Uniting to combat neglected tropical diseases: public-private partnership

Today, 13 pharmaceutical companies, the U.S., U.K. and U.A.E governments, 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.

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 whom are among the world’s poorest.

• Additional media and other resources
• Endorse the London Declaration on NTDs

Dengue – new site highlights disease information and research

Population growth, urbanization and rapid mass transportation have resulted in an explosive increase in dengue cases – from 1.2 million in 1998 to as many as 500 million annual cases today – and contributed to an ever growing number of countries and people at risk of infection. Dengue is now endemic in over 100 countries across the globe, and is the most prevalent mosquito-borne viral disease.

The Dengue Vaccine Initiative just launched a new site to provide a central resource for information about the disease, vaccines and other efforts.

Substantial progress towards finding a vaccine has been made in the last decade. Several vaccines are in various stages of advanced development, with clinical trials currently underway on five candidate vaccines. Trials in the most advanced stages are showing encouraging preliminary data.

Dengue is a major cause of morbidity and mortality and a leading cause of hospitalization of children in many countries in tropical and subtropical areas of the world. The greatest documented burden of dengue occurs in Asia and Latin America, but the disease is now appearing in previously unaffected areas. The cost of illness to society is considerable, from lost wages and decreased productivity to costs associated with seeking care and direct medical expenses. An estimated 60% of the economic strain caused by dengue is a result of indirect costs. The cost of dengue in the Western Hemisphere alone is estimated at $2.1 billion per year.

 

Key health issues of 2010: control of NTDs is possible

From the WHO’s photo story,  2010 in review:  key health issues.

Control of neglected tropical diseases is feasible

Neglected tropical diseases thrive in impoverished settings, where housing is substandard, environments are contaminated with filth, and disease-spreading insects and animals abound.

The misery and disability caused by these diseases can now be substantially reduced according to the WHO report Working to overcome the global impact of neglected tropical diseases.

WHO report on NTDs highlights ongoing commitment of pharmaceutical industry

An interesting article on neglected tropical diseases — and a recent report from the WHO — sourced from World Health Advocacy.

First WHO report on NTDs highlights ongoing commitment of innovative drug companies

The World Health Organization today released their first report on neglected tropical diseases – diseases that affect mainly poor people and cost billions of dollars in lost productivity annually.

“Good medicines are available for many of these diseases, and research continues to document their safety and efficacy when administered individually or in combination,” said Dr Margaret Chan, WHO Director-General. “Generous drug donations by pharmaceutical companies have helped relieve some of the financial barriers and allowed programmes to scale up coverage.”

Leading research-based pharmaceutical companies have already provided high-quality medicines free of charge for hundreds of millions of poor people suffering from such diseases, mainly in remote areas of Latin America, Asia and Africa, according to the WHO.  In coordination with the launch of this report, additional long-term industry commitments to combating neglected tropical diseases were announced today, including:

• Novartis renewed its commitment to donate an unlimited supply of multidrug therapy and loose clofazimine for leprosy and its complications.
• GlaxoSmithKline announced a new five-year commitment to expand their donation of albendazole through WHO, in addition to their current donation for lymphatic filariasis to treat school-age children for soil transmitted helminthiases in Africa. The commitment includes 400 million doses per year for this purpose.
• Sanofi-aventis has agreed to renew its support for the WHO programme to eliminate sleeping sickness, and its support for Buruli ulcer, Chagas disease and leishmaniasis for the next five years.

This continued support will ensure that necessary resources will be available also to move forward in combating leishmaniasis, Buruli ulcer and Chagas disease. In addition:

• Bayer has started discussions with WHO on how to evolve their current commitment to fight sleeping sickness and Chagas disease.
• EISAI has committed to work towards the global elimination of lymphatic filariasis by providing diethylcarbamazine (DEC) and
• Johnson&Johnson has recently also announced expanding its donation of mebendazole to supply up to 200 million treatments per year for treatment of intestinal worms in children

Despite these commitments from innovative drug makers, Dr. Chan added, “Production of medicines used to treat NTDs must be made more attractive to companies that manufacture generic pharmaceuticals.” It is important to note that many of these products are off- patent, but generic companies have not invested in their production.

“Neglected tropical diseases blight the lives of a billion people worldwide and threaten the health of millions more,” said Dr. Chan in the report.

