Nicoletta Dentico

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DNDi turning neglect into action

• Nicoletta Dentico
• Policy and advocacy advisor
• ndentico_at_dndi.org
• Access to medicines in developing countries
• Ottawa, 19-21 April 2007
• www.dndi.org

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• Founded in July 2003
• as a new collaborative,
• patients needs- driven,
• not-for-profit
• drug RD model for neglected diseases

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• Our Vision
• A virtual non-profit drug RD organization to
  develop new treatments against the most neglected
  communicable diseases
• and Mission
• Primary Objective To deliver 6 - 8 new
  treatments by 2014 for leishmaniasis, sleeping
  sickness, Chagas disease, malaria
• complementary Objectives
• Use and strengthen existing capacity in
  disease-endemic countries via project
  implementation
• Raise awareness about the need to develop new
  drugs for neglected diseases and advocate for
  increased public responsibility

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The DNDi team
7 Founding Partners
6 Liaison Offices
Medecins Sans Frontieres (MSF)
WHO/TDR (permanent observer)
17 Coordination team Geneva consultants
Institut Pasteur France
Japan
Malaysian Ministry of Health
Malaysia
Kenya
Oswaldo Cruz Foundation Brazil
India
RDC
Brazil
Indian Council for Medical Research (ICMR)
Kenya Medical Research Institute (KEMRI)
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Current DNDi Portfolio, 1Q2007 22 Projects
AVAILABLE to patients
Discovery
Lead selection
Lead optimization
Screening
DHFR inhibitors, LT
FDC Artesunate-Amodiaquine, M
CP inhibitors, T
FDC Artesunate-Mefloquine, M
TR inhibitors, L T
Nifurtimox- Eflornithine, H
Microtubule inhibitors, H
NPC1161B, an 8-aminoquinoline, VL
Scynexis screening, T
Paromomycin, VL
CDRI screening, T
Imiquimod, CL
Genzyme screening, T
AmBisome, L
Kitasato screening, T
Drug combinations, VL
Amphotericin B polymer, VL
Novel nitro- heterocycles, H
L Leishmaniasis VL Visceral leishmaniasis CL
Cutaneous leishmaniasis T Trypanosomiasis C
Chagas disease H Human African trypanosomiasis
Ravuconazole, C
Ascofuranone, H
Nitroimidazoles 1, L T
Nitroimidazoles 2, H
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The global dimension of neglect
sleeping sickness, leishmaniasis, Chagas disease,
malaria, Buruli ulcera lie outside of the world
market
Global Diseases
Most Neglected Diseases
Neglected Diseases
World pharmaceutical market 602 bn in 2005
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Spending on health RD has increased

• World-wide spending on health RD was never so
  high
• Estimated at US106bn for 2004 (GFHR, 2004)
• Since 90s private sector has become biggest
  investor

US-spending on health RD(gt2/3rd total)
Sources For government National Science
Foundation 2004, http//www.nsf.gov/sbe/srs/nsf
04329/pdf/nsf04329.pdf For Industry PhRMA 2004,
http//www.nsf.gov/sbe/srs/nsf04329/pdf/nsf04329
.pdf
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New drugs developed from 1975-2004
Total 1,556
Tropical diseases 18
1.3
TB 3
Tropical diseases and tuberculosis account for
12 of the global disease burden but only 1.3 of
new drugs developed.
Source Chirac P, Torreele E. Lancet. 2006 May
12 1560-1561.
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New Product Development Partnerships
receive only 16 of funding from governments
Public sector 16
UN Agencies 3
Private sector 2
Philanthropic organizations 79
Source LSE / Wellcome Trust. The New Landscape
of Neglected Disease Drug Development. 2005.
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The PDP reality more products in pipeline but
have yet to reach patients
2000
Some with TDR collaboration Further
SME in-house activity yet to be included
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Success rate for PDPs likely to be lower (WHO
CIPIH report)

• PDPs tend to seek breakthrough products rather
  than incremental innovation (as compared to
  industry)
• Attrition rate higher in the longer term, once
  the low hanging RD fruits have been picked
• RD costs lower, but failure rates may be higher
  due to inadequate funding
• CIPIH 3.3 governments cannot passively rely
  on what these partnerships clould eventually
  deliver there is a need for stronger commitment
  on their part for an articulated and sustainable
  effort to address the research gaps

