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MEDICINE AND HEALTH IN THE TROPICS
Plenary Session 3
« The Pharmaceutical Industry’s
R&D Drive and the issue of
Tropical diseases »
13 of September 2005
Dr Pierre Le Sourd
Leem President
La recherche avance, la vie progresse.
The issue of Tropical Diseases
 Definition
– « Neglected infectious diseases that disproportionately affect
poor and marginalized populations »
(TDR – Special Program for Research and Training in Tropical Diseases)
 Current disease portfolio
TDR
disease
category
Disease burden
DALYs* (thousands)
Total
Male
Deaths
(thousands)
Female Total Male Female
African
trypanosomiasis
1
1,598
1,029
568
50
32
18
Dengue
1
653
287
366
21
10
11
Leishmaniasis
1
2,357
1410
946
59
35
24
Malaria
2
22,256
1,124
532
592
Schistosomiasis
2
678
15
11
5
Tuberculosis
2
Chagas disease
3
649
333
316
13
7
6
Leprosy
3
177
98
79
4
3
2
Lymphatic filariasis
3
5,644
4,317
1,327
0
0
0
Onchocerciasis
3
987
571
416
0
0
0
42,280 20,024
1,760
1081
36,040 22,629
13,411
1,644 1,075
569
TDR Disease Category:
1 – « Emerging or
uncontrolled disease »
2 – « Control strategy
available, but disease burden
persists »
3 – « Control strategy effective
/ Elimination planned »
Source: World Health Report, 2004
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* DALYs - Disability Adjusted Life Years (the number of healthy years of life lost due to premature death and
disability)
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What is the Pharmaceutical Industry
doing about it ?

Drug Companies part of the solution
instead of the issue
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Medicines exist
but don’t reach the patients in need
• Most essential medicines are off-patent and inexpensive;
however over 50 % of populations in Least Developed Countries lack
regular access to these products
Disease
Current Status
Existing Treatment
Childhood
Diseases
1.12 million deaths
annually
Effective, low cost
vaccines
Diarrhoeal
Diseases
1.8 million deaths
annually
Oral rehydration
therapy at 10 cents per
treatment
Malaria
1.3 million deaths
annually
Effective prevention
and treatment tools
Schistosomiasis
200 million people
affected
Praziquantel at 30
cents per year, incl.
distribution
Vitamin A
deficiency
140 million childred
at risk of blindness
Vitamin A as a low cost
food supplement
Source: IFPMA, Septembre 2004
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4
What are the real barriers ?
 Poverty
 Lack of public health infrastructure
 Lack of human resources
 Lack of manufacturing capability
 High tariffs on medicines
 Political denial
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Successful interventions supported
by Drug Companies (1)
 In last decade, global companies have become
critical contributors to numerous programs and
initiatives targeting health needs of the poor
 In 2003, the value of donations by major
companies matched the US AID Global Budget
for Health
– 3,7$ billion over last 5 years
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Successful interventions supported
by Drug Companies (2)
 Examples of concrete actions
– Malaria

In 2001, Novartis formed a partnership with WHO to provide Coartem at no profit in
developing countries

Sanofi-Aventis launched a Specific Program: « Impact Malaria » to develop new
treatments, new therapeutic strategies, educational campaign and to provide drugs
at price, « not loss, not profit »
 Achievements: Pilot projects in South Africa resulted with outstanding
health outcomes:
 Malaria cases reduced by 86%
 Hospital admissions for malaria reduced by 82%
 Malaria deaths decreased by 87%
– Tuberculosis