The WHO report provides an overview of 17 neglected tropical diseases and provides details on their prevalence, distribution, economic and social impact as well as prevention and control strategies. Examples of these diseases include:

• Lymphatic filariasis – a mosquito-borne disease that causes intestinal worms and disfigures limbs and genital parts, costing an estimated $1.3 billion a year in lost productivity in Africa and South East Asia.
• Dengue fever – about 1 million confirmed cases of dengue are reported annually to WHO. The aggregated annual economic cost of dengue was estimated to be at least US$ 587 million. Preliminary adjustment for underreporting could raise this total to US$ 1 800 million
• Trachoma – in 57 countries where trachoma is endemic millions of people have irreversible visual impairment and blindness caused by the disease, and more than 40 million people are in need of treatment. The economic cost of trachoma in terms of lost productivity is estimated at US$ 2.9 billion annually.
• Chagas disease continues to persist in the Region of the Americas, but the estimated number of infected people has fallen from approximately 20 million in 1981 to around 10 million in 2009. A recent study in Colombia estimated an average expected annual cost per patient with chronic Chagas disease of US$ 1028. On average, the estimated lifetime cost of treating a patient with chronic Chagas disease in Colombia is US$ 11 619.

“The involvement of the pharmaceutical industry in NTDs, and subsequent donations made to support their control, have increased access to high-quality medicines free of charge for hundreds of millions of poor people,” according to the report. “The increasing willingness and commitment of local and global communities of partners to work with endemic countries have brought resources, innovation, expertise and advocacy to efforts to overcome NTDs. Intersectoral collaboration, involving education, nutrition and agriculture, has reinforced NTD control.”

New US legislation seeks R&D incentives for rare childhood diseases

New bipartisan legislation was introduced in the US Senate last week which seeks to encourage innovative R&D by drugmakers aimed at treating rare and neglected pediatric diseases. (source PharmaTimes)

The Creating Hope Act of 2010 builds on existing law to increase incentives for the development of treatments for disabling and deadly diseases, with a focus on rare conditions that may otherwise fail to attract sufficient R&D funding.

“Seven thousand known rare or orphan diseases afflict nearly 30 million Americans – approximately 50% of whom are children,” said Democrat Senator Sherrod Brown, who is co-sponsoring the bill with Republican Sam Brownback and Democrat Al Franken.

Under this law, companies which develop new drugs and biologics for neglected tropical diseases are eligible for a “priority review voucher” entitling them to expedited review of another drug produced by that manufacturer. Because this voucher can be used to expedite the marketing of a “blockbuster” or “me-too” drug, it provides a strong financial incentive for the development of treatments for otherwise neglected diseases.

The proposed new legislation would improve upon this incentive not only by increasing the commercial value of the priority review voucher by making it transferable, but by expanding priority review voucher eligibility to include rare pediatric diseases.

Fighting neglected diseases: anti-TB compounds offer hope

Compounds being developed against tuberculosis also show promise against deadly tropical diseases threatening millions of people.  As reported by Reuters, the Global Alliance for TB Drug Development has granted the Drugs for Neglected Diseases Initiative (DNDi) rights to develop a class of potential anti-TB compounds offering hope of treating Chagas disease, African sleeping sickness and leishmaniasis.

Chagas, a disease caused by a parasite found mainly in rural areas of Latin America, kills some 14,000 people annually and an estimated 8 million are infected. Infection is lifelong and can lead to heart disease and heart failure. Some 100 million people are deemed at risk of the disease.

Leishmaniasis and sleeping sickness, formally known as human African trypanosomiasis, each kill roughly 50,000 people a year and pose a threat to a combined total of 400 million people.

The Gates Foundation is providing a $1.5 million grant to DNDi for preclinical assessments of compounds specifically for use against visceral leishmaniasis, a deadly parasitic infection spread by the bite of a sandfly.

Though found in Europe, Asia and Africa, leishmaniasis is most concentrated in India. An estimated 350 million people worldwide are deemed at risk from infection.

63rd World Health Assembly – outcomes and resolutions

The 63rd World Health Assembly concluded at the end of last week, with delegates adopting proposed resolutions on a number of global health issues, including:

Counterfeit medical products
The World Health Assembly resolved that the WHO should convene an intergovernmental working group on counterfeit medical products, participation in which is to be open to all Member States.

This group will examine WHO’s:

• role in ensuring availability of good-quality, safe, efficacious and affordable medicines
• relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT)
• role in prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit medical products.

The group’s mandate is to focus on public health issues only – IP and trade issues will not be considered. Recommendations will be presented at the 64th World Health Assembly, in 2011.

Treatment and prevention of pneumonia
WHO Member States adopted a resolution on the treatment and prevention of pneumonia — the number one killer of children under five years globally. The resolution makes it clear that intensified efforts to address pneumonia are imperative if the achievement of Millennium Development Goal 4 is to be achieved.

