MDGH: Innovative Financing Clinical Development and Delivery of Moxidectin and Dovramilast for 7 of the most Neglected Tropical Diseases
Product: Moxidectin and Dovramilast (formerly known as CC-11050/AMG 634)
Product type: Small molecule antihelminth/antiectoparasitic, and host-directed therapy
Disease: Onchocerciasis (also known as “river blindness”), Lymphatic Filariasis, the Soil Transmitted Helminths, Strongyloides, Scabies, TB and Leprosy type 2 reaction
Moxidectin, a second generation medicine from the same class of pharmaceuticals as ivermectin, is predicted to accelerate the elimination of onchocerciasis (also known as “river blindness”) as a global health burden. However, the prospects for moxidectin are much broader than just one disease: moxidectin is being developed to be an important new treatment option for approximately 1.7 billion people affected by neglected tropical diseases (NTDs) lymphatic filariasis, soil transmitted helminths, strongyloides, and scabies. Following stringent regulatory authority approval of moxidectin in 2018 for onchocerciasis, development activities have increased in order to generate paediatric data, in use experience in endemic countries, and data in each of the other indications.
Medicines Development for Global Health, an Australian-headquartered not-for-profit, brings pharmaceutical company methods to the challenge of new medicines for neglected diseases. The company licensed moxidectin for human health (noting that moxidectin is one of the most commonly used veterinary medicines in the world) from the World Health Organization in 2014. Before Medicines Development for Global Health’s involvement, the development of moxidectin had been advanced by a partnership between UNICEF, UNDP, World Bank, the WHO Special Programme for Research and Training in Tropical Diseases (TDR), and Wyeth/Pfizer. Once Pfizer withdrew from the relationship in 2011, the development of moxidectin was carried by TDR alone. Medicines Development for Global Health works in broad partnership on research and development, and collaborates with NGOs for delivery to communities. The company couples the reassurance of stringent regulatory authority and World Health Organisation requirements to ensure moxidectin is available for community uptake.
“Moxidectin builds on the foundation of ivermectin’s outstanding impact in global health, with advantages that will move the field closer toward elimination goals. It has the potential to be one of the most important global health medicines in history and yet it has suffered from a tortuous development history common to NTD medicines. Having addressed these challenges, Medicines Development for Global Health is now working closely with the team from TDR, researchers, public health experts, affected communities, and regulators to achieve guideline inclusion and community adoption. Our role is to support the community in their decision making process on the role of this medicine.”
—MARK SULLIVAN, FOUNDER AND MANAGING DIRECTOR, MDGH
Medicines Development for Global Health, as part of the social impact investment in moxidectin from the Global Health Investment Fund (GHIF), signed legally binding supply, pricing, and quality obligations for moxidectin with GHIF. The U.S. FDA approved moxidectin on June 13, 2018, and awarded Medicines Development for Global Health a priority review voucher, the proceeds of which (after repaying the impact investors) have been committed to global health research and development. These funds, along with further social impact investment, are now also being deployed on dovramilast, a new medicine being developed to replace thalidomide and steroid therapy for the treatment of leprosy type 2 reaction. In addition, through partnerships with the Aurum Institute, development of dovramilast in TB is also underway.
Medicines Development for Global Health’s work is to deliver medicines to improve the lives of people with neglected diseases. For each of the seven diseases currently being targeted, the goal is to support the field to eliminate these diseases faster, improve their management, and/or reduce their impact on the quality of life of those affected. The use of the priority review voucher and social impact investment has enabled MDGH, as a relative newcomer to the PDP arena, to contribute to addressing health equity in low and middle income countries.