European CHMP Issues Positive Opinion for ATRIPLA(R) (Efavirenz 600 mg/ Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg)
18/10/2007 21:57
PR Newswire
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
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
This press release contains "forward-looking statements" as
that term is defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on management's current expectations and involve
risks and uncertainties, which may cause results to differ materially from
those set forth in the statements. The forward-looking statements may include
statements regarding product development, product potential or financial
performance. No forward-looking statement can be guaranteed and actual
results may differ materially from those projected. Merck undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise. Forward-looking
statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in
the risk factors and cautionary statements in Item 1A of Merck's Form 10-K
for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q
and Form 8-K, which the Company incorporates by reference.
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: Media: Cara Miller: +1-650-522-1616; Investors: Susan Hubbard, +1-650-522-5715; Merck & Co., Inc.: Media: Lynn Kenney: +1-908-423-4188; Investors: Graeme Bell, +1-908-423-5185