Institute for OneWorld Health

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Semi-synthetic Artemisinin A New Source of
Artemisinin to Reduce Barriers to ACT
Access November 18, 2008 London, 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
Global Health Challenges (Artemisinin Supply)
?SyntheticBiology (Biotechnology)
Increase Access to ACT Cures
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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
ACT Therapy
Months
DERIVATIVES
Days
Controlled Process
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Artemisinin As A Starting Material
Dihydroartemisinin
Artesunate
Artemisinin
Artemisinic acid
Artemether
Artelinate
Starting material Defined specifications
Raw material Defined specifications
Arteether
API Compendial specifications
GMP manufacturing
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Achievements Goals

• Achievements
• 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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Artemisinin A Starting Material for ACTs

• In the production of ACTs, artemisinin is a
  starting material NOT an API
• Derivatives manufactured from artemisinin are the
  active pharmaceutical ingredients (API) in ACTs
• The WHO monograph, which currently lists
  artemisinin as an API, may need to be updated to
  reflect current manufacturing practices
• The semi-synthetic process will consist of a well
  documented microbial fermentation to produce
  artemisinic acid (AA) followed by synthetic
  chemical steps to reach artemisinin.
• The plan is to pursue chemical comparability as a
  regulatory approach for semi-synthetic
  artemisinin

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Semi-synthetic Artemisinin Timeline
2011 - 2012
Process Development and Scale up
Industrialization
Commercial Production
Pre-Development
10,000L
1000L
100,000L
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