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Innovating to Fight Neglected Tropical Diseases

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Innovating to Fight Neglected Tropical Diseases Doing our part: Innovating to fight Neglected Tropical Diseases April 2017 Designed by ACW, London www.acw.uk.com Contents BIOPHARMACEUTICAL INDUSTRY Scaling Up Access to CONTRIBUTIONS TO THE GLOBAL Existing Treatments FIGHT AGAINST NTDs 16 Staying the Course: A Global Strengthening Health Commitment to Fight NTDs Systems - The scope of the NTD epidemic 4 - The London Declaration 18 Boosting Innovation - Discovery - Pipeline 8 - Funding R&D PIPELINE FOR NTDs American trypanosomiasis Mycetoma 20 (Chagas disease) 32 (river blindness) Chikungunya Onchocerciasis (river blindness) 22 34 Dengue Rabies 24 (dengue hemorrhagic fever) 36 Human African Schistosomiasis trypanosomiasis 26 (sleeping sickness) 38 28 Leishmaniasis 40 Trachoma 30 Lymphatic filariasis 42 Abbreviations STAYING THE COURSE: A GLOBAL COMMITMENT TO FIGHT NTDs We are witnessing one of the greatest public health achievements of the century. This year marks the 5th anniversary of the World Health Organization’s (WHO) Neglected Tropical Diseases (NTD) Roadmap1, establishing targets and milestones for the control and elimination of ten of the most prevalent NTDs by 2020. Inspired by the WHO NTD Roadmap, a group of 20 partners from governments, intergovernmental organizations, NGOs, foundations and R&D biopharmaceutical companies came together to pledge support to the WHO by signing the London Declaration2. THE SCOPE OF THE NTD EPIDEMIC Today, the London Declaration’s endorsers have grown to include over 200 organizations3. Although most NTDs are preventable and treatable, they sadly continue to be a heavy burden on the most vulnerable, disadvantaged people in the world. “Today, we have joined together to increase One person in seven suffers from one or more NTDs – comparable to the entire population of Europe – the impact of our investments and build on with the vast majority of cases in low- and middle- the tremendous progress made to date. income countries (LMICs). NTDs are caused by a range of different parasites, This innovative approach must serve as a bacteria and viruses, which primarily thrive in subtropical model for solving other global development climates. They can be painful, blinding and disfiguring; each year they lead to the poor-health, disability challenges and will help millions of people build and death of hundreds of thousands of people. self-sufficiency and overcome the need for aid.” As they are often chronic and disabling, NTDs have enormous educational and economic impacts, keeping Bill Gates, co-chair of the Bill & Melinda Gates Foundation, children out of school and adults out of work. At the start of this millennium, it was estimated that in India at the signing of the London Declaration in 2012 alone, an average of USD 1 billion was lost to lymphatic filariasis each year due to healthcare costs and loss of productivity. Research has shown that school children Now at the halfway mark of the WHO NTD infected with intestinal worms had a 20% lower Roadmap’s timeline, this publication outlines how probability of school enrolment and, subsequently, the R&D biopharmaceutical industry is contributing a 40% reduction in income as an adult4. to this global agenda, with active research projects to uncover new or improved treatments and vaccines. The landscape of neglected disease control is It also provides context of how these R&D efforts continuously changing. Climate change is driving are part of an integrated approach to combatting diseases beyond their traditional geographies, resulting NTDs, including an unprecedented medicines in outbreaks of dengue and Chagas disease beyond the donation program of 14 billion treatments over tropics. Furthermore, complex changes in demography, ten years and support for local capacity building. such as urbanization and globalization, impact upon the spread of disease, as illustrated by the recent outbreaks of Chikungunya, Ebola and Zika virus. NTDs mire communities in a cycle of poverty, and hinder progress towards the sustainable development agenda. The increased commitments from national governments and their partners to achieve the targets of the WHO NTD Roadmap means significant improvements to the health, wealth and quality of life of over 1 billion people worldwide. 