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Research and development

The research and development (R&D) of new drugs and vaccines is an essential element in improving health in the developing world. There are still no effective treatments for some widespread and life-threatening diseases. Many existing treatments for diseases such as malaria are becoming less effective due to drug resistance.

Many diseases disproportionately affect the developing world. But lack of resources means there is often no viable commercial market for new treatments. Public private partnerships (PPPs) are helping to address this problem.

GSK collaborates with several PPPs including the Medicines for Malaria Venture (MMV), the Global Alliance for TB Drug Development (GATB), the Aeras Global TB Vaccine Foundation (Aeras), the Malaria Vaccine Initiative (MVI) and the International AIDS Vaccine Initiative (IAVI). For more on how we work with them, and why they are important, see Public private partnerships.

GSK has created a dedicated group in our pharmaceutical R&D organisation, to focus on diseases of the developing world (DDW). This includes a dedicated drug discovery centre at our Tres Cantos R&D site in Spain and clinical development experts in the UK and US. DDW projects are prioritised according to their social and public health benefits rather than their commercial returns. A similar group exists in our vaccines organisation based in Belgium.

Unlike many diseases that disproportionately affect the developing world, HIV/AIDS is different because it affects both developed and developing countries, so there is a commercial market for new treatments. This encourages investment in the required R&D. GSK is an industry leader in research into HIV/AIDS treatment.

In total GSK has 13 clinical programmes for medicines and vaccines against eight diseases¹ particularly relevant to the developing world. Seven of these projects are for diseases that disproportionately affect developing countries.

Progress in 2005

Malaria
In 2004, phase IIb clinical trials of our malaria vaccine for children, that has been in development for 15 years, showed unprecedented results. In 2005, new data published in the leading medical journal, the Lancet, showed that the vaccine remained efficacious over 18 months. Several more years of clinical investigation will be needed before this vaccine is ready for use but these results indicate it has the potential to help save millions of children’s lives. To support this activity, in October the Bill & Melinda Gates Foundation announced a grant to the PATH Malaria Vaccine Initiative (MVI) to extend the public private partnership between MVI and GSK Biologicals. Most of the new grant will directly support clinical trials in Africa. From its own funds, GSK will at least match the $21.4 million it receives from MVI, to help defray some of the clinical development costs.

We are working with the Medicines for Malaria Venture (MMV), the World Health Organisation (WHO) and academic partners to develop CDA, an affordable fixed-dose artemisinin combination treatment for malaria in Africa, based on GSK’s existing anti-malarial, Lapdap. In November 2005 we announced clinical results indicating that CDA is likely to be effective against drug resistant P falciparum malaria as found in Africa. CDA has now progressed into phase III trials. Dr Chris Hentschel, CEO of MMV commented, “These results suggest that CDA could become a major weapon in the fight against drug-resistant malaria. Moving into phase III trials marks a key step in the development of this promising antimalarial.”

During 2005 GSK and the University of California, San Francisco received MMV’s Project of the Year award for our falcipain project, investigating a new class of compounds for use against malaria. We are now conducting further research to identify candidate compounds for development in 2006. GSK also received the Project of the Year award in 2004 for our pyridones project. This is the first time that a company has won in successive years.

Following extensive development work in 2005, we hope to identify a suitable candidate for our pyridones project in the first half of 2006 and commence Phase I trials in humans in 2007.

Significant chemical and pharmaceutical development was undertaken on our candidate GSK369796 (n-tert butyl isoquine) for malaria and we plan to start clinical studies in humans in 2006. During 2005 we progressed our clinical development programme for tafenoquine, a new antimalarial being developed in partnership with the US government's Walter Reed Army Institute of Research.

Additionally, we have a number of other targets with potential potency against malaria that we are working on at our Tres Cantos site or with our collaborators.

HIV/AIDS
In November 2005, GSK and the Institut Pasteur announced a new European collaboration to develop an AIDS vaccine by fusing genes from the human immunodeficiency virus (HIV) onto an existing measles vaccine. GSK will license the measles vaccine vector technology from Institut Pasteur and the two entities will jointly develop the AIDS vaccine. The project is being supported by a €5.5 million (£3.7 million) grant from the European Union and will include development of a production process for the experimental vaccine as well as two clinical studies. The first study will evaluate the safety profile of the vaccine candidate. The second will examine safety and whether the vaccine produces an immune response against HIV in volunteers with pre-existing immunity to measles. The clinical studies will begin in the third year of the five year collaboration.

Earlier in 2005, we also launched a public private partnership with the International AIDS Vaccine Initiative (IAVI) to develop an AIDS vaccine using nonhuman primate adenovirus vector technology. The collaboration – the first-ever in AIDS vaccine research between IAVI and a major vaccine company – will facilitate research into vaccines against types of HIV that circulate predominantly in Africa. Under the agreement, IAVI will contribute technical expertise and funding, and GSK and IAVI researchers will form a joint research team.

GSK Biologicals also has an in-house AIDS vaccine development project using the company’s proprietary adjuvant technology. A successful AIDS vaccine might need to combine several of these approaches.

We had mixed results in our antiretrovirals research in 2005. In December we announced positive results from a study evaluating the safety, tolerability and antiviral activity of our investigational protease inhibitor, brecanavir. Brecanavir is now expected to enter phase III development in 2006. If approved, it may be useful in treating patients infected with strains of HIV that have become resistant to multiple protease inhibitors.

