Cutting the price of malaria cure

Related tags Biotechnology Malaria

A non-profit pharmaceutical company, the Institute for OneWorld
Health, has been awarded a $42.6 million (€32.1m)grant from the
Bill & Melinda Gates Foundation to find a new way of producing
a valuable drug for malaria, which kills more than a million
children each year.

OneWorld Health will work in partnership with the University of California at Berkeley, and Amyris Biotechnologies as it tries to improve the manufacturing of artemisinin, a compound extracted from the wormwood plant that is regarded as the most effective treatment for drug-resistant malaria.

UC Berkeley will be given the task of developing a microbial strain suitable for producing artemisinin, while Amyris will develop the process for industrial fermentation and commercialisation. OneWorld Health will perform the drug development and regulatory work to demonstrate the bioequivalence of microbially produced artemisinin derivative to the drug's natural form.

Malaria has become increasingly resistant to front-line medications, but combination drugs containing artemisinin show nearly 100 per cent effectiveness after a short three-day regimen. Yet, at a price of $2.40 per adult course for artemisinin combination therapies (ACT) provided through the World Health Organisation, these drugs are still beyond the reach of millions of the world's poorest people.

One of the main reasons for the high cost is that artemisinin is in short supply, and the process of extracting it from plants at present it currently is labour-intensive. The new partnership aims to bring the cost down to less than $1, which should expand its use in developing countries.

Each year, between 300 and 500 million people, most of them poor, become infected with malaria, and at least 1.5 million die, primarily children in Africa and Asia.

To ensure affordability, UC Berkeley has issued a royalty-free license to both OneWorld Health and Amyris to develop the technology for malaria treatments. In exchange, Amyris will produce the drugs at cost, and OneWorld Health will perform the detailed non-clinical regulatory work that will be required by US and other regulatory agencies around the world to allow the low-cost, microbially-based product to be substituted for plant-based product by manufacturers of combination drugs containing artemisinin.

"The non-profit nature of this partnership could be a model for attacking neglected diseases in the developing world,"​ said Jay Keasling, professor of chemical engineering at UC Berkeley, who headed the team that created the genetically engineered microbial drug factories.

"This project will use some of the latest advances in molecular biology to engineer a microbial chemical factory and reduce the cost of a much-needed drug tenfold,"​ he said.

Extraction of artemisinin from the wormwood plant is labour intensive and, in some developing countries, it is produced by a diesel fuel purification process that may retain toxic impurities in the final drug product.

UC Berkeley will complete development of the synthetic process to make artemisinic acid, a precursor to artemisinin. Amyris, a new biotech company founded at the university, will develop processes to produce large quantities of microbial artemisinic acid and chemically convert it to artemisinin and other effective medicines.

In September, Amyris received a grant from the US National Cancer Institute to develop novel methods for the identification of biosynthetic enzymes responsible for the production of supply-limited chemotherapeutics. The US federal government is also providing funding for the artemisinin project via the National Institute of Allergy and Infectious Diseases.

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