Press Release: GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling GlaxoSmithKline awarded HHS contract Philadelphia, PA, November 20, 2006–– GlaxoSmithKline (NYSE:GSK), one of the world’s largest vaccine manufacturers, today announced it has been awarded a contract to supply pre-pandemic vaccines to the US strategic national stockpile. The company has received an initial $40 million order under the contract from the U.S. Department of Health and Human Services (HHS) for bulk H5N1 antigen - the substance in the vaccines that will help produce an immune response. Under the terms of the contract, GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the HHS Office of Public Health Emergency Preparedness and the Office of Public Health Emergency Medical Countermeasures. “We applaud the US government’s proactive steps in protecting American citizens against this potential public health threat,” said David Stout, President, Pharmaceutical Operations, GlaxoSmithKline. “We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the US government in its preparedness efforts.” GSK remains in active discussions with other governments to supply their public health programs and has been steadily increasing its support to flu pandemic preparedness efforts globally, leveraging the company’s vaccine and anti-viral expertise. About GlaxoSmithKline GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: About GSK Biologicals GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world’s leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems. Editor’s note In 2005, GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats. GSK was the first company to submit a “mock-up” dossier for an egg-based pandemic vaccine with traditional alum adjuvant to European regulators. In May 2006, GSK announced, along with HHS, that it had received an award of $274 million to develop cell-culture technology to speed the development of new cell culture-based seasonal and pandemic influenza vaccines, and to scale-up cell culture manufacturing capability at GSK’s Mariettasite. Clinical studies announced by GSK in July of this year showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system. GSK has supplied its anti-viral, Relenza ® (zanamivir for inhalation), to the U.S. government and is now working with private-sector businesses and other organizations to provide Relenza ® as part of their business continuity planning. A new agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnamand all Least Developed Countries. The US is one of several countries to sign a contract with GSK for a pre-pandemic vaccine.