Roche, the manufacturer of nelfinavir (Viracept) and saquinavir (Invirase), announced today that it has agreed to pass on the know-how to make its protease inhibitor saquinavir to three African companies, Aspen Pharmacare of South Africa and Cosmos and Universal Corporation in Kenya.
The three companies will be entitled to manufacture saquinavir and market it anywhere in sub-Saharan Africa and other least-developed countries, but the technology transfer could also enable the companies to make other protease inhibitors, since the basic processes required to manufacture drugs in this class are very similar, according to a Roche spokesperson.
Roche said that it is also working with applicants from 24 countries including Ghana, Zimbabwe and Nigeria to determine whether technology transfers can be set up. Maria Vigneau of Roche told aidsmap that the only criterion for determining whether technology transfer could take place was whether the company already had all the necessary equipment to make saquinavir tablets. Those that did would be the first to enter talks.
Roche announced in January that it was seeking to license saquinavir production to developing country manufacturers. Saquinavir is a recommended second-line drug in the WHO guidelines for antiretroviral treatment in resource-limited settings, but must be boosted by ritonavir (Norvir). Although a new tablet formulation of saquinavir is heat-stable, the ritonavir capsules currently available must be refrigerated.
Ritonavir’s manufacturer Abbott says that it is still working on a heat-stable tablet formulation of ritonavir, and has refused voluntary licensing or technology transfer agreements for its protease inhibitors because it says that the Meltrex technology used to make its HIV drug Kaletra heat-stable is proprietary.
However Maria Vigneau of Roche said that Abbott had emphasised the lack of patent restrictions on its product Norvir in sub-Saharan Africa when it declined to take part in technology transfer discussions already initiated by Roche.
Although saquinavir is one of the drugs recommended for second-line treatment by WHO, it's unclear whether generic manufacturers will be able to bring down its price to the same range as Kaletra, which is offered by Abbott to least-developed countries at $500 a year.