MERCK TO REGISTER ATRIPLA IN AFRICA, MIDDLE EAST

Merck announced it has begun to file registrations for Atripla, a once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults, with health authorities in many developing countries, including 45 countries in the Middle East and Africa.

Its availability to patients in these countries will depend on the pace of national regulatory processes, Merck said. In an additional 11 countries, Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) can be imported based on the U.S. registration. The company is also pursuing an application for WHO prequalification.

"Fixed-dose combination (FDC) drugs have revolutionized antiretroviral therapy in the developing world and brought treatment to millions," Richard Feachem, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said. "Atripla is a valuable addition to the FDC armory and requires only one pill per day."

For countries in the Low Human Development Index (HDI) category and countries in the Medium HDI category with adult HIV prevalence of 1 percent or greater, Atripla will be available for $1.68 per tablet, or $50.40 per pack.

Atripla was approved by the U.S. FDA in July 2006. Merck and Gilead entered an agreement in August to work together to pursue registration of the product with individual country health authorities in the developing world.