Italian drug maker Sigma-Tau selected MDS to conduct Phase III trials of Eurartekin™ on behalf of an international public/private collaboration involving the non-profit Medicines for Malaria Venture (MMV), China's Chongqing Holley pharmaceutical company and Oxford University
(Philadelphia, PA, August 10, 2005) – MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has been selected to manage Phase III clinical trials of the anti-malarial drug Eurartekin™ by Sigma-Tau, a research-based Italian pharmaceutical company. The trials will be conducted according to Good Clinical Practice (GCP) standards and will involve 2,550 malaria patients in China, Laos, Thailand, Burkina Faso, Kenya, Mozambique, Uganda and Zambia. Patient enrolment began in June 2005 and the trials are expected to be completed by the end of 2006, followed by application for registration of Eurartekin™ in Europe in mid-2007 and later in malaria-endemic countries in Africa and Asia.
The project developed out of an agreement signed in March 2004 by Sigma-Tau, the Chinese pharmaceutical company Chongqing Holley Holding, Oxford University and the non-profit Medicines for Malaria Venture (MMV) for the international development of Dihydroartemisinin-piperaquine (Eurartekin™). The drug is already registered in China under the Artekin® name.
“This is a pivotal study. For MMV, it will be the first major Phase III study conducted with so many patients across Africa and Asia,” said Dr. Carl Craft, Chief Scientific Officer of MMV, based in Geneva, Switzerland. “It will set the standard for conducting clinical trials in malaria-endemic countries. MDS Pharma Services is an important partner and we have full confidence that the appointed team will manage the Phase III trials and ensure that strict GCP standards are followed.”
“MDS Pharma Services is honored to have been chosen to conduct this study with world renowned experts such as Professor Nick White of Oxford University and Professor Umberto D'Allesandro of the Institute of Tropical Medicine in Antwerp,” said MDS Pharma Services International Project Director Jo Hudson. “Our involvement in this effort to find affordable and effective treatments for malaria in developing countries supports the MDS commitment to make a distinctive contribution to the health and well-being of people.”
The G8 has called malaria one of the “neglected diseases” that “undermine growth and exacerbate poverty in developing countries.” [1] Nearly 40 per cent of humanity is at risk for malaria, which kills one to three million people each year. The majority of its victims are pregnant women and children under five; it is estimated that every 30 seconds a child dies from this preventable and curable disease. More than 500 million new cases occur each year, fuelled by growing resistance to existing drugs.
A new generation treatment, Eurartekin™ is a fixed dose combination drug composed of dihydroartemisinin, a derivative of artemisinin, and piperaquine. Artemisinin is extracted from the Artemisia herb (wormwood), a 2000-year-old traditional medicine. Such Artemisinin Combination Therapy (ACT) is now the recommended treatment for drug-resistant malaria by the World Health Organization, and many countries in sub-Saharan Africa and Asia have adopted it as a first-line treatment.
About MDS Pharma Services
MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, the company applies advanced scientific and technological expertise to each stage of the drug discovery and development process – Early Stage: lead optimization, pre-IND research, pharmaceutical and biopharmaceutical development, early clinical research (bioequivalence, phases I-IIa) and bioanalysis; and Late Stage: global clinical development (phases IIb-IV) and central lab. For more information, visit MDS Pharma Services' Web site at www.mdsps.com.
MDS Pharma Services is an integral part of MDS Inc. (TSX: MDS; NYSE: MDZ). MDS Inc. has more than 9,000 highly skilled people in 27 countries providing a diverse range of superior products and services to increase its customers' speed, precision and productivity in the drug development and disease diagnosis processes. MDS Inc. is a global, values-driven health and life sciences company, recognized for its reliability and collaborative relationships as it helps create better outcomes in the treatment of disease. Find out more at www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.
About MMV
Medicines for Malaria Venture (MMV) is a non-profit organisation dedicated to reducing the burden of malaria in disease-endemic countries by discovering, developing and delivering new affordable anti-malarials through effective public-private partnership. After five years of operation, MMV is managing the largest-ever portfolio of malaria research with more than 20 projects in different stages of drug research and development. MMV's goal is to register at least one new anti-malarial before 2010 and maintain a sustainable pipeline of anti-malarials to meet the needs of the 2.4 billion people at risk of malaria. http://www.mmv.org
For further information, please contact:
Charlene McGrady (Charlene.Mcgrady@mdsps.com)
MDS Pharma Services, King of Prussia, PA, USA
Tel: (610) 239-7900, ext. 231.
Charlene Lo (Charlene.Lo@mdsinc.com)
MDS Inc., Toronto, ON, Canada
Tel: (416) 675-6777, ext. 2203.