European Commission Approves ATRIPLA(R) (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil (as Fumarate) 245 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
17/12/2007 19:39
PR Newswire
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
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.
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 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