Pharmaceutical Companies Pledge 14 Billion Treatments for Control and Elimination of Neglected Tropical Diseases

“For decades individual pharmaceutical companies have researched, developed, and donated medicines to fight disease and improve patients’ lives,” said Eduardo Pisani, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The research-based pharmaceutical industry jointly pledged a further 14 billion treatments to help the elimination or control of nine key neglected tropical diseases (NTDs). “This is our commitment as partners to help end NTDs and improve patient health,” Pisani said.  

Averaging 1.4 billion treatments annually, for each of the ten years from 2011 to 2020, the donations build upon companies’ existing medicines donation programs, which already reach millions of people around the world. 

The announcement came in conjunction with an NTD collaboration comprised of pharmaceutical companies, the Bill & Melinda Gates Foundation, the US and UK governments, international organizations, and endemic countries’ national governments.  At least one billion people worldwide — one person in seven — suffer from NTDs. Each year NTDs disproportionately kill or disable millions of poor people primarily in tropical and subtropical areas. 

These donations follow a World Health Organisation (WHO) announcement of new targets for NTDs whose elimination or control is achievable with adequate supply and distribution of the relevant medicines. The goals are set for 2020.  For maximum impact, these donations focus on those nine NTDs that represent more than 90 percent of the global NTD burden. 

Neglected Tropical Diseases 

One billion people worldwide – or one person in seven – suffer from NTDs. These illnesses primarily affect poor people in tropical and subtropical areas of the world. Nine NTDs represent more than 90% of the global NTD burden: 1) human African trypanosomiasis, 2) Chagas disease, 3) lymphatic filariasis, 4) soil-transmitted helminthiases, 5) onchocerciasis, 6) schistosomiasis, 7) leprosy, 8) fascioliasis, and 9) blinding trachoma) 

NTDs kill or disable millions of people every year.  These illnesses affect both children and adults for life, often lead to stigmatization, and can prevent children from developing to their fullest potential. As long as NTDs continue to be endemic in poor countries, they will remain a contributor to a vicious cycle of poverty in these regions. 

IFPMA members holistic fight against NTDs. The research-based pharmaceutical industry fights NTDs in several ways. Firstly, through cutting-edge research and development (R&D) IFPMA members are currently working on 82 projects either independently or in product development partnerships (PDPs). A recent report shows the industry was the second largest funder of R&D for  neglected diseases in 2010. 

Furthermore, as a partner in global health, IFPMA members’ work with the WHO and other partners to implement capacity-building efforts in developing countries. These efforts are complemented by medicine donation programmes, several of which date back decades. 

In 2010, WHO confirmed the adverse socioeconomic impact of NTDs on development and quality of life at all levels. WHO recommends five public health strategies for the prevention, control, or elimination of NTDs : (i) preventative chemotherapy; (ii) intensified case management; (iii) vector control; (iv) provision of safe water, sanitation and hygiene; and (v) veterinary public health. Of these, preventative chemotherapy and intensified case management are directly relevant to the research-based pharmaceutical industry’s medicine donation programmes. 

There are six NTDs for which preventative chemotherapy (i.e. treatment is applied to the whole population at risk, not just those infected) is an important approach. For diseases such as lymphatic filariasis, onchocerciasis (river blindness), soil-transmitted helminthiases, schistosomiasis, fascioliasis, and blinding trachoma, the adequate supply of medicines can lead to elimination. For those diseases where no preventative medicines exist, intensive case management (ICM) can be used. ICM involves caring for infected individuals and those at risk of infection. This strategy depends on early diagnosis, treatment to fight infection and reduced morbidity, and management of complications. ICM diseases are Chagas disease, human African trypanasomiasis (HAT, also known as sleeping sickness), and leprosy.  

Disease profiles: why these NTDs matter  

The IFPMA publication showcases nine NTDs where the industry is playing a vital role in achieving control or elimination. The following disease profiles demonstrate why these illnesses matter, and how the research-based pharmaceutical industry’s donations are making a difference to the lives of hundreds of millions of people in the developing world. 

