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The Bill and Melinda Gates Foundation has given US42.6 million to a US-based non-profit pharmaceutical company to fund research into ways of using genetically-engineered bacterium to produce the antimalarial compound artemisinin.

Artemisinin has proved to be one of the most effective compounds to combat malaria. But it is expensive — an adult course of artemisinin combination therapy provided through the World Health Organization (WHO) costs US$2.40.

It is also in short supply. Indeed although the current shortage of artemisinin was expected to end next March, the WHO announced today (22 December) that it could extend beyond March because of a "continued lack of raw materials".

If successful, the five-year Gates-funded project, to be carried out by the Institute for OneWorld Health, would create a valuable alternative to the existing method of producing the drug, which relies on extracting the compound from the Chinese herb sweet wormwood.

The company will collaborate with scientists at the University of California, Berkeley to design a microbial 'factory' by genetically engineering the bacterium Escherichia coli to produce artemisinin.

For the first three years of the project, researchers at the university will be working with Amyris Biotechnologies to 'optimise' the microbe for large-scale production. Amyris will then develop a process for industrial fermentation and commercialisation.

The role of the Institute for OneWorld Health will be to carry out drug development, and also to demonstrate that the artemisinin produced by the bacteria is 'bioequivalent' to that extracted naturally from Chinese wormwood. This will allow drug manufacturers to substitute the microbially-produced product for that obtained from plants.

Jay Keasling, the professor of chemical engineering at the University of California who first developed the microbial factories, told SciDev.Net that the artemisinin produced by the bacteria is likely to be a purer form than that extracted from the plant.

"The plan is to develop the compound just short of it being a drug," the Institute's founder Victoria Hale told SciDev.Net. "Our role is to make it as easy as possible for manufacturers to switch and move into production through a comprehensive regulatory package." 

Thus, she added, "the periodic shortages of artemisinin (such as we have now) will be much less of an issue, and the reproducible, high-quality supply will help drive down the costs."

To ensure that people in developing countries can afford the drugs, the University of California will provide the other two partners with royalty-free licences to develop the technology, and Amyris will produce the drugs at cost price.

Keasling also believes these sorts of public-private partnerships could be "a model for attacking neglected diseases in the developing world" (see Potential for public-private drug research 'untapped').

The World Health Organization estimates that about 300 million become infected with malaria every year, and one million people die of the disease, a large proportion in Africa.
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