Tibotec, a division of Johnson & Johnson, announced today that it has concluded a non-exclusive, royalty-free voluntary licensing agreement with South African company Aspen Pharmacare for its protease inhibitor darunavir (Prezista).
Darunavir boosted with ritonavir was licensed for use in treatment-experienced patients in the United States in June 2006 and in the European Union in March 2007. Darunavir is not coformulated with ritonavir, unlike its competitor protease inhibitor Kaletra (lopinavir/ritonavir).
The drug is licensed for use in treatment-experienced patients who have already failed one protease inhibitor in the US and Europe, but its utilisation in the developing world may be broader if the price is competitive with Abbott's Kaletra.
The agreement between the companies means that Aspen will co-market Prezista with Tibotec in sub-Saharan Africa, handling the packaging, registration and distribution of the drug. Aspen will take on manufacturing of the drug in South Africa if demand in the region eventually makes it economically viable.
Tibotec has already submitted regulatory dossiers for approval in South Africa, Botswana and Namibia, and said today that 20 countries in Africa with 80% of estimated patient need would be targeted in the first wave of regulatory submissions. Tibotec will pursue World Health Organization pre-qualification, which will assist in speeding these approvals.
Prezista is being offered at a price of not more than $3 a day ($1095), excluding taxes, duties and transportation costs, making it significantly more expensive than Kaletra, which is being offered at a price of $500 a year by manufacturer Abbott in sub-Saharan Africa.
Karen Manson of Tibotec told aidsmap: “Because we don’t have final regulatory approval, we can’t be specific about the price, but we wanted to indicate the region in which the price is likely to be.”
The final price of using daruanvir will also be affected by the availability and price of ritonavir. A total ritonavir dose of 200mg per day (a 100mg boosting dose with each 600mg dose of darunavir) will be necessary.
Karen Manson said that Tibotec was not ruling out future voluntary licensing arrangements with other manufacturers.
Roche, the manufacturer of saquinavir, is currently negotiating voluntary license and technology transfer deals with a number of African pharmaceutical companies, while Bristol Myers Squibb has concluded voluntary licensing deals for its protease inhibitor atazanavir with Aspen Pharmacare in South Africa and Emcure in India.