David Torstensson, Senior Consultant, Pugatch Consilium, considers what the London Declaration on Neglected Tropical Diseases reveals about research and development efforts into neglected and tropical diseases.
Last week, the Gates Foundation, several government aid agencies, the World Health Organization [WHO], and a host of biopharm companies including GSK, Merck, Eisai, J&J, Sanofi, Novartis, Bayer and Abbott, committed to control and eradicate a number of neglected and tropical diseases (NTDs). Together, the group approved a “London Declaration on Neglected Tropical Diseases.” This new framework protocol speaks volumes about a signal change taking place in the way big pharma manages R&D: when it comes to tackling difficult diseases and conditions, cast a wide net.
NTDs are diseases for which there is no significant market in developed nations and that disproportionately affect poor and marginalized populations, often in low and middle income countries. The WHO estimates that one billion people are afflicted by these diseases.
Despite the scale of the problem, relatively small amounts of biopharmaceutical R&D have gone into the development of new drugs and treatments for NTDs. One of the most frequently cited studies found that out of a total of 1,393 new chemical entities marketed in the period 1975-1999 only 16 were for NTDs.
Findings like this prompted a number of new initiatives and international programs aimed at increasing drug development and available medicines. Scholars, researchers, international organizations, drug companies and policymakers have all tried to understand how to best incentivize new R&D into NTDs and a host of new R&D models have all been put forward including patent pools, research prizes, advanced purchase commitments, R&D tax credits and product development partnerships (PDPs).
A new R&D model?
Since 2000 R&D in NTDs has increased substantially. Research by the Tufts Center for the Study of Drug Development shows that between 2000 and May 2009, 26 products for neglected diseases
were marketed with a total of 26 indications. Out of these almost half of approvals occurred in malaria with 11 new drugs being marketed. New partnerships between industry, governments and philanthropic groups have increased the funding for neglected diseases substantially. The Global Funding of Innovation for Neglected Diseases (GFINDER) survey finds that in 2009 $3.2billion was allocated for research relating to neglected diseases – a significant increase from a decade or two before.
While many of these new R&D initiatives are yet unproven, there is growing evidence that many PDPs are having some success in developing new drugs and treatments for NTDs and other diseases which disproportionately affect poor populations, including HIV/AIDS, malaria and tuberculosis. For example, the percentage of approved NTD products sponsored by public-private partnerships increased from 15% in the time period 1975-1999 to 46% in the decade 2000-2009. Significantly, one of the largest PDPs is the Drugs for Neglected Diseases initiative (DNDi), once a fringe group but now a key partner to industry – and a signatory of the London Declaration.
London Declaration: A Bold Group Consensus
The stated purpose of the Declaration is to mobilize and coordinate the development and dissemination of drugs and treatments for a number of NTDs. Specifically, the declaration seeks to eliminate five NTDs (Guinea worm, Leprosy, Lymphatic filariasis, Blinding trachoma and Sleeping sickness) and control 5 others (Schistosomiasis, River blindness, Soil-Transmitted Helminthes, Chagas and Visceral Leishmaniasis) by 2020. There are three main measures or methods that will be used to achieve these goals:
- Greater quantities of drugs donated by international manufacturers – examples include Eisai’s donation of 2.2 billion DEC tablets for the treatment of Lymphatic Filariasis and Merck’s commitment to continue unlimited supplies of ivermectin for the treatment of river blindness for an unlimited period.
- Research partnerships between DNDi and manufacturers – examples include partnerships with Eisai to develop ravuconazole for the treatment of Visceral Leishmaniasis; agreement with 11 companies to allow DNDi access to their compound libraries, including data and knowledge about the compounds; and clinical and preclinical partnerships with Abbott, Johnson & Johnson and Pfizer to repurpose flubendazole as a potential macrofilaricide used in the treatment of Lymphatic Filariasis and River Blindness.
- Technical support and implementation – examples include the World Bank continuing to play a crucial role in funding and overseeing local health systems’ efforts against NTDs; also USAID will continue to support integrated NTD programs in low and middle income countries.
The London Declaration in many ways confirms that the partnership route between industry, public sector, nonprofits and philanthropic organizations is a key component in the future arsenal of R&D. It also joins like never before the art of discovery and development with the crucial issue of building access to existing treatments targeting NTDs. Progress of the pact clearly bears watching over the next few years, with the key question yet to be answered: can cooperation on a large scale produce lasting gains in global public health?