Basel, 11/10/2003 - Novartis and Medicines for Malaria Venture (MMV), a not-for-profit organization, today signed an agreement to jointly develop a pediatric formulation of Coartem®, a breakthrough in treatment-resistant malaria.

Malaria is one of the leading causes of death in the developing world, killing more than one million people every year.2 The majority of victims are in Africa where a child dies every 30 seconds from the disease.1 In sub-Saharan Africa, 71% of deaths occur in children below the age of five.3 By the age of one, the average child in high-transmission areas of Africa has contracted three life-threatening malaria infections.4,5,6 However, less than half of all African children under five who are infected with malaria are treated with an antimalarial medicine.7,8

"With this new agreement MMV and Novartis will align and accelerate efforts to bring modern drug innovation to a population that desperately needs it – the millions of infants suffering unacceptably high malaria-induced morbidity and mortality" said Dr. Christopher Hentschel, Chief Executive Officer of MMV. "This drug will likely be the most effective treatment for young children who are by far the most vulnerable victims of this ancient but now resurgent disease."

Coartem, consisting of artemether and lumefantrine, is the first and only fixed artemisinin-based combination therapy, or ACT, for uncomplicated falciparum malaria available worldwide. Because the malaria parasite has become resistant to most traditional treatments, the World Health Organization now recommends that countries adopt ACT when there is strong evidence that existing conventional medicines are no longer working. This combination of artemether and lumefantrine is on the WHO's Essential Medicines list. Novartis is making Coartem available at cost to developing countries under a public-private partnership with the WHO to improve access to the lifesaving therapy.

"This partnership with MMV signals our commitment to the global fight against malaria," said Dr. Daniel Vasella, Chairman and CEO of Novartis. "We believe the most promising way to help increase access to life-saving therapies to the poorest people in the world is by working with partners such as MMV and the WHO with whom we already cooperate in the fight against malaria and leprosy."

"Malaria has a devastating impact on children, their families and the communities in which they live," said Dr. Fatoumata Nafo-Traoré, Executive Secretary of the Roll Back Malaria Partnership Secretariat, which coordinates the work of the global partnership, founded by the WHO, UNICEF, the United Nations Development Program and the World Bank, which now includes a diverse range of committed organizations. "New public-private partnerships for research, development and delivery of effective treatments are essential in fighting the disease."

A pediatric formulation would be easier for children to take and improve compliance, ensuring the drug's efficacy. Development of the new pediatric formulation is already underway and a clinical trial is expected to commence during the third quarter of next year. The target date for launch of the new formulation is 2007.

References
1. World Health Organisation. Expert Committee on Malaria: Twentieth Report (2000). WHO Technical Report Series 892.
2. Bremen, J. The ears of the hippopotamus: manifestations, determinants, and estimates of the malaria burden. Am. J. Trop. Med. Hyg 2001; 64(1,2)S, 1-11.
3. World Health Organisation. Roll Back Malaria Advocacy Guide WHO/CDS/RBM/2000.26:11-12.
4. Najera JA, Hemple J. The burden of malaria. WHO CTD/MAL/96.10,1996.
5. Murray CJL, Lopez AD. The global burden of disease: A comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020. Harvard School of Public Health, Harvard University Press, 1996.
6. Greenwood BM et al. Mortality and morbidity from malaria among children in rural areas of the Gambia, West Africa. Transactions of the Royal Society of Tropical Medicine and Hygiene 1987; 81(3): 478-473.
7. Breman JG, Campbell CC. Combating severe malaria in African children. Bulletin of the World Health Organization, 1988, 66(5):611-620.
8. Holtz TH et al. Health care seeking behaviour and home treatment of febrile illness in Blantyre District, Malawi, 2000. American Society of Tropical Medicine and Hygiene, 50th Annual Meeting November 11-15, 2001, Atlanta, GA: abstract 536.