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Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe
Date:12/11/2007

the Republic of Ireland.

Efavirenz is marketed by Bristol-Myers Squibb under the tradename SUSTIVA(R) 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(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 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.

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.

Important Product Safety Information (including Boxed WARNINGS) About

ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil

fumarate 300 mg), Emtriva (emtricitabine), Viread (tenofovir disoproxil

fumarate [DF]) and Truvada (emtricitabine/tenofovir DF) in the United

States Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.

Emtriva, Viread, Truvada and ATRIPLA are not approved for the treatment of chronic hepatitis B virus (HBV) infection and their safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread or Emtriva, which are components of Truvada and ATRIPLA. In some of these patients t
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SOURCE Bristol-Myers Squibb Company
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