LONDON and RESEARCH TRIANGLE PARK, N.C., May 1 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) is committed to supporting governments and health authorities around the world to respond to the emergence of the new influenza A (H1N1) strain.
The company has developed a number of potential interventions which it believes may be of value in efforts to reduce the impact and spread of this new influenza virus. These include the antiviral medicine Relenza (zanamivir) and significant vaccine capability and technology, including use of novel adjuvants.
To ensure continuity of supply and manufacture of all its critical medicines and vaccines, GSK has also invoked its own internal pandemic preparedness plan.
GSK has been working with governments to supply Relenza, for use in a pandemic situation, since the global spread of avian influenza (H5N1) which began in 2003. Relenza has typically been used to diversify and add to government stockpiles of Tamiflu (oseltamivir).
Since 2003, Relenza has been supplied to 26 governments for the purposes of pandemic stockpiling and on average the product constituted 13% of these stockpiles. Prior to the recent outbreak, the last significant order for Relenza was for 10.6 million treatment packs, which was delivered to the UK Government in April 2009.
In relation to the new influenza A (H1N1) strain, the WHO reported that the viruses obtained from the recent human cases were sensitive to oseltamivir and zanamivir but resistant to amantadine and remantadine.(1)
GSK has therefore contacted governments around the world to ascertain demand for Relenza, including those countries most affected by the virus, such as Mexico and the USA. As a result, GSK has put in place a series of measures this week to manage existing stocks of Relenza and raise production levels:
GSK has an active pandemic influenza vaccine R&D programme which includes development of pre-pandemic and pandemic vaccines and use of novel technology such as adjuvants systems.
In 2008, GSK became the first company to obtain a European license for a pre-pandemic vaccine, Prepandrix. This vaccine is designed to raise immune protection against several strains of the H5N1 virus. Also in 2008, GSK received a European license for Pandemrix, a 'mock-up' pandemic vaccine. This approval, which was based on data involving the H5N1 strain, will also enable faster registration of a potential pandemic vaccine against other strains, including H1N1.
This week, GSK has been in continuous discussions with the WHO, the US Centers for Disease Control and Prevention, The US Department of Health and Human Services and the European Centre for Disease Prevention and Control to gain a better understanding of the new influenza A (H1N1) strain. The company is sharing resources and data with these authorities, as requested, to help them develop estimates for manufacturing capability, timing of possible production and use of adjuvant technology in production of a potential pandemic vaccine.
GSK stands ready to begin manufacture of a potential vaccine against the new influenza A (H1N1) strain virus once the WHO and other public health authorities make recommendations for composition of the vaccine.
In the meantime, and in line with recommendations of the WHO and other public health authorities, GSK is continuing to produce and maximise supply of its seasonal influenza vaccine for use in the Southern hemisphere, as it enters the winter season, and for the Northern hemisphere later this year.(2) This remains a critical priority as seasonal flu infects 5% to 15% of the global population and accounts for up to 500,000 deaths each year.(3)
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.
Relenza(R) is a trade mark of the GlaxoSmithKline group of companies. Tamiflu(R) is a trade mark of the Roche.
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