GlaxoSmithKline and Gilead announce agreement to commercialise Viread® for chronic hepatitis B in key Asian countries

GlaxoSmithKline (GSK) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement to commercialise Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialisation activities will expand access to tenofovir for the treatment of HBV, once approved, to patients

Issued:  Tuesday 24 November, London UK & Foster City, CA

GlaxoSmithKline (GSK) and Gilead Sciences, Inc. (Nasdaq:  GILD) today announced a licensing agreement to commercialise Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia.   The companies’ combined commercialisation activities will expand access to tenofovir 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 commercialisation of Viread for HBV in Hong Kong, Singapore, South Korea and Taiwan.  In China, GSK will have exclusive commercialisation rights and registration responsibilities for tenofovir 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 commercialise tenofovir for the treatment of HBV under certain circumstances. 

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.”

“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 tenofovir for chronic hepatitis B in some of the world’s highest prevalence regions."

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.

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

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 visit www.gilead.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.

 

GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

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 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.

GlaxoSmithKline Enquiries:

UK Media enquiries:

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

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

Sally Ferguson

(020) 8047 5543

Gary Davies

(020) 8047 5503

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

Jen Hill Baxter

(215) 751 7002

Gilead Enquiries:

 Investor enquiries:

Susan Hubbard

(650) 522-5715

Media (International)

James Read

(020) 8587 2323  

Media (US)

Cara Miller

(650) 522-1616

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.