Drugs for Neglected Diseases Initiative Focuses on Developing New Treatments for Overlooked Diseases

© 2003, Deeth Williams Wall LLP. All Rights Reserved. By: Heather Watts (April 4, 2003)

An initiative headed by the Medicins Sans Frontieres (MSF), called the Drugs for Neglected Diseases Initiative (or DNDI), was begun in early 2002, and more recently put into action by linking in the support of the World Health Organisation, France's Pasteur Institute, Brazil's Oswaldo Cruz Foundation, the Indian Council of Medical Research and the Malaysian Health Ministry. The aim of the initiative is to develop new medicines and improve or combine existing ones to provide more effective and affordable treatment by mobilising the energy, experience and resources of an international network of research centres. The iniative also seeks to improve the disease prevention and treatment capacity of countries where the neglected diseases are endemic.

In 1999, MSF convened an international body of health experts to study the state of research and development of drugs for diseases that affect people in the developing world and found it to be severely lacking. The body conducted a survey which revealed that of 1,393 new drugs approved between 1975 and 1999, only 13, or less than 1%, were for tropical diseases and tuberculosis - diseases that account for more than one tenth of the world's illness and death ⁱ. This is due to the fact that publicly-funded research generally concentrates on more fundamental medical discoveries, while bringing such promising discoveries to market is left to the private sector. Companies in the private sector have no incentive to invest money in bringing products to market for diseases afflicting the world's poorest peoples, as they have no hope of ever recouping their investment. This is demonstrated by the fact that in 2001, less than US$70 million of a total global expenditure of US$60-70 billion on health research, was spent on developing new and badly needed treatments for malaria, tuberculosis, African sleeping sickness and kalazar (visceral leishmaniasis). More is known about the molecular biology, immunology and genetics of sleeping sickness and kalazar than any other parasitic organism, yet virtually no new medicines have resulted from this body of knowledge ⁱⁱ.

Neglected diseases can be defined as seriously disabling or life-threatening diseases for which treatment options are inadequate, or do not exist, and for which drug-market potential is insufficient to readily attract a private sector response. They can be further divided into two categories: those such as malaria and tuberculosis (TB), for which some pharmaceutical market exists in wealthy countries, attracting some private research and development efforts, such as the Global Alliance for TB Drug Development and the Medicines for Malaria Venture; and diseases such as sleeping sickness and kalazar noted above, along with Chagas disease and lymphatic filariasis, for which the market has completely failed. People in developing countries, who make up about 80% of the world's population, account for only about 20% of worldwide medicine sales.

Sleeping sickness, or human African trypanosomiasis is a parasitic disease transmitted by the tsetse fly that affects about 500,000 people and threatens a further 60 million in 36 African countries. The disease, which is prevalent in tropical Africa, is marked by fever, protracted lethargy, tremors and loss of weight; It is estimated that 150,000 people die from the disease annually. The drugs available to treat it are highly toxic and contain arsenic; given intraveneously, they are also extremely painful, and kill 1 in every 20 patients treated. For the 19 who survive, many will not even be cured due to the treatment failing in as many as one-quarter of cases in which it is employed.

Leishmaniasis, which is transmitted by mosquitoes, currently affects about 12 million people, while 200 million more are at risk in 88 countries. Visceral leishmaniasis, or kalazar, is fatal is left untreated, and the current treatment, which is based on painful injections, is the same treatment that has been used since the 1940s.

Chagas disease is caused by the Trypanosoma cruzi parasite and is transmitted by the vinchuca bug, or through blood transfusions, in Central and South America. Although it causes acute symptoms in just 1% of those it afflicts, it often leads to severe cardiac problems and death after lying dormant for as long as 20 years. An estimated 16-18 million people are infected with the parasite that causes Chagas disease, while another 100 million, or one quarter of the population of Latin America, are at risk of infection. There is no cure for the disease which kills between 20,000 and 45,000 people a year in Latin America ⁱⁱⁱ.

MSF will contribute $5-6 million per year to the iniative, and its partners will supply their labour and know-how. The DNDI will mobilise around $300 million in its first 10-12 years, and its pilot projects, aimed at improving or combining existing drugs could begin to bear fruit as early as 2005 ^iv. The iniative's approach will be to build a "virtual pharmaceutical company": a management company that will improve the capacity of countries in the South to manufacture and distribute the resulting drugs themselves. For example, Thailand, Brazil, India and Malaysia are to provide laboratories, and Brazil and India the manufacturing capacity, while Singapore has offered materials and facilities to make the drugs at cost price ^v. Three of the initiative's first pilot drug development projects include drugs for malaria, leishmaniasis and sleeping sickness, and involve experts from Brazil, Thailand, Malaysia and Burkina Faso ^vi. The project also hopes to attract contributions of technology, instruments and funding from large private drug companies thereby fostering public-private cooperation and strengthening pharmaceutical R&D capacity in developing countries.

Endnotes

Contact Heather Watts for more information on the Drugs for Neglected Diseases Initiative.