Millions of children in the world’s poorest countries could receive vaccination against rotavirus diarrhoeal disease under new offer made by GSK to the GAVI Alliance

Issued: London, UK

• Offer to supply up to 125 million doses of Rotarix^TM over five years to developing countries at approximate 95% reduction to Western market price
• Rotavirus causes 500,000 childhood deaths each year, which equates to a child a minute worldwideⁱ

GSK today announced that it has made a new offer to supply its rotavirus vaccine, Rotarix^TM, to the GAVI Alliance at $2.50 per dose, a small fraction of developed world prices. This announcement is part of the company’s efforts to increase access to its medicines and vaccines in the world’s poorest countries. It is estimated that more than half a million children die of rotavirus gastroenteritis each year – the equivalent of a child a minute worldwideⁱ – and it is responsible for the hospitalization of millions more.ⁱⁱ

GSK’s offer has been made in response to a UNICEF request for rotavirus vaccines and will now be reviewed by UNICEF. If accepted, large scale vaccination against rotavirus could begin later this year. The offer made to UNICEF was developed in consultation with the Bill & Melinda Gates Foundation and The Clinton Health Access Initiative with support from the Pan-American Health Organisation (PAHO), and comes ahead of the GAVI Pledging Conference for Immunisation which will be held in London on 13th June 2011.

This new commitment for Rotarix^TM follows the announcement in March 2010 that GSK would supply its pneumococcal vaccine, Synflorix^TM, to GAVI at a heavily discounted price through an innovative financing mechanism known as the Advance Market Commitment (AMC). Rotavirus related diarrhea, and pneumococcal disease are the two leading childhood killers in developing countries.^iii,iv

Andrew Witty, CEO of GlaxoSmithKline said: “Whilst most babies in the world will get rotavirus at some point, those in developing countries do not have access to the medical care they need which means millions of babies die unnecessarily.GSK is committed to playing its part in addressing the healthcare challenges faced by world’s poorest countries. By working in partnership with others including governments, international agencies, NGOs and developing countries, we can find innovative ways to accelerate access to vaccines that are urgently needed by children living in these countries.”

Andrew Mitchell,UK Secretary of State for International Development said: “It is unacceptable that in the 21st century a child dies every minute of every day from diarrhoea, a preventable disease. I hugely welcome today's announcement from GSK to reduce their price of the vaccine Rotarix and urge other suppliers to follow suit and cut their prices. We are very clear that more affordable vaccines mean increased vaccination rates benefitting the world’s children.”

GSK has committed to supply 125 million doses of Rotarix^TM to GAVI over the next 5 years at a 95% reduction of the price to developed Western markets to help meet the demand for rotavirus vaccination forecasted by UNICEF. The discounted Rotarix^TM price is in line with GSK’s long-standing tiered pricing policy which enables poorer countries to pay significantly less than higher income countries for the same vaccine, with the lowest prices reserved for agencies such as UNICEF which purchase large volumes of vaccines for the world’s poorest children.

Vaccination against rotavirus has so far been successfully introduced in four GAVI eligible countries: Nicaragua, Honduras, Bolivia and Guyana. By securing a guaranteed supply of low priced high quality vaccines, this new offer would enable GAVI to expand rotavirus vaccination further, with the aim to cover over 40 countries by 2015.

Notes

• Diarrhoea is the second leading cause of death in children under five years of age worldwideⁱⁱⁱ and rotavirus is the leading cause of severe diarrhoeal disease in children.ⁱⁱ

• Rotavirus has a devastating effect. It is estimated thaⁱ – and it is responsible for the hospitalization of millions more.ⁱⁱ Most (around 85%) of these deaths occur in Africa and Asia.^vt more than half a million children die of rotavirus gastroenteritis each year – the equivalent of a child a minute worldwide

• Growing evidence suggests that the introduction of rotavirus vaccines substantially reduce severe diarrhoea in young children. In Brazil, following the launch of Rotarix^TM, hospitalisations due to rotavirus gastroenteritis decreased by almost 60% just one year after the introduction of universal mass vaccination.^vi

• In April 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunisation programmes. Based on this decision, the WHO awarded global prequalification to Rotarix™. These decisions have opened the door to making rotavirus vaccines available to children worldwide.

• 100 million doses of Rotarix^TM have been delivered since its first launch in 2007 which means that around 50 million children across the world have been vaccinated with Rotarix^TM against rotavirus.

• Vaccination against rotavirus has so far been successfully introduced in 14 countries in Latin America and Mexico, including four GAVI eligible countries: Nicaragua, Honduras, Bolivia and Guyana. South Africa is the only country in Africa to currently vaccinate against rotavirus, with North Sudan expected to follow in June 2011.

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

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.

References

I.      World Health Organisation. Weekly epidemiological record 2011; 86: 173-176

II.      Forster J et al. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis among European children younger than 5 years of age. Pediatrics 2009; 123: e393-e400

III.      Black R et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 2010; 375: 1969-1987

IV.      GAVI Alliance (2009). Pneumococcal AMC: Frequently asked questions. Accessed 3 June 2011 from: www.vaccineamc.org/files/FAQs2009.pdf

V.      Parashar U et al. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases 2003; 9(5): 565-572

VI.      Safadi M et al. Hospital-based surveillance to evaluate the impact of rotavirus vaccination in Brazil. Poster presentation at ESPID. www.kenes.com/espid09/posters/abstract660.htm (accessed 9 May 2011)