GlaxoSmithKline (GSK), the World Health Organiaation's Special Program for Research and Training in Tropical Diseases (WHO-TDR) and the Medicines for Malaria Venture (MMV) today announced the signing of a collaborative agreement to develop a new-fixed dose artemisinin combination therapy drug (ACT), combining chlorproguanil, dapsone and artesunate (CDA) for the treatment of malaria.
In Africa, the malaria crisis is escalating mainly due to multi-drug resistance. The most frequently used treatments for malaria, such as chloroquine and sulfadoxine/ pyrimethamine (SP), are becoming less and less effective. To tackle drug resistant malaria, new treatments are urgently needed to provide effective therapy to the millions in need. The development of CDA responds to the World Health Organization's `Roll Back Malaria' recommendations for the National Malaria Control Programs (NMCP) to use artemisinin based combination therapy as the preferred treatment of uncomplicated falciparum malaria.
"Partnership is essential to combine resources and expertise; and accelerate the process of providing safe, effective and affordable drugs. It is the best way to help ensure that a drug such as CDA gets to the people in need as quickly as possible", explained Chris Hentschel, CEO of MMV.
"WHO-TDR has already collaborated with GSK and other partners to successfully develop an antimalarial and we believe that developing a drug combining chlorproguanil, dapsone, and artesunate will enhance clinical efficacy in malaria treatment and also delay the development of resistance by the malaria parasites." said Robert Ridley, acting director of WHO-TDR.
"GSK is committed to participating in public-private partnerships such as this one for CDA, and to bringing urgently needed medicines to people in the developing world faster," said Dr Lynn Marks, senior vice president of infectious diseases and Oncology Medicine Development Centers, GlaxoSmithKline
This new CDA development project is based on the development of dapsone and chlorproguanil supported by an initial grant from the UK Department of International Development (DFID). The development team is chaired by professor Peter Winstanley of the University of Liverpool, one of the academic partners involved in the development of the drug, along with the Liverpool School of Tropical Medicine and the London School of Hygiene & Tropical Medicine.
The agreement states that if the development of CDA is successful as a result of this initiative, it will be made available at preferential prices to the public sector in malaria endemic countries, so as to maximize its availability to those in need. If targets are met the drug should be ready for regulatory submission in 2006.
"This new treatment could be an important development in the fight against malaria", said Dr F. Nafo-Traoré, director of the Roll Back Malaria department for WHO. "We hope that it will prove useful in regions of Africa where resistance makes older antimalarials ineffective."
The World Health Organization estimates that there are 300 million to 500 million malaria cases annually, directly causing 1 million deaths and directly contributing to a further 1.7 million deaths . It is the leading cause of death in young children in Africa. Hundreds of millions of African children and adults are chronically infected with malaria. Between 30 and 50 percent of inpatient admissions and 50 percent of outpatient visits are attributed to malaria each year. Beyond the human toll, malaria has significant economic impacts in the endemic countries -- costing Africa $12 billion in lost GDP every year and consuming 40 percent of all public health spending.