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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. Visit Gilead on the World Wide Web at www.gilead.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the combination product will receive regulatory approval in Canada or other geographies, or, if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Gilead Forward-Looking Statement
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including that the combination product receive regulatory approval in Canada or other geographies, or, if approved, that physicians may not see advantages of ATRIPLA over other antiretrovirals and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2005, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc.
Bristol-Myers Squibb Contacts Eric Miller, Media (609) 252-7981 Sabrina Tremblay, Media (514) 333-2463 John Elicker, Investors (212) 546-3775 Gilead Sciences Contacts James Loduca, Media (650) 522-5908 Susan Hubbard, Investors (650) 522-5715Back to News Releases