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www.fdanews.com/articles/62947-bms-gilead-form-agreement-on-atripla-sales-in-canada

BMS, GILEAD FORM AGREEMENT ON ATRIPLA SALES IN CANADA

October 2, 2006

Bristol-Myers Squibb (BMS) and Gilead Sciences have announced an agreement to commercialize Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) 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 for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. The drug received approval from the FDA in July.

The agreement is the result of negotiations between BMS and Gilead and expands the companies' U.S. joint venture established in 2004. The companies will work together to complete regulatory filings in Canada and will share responsibility for commercializing the drug there. As in the United States, both companies will provide funding and field-based sales representatives in support of promotional efforts for Atripla.

Atripla combines BMS' Sustiva (efavirenz) and Gilead's Truvada. Truvada itself is a fixed-dose product that contains two of Gilead's HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), in a single once-daily tablet for use as part of combination therapy.