They need new drugs, vaccines and diagnosis now: reality of neglected diseases Bernard Pecoul...
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![Page 1: They need new drugs, vaccines and diagnosis now: reality of neglected diseases Bernard Pecoul Executive Director, DNDi Geneva 7 December 2005.](https://reader030.fdocuments.us/reader030/viewer/2022032802/56649e155503460f94affce1/html5/thumbnails/1.jpg)
They need new drugs, vaccines and diagnosis now: reality of neglected diseases
Bernard Pecoul
Executive Director, DNDi
Geneva
7 December 2005
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Infectious and Parasitic diseases 33%
Global causes of death
Infectious and parasitic diseases 19%
Perinatal4.3%
Maternal1%
Cancers12.5% Cardiovascular
29.3%
Other non-communicable diseases 16.9%
Respiratory7%
Injuries9%
Source: WHO Health Report 2004
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World pharmaceutical market> $518 bn in 2004
Neglected Diseases
Most Neglected Diseases
Global Diseases
Defining neglected diseases
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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
Sou
rce:
WH
O 2
001
Sou
rce:
WH
O 2
001
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The needs remain huge
Arsenical Anti-cancer drug
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Leishmaniasis
• An estimated 12 million people affected Different forms: visceral, (muco)cutaeous, PKDL
• 350 million people at risk in 88 countries
• 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
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Buruli ulcer
Source: WHO, WHO/CDS/CPE/GBUI/2001.1
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AIDS is a neglected diseasefor 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
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Treatments do not exist or are inadequate and inaccessible
• Toxic• Expensive• Painful to deliver• Difficult to follow up• Not adapted to
patient’s needs• Not registered in
endemic regions• Restricted by
patents
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Analysing the problems:Fatal imbalance
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Rest of Europe $9bn (1.8%)
Japan $58bn (11.1%)
Latin America $19bn (3.8%)
Asia, Africa and Australia $40bn
(7.7%)
North America $248bn (47.8%)
EU $144bn (27.8%)
Developing countries have a tiny share of the pharma marketWorld Pharmaceutical Market, 2004: Total $518 billion
Source: IMS Health
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Only 1% of new drugs developed are for neglected diseases
Tropical diseases: 13
Tuberculosis: 3
• Approx. 1-2% is spent on R&D for neglected diseases
• 10/90 gap in health research spending
• 1975-1999: 1,393 new chemical entities marketed
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• World-wide spending on health R&D was never so high
– Estimated at US$106bn for 2004 (GFHR, 2004)
• Since 90’s: private sector has become biggest investor
US-spending on health R&D:(>2/3rd total)
Sources:For government: National Science Foundation 2004, http://www.nsf.gov/sbe/srs/nsf04329/pdf/nsf04329.pdfFor Industry: PhRMA 2004, http://www.nsf.gov/sbe/srs/nsf04329/pdf/nsf04329.pdf
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
1980 1985 1990 1995 2000 2005
Government
Industry
Bn US$
Spending on health R&D has increased
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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
Validated candidate drugs do not enter clinical
development because of strategic company
choices.
New or existing drugs do not reach patients: registration
problems, lack of production, high prices, or not adapted to
the local conditions of use
mainly public sector
mainly industry (in North)
Availabilityto patients
DevelopmentPre
ClinicalDiscovery
GAP2 GAP3
GAP1
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…due to failure of the market and public policy
Drug development largely confined to the R&D-based pharmaceutical industry operating for profit
Poorer patients are thus neglected
Market failure Public policy failure
Public policy does not redress this imbalance
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DNDi’s created in 2003: vision
• Use an alternative model to develop new drugs for
neglected diseases - leishmaniasis, sleeping
sickness and malaria
• Ensure equitable access of needs-driven products
• Strengthen existing capacity in disease-endemic
countries
• Build public responsibility and leadership in
addressing needs of these patients
• Bring together the international community, public
sector and pharmaceutical industry
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DNDi’s Founding Partners
Kenya Medical Research Institute (KEMRI)
WHO/TDR (permanent observer)
Medecins Sans Frontieres (MSF)
Malaysian Ministry of Health
Institut Pasteur, France
Oswaldo Cruz Foundation, Brazil
Indian Council for Medical Research (ICMR)
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18 projects in DNDi’s portfolio 2005
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oth
er DNDi
Nitroimidazoles project for trypanosomiasisA
cad
emic
sP
har
ma
OBJECTIVE: To identify new drug candidates amongst old and new nitroimidazoles for trypanosomiasis
•Swiss Tropical Institute•Fiocruz, Brazil •U of Sao Paolo, Brazil•U of Tehran, Iran•U of Bern, CH•Silesian University, Poland•Roma University, Italy+ contacts Japan, USA
•sanofi-aventis, France-Germany•Roche, CH•Chiron, USA•Novartis (NITD), CH -Singapore
•Romark, USA•Alkem, India
•TB alliance•Dr Nagarajan , India
Discovery
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Ravuconazole project for Chagas disease
•Federal Univ of Ouro Preto, Brazil
•Instituto Venezolano de Investigaciones Científicas, Venezuela
OBJECTIVE:To investigate the
activity and toxicity of ravuconazole in
preclinical disease models for acute and
chronic Chagas disease
DNDi
Eisai, JAPAN
Pre-clinical development
Academic groups
Pharma companies
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Leishmaniasis East Africa Platform (LEAP) A group of scientists
and institutions working on
developing clinical trial capacity to
bring new treatments to
patientsETHIOPIA
SUDAN
KENYA
•Addis Ababa University•DACA•Ministry of Health
•University of Khartoum•Federal Ministry of Health•MSF- Holland
•Ministry of Health•KEMRI
IOWH- India
IDA
WHO/TDR
DNDi
Clinical development
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Agreement between DNDi and sanofi-aventis
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Governments should tackle this imbalance
• The response should not be purely philanthropic
• Governments should increase public responsibility towards R&D of drugs for neglected diseases– More political leadership– Sustained financial support– New rules to stimulate drug R&D
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Increased public responsibility:1. More public leadership
• Make global health and medicines a strategic priority
• Set R&D agenda according to the needs of patients
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Increased public responsibility: 2. Sustained financial support
Governments need to
• 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
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2. Sustained financial support
This funding should be focused on: A needs-driven R&D agenda for safe,
effective, affordable and field-adapted treatments
Encouraging scientific community to do basic research on neglected diseases
Translation of basic research to new medical applications, e.g. by supporting PDPs
Encouraging R&D capacity strengthening in disease-endemic countries
Securing the market
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Increased public responsibility: 3. New rules to stimulate drug R&D
• Regulatory standards • Streamline regulatory approval processes to
rapidly deliver essential medicines to patients
• Analyse risks and benefits of each drug or vaccine in relation to the needs of patients, severity of the disease and lack of alternative solutions
• Regulatory authorities (FDA and EMEA) should provide support and transfer know-how to authorities in developing countries
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3: New rules to stimulate drug R&D
Intellectual Property: develop drugs as public goods
• Guarantee that the public sector develops open access to information (recent Wellcome Trust policy) => open source (Human Genome Project) => freedom to operate
• Ensure that industry provides sustainable access to knowledge, chemical compounds and tools
• Make technology transfer happen to disease-endemic countries
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www.dndi.org