GlaxoSmithKline Files Its New Pre-Pandemic Influenza Vaccine In Europe

GlaxoSmithKline (NYSE: GSK) today announced that
its new generation H5N1 split antigen pre-pandemic influenza vaccine has
been accepted for review by the Committee for Medicinal Products for Human
Use (CHMP) in Europe. This innovative vaccine utilizes GSK's novel
proprietary adjuvant system technology which allows a very low amount of
antigen (3.8Вµg) to be used to elicit a strong seroprotective response --
the so-called 'antigen-sparing' effect.


In a recent pivotal clinical trial carried out in Belgium(1) involving
the new generation H5N1 influenza vaccine, it was shown that two very low
doses of antigen (3.8ug), given 21 days apart, combined with the novel
adjuvant system enabled over 80% of individuals to produce a high
seroprotective response, a level which exceeds target criteria set by
regulatory authorities for registration of influenza vaccines. This
'antigen-sparing' phenomenon permits a large number of vaccine doses to be
produced for mass vaccination ensuring protection for more people.
Furthermore, the magnitude of the immune response to the antigen, in the
presence of the novel adjuvant system, is also expected to give protection
against 'drifted' variants of the H5N1 virus. The vaccine also had an
acceptable safety and reactogenicity profile.(1)



Jean Stephenne, President of GSK Biologicals, the vaccine division of
GSK, commented: "Today's filing of our new generation pre-pandemic
influenza vaccine marks another important milestone in our pandemic
preparedness vaccine development program. I believe the rapidity with which
immunogenicity and safety data has been generated resulting in this filing,
pays tribute to our ongoing commitment to provide, in as short a timeframe
as possible, credible options against the threat of an influenza pandemic."



"As our new generation pre-pandemic influenza vaccine is also believed
to have the potential to offer a cross-protective response the vaccine
could be used as part of a proactive pre-pandemic vaccination campaign,
giving governments and health authorities the option to initiate
vaccination before or at the onset of a pandemic and potentially offering a
degree of early protection against the pandemic influenza virus," added
Jean Stephenne.



GSK are also planning to file the pre-pandemic vaccine in other
countries around the world. This new generation vaccine could also be
adapted for pandemic use once the causative influenza pandemic strain is
identified. Indeed, GSK has already entered into active negotiations with
various governments to supply pre-pandemic and/or pandemic influenza
vaccines. GSK are also planning to file the pre-pandemic vaccine in other
countries around the world subsequently.



Avian influenza



H5N1 avian influenza infections lead to severe disease in both birds
and humans. To date, the WHO has reported 267 human cases of avian
influenza (H5N1) from 10 countries resulting in 161 deaths(2).
















Public health experts fear that the H5N1 influenza virus may evolve
into a strain that is easily transmitted between people, triggering a
worldwide influenza pandemic(3). Influenza pandemics are global outbreaks
that involve viruses to which humans have little or no immunity.




GSK, a leader in flu treatment and preparedness



GSK has an active research and development programme targeted 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(R) (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: gsk.



Relenza is a registered trademark of the GlaxoSmithKline group of
companies



References:



(1) Borkowski A et al. Antigen sparing effect of a novel adjuvant
system in a split H5N1 pandemic vaccine. International Vaccines for the
World 2006



(2) Cumulative number of confirmed human cases of avian influenza
A/(H5N1) reported to WHO
(who.int/csr/disease/avian_influenza/country/cases_table_ l: accessed Jan 17, 2007)



(3) Global pandemic influenza action plan to increase vaccine supply,
WHO (who.int/csr/resources/publications/influenza/ : accessed Jan 17, 2007)


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