Shin Poong Pharmaceutical Co., Ltd was established in 1962 in Seoul, Korea, as a private company. In 1990, it became a public entity, with national distributors in 40 countries. The company has affiliations in China, Vietnam and Sudan for manufacturing and in the Philippines and Myanmar for distribution.
MMV and Shin Poong have worked together since 1999 to develop Pyramax® – the fixed-dose combination of pyronaridine and artesunate. The new medicine, a once daily, 3-day treatment for uncomplicated P. falciparum and blood stage P. vivax malaria in infants, children and adults is awaiting regulatory approval by the European Medicines Agency.
1. Why did Shin Poong get involved in antimalarial drug development?
Shin Poong is guided by its corporate vision: “For the health of the people”. Since the mid-1980s we have worked with a range of not-for-profit organizations, including the WHO, UNICEF and International Development Organization (IDO), to improve the supply of praziquantel for the treatment of schistosomiasis – a parasitic disease caused by trematode flatworms. In 1999, the WHO (under which MMV was initially launched) was in search of a production partner to develop a new fixed-dose combination of pyronaridine and artesunate. Given the huge need for innovative new antimalarials Shin Poong agreed to take on the challenge.
2. What are the most exciting attributes of Pyramax as a future antimalarial?
Once approved, Pyramax will be the first artemisinin combination therapy (ACT) registered by a stringent regulatory authority for the treatment of both P. falciparum and blood stage P. vivax malaria. As pyronaridine has a relatively longer half-life than some partner drugs of other ACTs, it will not only treat the initial infection but should also help reduce the risk of re-infection.
3. What were the main scientific challenges you faced in developing Pyramax? How did you overcome them?
It was challenging to develop a fixed-dose combination of artesunate and pyronaridine due to the sensitivity of the compounds to humidity and heat, the potential interaction between the two molecules, as well as the extremely bitter taste of pyronaridine. We eventually overcame these issues, through a process of trial and error and have developed a new formulation of appropriate stability.
4. What remains the biggest hurdle in developing drugs for malaria?
Cost still remains an issue. Maintaining the cost of Pyramax within international pricing limits for ACTs is difficult. The price of artemisinin – the starting point for the synthesis of artesunate – fluctuates with the vagaries of cultivation and harvesting of Artemisia annua.This is further exacerbated by the production cost of pyronaridine, given its lengthy synthetic pathway. In light of this, we are working to optimize the process to make it more cost effective.
5. In addition to funding, how have you and your team benefited from working in partnership with MMV?
Shin Poong and MMV have developed a solid relationship over the last 10 years, which together enabled us to make fast and reliable decisions. MMV’s scientific expertise and high-level global networks have been invaluable. MMV provided the know-how to drive the scientific development and coordinate organizations to manage the clinical trials. This allowed us to focus on product development, production and preparation of the complete regulatory dossier.
Initially, our partnership was purely scientific but is now expanding into drug access and delivery: MMV aims to enable more countries to adopt new innovative ACTs, and Pyramax might serve as an alternative first-line treatment. From our perspective, continued collaboration will enable us to efficiently launch our new, internationally proven, high quality product.
We feel our partnership is a perfect illustration of how a not-for-profit organization and a pharmaceutical company can work together to achieve the same goal.