Pfizer Inc and Sigma-Tau Industrie Farmaceutiche Riunite SpA (Sigma-Tau), a privately-owned Italian pharmaceutical company, have entered into 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), in Africa.

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 US Food and Drug Administration in 2009. Eurartesim has already been granted orphan drug status by both the European and US regulatory authorities.

The World Health Organization (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.

Malaria continues to be an endemic disease in sub-Saharan Africa and is one of the leading causes of infant mortality. The WHO estimates 881,000 deaths worldwide due to malaria in 2006, of which more than 90 percent occurred in Africa.

"Pfizer is excited about our collaboration with Sigma-Tau," said Jean-Michel Halfon, president and general manager, Emerging Markets, Pfizer Inc. "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."

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.

"Sigma-Tau is delighted to announce this alliance with Pfizer. By combining our respective resources and expertise, we are confident we will powerfully tackle one of the greatest public health threats of all time," said Ugo Di Francesco, vice president and chief executive officer at Sigma-Tau. "Sigma-Tau is firmly committed to providing its contribution to the eradication of malaria. Throughout the past century and until 1964, when the last case of malaria was reported in Italy, our country fought, and finally won, the tough battle against malaria. Through the development of new, effective treatments such as Eurartesim, we like to think that the same results can be achieved in countries, especially in Africa, where malaria continues to be an endemic disease."

"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."

Sigma-Tau is a leading, all Italian capital, international pharmaceutical group that invests in the research, development and marketing of innovative and effective treatments to improve patient well-being and quality of life.

Medicines for Malaria Venture (MMV) is a non-profit organization created to discover, develop and deliver effective and affordable anti-malarial drugs through public-private partnerships.