semi-synthetic artemisinin: a new source of artemisinin to reduce barriers to act access november...

Semi-synthetic Artemisinin: A New Source of Artemisinin to Reduce Barriers to ACT Access

November 18, 2008London, UK

Presented By Philippe Desjeux, PhD

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iOWH Mission

The Institute for OneWorld Health Develops Safe, Effective, and Affordable

New Medicines for People with Infectious Diseases in the Developing World

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The Partnership

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Project Vision: Semi-synthetic Artemisinin

Increase Increase Access to ACT Access to ACT

CuresCures

Global Health Challenges

(Artemisinin Supply)

SyntheticBiology

(Biotechnology)

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Semi-Synthetic Artemisinin Project Goals

Create a complementary source of non-seasonal, high-quality and affordable artemisinin to supplement the current plant-derived supply

Contribute to stabilizing the price of artemisinin to benefit all stakeholders

Ensure semi-synthetic artemisinin is available to all high-quality derivatizers and ACT manufacturers

Enable millions of people infected with malaria to gain consistent access to affordable, high-quality, life-saving ACTs

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A Second Source Supplements & Stabilizes the Artemisinin Supply Chain

O

O

O

OO

H

HHHO

O

H

H

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Chemistry

ArtemisininArtemisinic Acid

Yeast+

Sugar

Fermentation

DERIVATIVES

ACT Therapy

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O

O

OO

H

HH

Artemisinin

ExtractionCultivation

Months

Days

Controlled Process

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Artemisinin As A Starting Material

Artemisinin

Dihydroartemisinin

Artesunate

Artemether

Artelinate

Arteether

Artemisinic acid

Raw material Defined specifications

Starting materialDefined specifications

API Compendial specifications

GMP manufacturing

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Achievements & GoalsAchievements

• Completed strain engineering to reach productivity targets at bench scale fermenter level

• Transferred technology (fermentation, purification, and chemistry) to manufacturing partner

• Reproduced laboratory data at pilot scale

Goals• Demonstrate chemical comparability between semi-

synthetic and plant derived artemisinin No need for bioequivalence studies

• Process optimization and development of industrial processes suitable for 100,000L scale

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Semi-synthetic Artemisinin Timeline

Process Development and

Scale up

Industrialization

2011 - 2012

Pre-Development

10,000L1000L 100,000L

CommercialProduction

2nd Source of Artemisinin for ACTs

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Market Impact

Supplement botanical supply to support projected increased demand for ACTs

Semi-synthetic artemisinin cost is anticipated to be comparable to the current cost of high quality field production

Semi-synthetic artemisinin will be made broadly available to those derivative and ACT manufacturers who will apply the principle of “no profit, no loss”

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Thank You