The University of Siena today awarded the Drugs for Neglected Diseases initiative (DNDi) with a Goodwin Award for its innovative needs-driven approach in making 2 new antimalarials available as public goods, and in engaging public and private partners worldwide, especially in neglected disease-endemic countries, to ensure that the best science is made available for those neglected patients.
The Goodwin Award, which is the first one of its kind, is given to entities that – through concrete actions and initiatives – have shown attention to the theme of well-being, and also takes an entrepreneurial approach into perspective. DNDi is one of 4 recipients of the Goodwin Award, which marks the 40th anniversary of the Richard Goodwin Faculty of Economics of the University of Siena.
“We at DNDi are honored to receive this reward as it showcases the progress which DNDi has made since its short life, thanks to our diverse set of partners,” remarked Dr. Bernard Pecoul, Executive Director of DNDi. “We look forward to building upon our current successes by creating new partnerships along with further strengthening of current partnerships to address the needs of the most neglected.”
Prof. Joseph Stiglitz, Colombia University, Nobel Laureate, Prof. Angelo Riccaboni, Chair of the Faculty of Economics, University of Siena, and Dr. Bernard Pécoul, DNDi Executive Director, received the Goodwin Award.
In its short life, DNDi has worked hard to develop a new approach to medical R&D innovation and for access to essential medicines, and is today fortunate to have its first two needs-adapted products reach some of the most neglected patients. In so doing, DNDi has also learned a number of lessons from the experience of developing and delivering ASAQ for Africa and ASMQ for Latin America and Southeast Asia. These are critical in catalyzing DNDi to move forward in its goal to deliver new treatments for the most neglected and to build a robust portfolio that will produce safe, easy-to-use, effective, and affordable drugs.
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About DNDi and its Model
Background on Neglected Tropical Diseases
Tropical diseases such as malaria, leishmaniasis, lymphatic filariasis, Chagas disease, human African trypanosomiasis (HAT), dengue fever, and schistomiasis continue to cause significant morbidity and mortality worldwide. These disabling and/or life threatening diseases represent an enduring unmet medical need and are collectively called “neglected diseases”. Of the 1,556 new drugs approved between 1975 and 2004, only 21 (1.3%) were specifically developed for tropical diseases and tuberculosis, even though these diseases account for 11.4% of the global disease burden.
Although the R&D landscape has significantly changed for neglected diseases since 2000, there is an urgent need for new, field-adapted drugs to treat visceral leishmaniasis (VL), human African trypanosomiasis (HAT or sleeping sickness), and Chagas disease. A potentially fatal disease, VL is present in 62 countries, with 200 million people at risk and 500,000 new cases each year. Therapeutic options for VL are limited as there are significant drawbacks like route of administration, toxicity, or cost. HAT, a fatal disease if not treated, threatens more than 50 million people in 36 countries and has limited treatment options. For Chagas disease, which infects ~8 million and puts 100 million at risk in Central and South America, drugs are needed to treat both acute and chronic disease, as are safer and more effective drugs adapted to patient needs.
Collaborative Mode of Operation
DNDi follows the virtual research model adopted by other product development partnerships (PDPs), whereby most research is outsourced and actively managed by DNDi personnel. As an integral part of its mission, DNDi utilizes South-South and North-South collaborations in working with R&D partners. While using and supporting existing capacity in countries where the diseases are endemic, DNDi helps to build additional capacity in a sustainable manner through technology transfer in the field of drug R&D for neglected diseases. This includes early-stage access to molecules, pharmaceutical and clinical development, and working closely with control programs through, for example, the Leishmaniasis East Africa Platform (LEAP) and Human African Trypanosomiasis (HAT) platforms.
DNDi has built regional networks of scientists and clinicians actively involved in the research of new drugs for neglected diseases in Asia, Africa, and Latin America, as well as in the conduct of clinical trials in endemic countries.
DNDi has 18 projects in its portfolio as of January 2008: 9 discovery, 3 preclinical, 4 clinical, and 2 post-clinical projects. Discovery projects range from library screening on validated targets, reformulation studies, to therapeutic switching. Three preclinical projects will be ready to enter clinical studies by 2009; and clinical projects are ongoing for VL (combination therapies, regional extension of existing drugs) and for HAT (nifurtimox-eflornithine combination therapy [NECT]).
Two fixed-dose antimalarial ACTs (FACTs ‘ASAQ’ and ‘ASMQ’) have been developed and registered by DNDi and its FACT Project partners – these public goods are treatments which are easy to use (1-2 tablets a day over a 3-day treatment course) for both children and adults. Over 1 million treatments of ASAQ, the fixed-dose combination (FDC) of artesunate and amodiaquine, have now been distributed by industrial partner, sanofi-aventis; and the treatment is now registered in 21 African countries.
In order to achieve its objectives of building a robust pipeline and delivering 6-8 new treatments by 2014, DNDi requires a total of EUR €274 million. To date, a number of public institutional and private donors have contributed EUR €74 million to DNDi.