Sanofi and PATH’s Drug Development program announced the launch of the large-scale production line of semisynthetic artemisinin at Sanofi’s Garessio site in Italy, according to an April 11, 2013 press release. Global demand for artemisinin, the key ingredient of artemisinin-based combination therapies (ACTs), has increased since the World Health Organization identified ACTs as the most effective malaria treatment available. This semisynthetic route will allow a more consistent supply compared to the botanical supply of artemisinin.
Development of a new, commercial-scale alternative manufacturing process to produce artemisinin started nine years ago. The partnership is led by OneWorld Health, a nonprofit drug-development organization that established PATH’s Drug Development program and is funded by the Bill & Melinda Gates Foundation. The project built upon pioneering synthetic biology work by Dr. Jay Keasling at the University of California, Berkeley and involved a team of public and private partners, including Sanofi and synthetic biology innovator Amyris. The no-profit, no-loss production model helps maintain a low price for developing countries.
In the commercial process, Huvepharma in Bulgaria produces artemisinic acid through fermentation, followed by a synthetic transformation of the artemisinic acid into artemisinin via photochemistry, which will be performed at Sanofi’s Garessio site. Sanofi plans to produce 35 tons of artemisinin in 2013 and, on average, 50 to 60 tons per year by 2014, which corresponds to between 80 and 150 million ACT treatments.