Transcript Slide 1

Call to governments:
Boost innovation for
neglected diseases
Bernard Pécoul
Executive Director
MSF meeting 8 June 2005
Neglected patients need new drugs,
vaccines and diagnostics NOW
Neglected diseases desperately
need new therapies
Global Diseases
Most Neglected
Diseases
Neglected Diseases
World pharmaceutical market
> $518 bn in 2004
Sleeping sickness is a most
neglected disease
An estimated 300,000 infected
55 million at risk in sub-Saharan Africa
Difficult to diagnose
Fatal if untreated
Existing drugs: old - toxic - resistance - difficult to use
- expensive
Source: WHO 2001
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The needs remain huge
Arsenical
Anti-cancer drug
Leishmaniasis: 350 million at risk
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An estimated 12 million people affected in 88 countries
 Different forms: visceral, (muco)cutaneous, PKDL
Per year: 1-1.5 million new cases of CL/MCL
500,000 cases of VL
VL is fatal if left untreated
Existing drugs: old - toxic - resistance - difficult to use expensive
Chagas disease: 18 million infected
• Endemic in Latin America
• Threatens 100 million people in 21 countries
• In about one-third of the acute cases, chronic forms
develop 10 – 20 years after infection
• Severe chronic disease leads to death
• Only two drugs for this disease – not effective for
chronic patients
No drugs at all for Buruli ulcer
Source: WHO, WHO/CDS/CPE/GBUI/2001.1
18 new drugs for AIDS
But it is still a neglected disease for adults and
children living in developing countries
• Drugs not adapted to
health systems of
endemic countries
• No treatment
adapted to children
• Limited tools for
diagnosis and follow
up
• No field-adapted
preventive tools
The fatal imbalance
Developing countries have a tiny
share of the pharma market
World Pharmaceutical Market, 2004: Total $518 billion
Japan $58bn
(11.1%)
Asia, Africa and
Australia $40bn
(7.7%)
Latin America
$19bn (3.8%)
Rest of Europe
$9bn (1.8%)
EU $144bn
(27.8%)
Source: IMS Health
North America
$248bn (47.8%)
Only 1% of new drugs developed
are for neglected diseases
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Approx. 1-2% is spent on R&D for neglected diseases
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10/90 gap in health research spending
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1975-1999: 1,393 new chemical entities marketed
Tropical diseases: 13
Tuberculosis: 3
Insignificant progress towards new
health tools for the poor
In spite of
• Huge increase in global funding for health
research - from $30 bn in 1986 to
US$106bn for 2004
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(Monitoring Financial Flows for Health Research, Global
Forum for Health Research, 2004)
Higher levels of intellectual property
protection have not resulted in increased
drug R&D for global health needs
(UK Commission on Intellectual Property Rights, 2002)
Gaps exist in the R&D process for
neglected diseases
New knowledge on drug
targets and lead
compounds is published
but pre-clinical research
does not begin
mainly industry (in North)
GAP1
Discovery
mainly public sector
Pre
Clinical
Development
GAP2
Validated candidate drugs
do not enter clinical
development because of
strategic company
choices.
Availability
to patients
GAP3
New or existing drugs do not
reach patients: registration
problems, lack of production,
high prices, or not adapted to
the local conditions of use
In recent years…
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Increased
awareness from the
global community
Developing
countries
strengthening their
R&D capacity
New not-for-profit
initiatives
established
DNDi is an alternative model
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To develop new drugs for neglected
diseases
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Ensure equitable access to needs-driven
products
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Strengthen existing capacity in diseaseendemic countries
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Build public responsibility and leadership
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Bring together the public sector and
pharmaceutical industry
DNDi was created in 2003
Medecins Sans
Frontieres (MSF)
Institut
Pasteur,
France
WHO/TDR (permanent
observer)
Malaysian
Ministry of
Health
Oswaldo Cruz
Foundation, Brazil
Kenya Medical
Research
Institute (KEMRI)
Indian Council for Medical
Research (ICMR)
18 projects in DNDi’s portfolio 2005
2 new malaria drugs in 2006
e.g. DNDi/sanofi-aventis
agree to deliver AS/AQ antimalarial fixed dose
combination
• Easy to use: fewer tablets
in treatment regimen
• Affordable: Target price
for public sector, <$1 for
adult and $0.5 for children
• Available: 2006, non
exclusive rights
Neglected Diseases Appeal
1. More public leadership
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Make global health and
medicines a strategic
priority
Set R&D agenda according
to the needs of patients
More than just philanthropy
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Neglected diseases Appeal
2. Sustained financial support
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Raise current levels of funding for
neglected diseases by 3 billion euros per
year to start to correct the 10/90 gap
Put in place new, sustainable funding
mechanisms (IFF, Global tax, …)
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Neglected Diseases Appeal
2. Sustained financial support
focused on:
 A needs-driven R&D agenda
 Maintaining basic scientific
research
 Translation of basic research into
new medicines
 Strengthening R&D capacity in
DEC
 Securing the market
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Neglected Diseases Appeal
3. New rules to stimulate drug R&D
Regulatory standards
• Streamline approval processes
• Analyse risks and benefits of each drug
or vaccine
• Build regulatory capacities in developing
countries (support from EMEA and
FDA )
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Neglected Diseases Appeal
3: New rules to stimulate drug R&D
Intellectual Property: develop drugs as public
goods
• Ensure that public sector develops open
access to information
• Ensure that industry provides sustainable
access to knowledge, chemical compounds
and tools
• Freedom to operate in R&D for ND
• Make technology transfer to disease-endemic
countries happen
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Global Appeal
Without bold new steps disease
will continue to ravage the
developing world, with global
consequences.
Governments
should
act NOW
Neglected Diseases Appeal
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www.researchappeal.org