Examining Project Work for Neglected Tropical Diseases

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-03-07-2012, Volume 3, Issue 8

Several major pharmaceutical companies detail their contributions for combating neglected tropical diseases.

In late January, 13 pharmaceutical companies, the governments of the United States, the United Kingdom, and the United Arab Emirates, the Bill & Melinda Gates Foundation, the World Bank, and other global health organizations announced a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade. An overviewof pharmaceutical companies’ pledges was announced by the International Federation of Pharmaceutical Manufacturers and Associations in late January 2012. Other groups and pharmaceutical companies have further detailed public, private, and public–private efforts in combating NTD following a meeting in late January at the Royal College of Physicians in London.

In a large, coordinated effort to combat NTDs, the groups said that they would 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. Partners also endorsed the “London Declaration on Neglected Tropical Diseases,” in which they pledged new levels of collaborative effort and tracking of progress.

“Inspired by the World Health Organization’s 2020 Roadmap on NTDs, we believe there is a tremendous opportunity to control or eliminate at least 10 of these devastating diseases by the end of the decade,” said the London Declaration. “But no one company, organization or government can do it alone. With the right commitment, coordination and collaboration, the public and private sectors will work together to enable the more than a billion people suffering from NTDs to lead healthier and more productive lives, helping the world’s poorest build self-sufficiency.” The declaration was signed by Abbott, AstraZeneca, Bayer, Becton Dickinson, the Bill & Melinda Gates Foundation, Bristol-Myers Squibb, the Children’s Investment Fund Foundation (CIFF), the Department for International Development (DFID) (a department of the British government), the Drugs for Neglected Diseases Initiative (DNDi), Eisai, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, the Lions Club International, Merck KGaA, Merck & Co., Mundo Sando, Novartis, Pfizer, Sanofi, the United States Agency for International Development (USAID), and the World Bank.

These partners committed to the following:

• Sustain, expand, and extend programs that ensure the necessary supply of drugs and other interventions to help eradicate Guinea worm disease and help eliminate by 2020 lymphatic filariasis, leprosy, sleeping sickness (human African trypanosomiasis), and blinding trachoma

• Sustain, expand, and extend drug-access programs to ensure the necessary supply of drugs and other interventions to help control by 2020 schistosomiasis, soil-transmitted helminthes, Chagas disease, visceral leishmaniasis, and river blindness (onchocerciasis)

• Advance R&D through partnerships and provision of funding to find next- generation treatments and interventions for neglected diseases

• Enhance collaboration and coordination on NTDs at national and international levels through public and private multilateral organizations

• Enable adequate funding with endemic countries to implement NTD programs necessary to achieve these goals, supported by strong and committed health systems at the national level

• Provide technical support, tools, and resources to support NTD-endemic countries to evaluate and monitor NTD programs


• Provide regular updates on the progress in reaching the 2020 goals and identify remaining gaps.

“Today, we have joined together to increase the impact of our investments and build on the tremendous progress made to date,” said Bill Gates, cochair of the Bill & Melinda Gates Foundation, in a Jan. 2012, press release. “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, WHO unveiled a new strategy, Accelerating Work to Overcome the Global Impact of Neglected Tropical Diseases—A Roadmap for Implementation, which 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,” said WHO Director-General Dr. Margaret Chan, in the release. “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.”

Speaking on behalf of the CEOs of the 13 pharmaceutical companies involved, 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,” he said in the release. With new and existing pledges totaled, companies will donate an average of 1.4 billion treatments each year to those in need, according to IFPMA. In addition, new R&D collaborative efforts and access agreements with 11 companies and the R&D organization DNDi are providing access to compound libraries. Other research tools include access to WIPO Re:Search, a database of research compounds, knowledge and expertise.

To close the funding gap for Guinea worm eradication, Sheikh Khalifa bin Zayed Al Nahyan, president of the United Arab Emirates, the Gates Foundation, and CIFF are donating $40 million to the Carter Center. These commitments complement an October pledge from the DFID that it would contribute £20 million ($31 million) if others come forward—part of a four-year, £195 million ($307 million) commitment to NTDs announced by DFID.

USAID also announced an $890million appropriation by the US 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 that will 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 governments of Bangladesh, Brazil, Mozambique, and Tanzania, where NTDs are endemic, announced that they would implement integrated plans to defeat NTDs and devote political and financial resources to combat these diseases. All partners pledged accountability by exploring mechanisms to regularly track progress toward the 2020 goals.

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 diethylcarbamazine tablets to WHO for its Global Lymphatic Filariasis Elimination program. Combined with Eisai’s donation commitment that will start in 2014, these new tablets will ensure a sufficient supply of diethylcarbamazine 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 diethylcarbamazine for lymphatic filariasis to 2020.

• Gilead, which announced a donation of AmBisome for visceral leishmaniasis in2011, will continue its program 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.

• Merck & Co. 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 multidrug therapy (rifampicin, clofazimine and dapsone) to leprosy patients worldwide.

• 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 provide logistical support to ensure that the drugs continue to reach patients at the point of care cost-free.

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 preclinical development is successful, Johnson & Johnson will cofund clinical development and collaborate with other partners, including technical support from Pfizer’s staff scientists. Johnson & Johnson would obtain regulatory approval.

Additionally, 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 to generate new drugs for diseases including river blindness, lymphatic filariasis, sleeping sickness, Chagas disease, and visceral leishmaniasis, according to the release. For example, DNDi and Sanofi announced a product-development collaboration to codevelop a new drug candidate for sleeping sickness, oxaborole/SCYX-7158, in addition to fexinidazole, which is already in clinical development.