Artemisia

1
Artemisia Malaria

• Presented By Tom Chapman M.R.PharmS
• Essential Nutrition, Brough,
  United Kingdom

2
Artemisia A History

• Over 2000 years of documented history for
  treating fevers in China.
• 1972 Artemisinin isolated in China.
• 1982 Antimalarial activity reported (BMJ).
• 1982 Toxicity study reported (China Cooperative
  Research Group).
• 1985 Clinical trial data reported (Journal Of
  TCM).
• 1987 HPLC method for assay reported (XD LUO et
  al).

3
Problems In Producing Artemisinin

• Low yeilds. Overcome by selection Rutgers (Jim
  Simon).
• Growing and harvesting.
• Drying.
• Extraction.
• Conversion to GMP product Macfarlane Smith

4
Problems In Producing Finished Products

• Local manufacture GMP certificate.
• Pack design languages.
• Registration locally.
• Clinical trials.
• Registration fees.
• Time.

5
The Market

• WHO Combination Products.
• WHO Not For Prophylaxis

6
Why License Anyway ?

• Product liability insurance.
• Batch recall procedure.
• Pharmacovigilance.
• Adverse events reporting.
• Unable to export.

7
Why Are So Few Products Licensed?

• No profit incentive for large companies
  (exceptions).
• Too expensive for small companies.
• Which combinations to use?
• How many patients in clinical trials?
• Where do you register?
• How do you distribute finished products?

8
A Theoretical Solution

• WHO / MMV
• Agree combinations.
• Procure clinical trial supplies.
• Clinical trial each combination.
• Register each product with FDA / EMEA.
• Hold product licence.
• Sub License Manufacture To Suitable 3rd Parties
  Who Can Show
• Acceptable GMP certificate.
• Availability of GMP API.
• Suitable batch recall and pharmacovigilance.
• Produce GMP certificate with C of A.

9
Benefits Of This System

• Jobs Input for the country in both agriculture
  and manufacture.
• Export revenues and import substitution.
• Very good product.
• Good local distribution.
• Choice of antimalarial for that region.
• Good pharmacovigilance.
• Lower cost to produce.