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In May 2001, Novartis made a unique public-private collaboration agreement with the World Health Organization (WHO) in the fight against malaria. The essence of the agreement is that Novartis commits to make Coartem® available on a "not-for-profit" basis for distribution to public sector agencies of malaria-endemic developing countries. Through grants provided by the Global Fund For AIDS, Malaria and Tuberculosis, Novartis has equally undertaken to supply, under the aegis of WHO, Coartem® to public sector agencies.
The partnership aims at establishing sustainable supply chains for distribution; improving treatment regimens in malaria-endemic countries; and monitoring systems for new malaria drugs in the developing world. Novartis developed Coartem® with the Institute for Microbiology and Epidemiology in Beijing by combining a traditional Chinese plant-based remedy, artemether, with a synthetic substance, lumefantrine. The resulting oral, fixed-dose artemisinin-based combination therapy (ACT) is the fastest acting anti-malaria medicine – destroying parasites in 48 hours – with high documented cure rates. In the South African province of KwaZulu-Natal, a pilot program combining case management with Coartem, indoor house spraying and insecticide-treated bed nets resulted in a 95% decrease in malaria death, whilst malaria-related hospital admissions and outpatient visits decreased by 94%. Parasite prevalence in the province is now at an historic low, and KwaZulu-Natal continues to see annual decreases in the incidence of malaria. Other demonstrations of the company's commitment to good corporate citizenship have followed.
Zambia was the first country in sub-Saharan Africa to make a national policy change to Coartem® as first-line treatment in its malaria control program and in 2003, the Central Board of Health received its first shipment of 2,1 million treatments and 10 million treatments will be delivered by the end of 2005.
Beyond providing the treatment at a not-for-profit price, Novartis also supports a capacity building program to ensure optimal levels of patient access to the drug. The program includes conducting operational research, raising community awareness and educating healthcare workers. In addition, in partnership with WHO's Tropical Disease Research (WHO-TDR) and the Government of Zambia, Novartis is implementing a pregnancy registry to observe the safety and efficacy of ACT treatment in pregnant women. There is currently little rigorously acquired data available on their use to treat uncomplicated P. falciparum malaria in confirmed pregnancy. So, researchers will follow women who have been prescribed ACT in pregnancy as well as the newborns. Once underway, the Zambian pregnancy registry will be the only observational registry for ACT in the world.
Beyond this real-world study, Novartis is also supporting clinical research in pregnant women through an unrestricted grant to WHO-TDR. The tolerability and efficacy of Coartem® will be studied in the Shoklo Malaria Research Unit in Thailand. Finally, Novartis and the WHO have also announced the "Coartem® and Malaria" international education program to support the distinct packs of Coartem® that are to be made available for the public sector in order to improve compliance and therefore, response and cure rates of the treatment in less developed countries.
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