BRISTOL-MYERS SQUIBB AND GILEAD SCIENCES ESTABLISH AGREEMENT TO COMMERCIALIZE ATRIPLA™ (EFAVIRENZ 600 MG/ EMTRICITABINE 200 MG/ TENOFOVIR DISOPROXIL FUMARATE 300 MG) IN CANADA
If Approved, Product Would Be the First Once-Daily Single Tablet Regimen for HIV-1 Infection in Adults in Canada
Princeton, N.J. and Foster City, Calif. – (September 28, 2006) – Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement to commercialize ATRIPLATM (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 (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. ATRIPLA received approval from the U.S. Food & Drug Administration on July 12, 2006.
The agreement is the result of negotiations between Bristol-Myers Squibb and Gilead Sciences 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 United States, 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 ATRIPLA, while Bristol-Myers Squibb will record revenues at percentages relative to the contribution represented by its individual product.
“We are pleased to have finalized our agreement for Canada, and are working expeditiously to complete the regulatory filing for ATRIPLA with Health Canada,” said John C. Martin, PhD, President and CEO, Gilead Sciences. “We recognize the need for access to ATRIPLA, the first once-daily single tablet regimen, and are working to make it available to all patients who need it as quickly as possible.”
“This agreement with Gilead Sciences marks an important step forward in our efforts to deliver effective HIV therapies,” said Lamberto Andreotti, president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. “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 (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada® (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences. 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 for use as part of combination therapy.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com.