Pfizer - Azithromycin/chloroquine for Malaria

Pfizer, in partnership with Medicines for Malaria Venture (MMV) and London School of Hygiene and Tropical Medicine, is developing a fixed dose combination of azithromycin and chloroquine (AZCQ) for intermittent treatment of malaria in pregnant women (IPTp) in sub-Saharan Africa. IPTp is aimed at lowering the incidence of adverse pregnancy outcomes associated with malaria in pregnancy. Sulfadoxine/pyrimethamine (SP) is the current standard of care for IPTp in high transmission areas in Africa. However, recent emergence of resistance to SP, especially in East and Southern Africa has made the search for SP replacement IPTp regimens an urgent priority. The AZCQ development program is in Phase III of clinical development. In two multi-country clinical trials in sub-Saharan Africa, AZCQ recently demonstrated 98% and 100% efficacy in treatment of symptomatic, uncomplicated falciparum malaria in non-pregnant adults. The trials were conducted in Burkina Faso, Ghana, Mali, Kenya, Senegal and Uganda. A phase III multi-country pediatric treatment trial is currently ongoing in Burkina Faso, Ghana, Mali, Cote d'Ivoire and Kenya. The pivotal IPTp trial is planned to start in the third quarter of 2010 in Kenya, Uganda, Tanzania and Malawi.