Polio
On the topic of polio eradication, Member States welcomed the new Global Polio Eradication Initiative (GPEI) Strategic Plan 2010-2012, developed over the past 24 months at the request of the Assembly.  The delegates expressed serious concern that insufficient financing for the new Plan is compromising its full implementation, as US$1.3 billion is still needed for the period 2010-2012.

Global eradication of measles
Member States endorsed a series of interim targets set for 2015 as milestones towards the eventual global eradication of measles.  Success in achieving the measles 2015 targets is a key issue if the Millennium Development Goal 4 to reduce child mortality is to be reached.

Public health, innovation and intellectual property: global strategy and plan for action
A new consultative working group will examine the way to take this work forward and is expected to report back to the 65th Health Assembly in 2012.

Discussions on other global health issues at the 63rd WHA were summarized in a previous Patients and Patents posting.

Additional information on the resolutions is available at the World Health Organization site.

Ecuador eliminates river blindness

Ecuador has become the second country in the Americas to stop the transmission of river blindness (onchoceriasis), a disease that can cause blindness, skin rashes, lesions, intense itching and skin depigmentation. The parasitic disease is caused by the filarial worm and is spread by the bite of infected black flies.

Major progress in combating the disease was made in the late 1980s, when Merck offered to donate Mectizan, a drug used to treat and prevent river blindness. Ecuador’s ministry of health began distributing Mectizan in 1990.

In 1993, the Carter Center spearheaded the launch of the Onchocerciasis Elimination Program of the Americas, which worked with several global health groups, including the World Health Organization, to target Brazil, Colombia, Ecuador, Guatemala, Mexico and Venezuela.

Since the launch of OEPA, twice-annual doses of Mectizan have been administered to residents in at-risk communities. It’s led to 85 percent treatment coverage in each country and prompted Colombia to announce in 2008 that it had stopped transmission of the disease.

$10 billion commitment to vaccine research and delivery – Gates Foundation

The Bill & Melinda Gates Foundation announced today that they will commit $10 billion over the next 10 years to help research, develop and deliver vaccines for the world’s poorest countries (read more).  The Foundation estimates that increased vaccination could save more than 8 million children by 2020.

“We must make this the decade of vaccines,” said Bill Gates. “Vaccines already save and improve millions of lives in developing countries. Innovation will make it possible to save more children than ever before.”

Bill and Melinda Gates said their pledge was inspired by the remarkable progress made on vaccines in recent years. For example:

• Record-breaking vaccine access: New WHO data show that global vaccination rates have reached all-time highs.
• Improved routine immunization: Partnerships focused on reducing diseases like polio and measles are also helping build a stronger foundation for the delivery of both new and existing vaccines.
• New vaccine introduction: Important new vaccines for the two leading causes of global child deaths—severe diarrhea and pneumonia—are becoming available.
• R&D momentum: The vaccine research and development pipeline is more robust than ever.

Many of the recent advances in vaccine development and delivery have been driven by public-private partnerships such as the GAVI Alliance and the Rotavirus Vaccine Program at PATH, which coordinate the resources and expertise of vaccine companies, donors, UNICEF, WHO, the World Bank, and developing countries.

This commitment by the Gates Foundation follows the recent release of two studies in the New England Journal of Medicine which estimated that vaccines against rotavirus could save 2 million children over the next decade.  The studies showed that vaccinating babies against rotavirus significantly cut deaths from diarrhea — by 61 percent in Africa and by 35 percent in Mexico.

Pharmaceutical company opens access to malaria research and compounds

Pharmaceutical company GlaxoSmithKline has outlined a series of initiatives aimed at attacking neglected diseases and says that its experimental malaria vaccine is just a couple of years away from being approved.

GlaxoSmithKline (GSK) is to reveal previously confidential data on thousands of potential anti-malaria compounds. The company has 13,500 molecules which have been tested against the parasite which causes malaria.

In addition to this, the company is to pump millions into an ‘Open Lab’ for independent research teams.  One expert said more sharing of data could trigger advances like those that came from the human genome project.

Dr Timothy Wells, Chief Scientific Officer of the Medicines for Malaria Venture, which has worked with GSK on the project, said it had the potential to “dramatically alter” the way the world approached malaria research.

GSK also outlined what it calls a “sustainable approach” it has developed to price RTS,S, the world’s most advanced malaria candidate vaccine, which is currently in late-stage trials across seven African countries.  The pricing model “will cover the cost of the vaccine together with a small return” which will be “fully reinvested into R&D for second-generation malaria vaccines, or vaccines for other neglected tropical diseases”.