![Surviving-an-FDA-GCP-Inspection-500.jpg Surviving an FDA GCP Inspection](https://www.centerwatch.com/ext/resources/products/Surviving-an-FDA-GCP-Inspection-500.jpg?height=200&t=1605810958&width=200)
Home » International collaboration to combat 10 neglected tropical diseases by 2020
International collaboration to combat 10 neglected tropical diseases by 2020
January 30, 2012
Thirteen pharmaceutical companies, the U.S., U.K. and U.A.E governments, the Bill & Melinda Gates Foundation, the World Bank and other global health organizations will join forces to eliminate or control 10 neglected tropical diseases (NTDs) by the end of the decade.
Uniting efforts with NTD-endemic countries, partners pledged to bring a unique focus to defeating these diseases and to work together to improve the lives of the 1.4 billion people worldwide affected by NTDs, most of who are among the world's poorest.
In the largest coordinated effort to date to combat NTDs, the group announced at an event at the Royal College of Physicians that they plan to: sustain or expand existing drug donation programs to meet demand through 2020, share expertise and compounds to accelerate R&D of new drugs and provide more than $785 million to support R&D efforts and strengthen drug distribution and implementation programs.
The partners also endorsed the "London Declaration on Neglected Tropical Diseases," in which they pledged new levels of collaborative effort and tracking of progress.
"Today, we have joined together to increase the impact of our investments and build on the tremendous progress made to date," said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. "This innovative approach must serve as a model for solving other global development challenges and will help millions of people build self-sufficiency and overcome the need for aid." The Gates Foundation announced a five-year, $363 million commitment to support NTD product and operational research.
To guide the effort against NTDs, the World Health Organization (WHO) this week unveiled a new strategy: a roadmap for implementation that sets targets for what can be achieved by the end of the decade.
"The efforts of WHO, researchers, partners and the contributions of industry have changed the face of NTDs. These ancient diseases are now being brought to their knees with stunning speed," said Dr. Margaret Chan, director-general of the WHO. "With the boost to this momentum being made today, I am confident almost all of these diseases can be eliminated or controlled by the end of this decade."
New commitments from partners will close the funding gap to eradicate Guinea worm disease and expedite progress toward the 2020 goals of eliminating lymphatic filariasis, blinding trachoma, sleeping sickness and leprosy, and control of soil-transmitted helminthes, schistosomiasis, river blindness, Chagas disease and visceral leishmaniasis.
Speaking on behalf of the CEOs of the 13 pharmaceutical companies involved, Sir Andrew Witty, CEO of GlaxoSmithKline, said, "Many companies and organizations have worked for decades to fight these horrific diseases. But no one company or organization can do it alone. Today, we pledge to work hand-in-hand to revolutionize the way we fight these diseases now and in the future."
With new and existing pledges totaled, companies will donate an average of 1.4 billion treatments each year to those in need, according to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). In addition, new R&D collaborative efforts and access agreements with 11 companies and the R&D organization Drugs for Neglected Diseases initiative (DNDi) are providing unprecedented access to compound libraries that could lead to new treatments. These commitments will work in parallel with other efforts to speed the development of critical NTD treatments, including WIPO Re:Search, a database of research compounds, knowledge and expertise.
To close the funding gap for Guinea worm eradication, his highness Sheikh Khalifa bin Zayed Al Nahyan, President of the United Arab Emirates; the Gates Foundation; and the Children's Investment Fund Foundation will donate $40 million to The Carter Center. These commitments complement an October pledge from the U.K. Department for International Development (DFID) that it would contribute roughly $31 million if others come forward—part of a four-year, $306 million commitment to NTDs announced by DFID last week.
The U.S. Agency for International Development (USAID) also announced an $89 million appropriation by the U.S. Congress to strengthen drug delivery and distribution programs, building on its $212 million investment since 2006. In addition, the World Bank will extend its financing and technical support to help African countries build stronger community health systems to integrate NTD elimination and control, as well as work with other partners to expand a trust fund to combat river blindness to other preventable NTDs in Africa.
The pledges and declaration come in response to WHO's 2010 report, “Working to overcome the global impact of neglected tropical diseases,” which called for new resources to overcome NTDs.
Specific partner commitments include:
Sustaining, expanding and extending drug supply: All companies with NTD drug donation programs pledged to sustain or extend their programs to the end of the decade, and some pledged to increase their commitments. These commitments include the following:
- Sanofi, Eisai and the Bill & Melinda Gates Foundation will work together to provide 120 million DEC tablets to the WHO for its Global Lymphatic Filariasis Elimination program. Combined with Eisai's donation commitment to start in 2014, these new tablets will ensure a sufficient supply of DEC from 2012 through 2020.
