Semi-Synthetic Artemisinin Project

Partnership objective

Create a complementary source of non-seasonal, high-quality and affordable artemisinin to supplement the current botanical supply, thereby enabling millions of people infected with malaria to gain consistent access to lower-cost, life-saving artemisinin-based combination therapies (ACTs).

Field worker cleaning up after Artemisia annua harvest in Naivasha, Kenya. Field worker cleaning up after Artemisia annua harvest in Naivasha, Kenya. Copyright Carla Denly/ UC Berkeley

What are the health needs and challenges?

Malaria is one of the world’s major infectious diseases, infecting approximately 300-500 million people.  In 2012, an estimated 627,000 deaths resulted from malaria and most of the deaths occurred in children under five years old.

Artemisinin is a key ingredient in first-line malaria treatments recommended by the WHO. It is extracted from traditional Chinese medical herb Artemisia annua, but because it is extracted from plants, its supply can suffer from climatic variations, leading to unstable provision of antimalarial medicines and major price variations.

Description of partnership activities and how they address needs and challenges

The partnership aims at developing a complementary, semisynthetic, source of artemisinin, to improve the availability of high-quality artemisinin derivatives to drug manufacturers and contribute to stabilizing the price of artemisinin-containing antimalarials to benefit patients and payers. The original idea and the proof of concept were developed at the University of California-Berkeley, the project was then managed by the Institute for One World Health (IOWH), a nonprofit pharmaceutical company. From the proof of concept, a first chemical route was developed on a laboratory scale by Amyris Biotechnologies, a US based Biotech start-up. Sanofi was selected as the manufacturing partner, due to the malaria program within its Access to Medicines department, and because of its production and technological competences and capacity. The Bill & Melinda Gates Foundation (BMGF) provided significant financial support to this project, from its inception to its latest stages.

The partnership is managed through a board of partners that meet on a regular basis to validate the critical steps of the project’s development. Sanofi 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, which affects about 300 million people every year and was responsible for more than 620,000 deaths in 2012.

In April 2013, Sanofi and PATH launched an industrial production line of semisynthetic artemisinin, key ingredient of artemisinin-based combination malaria therapies (ACTs). The development of this new alternative manufacturing process to produce a complementary source of artemisinin started 9 years before.  This successful project is based upon the novel use of biology technology pioneering inventions from UC Berkeley and Amyris, in partnership with the National Research Council Canada Plant Biotechnology Institute.

Lessons learned

At Sanofi, a tremendous amount of work was done to access a scalable and cost-effective process to convert biosynthetic artemisinic acid into artemisinin, scaling-up the process to industrial scale, and ensuring production up to the highest quality standards. A large number of Sanofi staff, primarily in France and in Italy, are or were involved in this project.

Summary of impact and forward looking information

In 2011 the industrialization phase for fermentation and chemistry was completed. In 2012 production began using the fermentation of artemisinic acid and its conversion into artemisinin using photochemistry at the Sanofi Garessio site in Italy. Sanofi plans to produce 50 to 60 tons of artemisinin per year by 2014, which corresponds to between 80 and 150 million ACT treatments.

Videos

UC Berkeley Discovery Leads to Malaria Drug

Partnership information

Company(ies) Sanofi

Partner(s) Amyris, Bill and Melinda Gates Foundation, GenoClipp Biotechnology, Institute for One World Health, National Research Council Canada Plant Biotechnology Institute, PATH, University of California, Berkeley

Type of Partner(s) Academia / Hospitals, NGOs, Other Business

Therapeutic Focus Infectious Diseases

Disease(s) Malaria

Program Type(s) Research & Development - Development of Treatments

Targeted Population(s) Children, Elderly, Marginalised / Indigenous People, Men, Mothers, People with low income, Women, Youth

Region(s) East Asia & Pacific, South Asia, Sub-Saharan Africa

Number of Countries 57

Country(ies) Angola, Bangladesh, Benin, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, India, Indonesia, Kenya, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Mali, Mauritania, Mauritius, Mozambique, Myanmar, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Thailand, The Gambia, Togo, Uganda, Vietnam, Zambia, Zimbabwe

Research Country(ies) United States of America

Start Date 2004

More information PATH Press Release

Anticipated completion date Ongoing

« Taking lifesaving innovation to scale requires many things, but begins with strong partnerships & keeping a close ear to what’s most needed on the ground. I'm extremely pleased we have partnered with Sanofi in the scale up of semisynthetic artemisinin. »

Steve Davis, president and CEO of PATH