GlaxoSmithKline (GSK) and Gilead Sciences, Inc 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 per cent.

Under the agreement announced, 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.

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.