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.”
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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. http://www.mmv.org
Contact: Anna Wang, wanga@mmv.org, +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. http://www.sigma-tau.it
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