Pfizer Inc and Medicines for Malaria Venture (MMV) has entered into an agreement for the development, access and delivery of a fixed-dose combination treatment consisting of azithromycin dihydrate (AZ) and chloroquine phosphate (CQ) for the Intermittent Preventive Treatment of P. falciparum malaria in pregnancy (IPTp). There is currently an unmet need for new treatment options and the World Health Organization (WHO) estimates that some 30 million pregnant women are at risk for malaria in endemic areas in Africa each year.
A Product Development Team (PDT) comprised of representatives from Pfizer, MMV and the London School of Hygiene and Tropical Medicine (LSHTM) will coordinate the trials and an external independent Data Monitoring Committee of malaria experts will oversee them.
Under the agreement, Pfizer plans to seek marketing authorization in selected malaria-endemic African countries where, with MMV, it will seek to introduce the use of this important potential therapy to improve pregnancy outcomes and neonatal survival. “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,” said Jean-Michel Halfon, president & general manager of Pfizer's Emerging Markets Business Unit.
“MMV will provide several levels of support and advocacy on behalf of the project, including the development of a patient education campaign and recommendations on registration strategies in malaria-endemic countries. Pregnant women are at great risk from malaria,” said Dennis Schmatz, president and chief executive officer of MMV. “We are proud to be working with the Pfizer team by supporting the clinical trials of AZCQ for Intermittent Preventive Treatment in this highly vulnerable patient group, and look forward to advancing this exciting combination toward registration.”
Pfizer, the London School of Hygiene and Tropical Medicine and MMV have been informally working on the project for almost two years. The formal partnership will commence after signing with phase-III clinical trials expected to begin in Africa this summer with up to 5,000 participants. “This partnership marks great progress in targeting the unmet and specific health needs of patients in emerging markets,” said Sam Azoulay, senior vice president of Medical & Development in Emerging Markets at Pfizer. “This intervention has the potential to not only benefit expecting mothers but their newborns as well.”
As World Malaria Day approaches on April 25, it is important for pharmaceutical companies, governments, non-governmental organizations and all parties involved to continue to work towards ridding the world of this terrible yet curable disease. Through efficient partnerships such as this one, we are contributing to achieving the eradication goal by seeking to develop effective and affordable antimalarial treatments, she added.