PRINCETON, New Jersey and UXBRIDGE, England, December 17 /PRNewswire/ --
- Product Developed Through Joint Venture Between Bristol-Myers Squibb and Gilead Sciences, the First of its Kind in HIV Treatment
The European Commission has granted marketing authorisation for ATRIPLA(R) 600 mg/200 mg/245 mg film-coated tablets. Each film-coated tablet contains 600 mg efavirenz, 200 mg emtricitabine and 245 mg tenofovir disoproxil (as fumarate). The decision means that ATRIPLA is formally approved for marketing in the 27 countries of the European Union, as well as in Norway and Iceland.
"Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "ATRIPLA combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill and represents an important step forward in dosing simplification."
ATRIPLA has been approved in the European Union for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels < 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.
Efavirenz is marketed by Bristol-Myers Squibb (NYSE:BMY) under the trade name SUSTIVA(R) in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). Efavirenz is commercialised by Merck & Co., Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the trade name STOCRIN(R) in all other countries within the European Union and many countries outside of the United States. Emtricitabine and tenofovir disoproxil fumarate are commercialised by Gilead (NASDAQ:GILD) under the trade names Emtriva(R) and Viread(R), respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the trade name Truvada(R) for use as part of combination therapy.
The marketing authorisation 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 was approved by the U.S. Food and Drug Administration in July 2006.
For full prescribing information of ATRIPLA, SUSTIVA, STOCRIN, Truvada, Emtriva and Viread, physicians should consult their local product labelling.
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 (NASDAQ:GILD) is also not making adjustments to any of the other elements of guidance, including its updated Research & Development guidance of a range from US$510 million to US$520 million provided on Nov. 6, 2007, which includes the up front licensing payment related to LG Life Sciences collaboration for the caspase inhibitor.
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 commercialises 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.
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 the marketing of ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg) in Europe. 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 timing of the launch of ATRIPLA will occur in Europe as described in this release or that ATRIPLA will be commercially successful in Europe. 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 Sciences 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 market for ATRIPLA in Europe may not develop as anticipated. In addition, the commercial launch of ATRIPLA in the European Union may not occur in the currently anticipated timeframe. Further, as ATRIPLA or its components are used over longer periods of time by many patients taking numerous other medicines, many of whom have underlying health problems, we may find new issues such as safety, resistance or drug interaction issues, which may require us to provide additional warnings or contraindications on the label or narrow the approved indication, each of which could reduce the market acceptance of ATRIPLA. 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 Gilead's Annual Report on Form 10-K for the year ended December 31, 2006 and Quarterly Reports on Form 10-Q for the first, second and third 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.
Contacts: Bristol-Myers Squibb: Media: Carmel Hogan, +33-1-58-83-65-55. Media: Sonia Choi, +1-609-252-5132. Investors: John Elicker, +1-212-546-3775. Gilead Sciences, Inc., Media: Cara Miller, +1-650-522-1616. Investors: Susan Hubbard, +1-650-522-5715