Coartem Saving Precious Lives

1
Coartem Saving Precious Lives

• The 2008 Artemisinin Enterprise Conference Oct.,
  08-10th, 2006University of York
• Dr. Björn Treptow, Category Manager PharmOps
  COARTEM

2
Novartis Commitment to the Fight Against Malaria

• In May 2001, Novartis committed to a unique
  public-private agreement with WHO
• To make Coartem available at not-for-profit, for
  distribution to public sector agencies and
  malaria-endemic developing countries
• To supply Coartem, procured through WHO with
  funds from donors grants are provided by the
  Global Fund to Fight AIDS, Tuberculosis and
  Malaria (Global Fund) to public sector agencies
• Since the beginning of the program in 2001, we
  halved the average price per treatment to now USD
  0.80
• Cost to treat a very young child is just USD 0.37
• And...patients in the public sector receive
  Coartem for free!

COARTEM Combination Therapy with
Artemisinin-derived Artemether Lumefantrine
3
Coartem Background

• Development of Coartem resulted from
  collaboration between Novartis (Ciba-Geigy) and
  Chinese partners in 1994- first collaboration of
  its kind in Chinese history
• Significant technology transfer from Novartis to
  Chinese partners underway since 1994
• The product is manufactured by Chinese
  manufacturers and Novartis in China and USA
  according to Good Manufacturing Practices (GMPs)
• The product was pre-qualified by WHO and included
  on WHO Model List of Essential Medicines in 2002
• COARTEM obtained Market Authorization by
  Stringent Regulatory Authorities

Prof Zhou Yi-qing
4
Coartems Impact on Patients

• Novartis scaled up production capacity from 4
  million treatments in 2004 to 62 million
  treatments in 2006, a 15-fold increase over two
  years!
• In 2007 66 million treatments delivered in
  08/2008 cumulatively 200 mio treatments, and
  contributed to saving estimated 500,000 lives
• Novartis, along with its partner Medicines for
  Malaria Venture, is committed to the development
  of a pediatric formulation to be launched in 2009

5
COARTEM Sales 2001 2008The challenge of
unprecedented scale-up
In millions of treatments
Deliveries
In Aug 2008 200 mioTx have been delivered
62
66
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1.3
0.2
0.1
9
6
Artemisinin NVS Situation

• Raw Material Novartis is exclusively procuring
  Artemisinin and is NOT engaged in agricultural
  activities
• Sustainability Novartis is in a stable supply
  position for Artemisinin and able to adapt to
  changing demand in the COARTEM market
• Business Continuity - Novartis is
  geographically dually sourced committed -
  Safety Stock in warehouse in China to buffer
  agricultural cycles

7
Artemisinin Quality Regulatory

• Novartis tests against internal Testing Monograph
  (TM), based on WHO TM additionally for
  pesticides? Final quality influenced by
  extraction method and origin of biomass
• Suppliers are audited for basic GMP compliance,
  HSE compliance and corporate citizenship (UN
  Global Compact)
• Regulatory ? Novartis will implement new WHO
  monograph basics for new supplier
  approval incl. GAP ? basics of extraction ?
  Impact of new technologies e. g.
  microbially-derived Artemisinin UNCERTAIN !

8
Artemisinin Challenges to new suppliers

• New suppliers will compete with established
  suppliers in all aspects
• Need to manage regulatory consequences e. g.
  different impurity profile from conventional
  material (avoid bioequivalence studies)
• Time to market COARTEM is in the 2nd half of its
  life cycle
• Advantage over current biomass production to be
  demonstrated ? Focus economics low cost
  alternatives ? Shorter production lead time,
  availability ? longer shelf life higher yields

9
Back up Slides
10
ACT Production More Complex than Most Drugs
Jan
Mar
Aug
Feb
Raw Materials/Drug Substances
Drug Product
Production Lumefantrine 7 months
Seeds secured from prior Autumn
DS shipment 1 month
Tabletting 1 month
Shipping to country 1 month
Packaging 1 month
Extraction Artemisinin 1 month
Production Artemether 2 months
Planting of seeds in nursery, plantation in
fields, growing, harvest Artemisinin - 7 months

• Critical to align orders financing to guide
  supply investments for next year

Seeds to be available for next planting
Minimum total of 14 months lead time, if
capacities are established
ContractsArtemisinin
ContractsLumefantrine
Content ofleaves known
Deliveryvia WHO