Rise in R&D funding could set stage for malaria eradication by providing new tools

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PATH Malaria Vaccine Initiative
Rise in R&D funding could set stage for malaria eradication by providing new tools Report hails recent progress in reducing malaria illnesses and deaths, but warns new tools needed to fight emerging drug and insecticide resistance Washington, DC (6 December 2013)—A new analysis of funding trends in the global battle against malaria reveals that, over the last two decades, there has been a five-fold increase in annual funding for malaria research and development (R&D)—from US$131 million in 1993 to $610 million in 2011. Much of that increase took place after 2004, when support stood at $320 million.*

The report projects that malaria R&D will require up to $8.3 billion over the next decade (2013-2022) to develop some of the new tools needed to sustain efforts to combat the disease; the midrange projection calls for investment of about $700 million annually. While currently in retreat, malaria still kills about 660,000 people—mostly young children in Africa—each year. The study warns that R&D investments are critical, given the emergence of drug resistance in the malaria parasite and insecticide resistance in the mosquito.

It is crucial to sustain the momentum created by an R&D pipeline that has never been healthier, with nearly 90 products in development, notes the report. This pipeline includes almost 40 drugs, ten of which are in late-stage clinical trials; the first vaccine candidate to reach late-stage testing, with dozens of others in development; more than a dozen new mosquito control tools; and a host of new diagnostic tools.

Among the interventions coming into widespread use over the past two decades are long-lasting insecticide-treated bednets, artemisinin-based combination (drug) therapies for adults and children, and more rapid diagnostic tools. Using these and other tools, malaria control efforts helped avert 274 million cases of malaria and 1.1 million deaths between 2000 and 2010.

"The fruits of past investments in science and innovation have helped to turn the tide on an epidemic that has stolen the lives of millions," said Ashley Birkett, PhD, director of the PATH Malaria Vaccine Initiative. "But the only way to see its eventual eradication is to continue making strategic investments in research and development over the long term."

The report, From Pipeline to Product: Malaria R&D funding needs into the next decade, was authored by Policy Cures, an independent nonprofit research group, with input and funding from several malaria-focused product development partnerships. The analysis offers an update to a 2011 report, Staying the Course? Malaria research and development in a time of economic uncertainty, and is intended as a resource for policymakers to inform investment decisions regarding new tools to control malaria.

According to the report, about two-thirds of the projected funding needs for malaria R&D would be for new tools to support eradication, such as drugs that can completely eliminate parasites from infected patients, vaccines that can interrupt malaria transmission between humans and mosquitoes, vector control products that kill mosquitoes before they ever reach humans, and better diagnostic tools for health workers in the field.

The report also warns of the challenge posed by the Plasmodium vivax species of malaria parasite. While less life-threatening than the P. falciparum parasite, P. vivax can cause severe and relapsing malaria. It accounts for half of malaria cases in South and Southeast Asia and up to 81 percent of the malaria in Latin America—and its relative prevalence may be increasing in some regions. The report found difficulties in documenting the flow of resources into R&D for P. vivax malaria: only 5 percent of investments could be identified as exclusively for vivax R&D.

"For both P. vivax and P. falciparum malaria, we need new, effective, and affordable tools—including drugs—to ensure that we not only clear parasites from the body but also protect against immediate re-infection and ideally help limit transmission," said David Reddy, PhD, CEO of Medicines for Malaria Venture. "Rapid diagnostics for malaria are also urgently needed to ensure people are receiving the right treatment for their disease."

The funding requirements for malaria R&D contained in From Pipeline to Product are similar to those in the Staying the Course report of 2011. A key difference is that continued progress toward elimination and eradication goals will require investments to be sustained well into the future (2022 is the last year covered by the report).

What Will the Money Buy?

From Pipeline to Product uses modeling to derive how the resource envelope might be allocated to maximize impact, with 32 percent going to vaccine R&D, 27 percent to drugs, 11 percent to mosquito control R&D, and 3 percent to diagnostics. The remainder, about 27 percent, would fund basic research to better understand the biology of malaria infection and transmission.

From Pipeline to Product envisions an array of new tools that could be available by 2022, if R&D funding meets projected needs. These could include: Two new drugs, in a single dose, able to treat all types of malaria and prevent relapse. A drug that would provide a month of protection from all forms of malaria in a single dose. A first-generation vaccine against the P. falciparum malaria parasite that is 50 percent effective and lasts at least one year. Possibly a more protective second-generation vaccine that prevents clinical disease and/or infection with one or both of falciparum and vivax malaria. Three new "active ingredients" for killing mosquitoes that can be used in bednets and indoor spraying campaigns. A field test for detecting low levels of parasites, an important tool for pursuing eradication. A healthy pipeline of backup products in all areas.

The report notes that achieving these product development goals is reliant on a very small group of donors: the top five donors—the Bill & Melinda Gates Foundation, the US National Institutes of Health (US NIH), industry, the European Commission (EC), and the US Department of Defense (US DOD)—account for almost three-quarters of funding for malaria R&D. Further, only the Gates Foundation and US NIH have stepped up their funding, while the EC and US DOD experienced funding cuts through 2011, the last year of historical data in the report.

Increasing the number of donors, as well as sustaining industry investment, is among the recommendations of the report. Others include: Basic research needs to be better aligned with product development to maximize public health impact. Funding for vector control and diagnostics should double over the ten-year period. Funding should be flexible to support optimal portfolio management. Despite the small number of donors, greater coordination is needed to maximize effectiveness and minimize delivery time. Indeed, the projected resource needs in the report assume a higher level of coordination than currently exists.

"The malaria R&D field continues to evolve, and the level of investment required will have to adjust accordingly," said Dr. Mary Moran, director of Policy Cures. "The good news is that malaria R&D should not require unlimited and ever-increasing funding, because it has increasingly well-defined goals and strategies for getting there—such as those outlined in the recent update to the Malaria Vaccine Technology Roadmap."

"In this post-recession era, decisions about how to allocate still-scarce resources are measured against a 'value for money' benchmark," said Jeremy Lefroy, MP, chair of the United Kingdom's All-Party Parliamentary Group on Malaria and Neglected Tropical Diseases. "Investing in malaria R&D yields quantifiable results and has contributed to the 26 percent decrease in malaria deaths since 2000. Policymakers confronted with tough choices should rest assured that funding malaria R&D is a wise investment with results that can be measured in lives saved."

### Policy Cures is an independent not-for-profit group providing research, information, decision-making tools, and strategic analysis for those involved in the creation of new pharmaceuticals for neglected diseases. Its focus is on providing governments, funders, and civil society organizations with the information they need to make optimal R&D policy and funding decisions for diseases of the developing world. For more information, please visit http://www.policycures.org.

The Foundation for Innovative New Diagnostics, Innovative Vector Control Consortium, Medicines for Malaria Venture, and PATH Malaria Vaccine Initiative contributed to the report.

* All dollar figures in the report are expressed in 2011 USD. [1] PATH. Staying the Course? Malaria research and development in a time of economic uncertainty. Seattle: PATH; 2011. Available at: http://www.malariavaccine.org/files/RD-report-June2011.pdf.