New Combination Dose of Azithromycin and Chloroquine Phosphate as Intermittent Preventive Therapy to Enter Phase III Clinical Trials
NEW YORK & GENEVA--(BUSINESS WIRE)-- Pfizer Inc. and Medicines for Malaria Venture (MMV) 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,” stated 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.
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
About Medicines for Malaria Venture
Medicines for Malaria Venture (MMV) was established in 1999 as a not-for-profit organization created to discover, develop and deliver safe, effective and affordable antimalarial drugs through efficient public-private partnerships. MMV's vision is a world in which affordable and effective medicines will cure and protect the millions at risk of malaria and help to ultimately eradicate this terrible disease. www.mmv.org
The London School of Hygiene and Tropical Medicine
The London School of Hygiene and Tropical Medicine (LSHTM) is part of the University of London and is a Post-Graduate School specializing in the treatment of, and research into, healthcare and tropical medicine. For further details see www.lshtm.ac.uk.
According to the WHO, approximately 200,000 infant and 10 percent of maternal deaths are due to malaria each year. Although IPTp is one of four WHO goals, current available treatments are showing resistance and few options are being developed.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of April 23, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about an agreement for the development, access and delivery of a potential Intermittent Preventive Treatment of P. falciparum malaria in pregnancy using azithromycin dihydrate and chloroquine phosphate. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including risks related to the progress, timing and results of the clinical trials; decisions by regulatory authorities regarding whether and when to approve any new drug applications that may be filed for such indication, including the risk that such indication may never be approved for public or commercial sale in any jurisdiction, as well as their decisions regarding labeling and other matters that could affect the availability or public or commercial potential of any such indication, and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
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