Major joint initiative announced to end 10 NTDs by 2020

    Thirteen pharmaceutical companies, the governments of the U.S., U.K. and U.A.E., the Bill & Melinda Gates Foundation, the World Bank and other global health organisations “announced a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade.” The group said they would “sustain or expand existing drug donation programs to meet demand through 2020; share expertise and compounds to accelerate research and development of new drugs; and provide more than US$785 million to support R&D efforts and strengthen drug distribution and implementation programmes.” The group also endorsed the “London Declaration on Neglected Tropical Diseases,” in which they pledged new levels of collaborative effort and tracking of progress.

As part of the announcement, the Gates Foundation made a five-year, US$363 million commitment to support NTD product and operational research. Also, the WHO unveiled a new strategy, Accelerating work to overcome the global impact of neglected tropical diseases—A roadmap for implementation, that sets targets for what can be achieved by the end of the decade. Dr. Margaret Chan, Director-General of the WHO, commented, “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. 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 these partners “will close the funding gap to eradicate Guinea worm disease and expedite progress toward the 2020 goals of elimination for 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 organisations have worked for decades to fight these horrific diseases. But no one company or organisation 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.” New research and development collaborative efforts and access agreements with 11 companies and the R&D organisation 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.”

SPECIFIC PARTNER COMMITMENTS ANNOUNCED 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 programme. Combined with Eisai’s donation commitment that will 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 KGaA 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 the reduction in 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 that 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, Johnson & Johnson 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 Johnson & Johnson.

– If pre-clinical development is successful, Johnson & Johnson 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, GlaxoSmithKline, Johnson & Johnson, 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 programmes, including prevention, monitoring and education:

– Several partners announced US$40 million in new funding to The Carter Center that will close the gap to eradicate Guinea worm. The Gates Foundation will contribute US$23.3 million, His Highness Sheikh Khalifa bin Zayed Al Nahyan, President of the United Arab Emirates, will contribute US$10 million and the Children’s Investment Fund Foundation will contribute US$6.7 million.

– This funding complements £20 million in funding from DFID, announced last week as part of a £195 million commitment through 2015, targeted at Guinea worm disease, lymphatic filariasis, river blindness and schistosomiasis, as well as developing new programmes for blinding trachoma, visceral leishmaniasis, research and integrated country approaches.

– The Gates Foundation announced a 5-year, US$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 FY2012.

– 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 US$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, including:

. Reaching full geographic coverage of all endemic areas for lymphatic filariasis, soil-

transmitted helminthes and schistosomiasis

. Completely mapping and reaching full geographic coverage of trachoma by 2018

. Building capacity for surveillance and action to sustain gains from mass drug

administration programs

– 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 KGaA, Novartis and Sanofi— will organize and provide funding to support prevention, monitoring, education and intensified disease control efforts.

– Lions Clubs International announced US$6.9 million in funding to support the Government of China in efforts to eliminate blinding trachoma by 2017.

– Coordinating and measuring NTD commitments: Industry partners pledged to work together toward the achievement of the 2020 goals. Based on the WHO roadmap, partners will follow collective progress through a scorecard that will regularly and formally track progress including whether participating organisations are meeting their supply, research, funding and implementation commitments to work toward the 2020 goals. This process will ensure accountability and transparency and identify remaining gaps.

A webcast of this event can be viewed at www.UnitingToCombatNTDs.org

http://www.gatesfoundation.org/press-releases/Pages/combating-10-neglected-tropical-diseases-120130.aspx