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ROMEóPfizer Inc. and Sigma-Tau Industrie Farmaceutiche Riunite S.p.A (Sigma-Tau), a privately-owned Italian pharmaceutical company, announced in early December a license and supply agreement under which, following applicable regulatory submissions and approvals, the companies will market Eurartesim, a novel fixed-dose artemisinin-based combination therapy (ACT) for malaria, in Africa.
"The effective treatment of malaria, a preventable and treatable disease, is an essential need for patients in many countries in Africa and around the world. This agreement to make Eurartesim available supports Pfizer's vision to serve the needs of patients in developing countries and to improve global access to essential medicines." says Jean-Michel Halfon, Pfizer's president and general manager, emerging markets.
Under the agreement, Pfizer and Sigma-Tau will ensure access to this novel medicine in Africa in collaboration with the various local stakeholders. Following applicable regulatory submissions and approvals, Pfizer will market the drug in the public and private sectors locally in Africa, and Sigma-Tau will be responsible for the institutional sector. Further details of the financial terms were not disclosed.
Eurartesim (dihydroartemisinin + piperaquine), a Phase III product candidate, aims to treat uncomplicated Plasmodium falciparum malaria in adults and children, while reducing the potential for re-infection. The product candidate, developed jointly by Medicines for Malaria Venture (MMV) and Sigma-Tau, is expected to be filed for registration with the European Medicines Agency and the U.S. Food and Drug Administration in 2009. Eurartesim has already been granted orphan drug status by both the European and U.S. regulatory authorities.
Malaria continues to be an endemic disease in sub-Saharan Africa and is one of the leading causes of infant mortality. The World Health Organization estimates 881,000 deaths worldwide due to malaria in 2006, of which more than 90 percent occurred in Africa.
The WHO recommends that all uncomplicated malaria be treated with ACTs. This policy is designed to reduce drug resistance which has rendered the most widely used monotherapies, such as chloroquine, useless in many parts of the world.
"Currently, quality ACTs are practically non-existent in the private market in Africa, where many people get their anti-malarials," said Chris Hentschel, CEO and president of Medicines for Malaria Venture. "The Pfizer and Sigma-Tau alliance has the potential to make a huge impact in getting this life-saving medicine to those in need. As the co-developer of this medicine, we are delighted by this alliance because, ultimately, the measure of our success will be how many lives we can save." DDN