GlaxoSmithKline is making a vital contribution to healthcare in developing countries through action in three areas: investing in research & development (R&D) that targets diseases particularly affecting the developing world; preferential pricing of our antiretrovirals, anti-malarials and vaccines; and community investment activities and partnerships that foster effective healthcare⁵. We made significant advances in each of these key areas during 2002.

R&D FOR DISEASES OF THE DEVELOPING WORLD
Research into diseases of the developing world (DDW) is particularly important to address unmet needs, and to minimise the intrinsic threat in all infectious diseases of resistance developing to existing treatments.

A dedicated DDW group has been created within GSK’s R&D organisation to ensure a focus on this area. Projects are prioritised primarily on their socio-economic and public health benefits rather than their commercial returns. Our DDW research is now focused in dedicated facilities at Tres Cantos in Spain (see case study).

We believe GSK has the industry’s most extensive portfolio of DDW R&D projects and marketed products, and that we are the only company undertaking R&D into the prevention and treatment of all three of the World Health Organization’s priority diseases in the developing world – HIV/AIDS, tuberculosis and malaria. GSK focuses on these three diseases. We are also an industry leader in collaborating with external partners that want to use our specialist infrastructure or expertise.

R&D into diseases that primarily affect the developing world, such as malaria, differs in important respects from efforts aimed at diseases for which a developed world market also exists, such as HIV/AIDS. The lack of a commercially viable market for DDW treatments means that public/private partnerships are essential. Major companies such as GSK can provide technological, development, manufacturing and distribution expertise, while public sector partners can help fund development costs and ensure that new medicines and vaccines get to the people who need them. The partnership approach encourages R&D and accelerates the product’s uptake in the developing world.

We will maintain broadly the current level of human and financial resources dedicated to DDW as a proportion of our total R&D investment. We will work assiduously, with partners when appropriate, to ensure that any promising DDW drug is made available to patients as rapidly as possible. The R&D process is lengthy and risky. However, our long-term commitment is now bearing fruit and we are hopeful that we will be able to launch several new products relevant to DDW over the next five years.

We have seen some notable progress in 2002. In HIV/AIDS the first human clinical trials of our HIV candidate vaccine commenced in February, in collaboration with the US Government’s National Institutes of Health HIV Vaccine Trials Network⁶. In conjunction with other partners, GSK continues to support 29 HIV clinical trials in developing countries, including 20 in Africa. The purpose of these trials is to assess the use of antiretroviral therapy for treatment, and prevention of mother-to-child HIV transmission in resource-poor settings. Over 10,000 patients form or will form part of our HIV collaborative studies. Three thousand of these patients will be included in the DART Trial (Developing Antiretroviral Therapy) in Uganda and Zimbabwe, co-ordinated by the UK Medical Research Council.

There has been progress in malaria too. In October 2002, we submitted a regulatory application to the UK Medicines Control Agency (MCA) for Lapdap (chlorproguanil/dapsone) for the treatment of the most life threatening type of the malaria. MCA approval will be an important step in making Lapdap available across Africa, where there is great need for new malaria treatments.

Lapdap results from a successful partnership between GSK, the World Health Organization, the University of Liverpool, the London School of Hygiene and Tropical Medicine, and the UK Department for International Development (DFID)⁷. This is the first such product development to be directly sponsored by DFID.

5 www.gsk.com/responsibility/cr_issues/dev_world_challenges.htm 6 www.niaid.nih.gov/factsheets/hvtn.htm 7 www.who.int/inf-pr-2001/en/pr2001-10.html