New Potential TB Drugs to be Investigated Against Multiple Neglected Diseases

New York, United States / Geneva, Switzerland — 7 Jul 2010

A Unique Collaboration: TB Alliance and DNDi Enter Cross-Disease License Agreement to Speed Development of Novel Therapies
The Global Alliance for TB Drug Development (TB Alliance) and Drugs for Neglected Diseases initiative (DNDi) announced today a unique first-ever royalty-free license agreement between two not-for-profit drug developers that speeds progress toward markedly improved therapy of multiple neglected diseases. The TB Alliance has granted rights to DNDi to develop a class of potential anti-TB compounds that also show significant promise for treating other neglected diseases that largely affect the world’s poor. This agreement highlights the efficiency and synergy of product development partnerships (PDPs), and how investment in PDPs is producing a robust and diverse pipeline of tools to treat a wide variety of neglected diseases.

PDPs build partnerships between the public, private, academic, and philanthropic sectors to drive the development of new medical treatments, vaccines and diagnostics for underserved markets. The TB Alliance is a not-for-profit PDP searching for better and faster cures for tuberculosis. DNDi is a not-for-profit PDP working to research and develop new treatments for other neglected diseases, in particular human African trypanosomiasis (HAT), leishmaniasis, and Chagas’ disease.

“Developing drugs to fight neglected diseases, like tuberculosis, is about restoring to the world’s poor one of the most fundamental human rights — their health,” said Mel Spigelman, M.D., President and CEO, TB Alliance. “We are proud to join with DNDi to speed the development of compounds from our pipeline for new cures for multiple diseases, especially those affecting populations living in abject poverty. This agreement enables us to achieve a common goal and is a testament to the strength and efficiency of the product development partnership model.”

Under the agreement, the TB Alliance grants DNDi the rights to develop a series of compounds from the nitroimidazole class for use against many neglected tropical diseases, including visceral leishmaniasis, HAT or sleeping sickness, and Chagas disease. The TB Alliance will also share its scientific expertise and specific knowledge of the drug class, as gained through ongoing work with these compounds. The series of compounds covered by this agreement, designed and synthesized in collaboration with a medicinal chemistry group led by Professor William A. Denny at University of Auckland, New Zealand, is currently under development by the TB Alliance for its potential to yield new TB drug candidates. One of the furthest advanced and most promising TB drug candidates, PA-824, is a nitroimidazole, and is currently in Phase II testing.

“This agreement shows the unparalleled collaborative powers and efficiency of organizations like DNDi and the TB Alliance and the benefits of these approaches within neglected disease research and development,” said Bernard Pécoul, Executive Director of DNDi. “The not-for-profit model demonstrates that there are innovative ways to share knowledge, to avoid duplication in research, thereby saving costs and speeding up the R&D process for the benefit of the patients.”
The nitroimidazole drug class is effective in tackling a broad spectrum of bacteria, protozoa, and occasionally helminths, many of the pathogens which cause neglected diseases. The TB Alliance has built a library of nitroimidazoles in pursuit of developing the class for TB. Now, to ensure and promote more rapid, meaningful advances in global health, the groups have established a partnership that allows DNDi to more thoroughly investigate the compounds for their potential utility in treating additional neglected diseases.

This inter-PDP agreement maximizes the benefits from the global health community’s investment in research and development, and may serve as a model for future collaborations. With more than 140 active research programs among the 18 major global health PDPs, there may be opportunities to leverage other innovations across diseases which promises more rapid progress.
Over the next year the Bill & Melinda Gates Foundation has granted DNDi US$1.5 million to conduct the preclinical assessment of this class of nitroimidazole compounds specifically for visceral leishmaniasis.

About Product Development Partnerships
A PDP is a non-profit organization that builds partnerships between the public, private, academic, and philanthropic sectors to drive the development of new products for underserved markets. Through their unique, collaborative efforts, PDPs are able to access a variety of funding sources, and to apply a wide range of tools and knowledge to their programs. PDPs retain direct management oversight of their projects, though much of the work is done though external research facilities and contractors. In the global health arena, PDPs have been established to accelerate the development of new technologies that fight TB, AIDS, malaria, and a wide range of neglected diseases. PDPs are created for the public good; their products are made affordable to all those who need them.

About the Global Alliance for TB Drug Development
The TB Alliance is a not-for-profit, product development partnership accelerating the discovery and development of new TB drugs that will shorten treatment, be effective against susceptible and resistant strains, be compatible with antiretroviral therapies for those HIV-TB patients currently on such therapies, and improve treatment of latent infection.

Working with public and private partners worldwide, the TB Alliance is leading the development of the most comprehensive portfolio of TB drug candidates in history. It is committed to ensuring that approved new regimens are affordable, adopted and available to those who need them.

The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, Irish Aid, the Netherlands Ministry of Foreign Affairs (DGIS), the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). For more information on TB drug development and the TB Alliance, please visit www.tballiance.org

About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit product development partnership working to research and develop new and improved treatments for neglected disease, in particular human African trypanosomiasis, leishmaniasis, Chagas disease, and malaria. With the objective to address unmet patient needs for these diseases, DNDi was established in 2003 by the Oswaldo Cruz Foundation from Brazil, the Indian Council for Medical Research, the Kenya Medical Research Institute, the Ministry of Health of Malaysia, the Pasteur Institute, and Médecins sans Frontières/Doctors Without Borders (MSF). WHO/TDR acts as a permanent observer. Working in partnership with industry and academia, DNDi has the largest ever R&D portfolio for kinetoplastid diseases. Since 2007, DNDi has delivered three products, fixed-dose anti-malarials “ASAQ” and “ASMQ”, and a combination treatment for the advanced stage of sleeping sickness NECT (nifurtimox-eflornithine combination therapy). For more information: www.dndi.org