Pivotal clinical trials launched for new artemisinin-based malaria drug combination

The Medicines for Malaria Venture (MMV) and Shin Poong Pharm Co., Ltd. are pleased to confirm recruitment of the first patients into the pivotal clinical trials programme for PYRAMAX®, pyronaridine-artesunate, a new artemisinin-based combination treatment (ACT) for malaria. The Phase III clinical trials will involve over 3,000 children, adolescents, and adults in more than 12 countries where malaria is endemic. The first patients have been entered into the trials at a district hospital in the outskirts of Dakar, Senegal.

Malaria experts from Asian and African countries are collaborating in these trials to provide the final confirmatory evidence needed by international regulatory authorities to gain approvals for marketing and distribution in malaria endemic areas.

In initial clinical trials PYRAMAX® has shown great promise as an effective weapon against malaria. This innovative combination of known antimalarial agents is aiming to meet a challenging hurdle, namely to provide a low-cost, safe, efficacious, oral antimalarial therapy that is administered once a day, over just three days. The new trials aims to confirm the initial evidence of a high cure rate with a good safety profile in patients of all ages, particularly targeting young children with malaria. This drug will be available in tablet form for adults and granular form for infants.

“We are very proud of the progress of PYRAMAX®. It is a great example of an effective partnership combining a non-profit organisation and a leading South Korean Pharma Company, both focussed on accelerating the development of new malaria treatments for the billions of people at risk,” said Dr. J Carl Craft, Chief Scientific Officer of MMV.

“Shin Poong is delighted to be in such an innovative partnership with Medicines for Malaria Venture to develop a much-needed new medicine for malaria. We are also looking forward to collaborating to ensure that this affordable and effective drug reaches people who need it most, especially in Africa,” said Mr Hyun Taek Chang, President, Shin Poong Pharm.

Although malaria is a curable disease if promptly diagnosed and properly treated, it is still causing more than 1 million deaths every year. The majority of victims are young children in sub-Saharan Africa. Its resurgence since the late 1970’s is mainly due to multi-drug resistance. The efficacy of the most commonly available treatments, such as chloroquine, is severely compromised, rendering them useless in many malaria endemic areas. Beyond the human toll, malaria has a significant economic impact in endemic countries - costing Africa US$12 billion in lost GDP every year and consuming 40 percent of all public health spending.

Seoul, Republic of Korea and Geneva, Switzerland 24 January 2007

  Download a copy of this press release (Word)
  Download a backgrounder on the PYRAMAX® project (PDF)

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For further information or to arrange an interview with Mr Hyun Taek Chang of Shin Poong or Dr Carl Craft of MMV, please contact:
  Daewoo Hong, Shin Poong Pharm. +82 (2) 2189 3473
  Jaya Banerji, MMV, +41 79 707 7181 (Mobile)

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  About Shin Poong Pharm. Co., Ltd.

  Shin Poong Pharm. Co., Ltd. (Shin Poong) is one of the leading pharmaceutical companies of South Korea with the sales revenue of over USD 150 million in the year 2005. Since its foundation 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 of API as well as finished formulation for mebendazole and albendazole, which are treatments for soil-transmitted helminthiasis, and praziquantel, which is a treatment for schistosomiasis through public sector business with WHO and World Bank since the mid 1980s. Major schistosomiasis eradication campaigns carried out with praziquantel include Delta project in Egypt, Gezira project in Sudan, and China Project. It is also actively engaged in overseas business running 5 overseas affiliates including Sudan, Vietnam, China, Philippines, Myanmar and exports to over 50 countries.
http://www.shinpoong.co.kr

  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 drug research with over 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 3.2 billion people at risk of this deadly disease. For further information please consult http://www.mmv.org