approval for Prezista in Africa and will manage the mechanism for preapproval access for certain patients where permitted. The agreement also creates a framework for Aspen to manufacture Prezista in Africa in the future. Tibotec will be responsible for seeking prequalification from the World Health Organization.

The FDA is reviewing the Prezista application in the U.S. on an accelerated schedule. The drug was approved in Europe in February.