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GSK's candidate adjuvanted pre-pandemic H5N1 vaccine reaches important EU regulatory milestone
GSK’s Prepandrix™ is the first candidate pre-pandemic influenza vaccine to receive a Positive Opinion from the CHMP
Not for distribution to US media
Issued –
Thursday 21st February 2008, London, UK & Rixensart, Belgium
GlaxoSmithKline (GSK plc) today announced that its candidate H5N1 adjuvanted pre-pandemic vaccine, Prepandrix™, designed for use in advance of an officially declared influenza pandemic, has received the first Positive Opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) for an influenza pre-pandemic vaccine. This decision by the CHMP represents an important regulatory milestone in GSK’s adjuvanted pre-pandemic vaccine development programme which, it is hoped, will ultimately see the vaccine receive a pan-European marketing license.
Jean Stéphenne, President and General Manager GSK Biologicals,the vaccine division of GSK, stated: “GSK welcomes the Positive Opinion given today by the CHMP for our candidate adjuvanted influenza pre-pandemic vaccine as we believe it reflects the growing recognition of pre-pandemic vaccination as an important strategy for addressing the current pandemic threat posed by H5N1. A number of national governments have expressed significant interest in stockpiling our candidate pre-pandemic H5N1 vaccine, which further highlights the important role pre-pandemic vaccination could play in comprehensive pandemic preparedness plans to help insure against the devastating impact of a pandemic.”
The submission dossier for this proprietary adjuvanted pre-pandemic vaccine, which received the Positive Opinion today, was based on a series of data from numerous clinical and pre-clinical trials which evaluated the safety, reactogenicity, immunogenicity and cross-protection induced by the candidate pre-pandemic vaccine. In one of the pivotal trials, the vaccine, which utilizes the antigen from the H5N1 Vietnam strain, demonstrated a 4-fold increase in serum neutralizing antibodies in 77.1%, 75% and 85% of subjects against three distinct H5N1 strain variants, Indonesia, Anhui and Turkey respectively.1 Importantly, these results demonstrated that the immune response elicited by GSK’s candidate adjuvanted pre-pandemic vaccine against H5N1 variants currently circulating in Europe and Africa offers the possibility of protecting populations against an eventual pandemic strain. The EMEA’s (European Medicines Agency’s) pre-pandemic vaccine licensing criteria for seroprotection rate, seroconversion rate and seroconversion factor were all met with GSK’s candidate adjuvanted pre-pandemic vaccine. Additionally, the vaccine has been shown to be cross-protective in animal model studies, preventing mortality in 100% of animals receiving two doses of ≥3.8µg of adjuvanted vaccine.2 The vaccine also has an acceptable safety and reactogenicity profile.
In addition, the CHMP has adopted a positive opinion recommending the granting of a marketing authorisation for Pandemrix™, a mock-up pandemic influenza vaccine, intended for the prevention of influenza during an officially declared pandemic influenza situation, once the pandemic viral strain has been included.
H5N1 influenza
H5N1 influenza (often referred to as avian influenza) infections lead to severe disease in both birds and humans. To date, the WHO has reported 361 human cases of H5N1 infection from 14 countries resulting in 227 deaths.3
Public health experts fear that this virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic.4 Influenza pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu virus strain.
About GSK
GSK continues to be committed to doing all it can to support governments and health authorities around the world in planning to respond to a global influenza pandemic prior to its outbreak and in the event one is officially declared. GSK has made substantial progress in its vaccine development programme and continues to investigate ways to further improve our pre-pandemic and pandemic vaccine strategies. To this end more than $2 billion has already been invested in developing a vaccine to combat H5N1 influenza, increasing the production capacity for influenza vaccines and GSK’s anti-viral flu treatment Relenza
®, in addition to ensuring the continuity of critical business operations and processes.
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 company information, visit GlaxoSmithKline at www.gsk.com.
Relenza is a registered trademark of the GlaxoSmithKline group of companies
Prepandrix and Pandemrix are trademarks of the GlaxoSmithKline group of companies
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European Analyst/Investor enquiries:
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References
1. Leroux-Roels I et al, Broad Clade 2 Cross-Reactive Immunity Induced by an Adjuvanted Clade 1 rH5N1 Pandemic Influenza Vaccine (in Press) PLoS ONE, Feb 2008
2. Baras B, Stittelaar KJ, Simon JH, Thoolen RJMM, Mossman SP, et al (2008) PLoS ONE 3(1): e1401. doi:10.1371/journal.pone.0001401
3. Cumulative number of confirmed human cases of avian influenza A/(H5N1) reported to WHO: accessed 19 Feb, 2008)
4. Global pandemic influenza action plan to increase vaccine supply, WHO September 2006; accessed 7 Feb, 2008)
