Research & development

• Phase IIb clinical trials of our malaria vaccine for children showed unprecedented results. Data from the trials, conducted with the Malaria Vaccine Initiative (MVI), showed the vaccine protected a significant percentage of children against uncomplicated malaria, malaria infection and even severe forms of the disease for at least six months. Dr Melinda Moree, Director of MVI, commented: “The findings represent a breakthrough in the science of malaria vaccines.”
• GSK is working with the Medicines for Malaria Venture (MMV), the World Health Organisation (WHO) and academic partners to develop an affordable fixed-dose artemisinin combination treatment for malaria in Africa, based on GSK’s Lapdap.
• We received the MMV’s Project of the Year award for our Pyridone Project, investigating a new class of compounds for use against malaria. The project was chosen by the MMV’s Expert Scientific Advisory Committee - a group of 12 experts in malaria and drug development - for its rapid success in identifying a drug candidate. We have since signed an agreement with the MMV to take a lead compound into clinical development.

• We have also made progress on R&D into HIV/AIDS. Epzicom/Kivexa, a new fixed dose combination of Epivir and Ziagen, was approved in the US and Europe. This new once-a-day combination tablet will help to simplify treatment regimens for patients. We plan to register it across the developing world in 2005 once it has received a European Certificate of Pharmaceutical Product. Telzir, a new protease inhibitor, was approved in Europe in 2004 and is being registered in the developing world, where it will provide yet another treatment option.
• In September we signed a material transfer agreement with the International Partnership for Microbicides (IPM). Under the agreement, GSK’s HIV drug candidates will be tested for use in microbicides to prevent transmission of HIV and help women reduce their vulnerability to HIV infection during sexual intercourse.
• Phase II clinical trials of our CCR5 antagonist, a new class of AIDS therapy, produced positive data. The therapy will now be tested in further clinical studies. If trials are successful the therapy may benefit people living with HIV who have developed viral resistance to existing HIV treatments.
• Proof of concept trials and drug interaction studies are underway for two additional HIV/AIDS compounds, a protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI), and results are expected to be reported in 2005.
• GSK is supporting clinical trials that are 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 trials are currently underway mainly focussing on public health-related issues and involving more than 13,000 patients in the developing world.
• Phase l clinical trials on our most advanced HIV vaccine candidate continued in 2004 with no major milestones to report.

• GSK and Corixa, a US pharmaceutical company, began phase I clinical trials of a new vaccine for tuberculosis in 2004. This is the first study of this vaccine candidate to be conducted in humans.
• During 2004 GSK continued to screen compounds for possible use as new classes of anti-TB drugs against enzymatic targets of Mycobacterium tuberculosis and M. tuberculosis whole cells. Should our search be successful the leads identified from screening will be progressed to candidates for development.

• Our rotavirus vaccine, Rotarix, for the prevention of gastroenteritis, was launched in Mexico in January 2005. 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. We are now seeking regulatory approval for the vaccine in other developing countries.

• Clinical trials of our cervical cancer vaccine, Cervarix, produced positive results. Cervical cancer is the number one cause of cancer deaths in women in the developing world. Current studies suggest Cervarix could reduce by 70% a woman's lifetime risk of developing cervical cancer. We hope to launch the vaccine in Europe and our International region during 2007.

• GSK is developing sitamaquine, a new oral treatment for visceral leishmaniasis which affects at least half a million people a year in the developing world and is usually fatal if untreated. A new treatment for leishmaniasis is urgently needed since current medicines are either impractical or becoming ineffective due to drug resistance. Sitamaquine has shown good efficacy in phase II studies and clinical development is ongoing.
  

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