Bristol-Myers Squibb, Gilead Submit HIV NDA

Bristol-Myers Squibb and Gilead Sciences have submitted an NDA to the FDA for a product that combines the anti-HIV medications Sustiva (BMS) and Truvada (Gilead) in a once-daily single tablet regimen.

Truvada itself is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread and Emtriva, in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete Highly Active Antiretroviral Therapy (HAART) regimen in a single once-daily tablet, intended for the treatment of HIV-1 infection in adults as a complete regimen or in combination with other antiretrovirals.

The proposed single tablet regimen contains 600 mg of Sustiva, 200 mg of Emtriva and 300 mg of Viread. All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication.

BMS and Gilead will share responsibility for commercializing the product in the U.S. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. They will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the once-daily single tablet regimen. Sustiva, Truvada, Viread and Emtriva will continue to be sold by the respective companies as individual products

In December 2004, the companies established a U.S. joint venture to develop and commercialize the single tablet regimen in the U.S. The work necessary to file the NDA for the single tablet regimen, including bioequivalence studies and the initiation of stability studies, has since been completed.

“The partnership between Bristol-Myers Squibb and Gilead was founded on the companies’ shared commitment to addressing the needs of people living with HIV,” commented John C. Martin, Ph.D., president and chief executive officer, Gilead Sciences. “Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients.”