Bristol-Myers Squibb and Gilead Sciences have made an agreement to commercialize their combo-drug Atripla in Canada for the treatment of HIV-1 infection in adults, subject to the approval of the product by Health Canada. Atripla is the first once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. It received approval from the U.S. FDA on July 12, 2006.
The agreement is the result of negotiations between BMS and Gilead and expands the companies' U.S. joint venture established in December 2004. The companies will work together to complete regulatory filings in Canada and will share responsibility for commercializing Atripla in Canada, subject to regulatory approval of the product. As in the U.S., both companies will provide funding and field-based sales representatives in support of promotional efforts for Atripla. Gilead will record revenues from future net sales of the product, while BMS will record revenues at percentages relative to the contribution represented by its individual product.
"This agreement with Gilead Sciences marks an important step forward in our efforts to deliver effective HIV therapies," said Lamberto Andreotti, president, Worldwide Pharmaceuticals, BMS. "We look forward to working with Gilead Sciences and Health Canada to make available another effective treatment option for Canadian adult patients living with HIV/AIDS."
Atripla combines Sustiva (manufactured by BMS) and Truvada (a fixed-dose product that contains two of Gilead's anti-HIV medications: Viread and Emtriva) in a single once-daily tablet for use as part of combination therapy.