Coartem Saving Precious Lives

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Coartem Saving Precious Lives

• Rebecca Stevens
• Director of Public Affairs, Malaria Initiatives
• Novartis Pharma AG

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A Three-Day Cure to Fight Malaria is Available
Now!

• Artemisinin-based Combination Therapy (ACT) is
  the best available treatment
• ACTs are the only effective treatment in drug
  resistant areas and are recommended by WHO as
  first line therapy
• Novartis ACT, Coartem, is the first fixed-dose
  artemisinin combination prequalified by WHO

Coartem provides

• Prompt control of fever in as little as 24 to 36
  hours
• Rapid parasite clearance stopping disease
  propagation
• Cure rates gt96 after only three days of therapy!
• Good tolerance throughout treatment

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Novartis Commitment to the Fight Against Malaria

• In May 2001, Novartis committed to a unique
  public-private agreement with WHO to make Coartem
  available without profit for distribution to
  public sector agencies and malaria-endemic
  developing countries
• In September 2006, Novartis reduced the average
  price of Coartem to USD1.00 to help expand access
  to medicine
• Patients in the public sector receive Coartem
  for free!

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The Frame in Which We OperateThe challenge of
unprecedented scale-up
In millions of treatments
Production meets demand but still frequent
stock outs at health facility levels
Deliveries
Production capacity
To be delivered
Produced, not ordered
100
100
Potential orders
7
11
62
ErraticOrders
52
33
63-70
Funding Uncertain
Supply Challenges
Global Policy Uncertain
4
9
1.3
0.1
0.2
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Putting 62 Million Treatments into Perspective
Almost the total population of France
14 jumbo cargo planes full
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Training of Healthcare Professionals

• Coartem/WHO Field training
• Materials consisting of
• Training manual
• Detailed cards
• Surgery posters
• Produced in 5 official languages and many local
  languages. All distributed for free in
  conjunction with WHO

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Patient Information/Education

• Coartem Packaging
• Novel packaging
• User-friendly dispensing packs, color coded for
  4 dosage levels
• Designed to address problems associated with poor
  literacy rates

• Patient Information
• Developed patient compliance booklet, Juma, the
  strong boy, to encourage correct use of Coartem
• Reinforces the importance of prevention, rapid
  symptom recognition, prompt treatment,
  completing Coartem treatment
• Produced in Swahili, French, English, Portuguese
  and many local languages

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Best Practice Workshops for National Program
Managers

• Held four workshops in 2006-2007 Johannesburg,
  South Africa in May 2006 and Addis Ababa,
  Ethiopia in October 2006 Kampala, Uganda in
  April 2007 and Nairobi, Kenya in September 2007
• National Malaria Control Program Managers share
  information regarding best practices in their
  countries
• Workshops on pharmacovigilance, measuring the
  impact of ACT introduction, forecasting, ordering
  and distribution, financing and procurement, etc.
• Response has been positive, with encouragement to
  convene future workshops

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Pharmacies and Accredited Drug Shops in Africa

• Treatments are provided through local clinics and
  pharmacies

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Malaria and the UN Millennium Development Goals

• At UN Millennium Summit in September 2000, pledge
  to make a better world for all by 2015
• Millennium Declaration promises to free mankind
  from dehumanizing conditions of extreme poverty
  to make the right to development a reality for
  everyone
• Eight Millennium Development Goals (MDGs) adopted
  - all to be achieved by 2015
• Specific to malaria reduce malaria morbidity and
  mortality by 75

• Eradicate extreme poverty and hunger
• Achieve universal primary education
• Promote gender equality empower women
• Reduce child mortality
• Improve maternal health
• Combat HIV/AIDS, malaria other diseases
• Ensure environmental sustainability
• Develop a global partnership for development

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Coartems Role in Meeting the Millennium
Development Goals

• Provide Coartem treatments to public sector to
  save patient lives
• Provide training materials to healthcare
  professionals
• Equip patients with information/education
• Conduct Best Practice workshops for national
  program managers

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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!
• By the end of 2006, Novartis delivered 62 million
  treatments and contributed to saving
  approximately 200,000 lives
• Novartis, along with its partner Medicines for
  Malaria Venture, is committed to the development
  of a pediatric formulation to be launched in 2008

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Coartem Pediatric Dispersible formulation

• Excellent Phase III results (gt95 cure rate even
  at day 42)
• Easy to take for infants and children
• Well accepted cherry flavor
• To be submitted to health authorities end 2007

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Coartems Contribution to Patient
OutcomesKwaZulu Natal

• Successful deployment of ACT/Coartem in
  combination with indoor residual spraying
• Cases reduced by 78 in 2001 and 86 in 2002
• Hospital admissions for malaria reduced by 82

Insect Spraying
Coartem
1999
2000
2001
2002
2003
2004
2005
2006
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Coartem Showing Significant Patient Impact in
Zambia

• Nationwide
• 10.5 drop in malaria incidences in 2004 as
  compared to 2003
• Decline in malaria deaths from 50,000 to 33,000
  over the same time period
• At Macha Mission Hospital in rural Zambia
• 90 reduction of pediatric malaria cases over the
  past three years
• 87 reduction in malaria case fatalities recorded
  for the same two periods from 52 during the
  2001-2002 malaria season to only 7 during the
  2004-2005 malaria season

Source Dr. Philip Thuma, Senior Associate, Johns
Hopkins Bloomberg School of Public Health and
Director, Malaria Institute at Macha (MIAM)
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Coartem Treatment Demonstrates Cost
Effectiveness in Zambia

• Study design
• Coartem vs.SP for treatment of uncomplicated
  malaria
• 55,509 patients (2005) at public health
  facilities from six study districts selected by
  the National Malaria Control Centre
• Data on efficacy and compliance for Coartem and
  SP, including costs of drugs, personnel, medical
  exams administrative/equipment overhead
  capital cost
• Study results
• Total estimated treatment cost per cured patient
  
• Coartem 8.57 (despite the higher Coartem drug
  price)
• SP 10.65
• Better health outcomes (i.e., curative success
  and reduction in the cost of complicated or
  severe malaria treatment) with Coartem
• Conclusion decision to adopt Coartem is
  justifiable on both economic and public health
  grounds.

Source A cost-effectiveness analysis of
artemether and lumefantrine for treatment of
uncomplicated malaria in Zambia Chanda P. et al.
Malaria Journal 2007. 621
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Malaria Initiatives In Patient Numbers, Largest
Corporate Citizenship Program in Companys
Portfolio
Novartis Foundation for Sustainable Development
Patient Assistance programmes
Novartis Institute for Tropical Disease
Malaria Initiatives

• World-class Singapore RD site opened Jan 2003
• Leverage global knowledge to fight neglected
  diseases
• Dengue fever, TB, malaria

• 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 19,000
  patients in over 83 countries free of charge
• Discount program for the uninsured

• From 2001, supply Coartem without profit to
  public sector
• RD vulnerable patient populations
• Pediatric formulation
• Pregnancy registry
• Patients reached in 2006 33 million

In 2006, Novartis contributed USD755 million
worth of medicines through access to medicines
programs for patients in need. 33.6 million
patients were reached