Lymphatic filariasis (LF) – Target 2020: Global elimination 

LF is a severely debilitating and disfiguring disease, which can lead to permanent disability. Caused by parasitic worms, it is usually acquired in childhood. An estimated 120 million people in 72 countries suffer from the disease; 1.39 billion (15% of the world’s population) are at risk of infection. 

In 1998, GlaxoSmithKline pledged unlimited amounts of albendazole until the disease is eliminated.  Also in 1998, Merck & Co. pledged unlimited amounts of ivermectin for the elimination of LF.  In 2010, Eisai announced it would produce and supply for free to the WHO up to 2.2 billion 100 mg tablets of DEC between 2013 and 20206. Eisai has stepped up to manufacture this medicine despite having no history of making the medicine. Never before has a company agreed to produce a medicine solely for the purposes of an NTD elimination program.

Eisai’s DEC will be produced at its state-of-the-art facility in Vizag, India, and supply will begin in 2013. The product will reach over 800 million patients in the developing world over the course of the programme. 

The Bill & Melinda Gates Foundation, Sanofi and Eisai have announced a donation of 120 million DEC tablets to the WHO for their Global Lymphatic Filariasis Elimination programme. The consortium, the first of its kind, sees the partners jointly financing the donation which will allow the WHO to provide treatment of 30 million people (2 tablets per person, once a year for 2 years). The donation will ensure a stable supply of DEC to the WHO Global Lymphatic Filariasis Elimination programme for 2012 and 2013, after which Eisai will begin its Lymphatic Filariasis Elimination Partnership with WHO and continue to provide DEC at “price-zero” until 2020 (see above).As a result these ongoing pledges, there will soon be no shortage of medicines for the preventative treatment of LF.   

During 2010, the WHO reported over 466 million people were treated worldwide through this program. In a 2008 study published in PLoS Neglected Tropical Diseases, researchers found that the LF elimination effort prevented 6.6 million children from acquiring the disease.  The GAELF is a partnership initiated by the WHO and GlaxoSmithKline in 1998 and with Merck & Co., joining later.  In addition to the donation program of over a billion treatments, Merck & Co., Inc. and GlaxoSmithKline provide financial grants to support partners in program research, coalition-building, workshops and communications. Since its initiation, the Global Alliance to Eliminate Lymphatic Filariasis GAELF has become the most rapidly scaled-up Mass Drug Administration program in public health history. 

Onchocerciasis (river blindness) – Target 2020: Regional elimination 

Commonly known as river blindness, onchocerciasis is an infectious disease caused by infection of a parasite transmitted through the bite of infected blackflies. The larval worms move through the body, and when they die cause a variety of conditions, including skin rashes, lesions, intense itching, skin depigmentation and blindness. It is the world’s second-leading infectious cause of blindness. The WHO estimates that about half a million people have lost their eyesight due to river blindness. 

Merck donates as much ivermectin as is needed for as long as necessary.  The Merck Mectizan® Donation Programme (MDP) was launched in 1987, when Merck & Co., announced that it would donate Mectizan® (ivermectin) for the treatment of onchocerciasis to all who need it for as long as necessary. A multi-sectoral partnership was established with governments in countries where onchocerciasis is endemic, their ministries of health and other national and international stakeholders, including the WHO, to ensure appropriate infrastructure, distribution and support. The Mectizan® Donation Programme is the longest-running, disease-specific drug donation programme and public-private partnership of its kind in history, and is widely regarded as one of the most successful public-private health collaboration in the world.  Since the inception of the programme in 1987, Merck has donated nearly 1 billion treatments with Mectizan® for river blindness. The programme currently provides 100 million treatments annually through river blindness programs in Africa, Latin America and Yemen. 

Soil transmitted helminthiases (STH) – Target 2020: Control 

Johnson & Johnson announced that it would quadruple mebendazole donations over the next ten years, progressively reaching 200 million doses annually from 2014. GlaxoSmithKline extended its albendazole donation programme, previously restricted to LF, to soil transmitted helminthiases. This additional commitment represented 400 million tablets a year, on top of the 600 million tablets already pledged for LF.   

