Winning the fight against malaria

1
Winning the fight against malaria

• Dr Nathan MULURE
• Operations Manager for Africa

2
Malaria remains an African tragedy!Why Novartis
focuses on malaria

• Malaria is a preventable and treatable disease,
  yet it still places about half of the world
  population (3.3. billion) at risk
• Estimated 247 million clinical cases in 2006, 86
  are in Africa

• Nearly 1 million deaths per year, more than 90
  in Africa
• Children and pregnant women are most at risk
• A child dies of malaria every 30 seconds
• Most of the older treatments (e.g. chloroquine)
  are now ineffective

3
Holistic approach to fighting malariaPrevention
and cure

• Malaria can be prevented and controlled by three
  main strategies

Prevention
Cure

• Insecticide Spraying
• Control of the mosquitoes by spraying and
  drainage of areas where they live
• Indoor residual insecticide spraying (IRS)

Insecticide-treatedBed Nets (ITN)

• Drug Treatment
• ACT (artemisinin-combination therapies)
• ArtemetherLumefantrine tablets are included on
  the WHOs Model List of Essential Medicines

4
Artemisinin-Combination Therapy (ACT)A
highly-effective cure for malaria

• Artemisinin-combination therapies (ACTs) are a
  highly-effective treatment in drug resistant
  areas and recommended by WHO as first line
  therapy
• Artemisinin derivatives are potent,
  well-tolerated, rapidly acting drugs that carry
  a low risk of resistance, when combined with
  other antimalarial drugs
• Coartem is a combination drug of artemether, a
  derivative from the plant extract of Artemisia
  annua, and lumefantrine. Artemisia annua has been
  used for centuries in the traditional Chinese
  medicine.

Artemisia annua
Coartem tablets
5
Coartem is the result of unique partnerships with
Chinese institutions and WHO

• 1994 Unique collaboration starts between
  Novartis (Ciba-Geigy) and Chinese partners for
  the development of Coartem.
• 1997 Novartis CEO Daniel Vasella remained
  committed to the project for the benefit of
  millions of patients despite negative outlook
  for return-on-investment.
• 2001 Novartis makes Coartem available without
  profit to public sector agencies and
  malaria-endemic countries under a private-public
  agreement with the WHO.
• 2005 Novartis increased production capacity of
  Coartem from 30 million tablets to 100 million
  tablets, made possible through heavy expansion in
  production capacity at state-of-the art
  facilities in China and Suffern, New York.
• 2006, 2008 2009 Novartis announced price
  reductions of Coartem, cutting the public sector
  price by more than 50 overall.

6
Funds and donors

• The Global Fund provides money for countries to
  purchase antimalarial medicine
• Funds are primarily provided by G8 countries and
  Bill and Melinda Gates Foundation
• US Presidents Malaria Initiative
• The World Bank Malaria Booster Program
• New funds have become available through UNITAID
  using airline taxes as a sustainable funding
  source for HIV/AIDS, malaria tuberculosis

7
Coartem deliveries in 2008 reached 74 Mio45 Mio
Tx delivered in 2009 YTD
Most countries showed little or no interest in
Coartem
Large scale implementation of new malaria
treatment guidelines
New challenges and opportunities Coartem
Dispersible, Gx erosion
Txmillions
100
100
100
100
Funding Uncertain
Global Policy Uncertain
Supply Chal-lenges
ErraticOrders
85
12
7
74
66
62
45
580
33
125
4.0
9
1.3
0.1
0.2
8
95 of Coartem is used in Africa Used in more
than 45 countries worldwide
Top 10 country deliveries to date(Mio
Tx) Tanzania 47.1 Uganda 45.1 Kenya
25.6 Ethiopia 25.5 Nigeria 20.5 Zambia
14.9 Malawi 14.5 Mozambique 10.9 Angola
8.9 Rwanda 7.2 Others 29.8
Mali
Niger
Senegal
Sudan (N)
Chad
TheGambia
Nigeria
Ethiopia
Somalia
Sudan (S)
Guinea B.
CAR
Cameroon
Guinea
Uganda
Benin
BurkinaFaso
SierraLeone
Kenya
DR Congo
Rwanda
Gabon
Ghana
Zanzibar
Congo
Tanzania
Liberia
Togo
Cote dIvoire
Angola
Zambia
Mozambique
Zim- babwe
Madagascar
Namibia
Botswana
RSA
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Coartem for the public market makes great
progress2004 vs. 2008
2004
2008
Treatmentdeliveries
4mm treatments
74mm treatments
Patient shareof ACT market
30 ACT patient share
70 ACT patient share
Countriesserved
45 countries served
12 countries served

