The US National Institutes of Health Awards DNDi with a 3-Year Grant Dedicated to the Development of a Low-Cost Treatment for Visceral Leishmaniasis

[ Geneva, Switzerland – November 5, 2007
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), has granted Drugs for Neglected Diseases initiative (DNDi) USD 2.3 million to be disbursed over 3 years for research and development that focuses on developing a low-cost formulation of amphotericin B to treat visceral leishmaniasis.

“This grant, the first ever received from the US NIH by DNDi, gives hope to the hundreds of thousands of patients who unacceptably die or suffer from visceral leishmaniasis each year in the poorest regions of the world,“ remarked Dr. Bernard Pecoul, Executive Director of DNDi.

There is an urgent need for new drugs to treat visceral leishmaniasis (VL). A potentially fatal disease, VL is present in 88 countries, where 350 million people are at risk of infection. Yet, almost all the 500,000 new cases each year arise from recurrent epidemics in poor, rural areas of the Indian subcontinent, Brazil, and Sudan. Therapeutic options to treat VL are limited, based on old drugs with limited efficacy and severe side effects or more recent drugs to which patient access is limited by high cost, toxicity or parenteral administration. The liposomal formulation of amphotericin B (Ambisome) is highly effective but its cost limits use in endemic countries.

This NIH-funded project is aimed first at combining amphotericin B, a proven active molecule against VL, with a metha-acrylic polymer. This original combination will allow appropriate intracellular delivery of amphotericin while eliminating its known toxicity. The second objective of the project is to streamline the manufacturing process, bringing the cost per vial below 4 USD (compared to the current cost of 20 USD for Ambisome at WHO-reduced price).

The VL drug development project is designed as a partnership between Imperial College, the School of Pharmacy, and the London School of Hygiene and Tropical Medicine in the UK, Advinus Theraputics in India, and DNDi in Switzerland.

Dr. Pecoul said, “By supporting drug research and development, the US government via its funding of DNDi is leading the way in accelerating the fight against neglected diseases. We urge other governments and public institutions to join the fight against these devastating diseases.”

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The Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organisations – Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur – as well as an international humanitarian organisation, Médecins Sans Frontières. The UNICEF/UNDP/World Bank/WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) is a permanent observer. With a current portfolio of 18 projects, DNDi aims to develop new, improved, and field-relevant drugs for neglected diseases, such as malaria, leishmaniasis, human African trypanosomiasis, and Chagas disease that afflict the very poor in developing countries.

In order to achieve its objectives of building a robust pipeline and delivering six to eight new treatments by 2014, DNDi requires an additional EUR 220 million in funding from public and private donors. To date, DNDi has secured EUR 55 million including an initial contribution of EUR 25 million from Médecins Sans Frontières along with important funding from governments. These public donors include the European Union, France, the Netherlands, Switzerland, the United Kingdom, and the United States of America.

DNDi also raises awareness about the need for greater R&D for neglected diseases and strengthens existing research capacity in disease-endemic countries. For further information, please consult https://www.dndi.org

For more information, or to arrange an interview with Dr. Bernard Pecoul or the project team, contact Ann-Marie SEVCSIK at amsevcsik@dndi.org; +1-646-258-8131 or +41 (0)79 814 9147)