Johnson & Johnson’s global program, Children Without Worms, created in partnership with the Task Force for global health, worked with national and international partners to treat up to 25 million children a year with mebendazole in 2011. The programme also advocates hygiene, education and increased access to water and sanitation facilities as part of a comprehensive strategy to reduce the global burden of STH. The programme is active in countries with high STH prevalence. The original eight countries are: Bangladesh, Cambodia, Cameroon, Cape Verde, Lao People’s Democratic Republic, Nicaragua, Uganda and Zambia. Other countries will be added to this list as the program expands with the additional commitment of medicines. 

GlaxoSmithKline has pledged to donate 400 million tablets each year of albendazole to the WHO to treat children at risk of STH. Togo and Rwanda have received early shipments of albendazole treatments to begin scale up their school-based de-worming efforts.  Mozambique, Namibia, Uganda, Burkina Faso and others are expected to begin programmes in 2012.  To meet its commitment, GlaxoSmithKline has increased its production capacity of albendazole in South Africa.  GlaxoSmithKline and Johnson & Johnson will be collaborating closely with Children Without Worms to maximize the impact of the combined 600 million doses of treatments now available for the control of STH that is affecting the hundreds of millions of underserved children around the world. 

Schistosomiasis – Target 2020: Regional elimination  

Schistosomiasis is a parasitic disease. Humans become infected through contact with skin-penetrating parasitic worms in water. The disease can lead to chronic illness that damages internal organs. In children, it can impair growth and cognitive development. Children are the most heavily infected population. Schistosomiasis is the second most socioeconomically devastating parasitic disease after malaria. Individuals in developing countries who cannot access proper sanitation facilities are often exposed to contaminated water containing the schistosomiasis parasite.  More than 220 million people are infected worldwide, of which 100 million are children.

20 million praziquantel tablets are donated annually by Merck KGaA under its current ten-year program.  Merck KGaA recently announced a considerable increase of its donation of praziquantel tablets, from 20 million to 250 million tablets annually, depending on the availability of high quality active pharmaceutical ingredient (API) of praziquantel. This will allow treatment of about 100 million children per year and will contribute to the elimination of the disease by 2020.  Merck KGaA now intends to continue its efforts to fight schistosomiasis indefinitely.  Donations of praziquantel have enabled treatment to be significantly scaled up in recipient countries. 

Under the current Merck Praziquantel Donation Programme (MPDP), about 19 million children have been treated in 15 African countries since 2008.  The WHO coordinates local distribution.  In addition, Merck KGaA will financially support a WHO-led school awareness programme in Africa. The objective of which is to educate children about the consequences of schistosomiasis and ways to prevent the disease.   

Blinding trachoma – Target 2020: Global elimination 

Blinding trachoma is a bacterial infection of the eye that is spread through contact with eye discharge from an infected person. Untreated, this condition can significantly affect eyesight and even cause blindness.  An estimated 84 million people suffer from blinding trachoma, of which 8 million are visually impaired. 

Pfizer is committed to supplying azithromycin needed for implementation of the SAFE strategy to help meet the 2020 goal to eliminate blinding trachoma. Actual donations through 2020 are dependent on national program ownership, the use of antibiotics as part of the WHO-recommended SAFE strategy, continued partner commitment, and prevalence mapping.  Since 1998 Pfizer has provided 145 million treatments of azithromycin for treatment and prevention of the disease in 18 countries. 

Pfizer, the WHO, the Bill and Melinda Gates Foundation and the Edna McConnell Clark Foundation are among the ITI partners who share the goal of eliminating trachoma by 2020.  In March 2009, ITI and the Task Force for Child Survival and Development announced that they would join forces to scale up efforts to eliminate trachoma. ITI supports the implementation of the WHO’s recommended SAFE strategy. 