In October we terminated the clinical trial of aplaviroc, our CCR5 antagonist, due to concerns over liver toxicity. We are reviewing the safety data and following-up with all patients.

The red tablet versions of our HIV/AIDS medicines Combivir and Epivir, developed to avoid diversion, became the first medicines of any kind to be granted a positive scientific opinion by the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use. This opinion was granted under Article 58 of EU Regulation 726/2004 which allows the EMEA to give a scientific opinion on medicines intended for use outside the EU. The EMEA can now grant a Certificate of Pharmaceutical Product to facilitate registration of these ARVs in developing countries.

Liquid formulations of HIV medicines are currently the only way to treat very young children. However they are not always easy to use in a developing world setting and the WHO and UNICEF have stated that access to solid formulations would facilitate the treatment of older children. We are currently assessing the development of ARV tablets with a score line which can be more easily broken into smaller doses. This will help physicians and carers administer the right dose efficiently and safely to children. We organised and hosted a meeting in September 2005 with representatives from the EMEA, the FDA, Médecins Sans Frontières, UNICEF and the WHO to discuss the development of scored tablets for children. Our partners showed a great interest in this project and understood the challenges behind this development. We are now consolidating available information into a document for further discussion with regulators during the first half of 2006.

GSK has entered into a material transfer agreement with the International Partnership for Microbicides (IPM) under which GSK will select and provide proprietary anti-HIV compounds to be tested for possible use as microbicides to prevent transmission of HIV.

We are supporting clinical trials sponsored by external organisations - such as the WHO, the UK’s Medical Research Council and US National Institutes of Health (NIH) - through our HIV-collaborative research programme for resource-poor settings. Twenty-four trials, including 18 in Africa, are currently underway mainly focusing on public health issues. Some 12,500 patients currently form, or will form, part of our HIV collaborative studies in the developing world.

Tuberculosis (TB)
TB kills 2 million people a year and is a leading cause of death amongst people with AIDS in the developing world. But no new drugs against TB have been discovered in more than 40 years.

During 2005 GSK announced a joint drug discovery partnership with the Global Alliance for TB Drug Development (GATB), the leading public private partnership working on TB treatments. GATB aims to accelerate the discovery and development of affordable drugs that will shorten treatment and be effective against multi-drug-resistant strains of TB. All compounds will be screened to ensure they can be taken with HIV treatments, since people living with AIDS are often susceptible to TB infection. GATB will support 25 full-time scientists working exclusively on the TB drug programme at Tres Cantos. GSK will contribute a matching number of staff and all remaining overhead costs. Under this partnership, GSK is screening a number of compounds for possible use as new classes of drugs with potency against TB. Any medicines discovered will be made as affordable and accessible as possible to those most in need.

GSK continues to provide funds to the Faculty of Health Sciences at Stellenbosch University, South Africa for TB research projects. These projects aim to identify markers that can predict whether patients will respond quickly to treatment or if TB is likely to recur.

In October 2005, GSK and the Aeras Global TB Vaccine Foundation announced a new public-private partnership to develop GSK's TB candidate vaccine which has shown promising results in early-stage clinical trials. GSK and Aeras plan to conduct additional trials in Europe involving adults previously infected with TB or vaccinated with Bacillus Calmette-Guérin (BCG). Studies will then begin in Africa and other locations to test the safety and efficacy of the vaccine candidate in populations highly affected by TB.

Rotavirus
Our vaccine, Rotarix, for the prevention of rotavirus induced gastroenteritis, was launched in Mexico in January 2005 and has now been approved in 15 countries in Latin America. By early 2006, four countries – Brazil, Panama, Venezuela and El Salvador – had decided to vaccinate all new-born babies. We have distributed 1.4 million doses in Latin America, enough for 700,000 babies.

Rotavirus infection is the leading cause of severe diarrhoea and vomiting (gastroenteritis) in children under two and kills around 600,000 children each year - one child every minute - mostly in developing countries. Rotarix was tested in the largest phase III clinical trial ever performed for a vaccine, involving over 60,000 children. Since its first launch, Rotarix has been licensed in several additional countries worldwide. We continue to seek regulatory approval for the vaccine in other developing countries.

Cervical cancer
Clinical trials data presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on our candidate cervical cancer vaccine, Cervarix, showed very encouraging results. Cervical cancer is the most common cause of cancer deaths in women in the developing world. Current published data suggest that the vaccine could reduce by 70% a woman's lifetime risk of developing cervical cancer. We plan to apply for registration of the vaccine in the US and Europe as well as our International region during 2006.

Leishmaniasis
During 2005 we continued intensive development of sitamaquine, a new oral treatment for visceral leishmaniasis. This disease affects half a million people a year in the developing world and is usually fatal if untreated. GSK is providing all the funding for this project. A new treatment for visceral leishmaniasis is urgently needed, since current medicines are either impractical or becoming ineffective due to drug resistance. Sitamaquine has shown good efficacy in pilot phase II trials. A further phase IIb study will start in 2006 to investigate a shorter treatment course and positive results will enable phase III studies in 2007.

¹ HIV/AIDS, malaria, leishmaniasis, dengue fever, hepatitis E, N. meningitis, cervical cancer and pneumonia

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