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PDPs new RD business modela
transformational force or a non-threatening
niche?
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First steps towards a paradigm shift

• DNDis IP policy drug research as a public good,
  science in the public domain
• ?
• DNDis innovative partnership with Sanofi-Aventis
  on the production of antimalarials

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Malaria Rationale for the Fixed-Dose ACT Project

• 2002
• WHO recommends in particular the use of drug
  combinations containing Artemisinin
• Artesunate-SP
• Artemether-lumefantrine
• Artesunate-amodiaquine (AS-AQ)
• Artesunate-mefloquine (AS-MQ)
• For both AS-AQ and AS-MQ
• No co-formulations
• No partners

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DNDis FACT Project

• Objectives
• 2 fixed-dose ACTs
• Easy to use
• fewer tablets in regimen
• paediatric strengths
• ensure drugs are taken together and in correct
  proportions
• Affordable
• Available as public good

AS/AQ (s-a)
AS/MQ (Farmanguinhos)
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AS/AQ DNDi and sanofi-aventis An Innovative
Partnership

• DNDi licensed the product to s-a in Dec 2004
• Public price  at cost 
• target ltUS1 for adult, US0.50 for children
• Patent free arrangement
• Pediatric formulations available
• Drug registered in Morocco
• Production in Morocco ? good sicence in the south
  for south
• WHO pre-qualificationdossier presented in
  February 2007

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AS/AQ Simple 3-Day ACT Dose Regimen
Co-blistered Artesunate-amiodaquine
Fixed-dose Artemether/ lumefantrine (Coartem)
NEW Fixed-dose Artesunate/amodiaquine
AM 20 mg LF 120 mg
3 dosage strengths available
AS 50 mg AQ 153 mg
Infants (lt8 kg)
AS 25 mg AQ 67.5 mg
Young Children (8-17 kg)
AS 50 mg AQ 135 mg
15-25 kg
Children (17-35 kg)
AS 100 mg AQ 270 mg
25-35 kg
Adults (gt35 kg)
AS 100 mg AQ 270 mg
gt35 kg
A pediatric formulation of AR/LU is currently
under development by Novartis and MMV
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ASAQ governments reactions

• Germany I am particularly pleased of course that
  the new drug will be available without any
  patents for all suppliers and patients, i.e. as a
  public good. By taking this route, all those
  involved are making an important statement about
  affordable medical care for the people in
  developing countries Minister Heidemarie
  Wieczorek-Zuel
• Italy We do welcome the public good approach
  that has inspired the partnership between DNDi
  and Sanofi- Aventis.which has produced open and
  shared innovation. This is the way to follow
  State Secretary Patrizia Sentinelli
• UK The development of ASAQ is not only a
  wonderful breakthrough which will allow poor
  people to access effective treatment for
  malaria.  The beauty of ASAQ is its simplicity
  and the fact that it will be  non-patented. 
  This means that developing country
  governments and patients are much more able to
  afford it and I am confident that the lives
  of millions of people will be improved as a
  result of this successful and innovative
  partnership. " Gareth Thomas, UK Minister for
  International Development
•  

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ASAQ more reactions

• European Parliament I very much welcome the
  fact that the new ASAQ antimalarial fixed-dose
  combination is born without patent. This means
  that, for the first time, the health of millions
  of people has been rated more important than
  profits in the creation of a new life-saving
  drug.
• I therefore would like to offer my deepest
  congratulations to DNDi and Sanofi/Aventis, as
  you finally give us the tangible evidence that
  patents can be skipped in the interest of public
  health, especially for poor people with no
  purchasing power. As you know, this is a concern
  that all human rights organizations and the civil
  society worldwide have voiced for years, claiming
  the fundamental peoples right of access to
  essential health tools.
• Thanks to ASAQ solution, it will be more
  difficult now for the big pharmaceutical
  companies to defend the thesis according to
  which it is not possible to make progress in
  pharmaceutical innovation, without the patent
  profit mechanism
• MEP Luisa Morgantini, vice-president of the EP,
  delegated for Africa

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Which direction do we want to take ?

• IGWG provides a historic opportunity
• to increase appropriation about the requirements
  linked to essential health RD
• to project WHO/ government commitments globally,
  well beyond the mid-term framework defined by WHA
  59.24
• We cannot afford to pass it up!