Gilead and GlaxoSmithKline Announce Agreement to Commercialize Viread® for Chronic Hepatitis B in Key Asian Countries
November 24 2009 - 9:00AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) and GlaxoSmithKline
(NYSE:GSK) today announced a licensing agreement to commercialize
Viread® (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.
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® (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.comU.S. full prescribing
information for Hepsera is available at www.Hepsera.com
Viread and Hepsera are registered
trademarks of Gilead Sciences, Inc.
Gilead Sciences (NASDAQ:GILD)
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