- Bayer will double its existing donation of nifurtimox to treat Chagas disease.
- Eisai will extend its existing donation of 2.2 billion tablets of DEC for LF to 2020.
- Gilead, which announced a donation of AmBisome for visceral leishmaniasis in 2011, will continue its program to offer VL at cost and commit to investigate and invest in technologies and processes that could reduce that cost in resource-limited countries.
- GlaxoSmithKline will extend its existing donation of albendazole to treat soil-transmitted helminthes by providing 400 million tablets per year for an additional five years to 2020, as well as continuing its donation of 600 million tablets per year to combat lymphatic filariasis.
- Johnson & Johnson will extend its existing donation of mebendazole for soil-transmitted helminthes by providing 200 million tablets per year to 2020.
- MSD will continue its unlimited donation of ivermectin to combat river blindness and lymphatic filariasis (where co-endemic with river blindness), as well as discuss the use of ivermectin to combat other diseases.
- Merck will significantly increase its annual donation of praziquantel tablets from 25 million to 250 million tablets per year, extending the program indefinitely.
- Novartis will extend its commitment to provide multi-drug therapy (rifampicin, clofazimine and dapsone) to leprosy patients worldwide in a final push against the disease.
- Pfizer will continue its donation of azithromycin for blinding trachoma until at least 2020, as well as donate the drug and placebo to a study on reducing mortality of children treated with azithromycin.
- Sanofi will extend its existing donation of eflornithine, melarsoprol and pentamidine for sleeping sickness to 2020, as well as logistical support to ensure the drugs continue to reach patients at the point of care cost-free.
Accelerating R&D for new treatments:
- Product development partnerships under the coordination of DNDi with Abbott, J&J and Pfizer are underway to develop new drugs to treat helminth infections, notably a macrofilaricide, which kills adult worms that cause river blindness and lymphatic filariasis.
- Abbott is conducting initial drug reformulation studies and providing scientific expertise for preclinical development, with technical and supply assistance from J&J.
- If preclinical development is successful, J&J will co-fund clinical development and collaborate with other partners, including technical support from Pfizer's staff scientists. J&J would obtain regulatory approval.
- Innovative licensing or collaboration agreements with DNDi by 11 companies—Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, GSK, J&J, MSD, Novartis, Pfizer and Sanofi—are in negotiation or underway for the sharing of compounds and knowledge in order to generate new drugs for diseases including river blindness, lymphatic filariasis, sleeping sickness, Chagas disease and visceral leishmaniasis.
- DNDi and Sanofi announced a product development collaboration to co-develop a new drug candidate for sleeping sickness, oxaborole/SCYX-7158, in addition to fexinidazole, which is already in clinical development.
Increasing funding to improve drug product and operational research, delivery and implementation programs, including prevention, monitoring and education:
- Several partners announced $40 million in new funding to The Carter Center that will close the gap to eradicate Guinea worm. The Gates Foundation will contribute $23.3 million, President of the United Arab Emirates will contribute $10 million and the Children's Investment Fund Foundation will contribute $6.7 million.
- This funding complements approximately $31 million in funding from DFID, part of a $306 million commitment through 2015, targeted at Guinea worm disease, lymphatic filariasis, river blindness and schistosomiasis, as well as developing new programs for blinding trachoma, visceral leishmaniasis, research and integrated country approaches.
- The Gates Foundation announced a 5-year, $363 million commitment to overcome barriers to success and address critical gaps to achieve the control and elimination of targeted NTDs by 2020.
- USAID will continue support to over 20 countries to introduce and/or scale up integrated NTD programs, including three new countries: Mozambique, Senegal and Cambodia. The U.S. Congress appropriated $89 million to USAID for NTD control in fiscal 2012.
- At the country level, the World Bank will extend its financing and technical support to help countries build stronger community health systems that will integrate NTD elimination and control. At the regional level, the World Bank will continue fiduciary oversight of the existing trust fund that supports the fight against river blindness in Africa and will also work with other partners to expand the trust fund to eliminate or control preventable NTDs on the continent.
- Mundo Sano contributed $5 million to expand work in NTD control and program enhancement for selected sites in the Americas and Africa.
- The government of Mozambique announced specific goals for NTD control and elimination in endemic areas of the country.
- The governments of Brazil, Tanzania, Bangladesh and other NTD-endemic countries announced implementation of fully integrated or coordinated plans to control and eliminate NTDs in their countries.
- Three pharmaceutical companies—Merck, Novartis and Sanofi—will organize and provide funding to support prevention, monitoring, education and intensified disease control efforts.
- Lions Clubs International announced $6.9 million in funding to support the government of China in efforts to eliminate blinding trachoma by 2017.
Upcoming Events
-
21Oct