Sanofi Distributes Synthetic Malaria Drug to Six Countries

French drugmaker Sanofi is set to distribute large quantities of its new semisynthetic artemisinin malaria combination drug to six countries in which the mosquito-borne disease is endemic, a move that could address nearly one third of the global need.

Roughly 1.7 million treatments will be sent to Burkina Faso, the Democratic Republic of Congo, Burundi, Nigeria, Liberia and Niger in the coming months, Sanofi said of the product manufactured in Morocco.

Artemisinin-based combination therapies (ACTs) have been the standard of care for malaria since 2001. Until now, however, the active ingredient could only be obtained by extraction from the plant Artemisia annua, a product subject to wide swings in availability. Sanofi and partner PATH, a nonprofit global health group, began producing semisynthetic artemisinin at Sanofi’s Garessio, Italy, site in 2013.

The World Health Organization in May 2013 endorsed the quality of the semisynthetic form of artesunate and the methods used to manufacture it.

Sanofi spokesman Laurence Bollack saidthat the company is able to produce between 50 and 60 metric tons of artemisinin per year, roughly 30 percent of the global need for 200 tons. He stressed that Sanofi’s goal is only to complement agriculture artemisinin production, rather than supplant it entirely.

The problem with botanical artemisinin is that the plant from which it is made grows extremely slowly, says David Kaslow, M.D., vice president of drug development at PATH. In 2005, for instance, artemisinin cost $1,100 per kilogram, which caused farmers to produce an oversupply of the plant two years later. By 2007, the price of artemisinin had dropped to $180 per kilogram, which led to the opposite reaction, and by 2009, there was a global shortage of the drug.

“These fluctuations strained markets, and made it difficult for leaders, manufacturers, and others to stabilize and plan global supply, risking a global shortage,” Kaslow says.

Sanofi will adjust its manufacturing according to market needs, Bollack said. It also will sell both semisynthetic artemisinin and the resulting active ingredient artesunate to manufacturers at cost to use in their malaria treatments. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.