Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (NASDAQ: GILD) today announced an agreement to commercialize ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe for the treatment of virologically suppressed adults with HIV-1 infection, subject to the product's approval by the European Commission. If approved, ATRIPLA would represent the first and only once-daily single tablet regimen for HIV-1 infection in the European Union. The companies expect the European Commission to issue its decision by the end of the year.
Under this agreement, Bristol-Myers Squibb and Gilead share responsibility for commercializing ATRIPLA throughout the European Union and certain other European countries. Gilead will record revenues from future net sales of ATRIPLA in most of the European countries, while Bristol-Myers Squibb will record revenues in most of the European countries at percentages relative to the contribution represented by its individual product.
Bristol-Myers Squibb recently concluded an agreement with Merck & Co., Inc. under which Merck granted Bristol-Myers Squibb rights to co-commercialize ATRIPLA with Gilead in all of the European Union and certain other European countries. Previously, Merck had the exclusive right to market any product containing efavirenz (a component of ATRIPLA) in all European countries other than the United Kingdom, Germany, France, Italy, Spain and the Republic of Ireland.
Efavirenz is marketed by Bristol-Myers Squibb under the tradename SUSTIVA® in the United States, Canada and six major countries of the European Union. Efavirenz will continue to be commercialized by Merck & Co, Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename STOCRIN® in all other countries within the European Union and many countries outside of the United States. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead under the tradenames Emtriva® and Viread®, respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada® for use as part of combination therapy.
ATRIPLA is currently sold in the United States and Canada through a joint venture between Bristol-Myers Squibb and Gilead. ATRIPLA was approved by the U.S. Food and Drug Administration (FDA) in July 2006 and by Health Canada in October 2007. Gilead and Merck previously announced a collaboration to distribute ATRIPLA in developing countries.
For complete U.S. prescribing information, including Boxed WARNINGS, for ATRIPLA, visit http://www.atripla.com. For complete prescribing information for SUSTIVA, visit http://www.bms.com. For complete U.S. prescribing information for Truvada, Viread and Emtriva, including Boxed WARNINGS, visit visit www.gilead.com.
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.