● therapy, innovative, would also prevent reinfection.
● help to treat this serious disease which is transmitted by infected mosquitoes.
● In the world, 2,500 million people are at risk of contracting this infection.
Pfizer Inc. and Sigma-Tau Industrie Farmaceutiche Riunite SpA, an Italian pharmaceutical company, today announced a license and supply agreement under which, following the procedures and regulatory approvals, both companies traded in Africa dihydroartemisinin + piperaquine (Eurartesim ®), a new artemisinin-based combination therapy (ACT for short) in fixed doses for malaria.
The combination of dihydroartemisinin + piperaquine, a product candidate in Phase III, attempts to address malaria not complicated by Plasmodium falciparum in adults and children and reduce the potential for reinfection. It is expected that the candidate product, developed jointly by the Medicines for Malaria Venture and Sigma-Tau, is sent for approval to the European Medicines Agency (EMEA, for its initials in Spanish) and the Food and Drug Administration (FDA ) of the U.S. in 2009. Both the European and U.S. authorities have already secured the status of 'orphan drug' to this medication.
The World Health Organization (WHO) recommends that all non-complicated malaria is treated with Acts. This policy is designed to reduce drug resistance that has become useless to the more widely used monotherapies such as chloroquine, which has no effect on several parts of the world.
Malaria is a potentially fatal disease caused by a parasite that is spread by the bite of an infected mosquito. It is an endemic disease in sub-Saharan Africa and constitute a major cause of infant mortality. WHO estimates that in 2006 there were 881,000 deaths worldwide from this disease, of which over 92% occurred in Africa.
"Pfizer is excited about the collaboration with Sigma-Tau," said JeanMichel Halfon, President and CEO of Emerging Markets at Pfizer Inc. "An effective treatment for malaria, a preventable and treatable disease, is essential for patients of various African countries and elsewhere. This agreement to dihydroartemisinin + piperaquine available endorses Pfizer's vision: to serve the needs of patients in developing countries, and improve global access to essential medicines. "
Under the agreement, Pfizer and Sigma-Tau will ensure access to this innovative medicine in Africa in collaboration with a number of local landholders. After the formalities and obtaining regulatory approvals for, Pfizer will market the drug in public and private sectors in Africa, and Sigma-Tau will intervene in the institutional sector. No extended details on the financial terms of the agreement.
"Sigma-Tau is pleased to announce this alliance with Pfizer. By combining our respective resources and expertise, we are confident that we will face a major public health threats of all time, "said Ugo Di Francesco, VP and CEO of Sigma-Tau. "Our company is strongly committed to providing its contribution to the eradication of malaria. Throughout the last century until 1964, when the last reported case of malaria in Italy, our country fought and finally won in the battle against malaria ( "malaria" is, after all, an Italian word ). Through the development of new treatments and effective as dihydroartemisinin + piperaquine hope to achieve the same results in countries where malaria remains a endérmica disease, especially in Africa. "
"At present, the Acts of quality hardly exist in the African private market, where many people get their medicines for malaria," said Chris Hentschel, president and CEO of Medicines for Malaria Venture. "The partnership between Pfizer and Sigma - Tau has the potential to achieve a powerful impact in bringing this drug to save lives, to those who need them. As this co-medication, we are very pleased with this alliance as the measure of our success will manage to save many lives. "
About Pfizer
Pfizer discovers and develops innovative medicines to treat and help prevent disease in people and in animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and provide better quality healthcare and health systems.
About the philanthropic programs in Pfizer Malaria
"Mobilize Against Malaria" is the latest initiative by Pfizer to help close critical gaps in malaria treatment and education in Senegal, Ghana and Kenya. Clinton Global Initiative in 2006, Pfizer announced a program of five years (20072012) to prevent infection and transmission of malaria by improving the recognition of symptoms, treatment and referral through basic training to local staff, education and prevention. The partners of this initiative included Family Health International and the Foundation for Social Marketing of Ghana in Ghana, Population Services International to IntraHealth in Kenya and Senegal. The London School of Hygiene and Tropical Medicine worked as an evaluator global assessment working with local organizations.
To learn more about Pfizer's philanthropic programs, visit http://www.pfizer.com/responsibility/.
About Sigma-Tau
Sigma-Tau is an international pharmaceutical group of Italian capital that invests in research, development and commercialization of innovative and effective treatments to improve patient wellbeing and quality of life. The headquarters of Sigma-Tau Group is based in Pomezia (Rome, Italy), with subsidiaries in France, Switzerland, the Netherlands, Portugal, Germany, UK and USA, as well as in Spain and in Sudan, where the group operates two production plants. It has over 2,500 employees and an extensive network of licenses in the world.
Sigma-Tau was founded in Italy in 1957 and achieved a total return of € 665 million in 2007.
Sigma-Tau SpA invests 16% of its annual profit in research and development (R & D). The staff of R & D Sigma-Tau's (400) is working on 43 projects. A total of 14 new chemical entities and 12 known molecular entities in 30 different indications are in various stages of development.
The therapeutic areas in which R & D focus of the company include metabolic, neurological, cardiovascular, oncology and immunology.
To learn more about Sigma-Tau, please visit: www.Sigma-Tau.it
Programs for Malaria Sigma-Tau
For several years, Sigma-Tau has focused on an area with great social impact and health, research and development of drugs to treat rare diseases and malaria. In the case of malaria, the company's commitment was made in association with the Medicines for Malaria Venture.
About Medicines for Malaria Venture (MMV)
Medicines for Malaria Venture (MMV) is a nonprofit organization created to discover, develop and distribute effective and affordable drugs against malaria, through public and private partners. Its vision is a world in which innovative drugs to treat and protect millions of people against the risk of malaria, and finally, to help eradicate this terrible disease.
At present, MMV manages the largest portfolio of anti-malaria drugs, with 50 projects in collaboration with over 100 pharmaceutical partners, and academic areas endemic in 38 countries. The portfolio includes 19 completely new classes of components. Solutions are urgently needed new and improved for 2400 million people at risk of malaria. MMV is working to ensure that such products have the greatest impact on public health, and most importantly, save lives.
For more information, please visit www.mmv.org
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