Development partnership could boost artemisinin supply

US-based nonprofit pharmaceutical company The Institute for OneWorld Health (iOWH), synthetic biology innovator Amyris Biotechnologies and pharma company sanofi-aventis have entered into an agreement for the development of semisynthetic artemisinin, a key ingredient in first-line malaria treatments.

This partnership will build on technology originated by Professor Jay Keasling at the University of California, Berkeley. It aims to create a complementary source of non-seasonal, high-quality and affordable artemisinin to supplement the current botanical supply, thereby improving consistent access to lower-cost, life-saving artemisinin-based combination therapies (ACTs).

Under the terms of the agreement, OneWorld Health, Amyris and sanofi-aventis will work jointly to develop and design pilot and commercial scale manufacturing processes, with the goal of introducing low-cost, semisynthetic artemisinin into the supply chain and ACTs in 2010.

OneWorld Health, UC Berkeley and Amyris have been working together as the Artemisinin Project since late 2004 to develop a new, low-cost technology platform to produce artemisinin - a project funded by the Bill & Melinda Gates Foundation.

Keasling initially identified the genetic pathway and developed a microbial system that produces artemisinin via fermentation. After successfully completing its scientific responsibilities in the Artemisinin Project, UC Berkeley continues to license the technology to OneWorld Health and Amyris for further product development and ultimate use in ACTs for the treatment of malaria. Sanofi-aventis, which has extensive experience in the field of malaria drugs, will be the newest partner in this collaboration to increase global access to ACTs.

Amyris will provide strain engineering expertise using the novel tools of synthetic biology. Sanofi-aventis will provide fermentation and chemistry process development expertise, and OneWorld Health will focus on the achievement of public policy and global access goals. If technical benchmarks are achieved, sanofi-aventis will commercialise the semisynthetic artemisinin.

If it reaches commercial scale, this alternative source of artemisinin would supplement the supply that is currently extracted from the botanical source Sweet Wormwood plant (Artemisia annua) and produce enough artemisinin for ACTs to treat up to 200 million of the more than 500 million estimated individuals who contract malaria each year.

This complementary source of supply would improve the availability of high-quality artemisinin derivatives to drug manufacturers and contribute to stabilising the price of artemisinin-containing antimalarials to benefit patients and payers.

"Sanofi-aventis and Amyris are among the most advanced companies in synthetic biology," said Paul Baduel, director, process development biotechnology of sanofi-aventis. "Sanofi-aventis process development teams in biotechnology and chemistry are proud to be involved in the design of an industrial process for the production of artemisinin."