Fact Sheet: New Grants for Malaria Research and Development

EMBARGOED UNTIL SUNDAY, OCTOBER 30, 2005 AT 5:00 PM NEW YORK / 10:00 PM LONDON

(FOR PUBLICATION IN NEWSPAPERS ON MONDAY, OCTOBER 31)

Fact Sheet: New Grants for Malaria Research and Development

Malaria Vaccine: $107.6 million to the PATH Malaria Vaccine Initiative (MVI)

About MVI: MVI works in partnership with governments, industry, academia, and international organizations to accelerate the development and delivery of malaria vaccines for the developing world. MVI is a project of the Seattle-based Program for Appropriate Technology in Health (PATH).

Grant activities: MVI will use its foundation grant to work with GlaxoSmithKline (GSK) Biologicals to complete development of the RTS,S malaria vaccine candidate, following which, if the vaccine is successful, GSK will apply for licensure for its use in children in Africa. Specific activities include:

Phase IIb clinical trials: MVI and GSK will work with clinical trial sites in Africa to conduct a series of Phase IIb clinical trials to further evaluate the safety and efficacy of RTS,S in children. In a landmark proof-of-efficacy trial last year, RTS,S reduced the rate of malaria in young children, including a 58% reduction in the rate of severe malaria – the first time that a malaria vaccine candidate showed protection against severe disease in children.
Phase III trial: If RTS,S meets the milestones in Phase IIb trials, MVI, GSK, and the clinical trial sites will undertake a pivotal, large Phase III trial required for licensure.
Evaluation in infants: The Phase IIb and III trials will enroll young children and infants, and seek to confirm that RTS,S is safe and effective when given with other childhood vaccines.
Trial site development: Clinical trials of RTS,S will be conducted at multiple sites in Africa, enrolling a total of approximately 17,000 participants. Working with GSK, MVI will take the lead in ensuring that the clinical trials are conducted to international standards through the preparation of sites and training of local researchers.
Policy activities: MVI will expand its work with policymakers at national and international levels to ensure that if successful, the RTS,S vaccine would be procured and supplied in adequate quantities for developing countries. This will include developing a refined market assessment, ensuring that information required for decision-making is collected and shared.
Continued research into other vaccine candidates: In addition to the RTS,S program described above, MVI will continue to support additional research and development on other malaria vaccine candidates that may ultimately be used alone or in combination. MVI currently has 15 vaccine candidates in its portfolio.

Previous Gates Foundation support: MVI was created in 1999 with a $50 million foundation grant, and received an additional $100 million grant in 2003.

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New Malaria Drugs: $100 million to the Medicines for Malaria Venture (MMV)

About MMV: MMV is a Geneva-based nonprofit organization that works to discover, develop, and deliver new drugs to treat malaria. MMV manages a portfolio of drug development projects with public and private partners, and focuses on drug candidates that will be appropriate and affordable for developing countries.

Grant activities: MMV will use its foundation grant to work with public and private sector partners to advance and complete development of promising malaria drug candidates. MMV’s goal is support development of new malaria drugs that can be licensed at a price of $1 or less per treatment in developing countries. Specific grant activities include the following:

Advanced clinical trials: MMV will complete a series of advanced clinical trials of malaria drug candidates that have shown promise in earlier trials or pre-clinical studies. Six MMV-supported drug candidates are currently in clinical trials, including three in Phase III trials:
A pediatric formulation of an artemisinin combination that can be given to infants
Two next-generation artemisinin combinations that would be given once a day for three days for $1 or less
Regulatory approval and manufacturing: If Phase III trials of new malaria drugs are successful, MMV’s industrial partners will apply for regulatory approval and begin initial manufacturing. MMV will work with public and private sector partners to ensure that the drugs are accessible to patients in malaria-endemic countries.
Continued development of other drug candidates: In addition to the six malaria drug candidates in clinical trials, MMV has a portfolio of 14 projects in earlier stages of development. MMV will evaluate these candidates to determine which should be chosen for clinical studies, and continue work to discover other new drug candidates.
Focus on both artemisinin and non-artemisinin drugs: Four drugs in MMV’s portfolio are based on artemisinin, which is currently recommended as the most effective malaria treatment but is in short supply and relatively expensive. By developing new artemisinin-based drugs, MMV hopes to expand supply and lower prices. In addition, MMV is developing alternatives to artemisinin, to expand the range of drugs available and to ensure effective drugs are available if resistance develops to additional drugs.

Previous Gates Foundation support: $65 million ($25 million in 2000 and $40 million in 2003)

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Mosquito Control: $50.7 million to the Innovative Vector Control Consortium (IVCC)

About IVCC: IVCC is an international consortium of research agencies led by the Liverpool School of Tropical Medicine in the U.K. The consortium partners include the London School of Hygiene and Tropical Medicine, ColoradoStateUniversity, University of California at Davis, and the MalariaResearchCenter in Durban, South Africa. The consortium plans to enter into industrial partnerships to meet its product development goals.

Grant activities: IVCC will use its foundation grant to develop new strategies for controlling malaria-transmitting mosquitoes, focusing on insecticides that are more effective, safer, and more affordable than current products. Specific grant activities include:

Insecticide development: IVCC will develop and conduct field tests of insecticide candidates that have shown promise in preliminary studies.
Insecticide-treated materials: IVCC will develop new ways of formulating insecticides for use in insecticide-treated materials such as bed nets. Currently, only one class of insecticides – pyrethroids – is available for bed nets, and two types of malaria-transmitting mosquitoes have developed resistance. IVCC will also work to develop insecticides that last up to one year before needing to be re-applied.
Information tools: IVCC will develop information tools that health planners can use at the local level to make rational, data-based decisions about deployment of insecticides. These tools will include access to databases on insecticides and software that recommends insecticide strategies based on a community’s specific needs.
Additional focus on dengue: The strategies developed for controlling malaria-transmitting mosquitoes will also target mosquitoes that transmit dengue. Dengue virus infects up to 100 million people per year and can cause severe fever, hemorrhaging, and death.

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