Bristol-Myers Squibb Company and Gilead Sciences, Inc. submitted a New Drug Application (NDA) to the US FDA for approval of a product that combines 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 itself is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), 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, stated a release.
The collaboration between Bristol-Myers Squibb and Gilead is the first of its kind in the field of HIV therapy. On December 20, 2004 the companies established a US joint venture to develop and commercialize the single tablet regimen in the United States. 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.
John C. Martin, President and Chief Executive Officer, Gilead Sciences commented, "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."
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 active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication. It is important for patients to be aware that these medications do not cure HIV infection or prevent passing HIV to others.
Subject to marketing approval of the once-daily single tablet regimen, Bristol Myers-Squibb and Gilead will share responsibility for commercializing the product in the United States. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. Bristol-Myers Squibb and Gilead 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, added the release.