Corporate Responsibility Report 2008

Case studies

Potential malaria vaccine

Malaria kills more than one million people a year worldwide and makes millions more sick, most of them children living in sub-Saharan Africa. The international community urgently needs a safe and effective vaccine to control the disease. A vaccine, even with a partially effective profile, is a necessary component of a comprehensive malaria control programme and could potentially save hundreds of thousands of lives a year.

Our malaria vaccine candidate RTS,S is the most clinically advanced malaria vaccine candidate in the world. Since its discovery by GSK scientists in 1981, GSK has invested over $300 million of its own resources in progressing RTS,S to phase lll trials. A full set of clinical trials for a successful vaccine candidate can take 10 to 12 years, involve 50,000 to 100,000 volunteers, and cost $500 million or more. Few vaccine candidates survive this rigorous process, which is one reason why pharmaceutical research and development is so expensive. Creating a malaria vaccine for young children and pregnant women - one of the most important vaccine-development challenges today - is no exception.

In January 2001, GSK and MVI (PATH Malaria Vaccine Initiative), with support from the Bill & Melinda Gates Foundation, entered into a public-private partnership to develop an RTS,S-based vaccine for infants and children living in malaria endemic regions in sub-Saharan Africa. The clinical development of RTS,S is conducted by the Clinical Trial Partnership Committee, a collaboration of leading African research institutes, Northern academic partners, MVI and GSK with support from the Malaria Clinical Trial Alliance. To date, GSK has invested over $300 million of its own resources to develop the vaccine.

In December 2008, the New England Journal of Medicine published results of two separate studies demonstrating that the malaria vaccine candidate provides both infants and children with significant protection against malaria. In infants, data showed for the first time that the vaccine candidate can be administered as part of existing African immunisation programmes¹. In children aged five to seventeen months, the candidate RTS,S/AS01 reduced the risk of clinical episodes by 53 per cent over an eight-month follow-up period².

RTS,S is now entering pivotal phase lll studies, which will be the world’s largest malaria vaccine trial to date, involving 16,000 participants in 11 centres in Africa. Most of the places we are doing our trials have limited healthcare infrastructure. With partners we have therefore helped to set up these 11 clinics in seven African countries, with each training doctors, nurses and laboratory staff. We hope this infrastructure will remain long after the trials are completed.

Update August 2009

The Phase III trial of the RTS,S malaria vaccine candidate started in Bagamoyo, Tanzania, in May 2009.

The children who need this vaccine are among the poorest in the world. Price cannot be a barrier to access and we will work with supply organisations such as GAVI and UNICEF to ensure the price is set at the right level. We are also committed to working with the international community to mobilise the resources to fund the vaccine and the infrastructure needed to deliver it.

1. Abdulla S, Oberholzer R, Juma O, et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med 2008;359:2533-44.

2. Bejon P, Lusingu J, Olotu A, et al. Efficacy of RTS,S/AS01E : clinical malaria in 5 to 17 month old children. N Engl J Med 2008;359:

Extending our product portfolio in the developing world – low- and middle-income countries

In July 2008 GSK entered a partnership with the South African pharmaceuticals company Aspen. This is in line with our aim to grow a diversified business and operate in a way that is adapted to patient needs in low- and middle-income markets.

Aspen’s product portfolio covers a broad range of therapy areas relevant to the disease profile in developing countries, including: analgesics (for pain relief), anti-hypertensives (for high blood pressure), bronchodilators (for the treatment of asthma), anti-bacterials, anti-gout agents, anti-inflammatory agents, anti-depressants, anti-fungal agents, anti-histamines (for the treatment of allergies) decongestants, gastro-intestinal agents and dermatologicals (to treat skin conditions).

Through gaining access to Aspen’s current portfolio and future pipeline, GSK will be distributing more products and medicines needed by those in low- and middle-income countries. The long-term nature of this collaboration – initially beyond a 10 ten-year period – also underlines GSK’s philosophy of investing in a meaningful and sustainable manner in the developing world.

In January 2009 we announced an agreement with UCB S.A. to acquire its current marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America. As a result of the agreement, GSK will acquire several leading pharmaceutical brands in a number of disease areas. These include Keppra for the treatment of epilepsy and Xyzal and Zyrtec for the treatment of allergic rhinitis.

The Aspen partnership and the UCB deal sit alongside the recent acquisition of Bristol Myers Squibb’s mature pharmaceuticals businesses in Egypt and Pakistan and the two associated manufacturing facilities. Together, these deals will provide GSK with access to a renewable, high-quality and competitively priced pipeline of branded pharmaceuticals products that complements its existing portfolio of products, and will help drive patient access in low- and middle-income markets.

GSK vaccine eliminates Hib meningitis as a public concern in Uganda

A national, four-year immunisation programme using GSK’s TritanrixHB Hib vaccine has eliminated Hib meningitis as a public health concern in Uganda, according to the Global Alliance for Vaccines and Immunisations (GAVI)¹. Hib meningitis is a dangerous inflammation of the lining of the brain and spinal cord. GAVI, a public-private partnership that includes the World Health Organization and the World Bank and is supported by the Bill & Melinda Gates Foundation and others, says that the use of TritanrixHB Hib between 2002 and 2006 has reduced the number of incidences of the disease in Ugandan children to zero.

The news follows similar results in Bangladesh, Kenya, Chile and the Gambia, as well as Britain and the US, where the vaccine was shown to cut the number of cases of Hib meningitis by at least 88 per cent in a three-to-five year period.

Julian Lob-Levyt, Executive Director of GAVI, says the results are extremely positive. “We can applaud a true success in controlling this deadly disease, which has too often claimed so many lives,” he says.

Though developed countries have largely eliminated the disease, Hib vaccine distribution has been slow in poorer parts of the world due to financial and logistical problems, as well as limited awareness of the disease. In Uganda, the government obtained GAVI support to use 16.5 million doses of 5-in-1 vaccines, giving protection against Hib, diphtheria, pertussis, tetanus and hepatitis B. According to a study published in The Bulletin of the World Health Organization, the vaccination programme in Uganda is now preventing almost 30,000 cases of severe Hib disease and 5,000 child deaths every year. "The introduction of Hib vaccine has completely changed the epidemiology of bacterial meningitis in Uganda," says Adeodata Kekitiinwa, a paediatrician at Kampala's Mulago Hospital, who co-authored the study.

Hib kills about 400,000 children under the age of five every year, and is linked to around three million cases of illnesses that can result in long-term effects such as deafness, paralysis, mental retardation and learning disabilities. GAVI says that for every child with Hib meningitis in a developing country, there are thought to be five to ten others with Hib-related pneumonia, which is also preventable by vaccination.

1. GSK press release, March 2008