New Antimalarial Drug Enters Phase II Safety and Efficacy Trial in Asia and Africa
Geneva, Switzerland; Seoul, South Korea15 August 2005 – Shin Poong Pharm. Co. Ltd. (Shin Poong). and Medicines for Malaria Venture (MMV) announced today that enrollment has begun in its Phase II trial of the antimalarial fixed-dose combination drug, Pyronaridine-Artesunate. The study will enroll 480 patients with uncomplicated Plasmodium falciparum malaria in Thailand, Indonesia, Cambodia, The Gambia, Senegal and Uganda. The first patient was enrolled in Thailandat the Hospital for Tropical Diseases at MahidolUniversity in Bangkok. The trial will study safety and efficacy with a single daily dose for three days. Patients will be monitored for 42 days. The study is due to be completed by early 2006.Phase III comparative efficacy trials will follow in Asia and Africa.
Representing a new generation of antimalarial drug, Pyronaridine-Artesunate is a fixed-dose Artemisinin Combination Therapy (ACT) with artesunate, a potent derivative of artemisinin extracted from the herb Artemisia Annua. ACT is now the recommended treatment for drug-resistant malaria by the World Health Organization(WHO) and many countries in sub-Saharan Africa and Asia have adopted it as a first-line treatment.
“The need for effective and affordable antimalarial drugs is urgent due to the increasing resistance of the malaria parasites to commonly available drugs,” said Dr. Carl Craft, Chief Scientific Officer of MMV, “Pyronaridine-Artesunate could become an important new weapon against this deadly disease.”
“This is an important study which is aimed at assessing the safety and efficacy of three dose levels of this drug that combines two powerful known antimalarials,” said Mr. Hyun Taek Chang, President of Shin Poong. “This dose-ranging study will not only allow us to determine the clinical effectivedose to conductthe pivotal Phase III study, it will also indicate the likely cost of this drug which we hope will be lower than what is available on the market right now.”
Approximately 40% of the world’s population is at risk of malaria, a life-threatening disease that affects people predominately in the developing countries in Africa, Asia and South America. Recent estimates put new clinical cases at above 500 million with 25% percent occurring in Asiaresulting in at least 1 million deaths per year around the world. The most vulnerable are children under the age of five in Africa, where approximately one child dies of malaria every 30 seconds.
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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 Shin Poong
Shin Poong Pharm. Co., Ltd. (Shin Poong) is one of the leading pharmaceutical companies of South Korea with the sales revenue of USD 133 million in the year 2004. Since its inception in 1962 Shin Poong has grown to the 8th largest pharmaceutical company in prescription pharmaceutical sales in Korea. Shin Poong has been a major worldwide supplier for mebendazole and albendazole, treatments for soil-transmitted helminthiasis, and praziquantel, a treatment for schistosomiasis. It is also actively engaged in overseas business running 4 overseas affiliates including Sudan, Vietnam, China, Philippines, and exports to over 50 countries.
Contact:Won-June Chang, ,+82 (2) 2189 3470