GlaxoSmithKline Files Its New Pre-Pandemic Influenza Vaccine in Europe

PHILADELPHIA, LONDON, and RIXENSART, Belgium, Jan. 29

29 Jan, 2007, 00:00 ET from GlaxoSmithKline

/PRNewswire-FirstCall/ -- 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 (3.8�g) 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: http://www.gsk.com.
     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
     (http://www.who.int/csr/disease/avian_influenza/country/cases_table_
     2007_01_15/en/index.html: accessed Jan 17, 2007)
     (3) Global pandemic influenza action plan to increase vaccine supply,
 WHO (http://www.who.int/csr/resources/publications/influenza/
 WHO_CDS_EPR_GIP_2006_1/en/index.html: accessed Jan 17, 2007)
 
 

SOURCE GlaxoSmithKline
/PRNewswire-FirstCall/ -- 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 (3.8�g) 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: http://www.gsk.com.
     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
     (http://www.who.int/csr/disease/avian_influenza/country/cases_table_
     2007_01_15/en/index.html: accessed Jan 17, 2007)
     (3) Global pandemic influenza action plan to increase vaccine supply,
 WHO (http://www.who.int/csr/resources/publications/influenza/
 WHO_CDS_EPR_GIP_2006_1/en/index.html: accessed Jan 17, 2007)
 
 SOURCE GlaxoSmithKline