GlaxoSmithKline reaches EU regulatory milestone in its flu pandemic vaccine development programme

Friday 15 December 2006, London, UK & Rixensart, Belgium -GlaxoSmithKline Biologicals today announced that Daronrix®, its first generation alum-adjuvanted inactivated whole virus candidate flu vaccine* for use once a pandemic has officially been declared by the WHO/EU, has received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP). This is a first step in the preparation against a possible H5N1 pandemic.

GSK will submit a second file to the European Regulatory Authorities within the next few weeks for its second generation H5N1 candidate vaccine. This vaccine, which is currently in late-stage development, utilises GSK’s novel proprietary adjuvant system technology. Upon licensure, this second vaccine could potentially be used as part of a proactive pre-pandemic vaccination campaign, helping to prepare the human immune system in advance of a pandemic and give broad protection against different H5N1 strains. This new generation vaccine candidate could also be adapted for use as a pandemic vaccine once the flu strain causing the pandemic has been identified. It also has the added benefit of requiring a substantially lower amount of antigen to raise a strong immune response and gives the ability to produce very large quantities of vaccines for mass vaccination.

Jean Stéphenne, President of GSK Biologicals, the vaccine division of GSK, said: “Receiving this positive opinion today from the CHMP is testament to the company’s ongoing commitment to provide health authorities with concrete options against the threat of an influenza pandemic. I believe, with the imminent filing of our second generation vaccine GSK has brought two solid vaccine solutions to prepare for pandemic or proactive pre-pandemic vaccination.”

The submission dossier for the first generation vaccine, which received the positive opinion today, was based on a series of data including a pivotal clinical trial involving 400 healthy adults1. This trial evaluated the safety, reactogenicity and immunogenicity of different doses of the candidate vaccine and compared it to different doses of non-adjuvanted H5N1 influenza vaccine. It was concluded from the study, that two doses containing at least 15mg of H5N1 HA antigen are required to meet the EMEA’s (European Medicines Agency) licensing criteria for seroprotection rate (SP³70%), seroconversion rate (SC³40%) and seroconversion factor (2.5). The vaccine also had a safety and reactogenicity profile similar to non-adjuvanted vaccine1.

GSK’s proprietary-adjuvanted second generation (pre-)pandemic vaccine, which the company expects to file shortly, requires significantly less antigen (3.8mg) to meet the EMEA’s licensing criteria2. This marked reduction in the amount of antigen required to obtain a strong immunogenic response (the so-called ‘antigen-sparing’ phenomenon) should allow more people to be vaccinated in the event of a pandemic.

Avian influenza

H5N1 avian influenza infections lead to severe disease in both birds and humans. To date, the WHO has reported 260 human cases of bird flu from 10 countries resulting in 153 deaths3.

Public health experts fear that this virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic4. Influenza pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu virus strain.

GSK, a leader in flu treatment and preparedness

GSK has an active research and development programmetargeted at both seasonal and pandemic influenza and has recently committed over $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza® (zanamivir for inhalation). In North America, GSK acquired a major influenza vaccine manufacturer, ID Biomedical Corporation in 2005.

GSK is one of the world’s leading research-based pharmaceutical and health care companies. GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

ENDS

Daronrix and Relenza are registered trademarks of the GlaxoSmithKline group of companies

*GSK’s alum-adjuvanted inactivated whole virus candidate pandemic vaccine can only be marketed when the following conditions have been fulfilled:

- There is an official WHO/EU declaration of an influenza pandemic

- The flu strain variation to be introduced into the pandemic vaccine has been approved

References:

1. Hehme N et al. Whole virus alum-adjuvanted pandemic vaccine: safety and immunogenicity data on a vaccine formulated with H5N1. IVW 2006 oral presentation

2. Borkowski A et al. Antigen sparing effect of a novel adjuvant system in a split H5N1 pandemic vaccine. IVW 2006 oral presentation

3. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO, 13 November 2006(www.who.int)

4. Global pandemic influenza action plan to increase vaccine supply, WHO September 2006

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