Source: BUSINESS WIRE
Tuesday, November 24, 2009
FOSTER CITY, Calif. & LONDON, Nov 24, 2009 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) and GlaxoSmithKline (NYSE:GSK) today
announced a licensing agreement to commercialize Viread(R)
(tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B
(HBV) infection in adults in five countries in Asia. The companies'
combined commercialization activities will expand access to Viread for
the treatment of HBV, once approved, to patients in Asia where the
prevalence in most countries is greater than 8 percent.
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Under the agreement announced today, Gilead will retain exclusive rights
for commercialization of Viread for HBV in Hong Kong, Singapore, South
Korea and Taiwan. In China, GSK will have exclusive commercialization
rights and registration responsibilities for Viread for HBV. Each
company will pay royalties to the other on sales of Viread for HBV in
their respective Asian territories. The companies are working to expand
this agreement to include Japan and other countries.
The Viread agreement modifies the terms of the April 2002 licensing
agreement between Gilead and GSK under which GSK received exclusive
rights to Hepsera(R) (adefovir dipivoxil), Gilead's first
hepatitis B treatment, in various territories including China, Japan,
South Korea and Taiwan, as well as the right to commercialize Viread for
the treatment of HBV under certain circumstances.
"Chronic hepatitis B infection is a significant global health problem
and the need for new effective treatment options is particularly urgent
in Asia, where approximately 280 million people are living with this
serious, life-threatening disease," said John C. Martin, Chairman and
Chief Executive Officer of Gilead. "Through this agreement, Gilead is
proud to ensure broader access to Viread for chronic hepatitis B in some
of the world's highest prevalence regions."
Abbas Hussain, President, Emerging Markets GSK said, "The agreement with
Gilead to develop and launch Viread in China builds on GSK's strong
heritage in hepatitis B and provides an important addition to GSK's
current portfolio in one of our key markets. Together with Gilead, we
are committed to increasing access to this medicine for more patients in
Asia, bringing new ways to address the burden of chronic hepatitis B
where it is most needed."
Viread is currently approved for the treatment of chronic hepatitis B in
the United States, European Union, Turkey, Australia, New Zealand and
Canada. Viread is also indicated in combination with other
antiretroviral agents for the treatment of HIV infection in adults.
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. For more information, please visit www.gilead.com.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and
live longer. For further information please visit www.gsk.com.
About Chronic Hepatitis B
Chronic hepatitis B is a common and potentially fatal liver disease
caused by the hepatitis B virus, which is up to 100 times more easily
transmitted than HIV. Chronic hepatitis B can produce no symptoms in its
earlier stages, meaning many individuals are unaware that they are
infected until they have advanced liver disease. Complications commonly
associated with chronic hepatitis B include scarring of the liver
(cirrhosis), liver failure and liver cancer. More than 400 million
people are estimated to be chronically infected with HBV worldwide and,
without treatment, up to one quarter of those will ultimately die of
liver disease.
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
risks related to the ability of Gilead to obtain regulatory approval of
Viread for HBV in Asia and the ability of Gilead and GSK to successfully
commercialize Viread for the treatment of chronic hepatitis B in the
Asian markets or to agree to extend the agreement to apply to other
countries. 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 Quarterly Report on Form 10-Q for quarter ended
September 30, 2009, as 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.
U.S. full prescribing information for Viread is available at www.Viread.com
U.S.
full prescribing information for Hepsera is available at www.Hepsera.com
Viread and Hepsera are registered trademarks of Gilead Sciences, Inc.
SOURCE: Gilead Sciences, Inc.
Gilead Contacts
Investor Relations:
Susan Hubbard, 650-522-5715
or
Media (International):
James Read, (020) 8587 2323
or
Media (U.S.):
Cara Miller, 650-522-1616
or
GlaxoSmithKline Contacts
Investor Relations (European):
David Mawdsley, (020) 8047 5564
Sally Ferguson, (020) 8047 5543
Gary Davies, (020) 8047 5503
or
Investor Relations (U.S.):
Tom Curry, 215-751-5419
Jen Hill Baker, 215-751-7002
or
Media (U.K.):
Philip Thomson, (020) 8047 5502
Claire Brough, (020) 8047 5502
Stephen Rea, (020) 8047 5502
Alexandra Harrison, (020) 8047 5502
Gwenan White, (020) 8047 5502
or
Media (U.S.):
Nancy Pekarek, 919-483-2839
Mary Anne Rhyne, 919-483-2839
Kevin Colgan, 919-483-2839
Sarah Alspach, 919-483-2839