Abbott seeks registration in South Africa of new formula to treat HIV

By E. Janene Geiss

Philadelphia, April 4 - Abbott announced Tuesday that it has filed for registration of the new tablet formulation of its HIV medicine lopinavir/ritonavir in South Africa.

The government of South Africa has granted fast track review of the new tablet formulation, according to a company news release. This filing marks a milestone in Abbott's ongoing efforts to expand availability of the new formulation for patients with HIV in developing countries.

Abbott said it plans to maintain its current lopinavir/ritonavir price of $500 per patient per year in Africa and the "least developed countries" for the new formulation. By maintaining this price, lopinavir/ritonavir will continue to be one of the lowest-priced protease inhibitors (branded and generic) in Africa and the least developed countries.

Abbott said it has made a significant investment in advanced technologies to bring the new formulation to HIV patients, including expanding manufacturing capacity to meet the growing demand for second-line HIV treatment when first-line treatment has failed in developing countries, and developing the innovative and complex Meltrex technology for the new tablet formulation.

With this novel, breakthrough technology, the more convenient lopinavir/ritonavir tablet formulation will allow adult patients to take fewer pills with or without food as part of their treatment regimen.

The new formulation does not require refrigeration - an important advance for patients in developing countries, Abbott said.

Efforts are underway to register this new formulation in countries around the world. Abbott also said it has taken extensive steps to make the capsule formulations of its HIV medicines lopinavir/ritonavir and ritonavir available around the world.

The company also said it also has worked to make available its liquid formulations of both medicines that have demonstrated safety and efficacy in pediatric HIV treatment.

All current formulations of Abbott's HIV medicines are available in Africa and the least developed countries at $500 per patient per year, Abbott said.

Abbott said it is applying the Meltrex technology to develop additional new formulations of its HIV medicines to benefit patients around the world.

Initiatives include a new lower-dose pediatric tablet being developed with the goals of eliminating the need for refrigeration and providing dosing option flexibility. Abbott said it also is developing a tablet formulation of its protease inhibitor ritonavir that does not require refrigeration.

Abbott, based in Abbott Park, Ill., is a broad-based health care company devoted to development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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