Bristol-Myers Squibb, Gilead submit NDA for once-daily single tablet regimen for HIV

By Lisa Kerner

Erie, Pa., April 27 - Bristol-Myers Squibb Co. and Gilead Sciences, Inc. submitted a New Drug Application to the Food and Drug Administration for their product combining the anti-HIV medications Sustiva (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, in a once-daily single tablet regimen.

Truvada, a fixed-dose product, contains two of Gilead's anti-HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), in a single once-daily tablet, according to a company news release.

The proposed once-daily single tablet regimen contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, all three of which block reverse transcriptase, an enzyme necessary for HIV replication.

Bristol-Myers said that following FDA approval, the new single tablet regimen would be the first product that contains a Highly Active Antiretroviral Therapy regimen in a single once-daily tablet for the treatment of HIV-1 infection in adults as a complete regimen or in combination with other antiretrovirals.

Bristol Myers Squibb and Gilead will share responsibility and funding bringing the product to market and selling it in the United States. Both companies will receive revenues from future net sales of the new product, while Sustiva, Truvada, Viread and Emtriva will continue to be sold as individual products.

Bristol-Myers Squibb is a Princeton, N.J.-based pharmaceutical and related health care products company.

Gilead Sciences is a biopharmaceutical company based in Foster City, Calif.

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