PRINCETON and WHITEHOUSE STATION, New Jersey, UXBRIDGE, England, October 18 /PRNewswire/ --
-- Once Validated 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
Bristol-Myers Squibb Company (NYSE: BMY), Gilead Sciences, Inc. (Nasdaq: GILD) Merck & Co., Inc., Whitehouse Station, N.J., U.S.A. (NYSE: MRK) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on the Marketing Authorisation Application for ATRIPLA(R) (efavirenz 600mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Specifically, the CHMP has recommended ATRIPLA for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in ATRIPLA prior to initiation of their first antiretroviral treatment regimen.
The CHMP's positive recommendation will now 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 was approved by the U.S. Food and Drug Administration (FDA) in July 2006.
For full prescribing information of SUSTIVA, Stocrin, Truvada, Emtriva and Viread, physicians should consult their local product labelling.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company.
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.
About Merck
Merck & Co. Inc., which operates in many countries as Merck Sharp & Dohme (MSD), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but also help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service.
Forward-Looking Statements
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 the European Union or other geographies. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb's business, including those identified in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q, particularly under "Item 1A. Risk Factors". 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 the risk that the European Commission will not formally approve ATRIPLA for marketing in the European Union prior to the end of the year or at all, and any marketing approval, if granted, may have significant limitations on its use. In addition, Gilead, Bristol-Myers Squibb and Merck may be unable to reach agreement related to the manufacture, commercialization and distribution of ATRIPLA in the European Union in a timely manner or at all. 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's Annual Report on Form 10-K for the year ended December 31, 2006 and its Quarterly Reports on Form 10-Q for the first two quarters of 2007, 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.
Merck Forward-Looking Statement
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