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MALARIA AND NEGLECTED TROPICAL DISEASES (NTDs): FINDINGS FROM THE 2012 G-FINDER REPORT

Jan 12, 2016

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G-Finder 2012

MALARIA AND NEGLECTED TROPICAL DISEASES (NTDs): FINDINGS FROM THE 2012 G-FINDER REPORT

Policy CuresInnovative ideas and accurate analysis to accelerate development and uptake of new drugs, vaccines, diagnostics and other products for neglected diseases of the developing world

Annual survey of global investment into R&D of new neglected disease productsNeutral, comparable, comprehensive analysisCommissioned by the Bill & Melinda Gates Foundation31 neglected diseases134 product areasAll R&D stagesG-FINDER

2012 report looked at five-year trends3$84.9m higher in 2011 than in 2007 Malaria overall funding

General upwards trend over the five years (contrast to other disease areas, such as HIV/AIDS and kinetoplastids)Effect of grant cycles (peak in 2009, uneven disbursement)Funding fluctuations can be driven by a single product (eg winding down of RTS,S vaccine funding caused a large drop in 2010)4Malaria by product area

Vaccines, diagnostics and vector control R&D Drug R&D Basic research

Vaccines $135m in 2011 compared to $88m in 2007 (although there have been some large fluctuations, eg large increases in funding in 2008 and 2009 reflected upfront funding to support RTS,S Phase II and III trials, followed by a large drop (-50%) in 2010 as the trials wound down)Diagnostics - $14m in 2011, compared to $1.6m in 2007Vector control - $23m in 2011, compared to $17.5m in 2007Drug development - $201.4m in 2011, compared to $206.9m in 2007 (although there have been some large fluctuations)Increases in basic research primarily driven by increases from the US NIH and the Wellcome Trust (overall basic research funding was $107.8m in 2007, compared to $142.9m in 2011)

How does this compare to what is required? (Staying the Course report in 2011, estimated malaria R&D funding needs)Investments in drug R&D were generally in line with the reports recommendation for stable drug funding in the short-termDespite substantial increases, funding for diagnostic and vector control R&D fell well short of the report recommendations (diagnostics meant to be about $50m per year, only currently $13.9m) (vector control R&D recommended to increase up to $90m in 2016-17, currently only at $22.9m)Vaccine funding has also recently fallen below the recommended levels5Who funds malaria R&D?

Gates Foundation 26.3%US NIH 20.7%Industry (aggregate) 18.7%66%Who funds malaria R&D?

Most (about half) from public (in 2011, $277m out of total $559m)Compared to other diseases, quite a healthy funding profile, relatively evenly spread between the public, philanthropic and private sectors (cf HIV/AIDS, where 85% of funding comes from the public sector)Increases have come from all three sectors (compared to other diseases, such as dengue, where increases have been driven by one sector)Funding concentration has remained relatively high top three funders (Gates Foundation, US NIH and the pharmaceutical industry (counted as a single entity) have provided, on average, two-thirds (65.7%) of funding (average % of total, over five years)6NTDs50%65%

Buruli ulcerDengueKinetoplastids (Chagas, HAT, leishmaniasis)Helminths (lymphatic filariasis, STHs, cysticercosis, onchocerciasis, schistosomiasis) LeprosyTrachomaHIV/AIDSMalariaTBDiarrhoeal diseasesBacterial pneumonia & meningitisSalmonella infectionsRheumatic feverGuinea worm diseaseEchinococcosisFoodborne trematode infectionsRabiesYaws WHO classificationG-FINDER12 of the 17 NTDs defined by WHO are included in G-FINDERNote that G-FINDER also includes other poverty-related diseases (HIV/AIDS, malaria etc)This section focuses on the NTDs that are included in G-FINDER (not a complete picture of funding for the WHO list of NTDs)

If asked why other NTDs werent included:G-FINDER focuses on neglected diseases where there is a research & development gapDiseases can be neglected in a number of ways sometimes, we may have the tools to address these diseases, but simply not enough funding to implement and deploy those toolsFor G-FINDER, what we mean by neglected is that there is gap in terms of existing toolsAdvisory Committee decided on inclusion of diseases, based on three filters (disease disproportionately affects developing countries, need for new products, market failure (insufficient commercial market to attract R&D by private industry)7NTDs dengue, kinetoplastids and helminths

Different funding profiles for individual NTDs (more useful than talking about overall funding for NTDs)

(Overall NTD figures - $465m in 2011, compared to $268m in 2007)

DengueUnique funding profile across the NTDsSeen the most growth across the five years of the report, primarily driven by increased funding by pharmaceutical companies for the clinical development of vaccines (incl Sanofi-Pasteur Ph III and NIH vaccine that has just come out of Ph I)Overall funding for dengue more than doubled between 2008 and 2011 (note that we measure increases from 2008 for this disease, as we had limited participation from pharmaceutical companies in 2007) ($108m in 2008, $224m in 2012)Most important factor is funding by pharmaceutical companies for the clinical development of vaccines, which has more than tripled of the last four years ($40m in 2008 to $142m in 2011)Shift in funding sources from governments to the private sectorSemi-commercial disease (stronger commercial drivers, market in emerging middle-income countries)

KinetoplastidsDifferent funding pattern steady increases until 2009, and then decreaseCommon pattern across funding for other diseases (eg diarrhoeal diseases, HIV/AIDS)Declining philanthropic funding (particularly from Gates) since 2009 has played a large roleCuts in funding from governments since the global financial crisis have also contributed to the decline

HelminthsFunding for helminths has risen steadily over the five yearsInvestment in drug development, particularly for river blindness and lymphatic filariasis, have been important drivers (boosted by funding from Gates and industry)If asked:Although there are existing drugs for these diseases that are used in MDA campaigns, there is evidence of increasing resistance and loss of efficacyDrugs in development include moxidectin for river blindness (developed by Pfizer and WHO/TDR) (in Phase III trials) and flubendazole for lymphatic filariasis (DNDi & McGill, in preclinical)

8NTDs leprosy, Buruli ulcer and trachoma

$7.4m$5.8m$9.6mVery low levels of funding for these diseases (always less than $10m globally per year)Very few funders (sometimes just two or three reporting organisations)This means that changes in single grants by single organisations can really skew the figures, and drawing any conclusions about trends is very difficultWith that caveat:Funding for trachoma and Buruli ulcer has tended to increase over the course of the surveyTrachoma largely due to increased investments in diagnostics by Cepheid, but also increased investment in vaccines by the NIHBuruli ulcer mainly driven by ECs BURULIVAC programAfter peaking at $8.4m in 2009, funding for leprosy has tended to decline ($4.6m in 2011), with most of that spent on basic researchMay reflect decreasing burden of disease (well advanced towards elimination and eradication), smaller R&D needsWhat is interesting is to compare are the funding profiles for the three diseases (shows average % of total funding, by sector) (blue = public, red = philanthropic and green = private):Leprosy highly reliant on funding from the public sector (all from developed countries)Buruli ulcer slightly more balanced, with a quarter of funding coming from the philanthropic sector, although contributions from the private sector and still very lowTrachoma higher involvement from the private sector (Cepheid)

9Download the full report atwww.policycures.org/g-finder2012.html

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