Healthcare Industry News:  influenza 

Biopharmaceuticals

 News Release - June 13, 2007

GlaxoSmithKline to Make Unprecedented Vaccine Donation to WHO Pandemic Flu Stockpile

PHILADELPHIA, June 13 (HSMN NewsFeed) -- GlaxoSmithKline (NYSE: GSK ) today announced its intention to donate 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine to the World Health Organization (WHO) in support of its stockpile initiative. The donation will help establish a much needed stockpile of pre-pandemic vaccines that can be distributed to the world's poorest countries at short notice by the WHO. Delivered over a three-year period, it will provide enough doses of vaccine for 25 million people at 2 injections per person.

As the WHO has made clear, pandemic influenza poses a serious global public health threat with substantial estimated morbidity and mortality. The WHO has expressed its desire to create an international stockpile of H5N1 pre- pandemic vaccines, a strategy which received the endorsement of the 193 Member States in attendance at the World Health Assembly in Geneva last month. GSK supports this proactive strategy of worldwide stockpiling of H5N1 pre-pandemic vaccine which may be able to save millions of lives by protecting some of the most vulnerable populations in the world at the outbreak of a pandemic.

The exact strain that may cause an influenza pandemic cannot be accurately predicted. Some experts believe that the avian H5N1 strain, now endemic in many bird species across the world, is a likely candidate pandemic strain. A tailored pandemic vaccine would not be available until four to six months after a pandemic strain has been identified, highlighting the need for earlier access to protection.

In addition to the donation, the company confirmed its intention to provide additional doses of its H5N1 adjuvanted vaccine at preferential prices to the WHO for GAVI-eligible countries following the necessary regulatory approvals. In line with its long established tiered pricing business model, GSK intends to provide its H5N1 pre pandemic vaccine to middle and low income countries at preferential prices reflecting individual countries' income level.

GSK is also prepared to make its adjuvant available to Governments for public purchase in order to maximize the number of doses of H5N1 vaccines available, demonstrating GSK's broader commitment to working with Governments and organizations such as the WHO to provide a solution to this potential public health crisis.

Adjuvant systems are a proprietary novel technology that the company has been developing for over 10 years. An adjuvant is an ingredient that can be added to the core antigen of a vaccine to stimulate higher immune response while using a smaller amount of antigen. The 'antigen-sparing' phenomenon for H5N1 adjuvanted influenza vaccine permits a large number of vaccine doses to be produced for mass vaccination ensuring protection for more people.

Jean-Pierre Garnier, CEO GlaxoSmithKline said: "An outbreak of pandemic flu could have a devastating effect on some of the poorest countries on our planet. As a healthcare company, GSK takes seriously its responsibility to ensure access for the world's poorest people to our medicines and vaccines. Today's announcement enables us to play a part in the WHO's efforts to coordinate a more comprehensive global solution to this potential healthcare crisis."

Since 2000 GSK has invested $2 billion to expand and enhance its manufacturing capacity and research capabilities for both influenza vaccines and anti-virals. GSK will work with the WHO to finalize the details of this donation in the coming months.

Notes to editors:

GSK has been working to develop pandemic influenza vaccines since 2000, initially on the H2N2 and H9N2 strains. In March 2007, the company announced data that demonstrated GSK's novel adjuvant system technology allows a very low amount of antigen to be used to create a strong immune response - the 'antigen-sparing' effect. GSK's candidate vaccine, containing very low levels of antigen (3.8 micrograms), enabled over 80% of individuals to produce a high immune response in humans exceeding the registration criteria set by European and US regulatory authorities for influenza vaccines (2 doses given 21 days apart). The GSK vaccine is expected to protect against 'drifted' variants of the H5N1 virus. These recent clinical data point to the potential public health benefits of creating a stockpile of pre-pandemic influenza vaccine.

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 on the World Wide Web at http://www.gsk.com.


Source: GlaxoSmithKline

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