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European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
Date:12/17/2007

irenz is commercialized by Merck & Co., Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename STOCRIN(R) 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 Sciences, Inc. (Nasdaq: GILD) under the tradenames Emtriva(R) and Viread(R), respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada(R) for use as part of combination therapy.

The marketing authorization application for ATRIPLA in the European Union was filed by a three-way joint venture based in Ireland called Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited.

ATRIPLA is currently the first and only once-daily single tablet regimen approved for the treatment of HIV-1 infection in adults in the United States for use either as stand-alone therapy or in combination with other antiretroviral agents. ATRIPLA was approved by the U.S. Food and Drug Administration in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States.

As the commercial launch of ATRIPLA in the countries of the European Union is not anticipated to begin until the early part of 2008, Gilead is not making any adjustments to the full year 2007 Product Revenue guidance provided on the third quarter 2007 earnings conference call on Oct. 18, 2007. Gilead is also not making adjustments to any of the other elements of guidance, including its updated Research & Development guidance of a range from $510 million to $520 million provided on Nov. 6, 2007, which includes the up front licensing payment related to LG Life Sciences collaboration for the caspase inhibitor.

Important Product Safety Information (including Boxed WARNINGS) About ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), Emtriva (emtr
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SOURCE Bristol-Myers Squibb Company
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