4 THE LONDON DECLARATION The London Declaration represented a turning point in global efforts to control and eliminate the most common NTDs. The R&D biopharmaceutical industry remains a committed partner in this agenda IFPMA signatories to the London Declaration are AbbVie, Bayer, Bristol-Myers Squibb, Eisai, GlaxoSmithKline, Johnson & Johnson, Merck, MSD, Novartis, Pfizer and Sanofi. COMMITMENTS OF THE LONDON DECLARATION ON NTDs Sustain, expand and extend programs that ensure the necessary supply of drugs and other interventions to help eradicate some diseases and to help control others by 2020. Advance R&D through partnerships and provision of funding to find next-generation treatments and interventions for neglected diseases. THE SCOPE OF THE NTD EPIDEMIC 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 programs. AT THE HALFWAY MARK, THE WORLD IS ON TRACK TO DELIVERING ON PROMISES OF THE LONDON DECLARATION5 • In 2015, biopharmaceutical companies donated an estimated 2.4 billion tablets, enough for 1.5 billion treatments to prevent and treat NTDs – an increase of 11.7% from 2014. • Between 2012 and 2014, the number of people who needed treatment decreased by 230 million. 1 http://www.who.int/neglected_diseases/NTD_RoadMap_2012_Fullversion.pdf 2 http://unitingtocombatntds.org/sites/default/files/resource_file/london_ • Since the London Declaration, there have been over 7.9 billion tablets declaration_on_ntds.pdf 3 http://unitingtocombatntds.org/endorsements in pharma donations, which is enough for 5 billion treatments. 4 http://www.globalnetwork.org/sites/default/files/Social%20and%20 Economic%20Impact%20Review%20on%20Neglected%20Tropical%20 • 87% of countries in Africa have been fully mapped for the London Diseases%20Hudson%20Institute%20and%20Sabin%20Institute%20 November%202012_1.pdf Declaration’s targeted NTDs. 5 http://unitingtocombatntds.org/report/fourth-report-reaching-unreached 5 DOING OUR PART: COMPREHENSIVE EFFORTS TO FIGHT NTDs Scaling up access to existing treatments Donation of 14 billion treatments over 10 years to help eliminate or control 10 NTDs Strengthening health systems Boosting innovation Over 40 health 109 active R&D projects to partnerships to build develop the next generation capacity to fight NTDs where of medicines and vaccines they are endemic for NTDs NTDs require a multi-stakeholder approach to drive further research tailored to developing needs, improve health policies and access to treatments, and boost healthcare system capacity. That is why the R&D biopharmaceutical industry combats NTDs in an integrated manner. 6 7 BOOSTING INNOVATION DISCOVERY There has been considerable progress in new technologies, including 1medicines, vaccines, diagnostics and pesticides, to combat NTDs. Since the launch of the London Declaration in 2012, a number of new product approvals helped better address NTD challenges. DENGUE (2015) SOIL-TRANSMITTED LYMPHATIC HELMINTHIASES (2016) FILARIASIS (2013) Dengue is a threat to nearly half of the world’s population, yet Soil-transmitted helminthiases, Lymphatic filariasis is often until recently there was no specific otherwise known as intestinal referred to as elephantiasis, due to treatment or vaccine available to worms, are a chronic and debilitating severe disfigurement, disability, and reduce the burden of this disease. illness with particular impact swelling from fluid build-up caused Dengue is the fastest progressing on children, stunting growth, by improper functioning of the vector-borne disease and can cause impairing cognitive development lymphatic system. Infection massive outbreaks with a disruptive and keeping children out of school. occurs when filarial parasites are effect on healthcare systems. transmitted to humans through The approval of a chewable Mostly asymptomatic, dengue can mosquitoes. An estimated 120 formulation of mebendezole7 also lead to hospitalization, serious million people worldwide live supports global efforts to reduce illness and death among people with the disease. the burden of parasitic infections leaving in endemic areas in Asia in young children. Donations of this The development and distribution Latin America and Africa. treatment are planned to be rolled of diethylcarbamazine citrate The newly approved dengue vaccine6 out towards the WHO’s objective (DEC)8 through large-scale mass presents a major advance towards to provide treatment to over 75% drug administration supports the the achievement of WHO objectives of 870 million at-risk children. WHO target of eliminating the to reducing dengue mortality and disease by 2020. morbidity by at least 50% and 25% respectively, by 2020. Additional dengue vaccine candidates are in development. 6 Dengvaxia® (CYD-TDV), developed by Sanofi Pasteur. 7 VERMOX™ chewable (mebendazole chewable 500 mg tablets), developed by Janssen Pharmaceuticals, Inc. 8 Eisai Co., Ltd. received prequalification from the WHO for diethylcarbamazine citrate (DEC)
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