November 10, 2016
Neglected tropical diseases (NTDs) remain important sources of morbidity, mortality and disadvantage in low and middle-income countries, and yet the development and registration of new treatments for these diseases is rare.
Funding to support the research and development of new medicines for these diseases is directly correlated with their low potential for return on investment, and remains insufficient to consistently meet regulatory standards. To drive this drug development, in 2007 the United States Congress created the priority review voucher (PRV) to reward sponsors who successfully register medicines to treat specified NTDs. The PRV is saleable to any company wishing to gain priority review of their new treatment, regardless of indication, creating a market that has yielded up to US$350 million per PRV. Although three new NTD treatments have been approved under the scheme, concerns have been expressed that sponsors benefitting from PRV sale are not bound to ensure treatment access and that the program does little to drive new NTD drug development.
Medicines Development for Global Health (MDGH), a non-profit biotechnology company, partnered with the Global Health Investment Fund (GHIF), a U.S.-based social impact investment fund, to develop and register moxidectin for the treatment of onchocerciasis. MDGH is the first company to attract venture capital investment for a new treatment for a NTD on the basis of the PRV program. With limited commercial return, the investment in moxidectin would have been previously inconceivable, particularly as the registered treatment option for onchocerciasis (ivermectin) is donated. GHIF and MDGH, both with constitutionally enshrined global health objectives, have entered into a legally binding commitment to use PRV funds to support equitable and sustainable access to moxidectin for onchocerciasis, as well as support further development of moxidectin for other NTDs. In conclusion, this is the first example of a program utilizing the PRV scheme to support NTD drug development and access, directly addressing the majority of concerns raised about the use of PRV scheme to achieve global health impact.