GlaxoSmithKline update: A (H1N1) influenza

* WHO raises influenza pandemic alert to phase 6
* GSK has started development ofa new candidate A (H1N1) adjuvanted influenza vaccine
* Production of seasonal influenza vaccine for 2009/2010 Northern Hemisphere influenza season continues in parallel

The World Health Organisation (WHO) has announced it has raised the current level of influenza pandemic alert from phase 5 to phase 6. As stated by the WHO, phase 6 indicates that there now is a pandemic ongoing caused by the new A (H1N1) influenza virus. The WHO has stated in their current assessment of the situation that this pandemic is currently of a moderate severity.

In addition to increasing production and supply of the anti-viral medication, Relenza (zanamivir), the company continues to focus efforts on the development of a candidate A (H1N1) adjuvanted influenza vaccine.

Following receipt of the seed strain from the WHO at the end of May, the company has begun the process necessary for development of the new vaccine at both the Canadian and German manufacturing sites. The first step for manufacturing an influenza vaccine is to prepare the seed strain for production, which will take several weeks. The company will then start production of the new candidate A (H1N1) influenza vaccine. The first doses of the A (H1N1) vaccine antigen are expected to be available in four to six months time, subject to regulatory approval.

GSK remains committed to supporting governments and health authorities around the world respond to the emergence of the new A (H1N1) influenza virus, including addressing the needs of developing countries. GSK has offered to convert its intended donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine once production begins. As capacity increases, GSK will supply the vaccine to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.

In parallel,GSK will continue production of its seasonal influenza vaccine supply for the 2009/2010 Northern Hemisphere influenza season. GSK also continues to supply vaccine for use in the Southern Hemisphere as it enters the winter season this year.