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European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
Date:10/18/2007

tiretroviral treatment regimen.

The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. The companies expect the European Commission to issue its decision on the marketing authorization for ATRIPLA toward the end of the year. Once granted by the European Commission, ATRIPLA would represent the first and only once-daily single tablet regimen for many HIV/AIDS patients in the European Union.

"Each of the components in ATRIPLA has been shown to be effective and has a well-established tolerability profile in HIV patients," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "This first one-pill-a-day treatment for HIV represents a simplification of dosing, which is important as patients remain on therapy longer."

Efavirenz is marketed by Bristol-Myers Squibb under the tradename SUSTIVA(R) in the United States, Canada and six European countries (France, Germany, Republic of Ireland, Italy, Spain and the United Kingdom). In other territories, including all other countries of the European Union, efavirenz is commercialized by Merck & Co., Inc., (known as Merck Sharp & Dohme (MSD) in many countries outside of the United States) and is marketed in most of these countries under the tradename Stocrin(R). 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.

The MAA for ATRIPLA in the European Union was filed jointly by the three companies through 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 fo
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SOURCE Bristol-Myers Squibb
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