Corporate Responsibility Report 2008

Research and development

For some diseases affecting developing countries there are no effective treatments. In other cases, treatments exist but have become less effective due to drug resistance.

Sometimes treatments are not suitable, for example, because they are difficult to administer in areas with poor healthcare infrastructure or they are too expensive. As a research-based company, we aim to make a major contribution to health in developing countries by researching and developing affordable new vaccines and treatments for infectious diseases. We are currently conducting R&D into 12 diseases of particular relevance to the developing world: bacterial meningitis, chlamydia, dengue fever, hepatitis E, HIV/AIDS, leishmaniasis, malaria, pandemic flu, pneumococcal disease, Chagas disease, human African trypanosomiasis and TB. For more information on our R&D pipeline see our Annual Report.

Biomedical R&D is a costly, risky and time consuming activity. To develop one successful medicine or vaccine it can typically take 10 to 12 years and, on average, including the costs of failures, costs around $1.2 billion¹. For every 5,000 to 10,000 compounds tested, an estimated five reach clinical trials and only one reaches the market².

What’s different about R&D for medicines for the developing world?

GSK scientists working on treatment projects for diseases of the developing world (DDW) make access to medicines a priority right from the start of the R&D process.

When researching a new DDW treatment we emphasise factors such as:

Heat and humidity resistance – the product must be able to survive in a hot climate where there may not be refrigeration facilities
Ease of use – it must be easy to use in settings where there are limited healthcare facilities. For example, once-a-day tablets that can be taken at home are preferable to an injectable medicine that must be administered in a hospital or clinic
Affordability – price is one of the most important factors. We look for molecules and formulations that are straightforward to manufacture and therefore inexpensive to produce

For diseases which disproportionately affect the developing world, but where a market exists in developed countries such as HIV/AIDS, we can still pursue this business model. We will accept all the R&D costs and risks involved on the expectation that there will be a market in wealthy countries that can subsidise poorer ones.

For other diseases of the developing world where no such market exists we have to pursue new ways of working. One solution is the public-private partnership (PPP) model, in which businesses and the public sector work together. The model enables collaborators to achieve more together than they would do alone. We are also exploring ways to share knowledge with other organisations to help facilitate and speed up the discovery and development of new medicines. By being more flexible with our intellectual property, we aim to encourage other pharmaceutical companies to follow suit.

We believe GSK is currently the only company researching new vaccines and treatments for all three of the WHO’s priority infectious diseases, malaria, TB and HIV/AIDS. We also have an extensive portfolio of R&D projects for diseases of the developing world. We are an industry leader in research into HIV/AIDS treatment, and are currently evaluating multiple second-generation integrase inhibitors in clinical development.

We also look for new treatments for other neglected diseases, typically in collaboration with external partners. For example, we engage in ongoing R&D programmes in leishmaniasis, Chagas disease and human African trypanosomiasis (African sleeping sickness).

We have created a dedicated group to focus on diseases of the developing world which is fully integrated into our pharmaceutical R&D organisation. This group prioritises projects based on their socio-economic and public health benefit rather than on commercial returns. In addition to scientists based in the UK and US, this includes a drug discovery centre at our Tres Cantos R&D site in Spain where over 100 scientists focus primarily on malaria and TB. Half of these scientists are funded by PPPs, the Medicines for Malaria Venture and TB Alliance. A group focused on developing world diseases is also active in our vaccines organisation in Belgium.

We are looking at ways to expand the Tres Cantos site into a global centre of excellence by encouraging investment and collaboration from governments, NGOs and other companies. Our overriding objective is to ensure that GSK makes the best possible contribution to improving the health of those affected by neglected diseases of the developing world. This will be achieved by pursuing an approach that will lead to the most extensive, effective and sustainable pipeline for diseases of the developing world (DDW) by:

Increasing partnerships with external DDW communities to cover more neglected diseases, more diverse expertise, research tools, novel targets, developable drug candidates and worldwide talent pool including strong links with the best academic groups
Spreading the DDW remits and learning in developing countries and emerging markets by sharing training activities and science forums for researchers or upcoming scientists from these countries, while avoiding any brain drain downsides
Strengthening current R&D partnerships with organisations such as with Medicines for Malaria Venture (MMV), TB Alliance, Drugs for Neglected Diseases Initiative (DNDi), International AIDS Vaccine Initiative (IAVI), PATH, Malaria Vaccine Initiative (MVI) and the Aeras Global TB Vaccine Foundation, as well as seeking new partnerships

Read our positions statements on:

1. Tufts Center for the Study of Drug Development

2. Pharmaceutical Industry Profile 2008, Washington DC, PhRMA March 2008