Gilead, Merck to distribute Atripla in developing countries

By Elaine Rigoli

Tampa, Fla., Aug. 11 - Gilead Sciences, Inc. and Merck & Co., Inc. have established an agreement for the distribution of Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily, single tablet regimen for the treatment of HIV-1 infection in adults, in developing countries.

Atripla was approved by the Food and Drug Administration on July 12. In the United States, the product is commercialized by Bristol-Myers Squibb and Gilead through the companies' joint venture.

The FDA also granted approval of an alternate trade dress of Atripla for developing countries, where Atripla will be made available as a white-colored tablet to distinguish it from the salmon-colored version currently available in the United States. Gilead and Merck plan to pursue registration of the product with individual country health authorities. The component therapies are already registered, or are in the process of being registered, in many of these countries.

Under the agreement, Gilead will manufacture Atripla using efavirenz supplied by Merck. Merck in turn will handle distribution of the product in the countries covered by the agreement.

Based in Foster City, Calif., Gilead is a biopharmaceutical company.

Merck is a global research-driven pharmaceutical company based in Whitehouse Station, N.J.

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