In South Africa, a huge involvement of Sanofi-Aventis
• Rifafour – a combination of 4 medicines –commercialized to enable better
compliance
• A specific training program of 15$ million developed – DOT Supporters (DOT:
Directly Observed Treatment) for Health agents
Ambitions:
 Building of 9 Training centers
 100,000 Health agents trained
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Successful interventions supported
by Drug Companies (3)
 Examples of concrete actions
– Leishmaniasis
 Ampules of Glucantime (Sanofi-Aventis) provided at no profit
– Onchocerciasis
 40 million doses of Mectizan (Merck) donated annually in 34 countries
– Trachoma
 16 million treatments donated in 11 countries
 More than 80$ million of Zithromax (Pfizer) donated
– Leprosy
 35$ million donated in multi-drug treatment (Novartis)
 Achievements:
• About 13 million people cured over the past 15 years, while some
2-3 million people have been protected from developing
deformities
– Lymphatic Filariasis
 6 billion treatments of albendazole (GSK) planned to be donated
 20 million treatments of Mectizan (Merck) donated
 Achievements:
• 80 million people have received treatment
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Successful interventions supported
by Drug Companies (4)
 HIV/AIDS reference
– To increase access to ARVs in developing countries, a huge
involvement of the Pharmaceutical Industry
 564$ million in 2002
 Involvement in International Programs
 ONUSIDA
 ACCESS: thanks to significant price discounts, more than 330,000
patients in developing countries received ARVs by the end of
September 2004
 Pharmaceutical Initiatives
 Determine Donation Program (Abott), Secure the Future (BMS),
African Comprehensive HIV/Aids Partnership (Merck&Co),
International HIV/Aids Health Literacy Grants Program (Pfizer)…
 Health agents Training, equipments supply, prevention technical
aids, health education
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New or improved treatments needed
Disease
Existing
Medicines
Limitations of Current
Medicines
Efficacy
African
trypanosomiasis
YES
Chagas disease
YES
and safety
Dosage form (injectable)
Cost
Possible resistance
Active
only in acute stage
Safety
Safety
Leishmaniasis
YES
Dosage
Cost
Possible
Dengue fever
form (injectable)
Resistance
NO
N.A.
Compliance
Malaria
YES
Cost
Resistance
Long
Tuberculosis
YES
6-9 month course of treatment
Compliance
Resistance
Source: IFPMA, Septembre 2004
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Drug resistance is widespread:
the example of Malaria
Chloroquine resistance
Sulfadoxine-Pyrimethamine resistance
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What about new drugs and vaccines ? (1)
 Quantum leap in Research is coming
– R&D is at a crossroad
– Development of Biotech Products…
 2003: 40% of New Molecular Entities
 2010: around 100 New Molecular Entities
expected
– … could deliver major breakthroughs…
– … leading to new hope for Tropical
Diseases
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What about new drugs and vaccines ? (2)
 New dynamics in R&D for Neglected Diseases
– Establishment of dedicated research centers by major
companies and increasing not-for-profit approach to R&D
for neglected diseases
– Creation of a R&D efforts database of IFPMA members
– Growing number of product development public private
partnerships (PPPs)
– Proliferation of R&D players, including public research
institutes, academia, major pharma companies, small
specialized biopharmaceutical companies from developed
and developing countries, etc.
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Establishment of
Dedicated Research Centers
AstraZeneca
Bangalore Research
Institute
$40
GlaxoSmithKline
Tres Cantos Centre
for Diseases of the
Developing World
Drug Discovery
This
million drug discovery facility with 100 scientists
working on new drug candidates for TB
First drug candidates are expected in 3 years
research facility covers necessary expertise,
human resources and capacities to assess disease
targets and identify candidate compounds for malaria
and TB
This is a principal location for discovery projects
within the joint GSK/MMV portfolio.
Novartis
$122 million research institute with 100 scientists
Novartis Institute for working on research and discovery of new drugs form
TB and Dengue fever.
Tropical Diseases
Source: IFPMA, Septembre 2004
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Creation of a R&D efforts database
 In September 2005, launch of a database
collecting all the health initiatives involving the
pharmaceutical industry to benefit the Developing
countries
– A comprehensive list of both R&D and Access Initiatives
– Accessible on the Internet (via the IFPMA website) by
the general public
– Create an overall vision for industry activities in
addressing developing countries needs
– Build a central depositary used to create new
collaborations and partnerships
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Public-Private Partnerships
development (1)
 TDR – The Special Program for Research and Training in Tropical
Diseases - and its Industry Partner: a long and fruitful
collaboration
ACF Beheer
Bayer AG
Biobras-Bioquimica
Ciba Geigy (currently Novartis)
Daiichi Pharm
Eli Lilly
Genetic Institutes
GlaxoSmithKline
Hoffmann – La Roche
Iharabras
Janssen Pharmaceutica
Jomaa Pharmaka
Laboratorios Gador
Merck and Co., Inc
E. Merck Pharma
Novo Nordisk
Pasteur-Merieux-Connaught.
Pharmacia Farmitalia
Rhône-Poulenc Rorer Doma
(currently Aventis)
Shin Poong
Vestar
Wyeth
Wanxing Pharmaceuticals
Zeneca Pharmaceuticals
Zentaris
67 disease control tools developed
Of which 38 in use in disease control initiatives
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Public-Private Partnerships
development (2)
 Examples of Product Development PPPs for
Neglected diseases
Medicines
Malaria
for Malaria Venture (MMV)
Malaria Vaccine Initiative (MVI)
European Malaria Vaccine Initiative (EMVI)
Japanese Pharmaceutical, Ministry of Health, WHO
Malaria Drug Partnership (JPWM)
Lapdap Antimalarial Product Development (Lapdap)
Global
Tuberculosis
African
trypanosomiasis
Leishmaniasis
Chagas disease
Alliance for TB Drug Development (GATB)
Global TB Vacine Foundation (Aeras)
Foundation for Innovative New Diagnostics (FIND)
Drugs
for Neglected Diseases Initiative (DNDi)
Gates Foundation/Universtity of Carolina Partnership
(GFUNC)
Infectious Diseased Research Institiute (IDRI)
Institute for One World Health (IOWH)
Source: IFPMA, Septembre 2004
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FAC Project: an innovative
partnership against Malaria
 For Malaria, new medicine needed to adress drug resistance
– WHO recommands the development of 4 Artemisine Combination
Therapies (ACT) :
– But, 2 combinations needed a new fixed-dose combination
 FAC Project:
– A scientific partnership, coordinated by DNDi, to develop fixeddose combination of Artesunate/Amodiaquine (AS/AQ) and
Artesunate/Mefloquine (AS/MQ)
– A public-private Innovative partnership: Sanofi-Aventis & DNDi
 In 2006, a new medicine available
• Easy to use for adults and children
• Less expensive: Target price 1$
• Off patent
 WHO estimations: 50 to 100 million of people could received this
treatement
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Results: a growing R&D pipeline
Discovery &
Preclinical
Development
Phase I
Phase II
African
trypanosomiasis
3
1
1
Chagas disease
5
Leishmaniasis
3
Dengue fever*
5
2
1
Malaria
21
1
3
Tuberculosis
18
2
2
1
Phase III
2
5
Source: IFPMA, Septembre 2004
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Conclusions
 Public-private partnerships prove to offer the
most effective solution
 Pharmaceutical companies increasing its
commitment in:
–
–
–
–
Developing dedicated R&D projects
Establishing many health partnerships
Bringing critical resources (products, money, people)
Contributing in valuable cross-country experience and
expertise in health care delivery
– Introducing a private sector management philosophy
that helps achieve needed results
 Significant and promising global awareness
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Conclusions
 Therefore, any successful initiatives must
include:
– Political will
– Partners
– Infrastructure to get the medicines to patients
– Physicians training and patient education
– Proper diagnosis & dispensing
– Quality control
– Proper dispensing
– Monitoring of outcomes
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