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Bristol Myers Squibb announces voluntary licenses for atazanavir in India and South Africa
Keith Alcorn, Wednesday, February 15, 2006
Bristol Myers Squibb announced today that it will grant voluntary licenses for manufacture of its new protease inhibitor atazanavir, sold in Europe and North America under the brand name Reyataz, to pharmaceutical companies in India and South Africa for sale in India and Africa.

The company will also provide technical know-how to its licensees, Emcure in India and Aspen Pharmacare in South Africa, to teach them how to make the protease inhibitor.

Atazanavir is the second protease inhibitor to be offered for technology transfer. In January Roche announced that it was prepared to transfer the technical know-how to make its protease inhibitor saquinavir to any pharmaceutical manufacturer in Africa that wanted to make the drug, and that it would not enforce its patent rights on saquinavir.

The move potentially broadens the choice of second-line treatments available in resource-limited settings, but atazanavir use may be limited by the lack of access to the boosting agent ritonavir, another protease inhibitor manufactured by Abbott Laboratories. In Europe atazanavir is only licensed for use in treatment-experienced patients when boosted by ritonavir, but ritonavir is vulnerable to high temperatures and should not be stored outside a refrigerator for more than a few days in a hot climate. Although Abbott Laboratories has developed a heat stable tablet version of its own boosted protease inhibitor Kaletra (lopinavir/ritonavir), it has still to develop a heat stable version of ritonavir.

The heat stable version of Kaletra remains unlicensed outside the United States, and Medecins Sans Frontieres (MSF) last week called on Abbott Laboratories to move quickly to register the new version in all countries eligible to receive the drug at the no-profit access price of approximately $500 a year.

MSF also called on Abbott Laboratories to cut the price of Kaletra through its access programme, arguing that the reduction in pill burden from six to four pills per day justified a reduction in price to approximately $333 a year.