Over the next few months Sanofi and non-profit PATH are delivering the first large-scale batches of an artemisinin-based combination therapy to five African countries, which will for the first time be manufactured with semi-synthetic artesunate.
More than 1.7m treatments of Sanofi’s ArteSunate AmodiaQuine Winthrop, manufactured with semi-synthetic artesunate in Morocco, are being shipped from Sanofi’s distribution centre to Burkina Faso, Burundi, Democratic Republic of the Congo, Liberia, Niger, and Nigeria.
“This shipment represents a critical step in improving access to effective treatments and combatting malaria in some of the most affected countries in the world,” said Dr Robert Sebbag, VP of Sanofi’s Access to Medicines.
Sanofi claims, and the WHO’s Prequalification of Medicines Programme agrees, that artesunate, the active ingredient produced from semi-synthetic artemisinin, and semisynthetic artemisinin itself, are identical to what is derived from botanical sources in order to acquire artemisinin.
The advantage of using the semisynthetic sources, however, is that the existing botanical supply of artemisinin, which is derived from the sweet wormwood plant, is volatile and can result in inconsistent prices and periodic shortages.
“The majority of agriculturally produced artemisinin is cultivated by small farmers in Southern China and Vietnam,” as well as in Madagascar and Kenya, Sanofi spokesman Laurence Bollack and PATH spokeswoman Elena Pantjushenko told us. “Farmers typically make decisions with a goal of optimizing the net revenue, and have other crop options.”
Sanofi has committed to supplying semi-synthetic artemisinin “at cost” prices to manufacturers of WHO prequalified artemisnin-based combination therapies or of API (Active Pharmaceutical Ingredients) used in such combo therapies, Bollack and Pantjushenko said.
Prequalified manufacturers can order the semi-synthetic from Sanofi to produce the API, or they can order the API itself, though “at this stage they have not yet placed an order,” according to the spokes people.
Last year, PATH and Sanofi began producing semi-synthetic artemisinin at Sanofi’s Garessio site in Italy. In May 2013, the WHO’s Prequalification of Medicines Programme 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, which corresponds to a third of the global annual need for artemisinin and translates to up to 125m treatments.
“It is planned for 50% of the total Sanofi semi-synthetic artemisinin production to be dedicated to third party companies,” the spokes people told us. “Multiple sources of high-quality artemisinin can strengthen the artemisinin supply chain, stabilize pricing, and ensure greater availability of treatment to people suffering from malaria.”
The partnership for semi-synthetic artemisinin is led by international non-profit PATH’s Drug Development program, and is funded by the Bill & Melinda Gates Foundation.