US Department of Health and Human Services (HHS) purchases GSK’s A (H1N1) influenza antigen and proprietary adjuvant system

Issued: Friday 22 May 2009, London UK & Philadelphia US

GSK announced today that the US Department of Health and Human Services (HHS) has placed initial orders for A (H1N1) influenza vaccine antigen and the company’s proprietary adjuvant system, AS03, to support its pandemic influenza preparation efforts. 

GSK manufactures both a traditional vaccine antigen, which will be made from the recently isolated A (H1N1) influenza strain, as well as an adjuvant system.  An adjuvant system can be added to the antigen at time of administration.

GSK expects to fill the US adjuvant order within the next few months.  The first doses of the vaccine antigen are expected to be available four to six months after the company receives the H1N1 seed strain, subject to regulatory approval.  The new vaccine will be tested in clinical trials.

In clinical studies using the H5N1 influenza strain, an adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The adjuvant system therefore helps to increase the number of vaccine doses that can be produced. 

GSK’s H5N1 vaccine, which includes the AS03 adjuvant system, is currently approved in Europe and some Asian countries,  GSK is working with US Food and Drug Administration (FDA) and other government authorities with regard to its adjuvant and A (H1N1) candidate vaccine development.  Fifteen clinical trials are ongoing to generate additional data for the adjuvant system, including a trial program for a seasonal influenza vaccine.  

GSK continues to support governments and health authorities around the world with their response to the emergence of the new A (H1N1) influenza strain.  The Company is in ongoing discussions with several other countries regarding possible supply of its candidate A (H1N1) adjuvanted vaccine.

Notes to Editors

• Adjuvants, from the Latin word adjuvare meaning ‘to help’, are compounds used to enhance a vaccine’s ability to elicit a strong, durable, protective immune response making them more effective. Until recently, vaccine research and development focused nearly exclusively on the antigen, the target molecule that is selected to trigger a specific immune response in the body to protect against a particular disease. It is now widely accepted that adjuvants can also contribute substantially to the immune response induced by a vaccine.

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.

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.