A new antimalarial combination treatment to be taken as a fixed dose once a day has been developed by a non-profit organisation for use in developing countries. The combination of artesunate and amodiaquine will be known by the brand name Coarsucam in private sector sales.
The non-patented drug is the first result of the drugs for neglected diseases initiative (DNDi), a non-profit product development organisation, and was produced in partnership with one of the world's largest drug companies, Sanofi-Aventis. Two other major sources of funding were Médecins Sans Frontières and the European Commission.
“Tens of millions of people could benefit from this treatment each year,” said Bernard Pécoul, executive director of the initiative, in a statement. “The new artesunate-amodiaquine fixed dose combination has been adapted to patients' needs.”
Artesunate is a water soluble derivative of artemisinin, which comes from the shrub Artemisia annua, long used in traditional Chinese medicine. The World Health Organization recommends treating malaria with artemisinin in combination with another antimalarial drug rather than on its own to prevent the development of resistance.
“We urgently need affordable drugs but also combination therapies with an artesunate based combination because this is the recommendation of the WHO,” said Awa Coll-Seck, executive director of the Roll Back Malaria Partnership. “We really welcome the focus of this initiative on affordable drugs and on drugs reaching a lot of children under five.”
Until now the combination of artesunate and amodiaquine was available only in multi-tablet formulations. The new drug is a single tablet, which ensures that the two drugs are taken together and in the correct proportion.
“We wanted to make it easy for patients to be compliant and to prevent resistance,” said Jean-Rene Kiechel, manager of the fixed dose artesunate based combination therapies project at DNDi. “In the field you need to have simplicity.”
The drug is also the first combination of artesunate and amodiaquine that is available at three strengths suitable for children, including for infants.
To public sector organisations the three day course of the drug will cost less than $1 for adults and less than $0.50 for children aged under 5 years. Dr Pécoul said, “The fact that the artesunate and amodiaquine six dose combination drug is made so affordable right from the start and is not under patent removes a significant barrier to its availability and should serve as a model for future drug development for all neglected diseases.”
Further tightening of the price may be possible, depending on the cost of active ingredients and the amounts ordered by international organisations and the countries concerned. DNDi will use its portion of the profits from private sector sales to lower the drug's public sector price.
A comparative clinical assessment of the fixed dose drug and the loose formulation of artesunate and amodiaquine showed similar efficacy, with a cure rate of 90%. The assessment was carried out in 750 children in Burkina Faso aged 6 months to 6 years who had Plasmodium falciparum malaria.
“This pivotal study demonstrated that clinically the percentages of treatment success were absolutely comparable,” said Dr Kiechel. The results of the assessment were presented at the 2006 annual meeting of the American Society of Tropical Medicine and Hygiene, and DNDi is seeking publication.
Dr Kiechel added that the combination should be used in “all countries where resistance to amodiaquine is low.” The drug is therefore being targeted at west African countries and Indonesia. Early stability studies indicate a shelf life in tropical conditions of two years, and ongoing studies may support a longer shelf life.
Malaria is a major cause of mortality and morbidity worldwide, WHO says, and in Africa it accounts for 40% of public spending on health. Malaria remains the single largest cause of death in African children aged under 5 years, killing 3000 a day.
More information is available at www.actwithasaq.org.