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

Example of an effective partnership between a non-profit organization and a leading South Korean Pharma Company

25 Jan 2007

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