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Sanofi and PATH launch large-scale malaria drug production

Published on 19/08/14 at 08:19am
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Sanofi and global health charity PATH have come together to launch a large-scale production line of malaria jab semisynthetic artemisinin at Sanofi’s Garessio site in Italy.

Global demand for artemisinin, the key ingredient of artemisinin-based combination therapies (ACTs) for malaria, has increased since the World Health Organization identified ACTs as the most effective malaria treatment available.

Because the existing botanical supply of artemisinin – derived from the sweet wormwood plant – is inconsistent, having multiple sources of high-quality product will strengthen its supply chain, contribute to a more stable price, and ultimately ensure greater availability of treatment to people suffering from malaria, according to Sanofi.

The development of a new commercial-scale alternative manufacturing process to produce a complementary source of artemisinin started nine years’ ago, led by OneWorld Health and 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 firm Amyris, to take the project from laboratory research to commercialisation.

The drugs were manufactured with semisynthetic artesunate in Morocco, and are being sent to Burkina Faso, Burundi, Democratic Republic of Congo, Liberia, Niger and Nigeria.

“Taking lifesaving innovation to scale requires many things, but it begins with strong partnerships and keeping a close ear to what’s most needed on the ground,” says Steve Davis, president of PATH.

“That’s why I’m extremely pleased we’ve partnered with Sanofi in the scale up of semisynthetic artemisinin, a key ingredient in the treatment for malaria. Promoting a steady and affordable supply of high-quality artemisinin is a critical part of PATH’s efforts to ultimately eradicate malaria and advance health equity. A life free from malaria is a life full of possibilities.”

The industrial process to produce semisynthetic artemisinin consists in the production of artemisinic acid through fermentation – which is performed by Huvepharma, in Bulgaria – followed by a synthetic transformation of the artemisinic acid into artemisinin via photochemistry, which will be performed at Sanofi’s Garessio site.

Sanofi says it has produced 35 tonnes of artemisinin in 2013 and, on average, 50 to 60 tonnes a year by 2014, which corresponds to between 80 and 150 million ACT treatments.

“Sanofi is very proud to announce the launch of large-scale production of semisynthetic artemisinin at Sanofi’s Garessio site in Italy,” says Philippe Luscan, senior VP of industrial affairs at Sanofi.

“This production milestone exemplifies Sanofi’s industrial chemists’ exceptional expertise and innovative mindset and capabilities, for which we were honoured with the French Pierre Potier Scientific Prize in 2012.”

Sanofi adds it is “committed to producing semisynthetic artemisinin using a no-profit, no-loss production model, helping to maintain a low price for developing countries”.

This is a ‘pivotal milestone’ in the fight against malaria according to the firm, which affects about 300 million people every year and was responsible for more than 650,000 deaths in 2010.

Ben Adams 

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