Pfizer and the Medicines for Malaria Venture have agreed to co-develop a fixed-dose combination therapy of azithromycin dihydrate (AZ) and chloroquine phosphate (CA) for the intermittent preventive treatment of Plasmodium falciparum malaria in pregnacy (IPTp). Phase III trials are expected to start in Africa later this year and include up to 5,000 participants.
The agreement between Pfizer and MMV builds on two years of informal collaborative research by the organizations together with the London School of Hygiene and Tropical Medicine (LSHTM).
Under the terms of the formal deal, Pfizer will seek marketing approval for the drug combination in selected malaria-endemic African countries and will work with the MMV to introduce the therapy in relevant territories. MMV will also provide support and advocacy on several levels including the development of a patient education campaign and recommendations on strategies for registration in malaria-endemic countries. The LSHTM will coordinate clinical trials of the AZ-CQ combination.
Pfizer says that WHO figures estimate some 30 million pregnant women in malaria-endemic African regions are at risk of the disease every year. “Pfizer believes that an affordable price for public sector sales of the medicine in endemic countries, if approved, is an important step towards increasing access and safe intermittent preventive treatment for pregnant women,” remarks Jean-Michel Halfon, president and GM of Pfizer’s emerging markets business.