Sanofi Begins Delivery of Semisynthetic Malaria DrugBy
Sanofi and PATH announced the delivery of the first large-scale batches of antimalarial treatments manufactured with a new semisynthetic artemisinin derivative to malaria-endemic countries in Africa. More than 1.7 million treatments of Sanofi's ArteSunate AmodiaQuine Winthrop (ASAQ, fixed-dose artemisinin-based combination therapy), manufactured with semisynthetic artesunate in Morocco, are being shipped from Sanofi's distribution center to Burkina Faso, Burundi, Democratic Republic of the Congo, Liberia, Niger, and Nigeria over the next few months.
Artemisinin is a key ingredient in artemisinin-based combination therapies, recommended by the World Health Organization (WHO) as the first-line treatment for infection with the most deadly form of malaria. Sanofi says that both artesunate, the active ingredient produced from semisynthetic artemisinin, and semisynthetic artemisinin itself, have been shown to be identical to those derived from botanical sources. The existing botanical supply of artemisinin, derived from the sweet wormwood plant, is volatile due to a number of factors, resulting in inconsistent price and periodic shortages. Sanofi produces semisynthetic artemisinin using a no-profit, no-loss pricing model, and supplies it to WHO-prequalified manufacturers. Multiple sources of artemisinin can strengthen the artemisinin supply chain, stabilize pricing, and ensure greater availability.
Last year, PATH and Sanofi launched commercial production of semisynthetic artemisinin at Sanofi's Garessio site in Italy. In May 2013, the WHO's Prequalification of Medicines Program announced the acceptability of semisynthetic artemisinin produced by Sanofi for use in the manufacture of artemisinin-derived active substances. Sanofi currently has the capacity to produce 50 to 60 metric tons annually of semisynthetic artemisinin, which corresponds to a third of the global annual need for artemisinin and translates to up to 125 million treatments.
The partnership for semisynthetic artemisinin is led by PATH's Drug Development program and is funded by the Bill & Melinda Gates Foundation. The project began in 2004, and partners include Sanofi, the University of California, Berkeley (UC Berkeley), and Amyris. The use of synthetic biology technology is based on inventions from the UC Berkeley, Amyris, the National Research Council Canada Plant Biotechnology Institute, and GenoClipp Biotechnology BV.