Last week, stakeholders in the production and delivery of artemisinin for malaria medicines met at the Artemisinin Conference 2013 in Nairobi, Kenya, organized with Roll Back Malaria partners UNITAID, The Global Fund, and the World Health Organization (WHO). Topics included artemisinin demand forecasts, market and production reports from endemic countries, and an update on the production of semisynthetic artemisinin from PATH’s Drug Development program leader, Dr. Ponni Subbiah, and Dr. Wolfgang Laux from Sanofi, a leading pharmaceutical company and our partner in this project.
Malaria, though preventable and treatable, sickens an estimated 219 million people and kills 660,000—most of them young children in sub-Saharan Africa—each year. Pregnant women, developing fetuses, newborn babies, and the elderly are particularly at risk of adverse, long-term health effects due to malaria. Today, artemisinin, a drug derived from the sweet wormwood plant, is the main ingredient in artemisinin-based combination therapy (ACT), the first-line treatment recommended by WHO.
While many countries have adopted the WHO recommendations, the supply of artemisinin has been dependent upon the volatile sweet wormwood crop that is grown commercially in a very small part of the world and fluctuates drastically in supply and price from year to year. Mostly cultivated in China and Vietnam, the sweet wormwood plant requires 12 to 18 months from sowing to harvest, and its yield and quality vary depending on weather, region, growing practices, and market conditions. This naturally derived artemisinin often does not meet worldwide demand, and the high cost of ACTs creates barriers to quickly and effectively treating the illness in endemic areas of Africa and Asia.
To meet this challenge, OneWorld Health, a drug development affiliate of PATH, formed the Artemisinin Project, a partnership between synthetic biology innovator Amyris Inc., Sanofi, and the University of California, Berkeley. Together with support from the Bill & Melinda Gates Foundation, and using pioneering synthetic biology inventions licensed from the University of California, Berkeley, and the National Research Council Canada Plant Biotechnology Institute, the collaborators set out to shorten the 15-month lead time required for traditional agricultural methods of producing artemisinin to 3 months, from lab to ACT. In 2011, the partnership announced successful completion of the scientific work necessary to enable production and distribution of semisynthetic artemisinin.
This year’s Artemisinin Conference brought exciting updates from Artemisinin Project collaborators. Sanofi is reporting completion of several important milestones in the production process, including process development and industrial scale-up, facility and equipment procurement, technology transfer to manufacturing sites, and validation. Routine production of semisynthetic artemisinin is now under way, with several tons of materials available for testing by derivative manufacturers, and a goal of manufacturing 35 tons in 2013. With ongoing improvements in the process, Sanofi has an even higher goal of producing 50–60 tons of semisynthetic artemisinin in 2014.
With this complementary source of high-quality, affordable artemisinin, ACTs can become more accessible than ever before to the hundreds of millions of people affected by malaria each year. Together, the Artemisinin Project collaborators demonstrate the power of public-private partnerships to leverage resources and scientific discoveries to achieve real impact in the global fight against malaria.
For more information on the Artemisinin Project, please contact PATH’s Drug Development program at email@example.com.