ICYMI: How one Shanghai pharma became a model for malaria drug production
Part 1 of a 2-part series on CleveXel, anti-malarials, and China's Guilin
It may take a village to raise a child -- but it takes an entire network of physicians, researchers, manufacturers, distributors, and activists to save a child from malaria.
The World Health Organization (WHO) reports that half of the world’s population is at risk for malarial infection. In 2012, there were 216 million malaria cases, including eight million cases of severe malaria and more than 627,000 deaths. Of those who died, 86% were children under the age of five.
Although sub-Saharan Africa is hardest hit, malaria also affects people in Latin America, the Middle East, and Asia -- including parts of China (specifically the Yunnan peninsula), which borders Burma.
There are a variety of ways to shield against malaria. But the mainstay treatment for those already infected is artemisinin and its derivatives. The WHO recommends artermisinin-based combination therapy (ACT) for first-line treatment of malaria and artesunate, the intravenous, water-based formulation of artemisinin, for treatment of severe malaria.
Malaria is a formidable epidemic both in terms of raw numbers of afflicted patients and morbidity and mortality. And keeping up with the demand for artemisinin and its derivatives has been challenging for manufacturers, especially in light of the WHO’s stringent manufacturing and regulatory guidelines for production.
3 countries, 2 companies, 1 continent -- and many lives
Earlier this month, two companies -- one in France and one in China -- announced that they had expanded their partnership to increase anti-malarial manufacturing at Guilin Pharma Company, Ltd., based in Shanghai. The companies are splitting the risks and development costs equally while they focus on ramping up production of both pediatric and adult formulations of artesunate across three units.
CleveXel, a French company, has been working actively in China for eight years. The way this deal is structured, CleveXel will focus on process optimization, industrial transfer, and formulation development. Guilin will provide raw product, do all of the manufacturing, and handle distribution and local-market communications through African subsidiaries. As the project progresses, Guilin will receive development milestone and royalty payments from CleveXel.
The partnership makes sense on several levels. First, artemisinin is part of the traditional Chinese pharmacopeia, and China is the largest manufacturer of artemisin globally. And Guilin, which was founded in 1958, is the largest artesunate manufacturer in China, as well as one of the largest pharmaceutical companies in Guangxi province.
A Shanghi-based pharma role model
Guilin isn't just notable for the volume of its artesunate production -- it's considered one of the most successful pharmaceutical companies in China, with expertise in anti-malarials, antibiotics, generics, and gastrointestinal drugs. It has the most integrated artemisinin industry value chain of all of the artesunate manufacturers and has also gained a favorable regulatory profile. Guilin's plants have been inspected and found in compliance with cGMP standards by the FDA and the WHO, and two of its lead products -- artesunate active pharmaceutical ingredient (API) and artesunate tablets -- have been listed in USP monographs.
But like any company, Guilin has its challenges. Although it has been producing IV artesunate since 1987, Guilin still relies on partnerships to move forward and tackle major challenges. In 2010, Guilin decided that it wanted to become WHO prequalified -- a requirement for companies that would like to sell their products through international procurement agencies or have them be purchased with donor funds.
The process for winning this status requires multiple steps and a great deal of paperwork. Applicants must apply, prove that the treatment in question is consistent with WHO treatment guidelines, and submit a dossier attesting to the safety, efficacy, and quality of the target therapy.
In order to become a WHO-prequalified manufacturer of artesunate, Guilin worked with the not-for-profit Medicine for Malaria Venture (MMV), based in Switzerland. MMV, which focuses on research and development -- as well as distribution of effective, affordable antimalarial drugs -- worked collaboratively with Guilin. As a result of their joint efforts, Guilin became the very first Chinese company to be WHO-prequalified for the production of artesunate in October 2010.
In part 2 of this series, BioPharma Dive speaks with Christian Bloy, CEO of CleveXel. Stay tuned to learn more about the company's approach to working in China for almost a decade.
- www.outsourcedpharma.com CleveXel And Guilin To Co-Develop 2 Anti-Malarial Products