A comprehensive public health approach that combines treatment and prevention, including sight-saving surgery, mass treatment with the Pfizer-donated antibiotic azithromycin, facial cleanliness education, and environmental improvements to increase access to clean water and improved sanitation.ITI has trained thousands of healthcare workers who have performed more than 416,000 surgeries to treat advanced cases of trachoma. Morocco became the first country to complete the campaign for trachoma control in 2006, and is now working toward WHO certification to signify that blinding trachoma has been eliminated as a public health problem. 

To date Pfizer along with the WHO and the Bill and Melinda Gates Foundation have led the initiative to ensure the provision of antibiotics needed for the treatment of trachoma.  Pfizer is committed to providing azithromycin to help achieve the WHO 2020 elimination goal. However, to achieve the shared goal of elimination multiple partnerships in various sectors such as water management, sanitation and education are particularly necessary. 

Human African Trypanosomiasis (HAT/sleeping sickness) – Target 2020: Global Elimination 

HAT is one of the most complex endemic tropical diseases. It is a parasitic disease spread by the bite of the ‘Glossina’ insect, or tsetse fly.  Untreated HAT can be fatal with death following prolonged agony.  60 million people in Africa are at risk of infection.   

Sanofi pledged unlimited amounts of eflornithine, melarsoprol and pentamidine to the WHO until 2020.  Bayer is committed to supply suramin and nifurtimox to the WHO for the treatment of HAT.  Since 2001, Sanofi has provided over 1.5 million vials of melarsoprol (Arsobal), pentamidine (Pentacarinat) and eflornithine (Ornidyl) and over 170,000 patients have been treated for human African trypanosomiasis (sleeping sickness) which, unless treated, is generally fatal. 

During this same period, Bayer has provided free of charge suramin (Germanin™) and nifurtimox (Lampit™) to the WHO to treat African sleeping sickness in the early stages of the disease.  The WHO coordinates and finances (thanks to the partnership with Sanofi) the distribution of medicines to affected countries, and provides kits, prepared by Médecins Sans Frontières logistics, containing complete treatment packs of eflornithine and nifurtimox, together with the necessary materials (perfusion fluids IV giving sets, needles, gauze, adhesive tape) for treatments to be administered safely. 

Because sleeping sickness affects patients living in remote areas, mobile medical teams have been organized and are specially trained and equipped to detect the disease, and arrange for treatment. These actions aim to ensure screening and diagnosis of the disease at the earliest stage possible. As a result of these initiatives and others, since 2001 the annual incidence of sleeping sickness has decreased by over 60%, patient numbers decreased to 7,139 in 2010. Since 2001 the annual incidence of sleeping sickness has decreased by over 60%. 

Leprosy – 2020 Target: Global elimination 

Leprosy, a chronic bacterial infection transmitted via droplets, from the nose and mouth, during close and frequent contact with untreated sufferers. Untreated, leprosy can cause progressive and permanent damage to the skin, nerves, limbs and eyes. 

The Novartis Group (Novartis Pharma, Novartis Foundation for Sustainable Development and Sandoz) provides high-quality multi-drug therapy (MDT) free of charge to all leprosy patients globally through the WHO.  Novartis Foundation has supported national health ministries, the WHO and NGOs in field programmes since the mid-1980s.  More than 14 million people have been cured of leprosy since 1985, over 4.5 million of them with drugs provided free of charge by Novartis. 

As recently as two decades ago, leprosy was a public health problem in 122 countries. Today the disease has been eliminated as a public health problem (i.e. reaching a prevalence rate of less than one case per 10,000 inhabitants) from all but three countries (Brazil, Nepal and Timor Leste). Novartis also provides the funds for managing the donation, transport, insurance and independent quality control of MDT. The value of the Novartis MDT donation from 2000 to 2009 was USD 60 million. The Novartis Foundation has also helped simplify the provision of disability prevention services in communities. Many of the approaches devised by the Novartis Comprehensive Leprosy Care Association in India have now been incorporated in the government and NGO disability care packages. 

