Call to governments: Boost innovation for neglected diseases

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Call to governments Boost innovation for
neglected diseases

• Bernard Pécoul
• Executive Director
• MSF meeting 8 June 2005

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Neglected patients need new drugs, vaccines and
diagnostics NOW
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Neglected diseases desperately need new therapies
Global Diseases
Most Neglected Diseases
Neglected Diseases
World pharmaceutical marketgt 518 bn in 2004
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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

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The needs remain huge
Arsenical
Anti-cancer drug
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Leishmaniasis 350 million at risk

• 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

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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

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No drugs at all for Buruli ulcer
Source WHO, WHO/CDS/CPE/GBUI/2001.1
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But it is still a neglected disease for adults
and children living in developing countries
18 new drugs for AIDS

• 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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The fatal imbalance
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Developing countries have a tiny share of the
pharma market
World Pharmaceutical Market, 2004 Total 518
billion
Source IMS Health
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Only 1 of new drugs developed are for neglected
diseases

• Approx. 1-2 is spent on RD for neglected
  diseases
• 10/90 gap in health research spending
• 1975-1999 1,393 new chemical entities marketed

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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 US106bn for
  2004
• (Monitoring Financial Flows for Health
  Research, Global Forum for Health Research, 2004)
• Higher levels of intellectual property protection
  have not resulted in increased drug RD for
  global health needs
• (UK Commission on Intellectual Property
  Rights, 2002)

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Gaps exist in the RD 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)
mainly public sector
New or existing drugs do not reach patients
registration problems, lack of production, high
prices, or not adapted to the local conditions of
use
Validated candidate drugs do not enter clinical
development because of strategic company choices.
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In recent years

• Increased awareness from the global community
• Developing countries strengthening their RD
  capacity
• New not-for-profit initiatives established

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DNDi is an alternative model

• To develop new drugs for neglected diseases
• Ensure equitable access to needs-driven products
• Strengthen existing capacity in disease-endemic
  countries
• Build public responsibility and leadership
• Bring together the public sector and
  pharmaceutical industry

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DNDi was created in 2003
Medecins Sans Frontieres (MSF)
WHO/TDR (permanent observer)
Institut Pasteur, France
Malaysian Ministry of Health
Oswaldo Cruz Foundation, Brazil
Indian Council for Medical Research (ICMR)
Kenya Medical Research Institute (KEMRI)
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18 projects in DNDis portfolio 2005
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2 new malaria drugs in 2006
e.g. DNDi/sanofi-aventis agree to deliver AS/AQ
anti- malarial fixed dose combination

• Easy to use fewer tablets in treatment regimen
• Affordable Target price for public sector, lt1
  for adult and 0.5 for children
• Available 2006, non exclusive rights

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1. More public leadership
Neglected Diseases Appeal

• Make global health and medicines a strategic
  priority
• Set RD agenda according to the needs of patients
• More than just philanthropy

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2. Sustained financial support
Neglected diseases Appeal

• 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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2. Sustained financial support
Neglected Diseases Appeal

• focused on
• A needs-driven RD agenda
• Maintaining basic scientific research
• Translation of basic research into new medicines
• Strengthening RD capacity in DEC
• Securing the market

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3. New rules to stimulate drug RD
Neglected Diseases Appeal

• 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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3 New rules to stimulate drug RD
Neglected Diseases Appeal

• 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 RD 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
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(No Transcript)
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Neglected Diseases Appeal
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