Press Release: MDS Pharma Services Appointed to Collaborate with Medicines for Malaria
Press Release: to be embargoed until Sept. 30th 2005
Dihydroartemisinin and Piperaquine shows promise as the next generation Artemisinin-based Combination Therapies (ACT) for the treatment of Malaria.
Malaria is one of the most devastating and deadly diseases in the world killing more people today than 30 years ago. The challenge posed by drug resistance has become one of the most important issues in malaria control over the last decade.
Artemisinin-based Combination Therapies (ACTs) are now the recommended treatment for malaria due to the growing resistance to widely-used drugs. However, despite their efficacy, limited patient compliance due to the high number of pills in addition to treatment cost and availability of treatment options still hamper its widespread use.
Fixed-dose combination of Dihydroartemisinin and Piperaquine, an antimalarial drug registered already in China as Artekin®, has been used effectively against drug-resistant malaria in China. Because of its potential for widespread adoption due to the low number of pills and a lower cost, the drug has been selected to be developed to European regulatory standards under the new name of Eurartekin®. This project is part of a joint partnership effort with Chongqing Holley Holding, a Chinese pharmaceutical company, sigma-tau, an Italian pharmaceutical company, Medicines for Malaria Venture (MMV), a not-for-profit organization based in Geneva, and University of Oxford in the United Kingdom.
Prof. Nicholas White from the University of Oxford, one of the most renowned international experts on malaria, discussed ACTs and the combination of Eurartekin® during the 2nd COST B 22 Congress on “Drug Discovery & Development for Parasitic Diseases”.
“Dihydroartemisinin and Piperaquine could become a major weapon against malaria,” said Prof. White, “We hope the large Phase III trial currently underway will confirm that it is safe and effective, and also easy to use and well tolerated. With the easy once-a-day regimen for three days and the low cost, it could potentially have widespread use and save many lives.”
Artemisinin is extracted from Artemisia herb, a traditional Chinese medicine with a 2000-year history. It is especially potent against malaria as it acts rapidly and is extremely well tolerated. In addition, there are no known cases of resistance to artemisinin so far. A combination drug further reduces the chances of resistance and improves its efficacy.
Currently two of the largest phase III GCP clinical studies ever performed for drug treatments in malaria are ongoing with Eurartekin® in Far East Asia and Africa with more than 300 patients already enrolled. The plan is to enrol 2,550 patients in some 8 malaria endemic countries by the mid-2006.
“The COST B22 Congress is a very important meeting addressing diseases representing major medical and social challenges,” said Dr. Paolo Carminati, Director of R&D of the sigma-tau Group. “We are grateful to the University of Siena for hosting the event and showing keen interest in malaria and our efforts to combat the disease.”
“We are particularly proud to have Eurartekin® being discussed in such important international setting,” said Dr. David Ubben, director of clinical development at MMV, “If successful, this antimalarial drug will be one of the few drugs in history designed and developed primarily for a disease of the poor. It has the potential to make a major impact in the lives of people at risk of malaria.”
Malaria kills between more than one million people annually. The majority of its victims are children under five and pregnant women. It is estimated that every 30 seconds one child dies from the disease. Each year there are 300–660 million new clinical cases with nearly half of humanity at risk. Malaria is also a primary cause of poverty - undermining development in some of the poorest countries. Poor families spend up to 25% of their income on malaria expenditure.
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 antimalarial drugs 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 antimalarial before 2010 and maintain a sustainable pipeline of antimalarials to meet the needs of the 2.4 billion people at risk of this deadly disease.
Contact: Anna Wang, , +41 79 204 2875
About sigma-tau
Sigma-tau is a leading research-based Italian pharmaceutical company with annual revenues that in 2004 accounted for € 670 million and with over 2400 employees worldwide. Therapeutic areas in which the company's research and development are focused include metabolism, neurology, cardiovascular, oncology and immunology. Currently, the Company is carrying out 48 projects in R&D. 32 are the indications explored in clinical trials. 16 proprietary molecules are being studied and the majority of them (13) are NCEs. sigma-tau has operating subsidiaries throughout Europe and U.S and maintains a presence in all of the world's major pharmaceutical markets. Sigma-tau has been operating in Africa through sigma-tau Sudan Ltd since 1982.
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