Chagas disease (American trypanosomiasis) 2020 Target: Control 

Chagas disease is a parasitic infection transmitted primarily through bug bites, but also from mother to child, through blood transmission, organ transplantation or rarely by an oral route. It is a significant public health problem in South America. 10 million people are infected and 25 million are at risk, primarily in South America. More than 10,000 die each year from this disease, mostly from cardiac complications. 

From 2004, Bayer donated nifurtimox tablets free of charge to WHO.  In March 2011, the company signed an extension of its agreement with the WHO to fight the parasitic infection.  Bayer has also committed to doubling its initial donation of 2.5 million nifurtimox tablets for the treatment of Chagas disease to a total of 5 million by 2017. I n addition, the company will contribute USD 1.5 million to fund logistics and distribution. Bayer is willing to extend the nifurtimox donations on Chagas Disease through 2020. 

Fascioliasis 2020 Target: Global elimination 

Fascioliasis is a food-borne trematode, also known as “common liver-fluke”. People living in rural, agricultural villages in the Andean highlands of Bolivia and Peru have the highest rates of infection. Millions of people are infected with fascioliasis and an estimated 180 million are at risk. 

As per WHO requests, Novartis donates triclabendazole for the treatment of infected individuals in endemic countries. The medicine is available free of charge upon application from ministries of health. Countries such as Bolivia, Egypt, Georgia, the Islamic Republic of Iran, Peru, Tajikistan, Vietnam and Yemen applied for donated triclabendazole and started treatment programmes.  In addition to medicine donations, the research-based pharmaceutical industry supports the fight against NTDs with capacity-building efforts in developing countries and medical innovation. The research-based pharmaceutical industry was the second largest funder of R&D for neglected diseases in 2010, reaching more than USD 500 million. 

Industry Also Supports Research 

In October 2011, IFPMA announced the creation of WIPO Re:Search, a new voluntary database for sharing intellectual property for R&D on medicines and vaccines for tuberculosis, malaria and neglected tropical diseases. WIPO Re:Search was launched in Geneva by the World Intellectual Property Organisation (WIPO), and was followed by a roundtable with key supporters of the initiative including the WHO, the private sector, and multiple non-profit research organisations. 

The IFPMA will be a WIPO Re:Search “supporter” which it sees broadening the pharmaceutical industry’s already considerable commitment in this area to deliver innovative products, push the limits of medical science and improve global health. 

WIPO Re:Search will provide a searchable database which enables access to clinical trial data, knowledge and expertise, compound libraries and intellectual property assets with a view to encouraging innovation on medicines and vaccines for Tuberculosis (TB), Malaria and neglected tropical diseases (NTDs) which impair the lives of more than 1 billion people in the developing world. NTDs can affect individuals for life; others lead to acute infections which are sometimes fatal. These diseases whose names are not commonly known, include, Buruli ulcer disease, dengue, cholera, trachoma and guinea worm disease, primarily affect poor people in tropical and subtropical areas. Eduardo Pisani is confident that “WIPO Re:Search is an important pioneering step in meeting the present and future treatment needs of patients from across the developing world. It will facilitate greater research into these multiple disease indications and provide an effective platform to facilitate sustainable innovation for NTDs, malaria and TB.” 

WIPO Re:Search is a an important complimentary initiative to the pharmaceutical industry’s existing efforts. IFPMA member companies are already involved in finding new treatments by conducting research and development (R&D) on their own and in partnerships, supporting capacity-building efforts in developing countries and donating millions of dollars’ worth of medicines to support elimination programs. This includes engagement in 24 capacity-building and R&D NTD-related partnerships, working to reduce the burden of these diseases on the world’s poorest populations. These efforts make the research-based pharmaceutical industry the third largest funder of R&D into NTDs in the world, after the US National Institutes of Health and the Bill & Melinda Gates Foundation. In 2009, the research-based pharmaceutical industry contributed 75% of the R&D funding for TB, malaria and dengue.