PATH & Sanofi start major production of synthetic anti-malaria drug | 

African child with cerebral malaria
African child with cerebral malaria
Mike Urban

Malaria remains one of the world’s biggest killers and also a massive economic drag on poor countries, poor families.

One of our best weapons against this scourge is a drug known as artemisinin, which is harvested from the plant sweet wormwood and, as a crop, is about as predictable as corn or hog futures.

A major new initiative to be launched tomorrow in Italy by Seattle-based PATH in collaboration with the French drug maker Sanofi aims to introduce more predictability – and more of the drug.

“Our goal is to stabilize both the price and supply,” said Ponni Subbiah, head of global drug development for PATH’s subsidiary OneWorld Health – a non-profit drug company based in San Francisco that PATH acquired in 2011 to expand its global health expertise in this area usually left up to commercial drug makers.

On Thursday, at Sanofi’s manufacturing facility in Garessio, Italy, Subbiah and others will officially launch industrial scale production of  semi-synthetic artemisinin aimed at producing 35 metric tons of it – approximately 70 million antimalarial treatments.

Sanofi has agreed to produce the artemisinin at cost, for no profit, as part of its collaborative arrangement with PATH and OneWorld Health.

“The goal is to eventually get to something like 50 to 60 million tons per year, which would supply approximately one third of the need globally,” said Subbiah.

Artemisia, anti-malaria botanical
Artemisia
WHO

Artemisinin is an herbal medication used for millennia by the Chinese and refined into an effective anti-malarial drug in the 1960s — during the turbulent days of Mao Zedong – and only fairly recently accepted by Western health officials. Last year, the NYTimes’ Don McNeil did a great story on the Cold War intrigue that delayed the West’s acceptance of this drug.

Once we got over our reluctance to accept Mao’s little green anti-malaria plant, artemisinin has today become the treatment of choice for malaria — used in combination with other drugs as ACT,  or artemisinin-combined therapies, to reduce the risk of drug resistance.

The ability to produce artemisinin was developed by a UC Berkeley professor of chemical engineering, Jay Keasling. He figured out how to get engineered microbes (later yeast cells) to produce artemisinin rather than having to get it from wormwood.

In 2004, the Bill & Melinda Gates Foundation gave Keasling a $42.6 million grant to transform this lab finding into a large-scale initiative that can get this life-saving drug to the hundreds of millions of people who need it.

Nearly ten years later — after Keasling created and then was apparently ousted from his biotech start-up and after OneWorld Health, which had taken up this cause, also struggled before being acquired by PATH — the dream of large-scale synthetic artemisinin appears to be coming to fruition.

Ponni Subbiah, OneWorld Health, PATH
Ponni Subbiah

“From the drug industry perspective, that’s not a very long time or too surprising,” said Subbiah, who before joining PATH worked at Pfizer, a major commercial drug maker. “This had to be taken from a small lab and get it to industrial scale, while maintaining its reliability and quality.”

The World Health Organization has not yet signed off on this artificially produced artemisinin, but Subbiah said the WHO has given positive feedback so far and they expect it to be approved.

OneWorld Health was frequently hailed years ago when it was launched as the first non-profit drug company – framed as a solution to the ‘market failure’ of for-profit drug makers ignoring the health needs of the poorest. Non-profit PATH, when it acquired OneWorld Health said it did so because it was also a non-profit organization with an aligned global health mission.

But this is all finally happening, it appears, because the for-profit drug company Sanofi has agreed to make the drug.

Here’s Sanofi’s website explanation of why it has agreed to make synthetic artemisinin for no profit at cost (estimated by Subbiah to be about $350-400 per kilogram).

Since PATH has worked with private industry on other projects (mostly on vaccines or to get firms to develop gizmos like heat sensitive vaccine labels or single-use syringes), I asked Subbiah why PATH even needed OneWorld Health.

“PATH has had experience working with industry, but they had little expertise in drug development,” she said. This project launching in Italy, Subbiah said, is the culmination of ten years of work that got it start thanks to the Gates Foundation grant and has come full circle with PATH’s active management of the drug development strategy.

“We can do a lot, but the only way this is sustainable at scale is if it’s done by industry,” Subbiah said.