The Drugs for Neglected Diseases initiative (DNDi) has been awarded USD 2.34 million from a new pooled fund for health research and development (R&D) set up by Member States of the World Health Organization (WHO) and hosted by the Special Programme for Research and Training in Tropical Diseases (WHO-TDR), for a large-scale R&D project for the parasitic disease leishmaniasis.
The project, the ‘Leishmaniasis Global R&D and Access Initiative’, is the result of the merger of two demonstration projects – the DNDi ‘Visceral Leishmaniasis Global R&D and Access Initiative’ and the US Food and Drug Administration (FDA) project on the ‘Development of Class D Cpg Odn (D35) as an Adjunct to Chemotherapy for Cutaneous Leishmaniasis and Post Kala-Azar Dermal Leishmaniasis (PKDL)’. Both were selected in 2014 by WHO regions and by expert groups.
WHO Member States (MSs), according to the WHO resolution 66.22, undertook a regional and expert committee process to select from the proposed projects, which aim to provide evidence from innovative mechanisms to fund and coordinate public health R&D to address unmet medical needs of developing countries. Also aimed at contributing to further discussions on a sustainable global framework, as recommended by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), the project selection was based on projects’ ability to demonstrate the effectiveness of alternative, innovative, and sustainable financing and coordination approaches to address R&D gaps.
The Leishmaniasis Global R&D & Access Initiative aims to demonstrate that R&D for visceral leishmaniasis (VL), post kala-azar dermal leishmaniasis (PKDL), and cutaneous leishmaniasis, can be incentivized and optimized through various mechanisms to fill R&D gaps, such as the NTD Drug Discovery Booster, and new health R&D funding mechanisms, notably the new WHO-TDR pooled fund which leverages new sources of funding, for example from middle-income countries. The demonstration project is based on the principle of de-linkage, which dissociates the cost of R&D from that of the price of products that result from it, as well as on strengthening cross-regional coordination with multidisciplinary partners, while reinforcing the key role of endemic countries.
‘DNDi has been deeply involved with the CEWG process for over a decade’, said Dr Bernard Pécoul, Executive Director of DNDi. ‘While the Leishmaniasis Global R&D & Access Initiative will demonstrate an alternative way forward for some neglected diseases, we need to go further and create a new global R&D framework to addresses the numerous market failures inherent in what is today a broken system.’
DNDi welcomes the political support and funding participation in the new pooled fund through funding from Brazil, South Africa, India, which matches funding from Switzerland and Norway. However, DNDi adamantly emphasizes the importance of the WHO open-ended meeting that will take place in March 2016, at which Member States will assess the progress made and determine the future of health R&D and treatment access. The current R&D crisis, which exposes the broken innovation system, along with over 10 years of negotiation at the WHO, should serve as the basis for this meeting, at which WHO Member States will have the opportunity to set-up innovative mechanisms to fund and coordinate public health R&D to address unmet medical needs.
About the Drugs for Neglected Diseases initiative (DNDi)
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary. www.dndi.org
Gabrielle Landry Chappuis
Tel: +41 79 309 3910