New business models are helping large pharmaceutical companies tackle diseases of the poor around the world, especially of sub-Saharan Africa. Most of the attention goes to the effort to build a vaccine for HIV, but since the recent scientific collapse of the most interesting vaccine candidate, hopes and attention have shifted to malaria.
GlaxoSmithKline (GSK), a big pharma company, has the leading malaria vaccine candidate, called RTS,S, originally created in 1987 and coming to phase-3 trials (finally) in 2008. The candidate vaccine, while welcome, has only so far proved to be effective in protecting roughly 50% of people from malaria for at least 18 months. Because of the vaccine-candidates relatively weak protections, GSK plans to market RTS,S to children. Children tend to die more quickly and often from malaria than adults, who gain resistance over time and generally respond to existing treatments.
GSK is getting support from the Gates foundation (through both the Malaria Vaccine Initiative and Seattle-based PATH, a partnership to promote attacks on tropical diseases) to reduce the costs of gaining regulatory approval and finishing its scientific tests. The company hopes to negotiate "advance market committments," or contracts, with international donors who have pledged to foot the bill for rolling out a malaria vaccine in willing African countries.
GSK's field trials, likely to commence in about eight months, are expected to be done in Kenya, Tanzania (2 sites), Mozambique, Gabon, and Ghana (2 sites).
Aside from the health benefits that would come from an even a partially effective, the RTS,S vaccine, should it get market approval in the next 2-4 years, will mark a watershed in the pharmaceutical industry's approach to tropical diseases. The scientific benefits from field-testing the vaccine candidate in Africa -- at a cost running more than $100 million -- may result in improved capacity around the region to hold similarly-ambitious trials for other drugs.
Equally, the stakes are high. If GSK fails, radically-new scientific approaches may get attention, such as as the capsid-interruption approach to halting diseases promoted by Prosetta Corp. As many as 90 teams around the world are working on malaria vaccines.
Another notable trend is that of supplementing these development efforts with a renewed emphasis on behavioral adaptations to reduce malaria incidence, especially greater reliance on treated bed nets and on indoor spraying of DDT, an effective killer of mosquitoes that carry malaria. GSK itself supports these activities in different African countries in a recognition that science must be married to social changes in order to maximize outcomes in battles against disease.