WHO lt20
Distributiondependence
Other partners gt80
Average priceper treatment
1.57 US per treatment 0.90 US per treatment for
infants
0.80 US per treatment 0.37 US per treatment for
infants
Estimate based on 2008 Coartem shipments to
public sector buyers in malaria endemic
developing countries (74 million treatments)
Estimate of ACT shipments to public sector buyers
in malaria endemic developing countries (105
million treatments)
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Coartem Leading the fight in malariaKey
milestones and achievements in 2009

• ACCESS250,000,000 Coartem treatments
• Estimated 630,000 lives saved

• REGULATORYFDA Approval
• First FDA-approved ACT, endorsement of high
  quality

• INNOVATIONLaunch of Coartem Dispersible
• Meets need for child-sized medicine

• PARTNERSHIPJoins United Against Malaria
• First healthcare company to join

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Putting 250,000,000 treatments into perspective
67 jumbo cargo planes full
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The need for a child-friendly medicineMalaria
and children The challenge
Saving Young Lives Pediatric Malaria Facts
1,000,000 of malaria deaths annually
700,000 of children under 5 who die each year
1 of child-sized ACTs
30 Every 30 seconds a child dies from malaria
Refers to ACTs approved by stringent health
authorities
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Coartem Dispersible Rolling out in Africa

• Coartem Dispersible Phase III data published in
  The Lancet on 15 October 2008
• High cure rates of 97.8
• Coartem Dispersible tablet already approved in 21
  countries
• Benin, Burkina Faso, Cameroon, Central African
  Republic, DRC, Gabon, Ghana, Guinea, Ivory Coast,
  Kenya, Madagascar, Mali, Mauritania, Mozambique,
  Niger, Nigeria, Senegal, Tanzania, Togo, Uganda,
  Zambia
• SwissMedic approval granted end of 2008
• WHO prequalification granted February 2009

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Novartis patient-centric approach

• Formulations tailored to meet patients needs
• Coartem Dispersible, the first ACT developed for
  children

• User-friendly packaging
• Separate pre-sentations per bodyweight ranges
• Visual instruc-tions to help administration

• Training of Healthcare Professionals(several
  languages, e.g. Swahili)

• Best Practice Sharing Work-shops with National
  Malaria Control Program Managers

• Patient education through Coartem patient booklet

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Employing a strategy of prevention (bed nets)
plus treatment with ACTs yields real patient
impact

• Rwanda 67 reduction in mortality in children
  lt5 years old
• Ethiopia 62 reduction in mortality in children
  lt5 years old
• Zambia 66 reduction in malaria deaths

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KwaZulu Natal, South Africa malaria deaths fell
by over 95

• South Africa KwaZulu Natal district
• Malaria outpatient cases reduced by 85 in 2001
  and 99 in 2003
• Hospital admissions for malaria reduced by 99 by
  2003

• NNumber of notified cases of malaria in
  KwaZulu-Natal by month. A indicates indoor
  residual spraying in KwaZulu-NatalB indicates
  introduction of indoor residual spraying in
  neighboring Southern MozambiqueC indicates the
  implementation of Coartem as first-line therapy
  in KwaZulu-Natal

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Collaboration is key to fighting malaria
Holistic Approach
Drug Supply
Funds
Working Together For Sustainable Health Impact
Healthcare Infrastructure
OrderlyDistribution
18
Saving Precious Lives An Achievable Goal in
Malaria
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Four pillars of Novartis CSR program Coartem
Largest corporate citizenship program in
companys portfolio
Novartis Foundation for Sustainable Development
Patient Assistance programmes
Novartis Research Institutes
Malaria Initiatives

• Novartis Institute for Tropical Disease (NITD) in
  Singapore
• Dengue fever, TB, malaria
• Leverage global knowledge to fight neglected
  diseases
• Novartis Vaccines Institute for Global Health
  (NVGH) in Siena, Italy
• First priority diarrheal diseases

• Donation of Leprosy medication more than 4
  million patients cured since 2000
• Donations of fixed-dose TB combination Tx aiming
  at 0.5 million patients over 5 years

• Glivec cancer treatment provided to over 27,000
  patients in over 83 countries free of charge
• Discount program for the uninsured

• Since 2001, 250 million Coartem treatments
  supplied at not-for-profit to public sector
• RD vulnerable patient populations
• Pediatric formulation
• Pregnancy registry
• Coartem Dispersible, first child-friendly ACT,
  launched in 2009

In 2008, Novartis contributed estimated USD 1.259
billion worth of medicines through access to
medicines programs for patients in need.