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Nicoletta Dentico

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Clinical. Pre-Clinical. Discovery. Screening. Lead. selection. Lead ... clinical ... have ensured the pharmaceutical and clinical development ... – PowerPoint PPT presentation

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Title: Nicoletta Dentico


1

DNDi turning neglect into action
  • Nicoletta Dentico
  • Policy and advocacy manager
  • ndentico_at_dndi.org
  • A more enabling environment medical innovation
  • Berlin - 10 May 2007
  • www.dndi.org

2
DNDi was created in 2003
5 Regional Support Liaison Offices
7 Founding Partners
Indian Council for Medical Research (ICMR)
Coordination team Geneva consultants
Brazil
Kenya Medical Research Institute (KEMRI)
India
Kenya
Malaysian MOH
Malaysia
Oswaldo Cruz Foundation Brazil
USA
Medecins Sans Frontieres (MSF)
Japan
Institut Pasteur France
2 Project Support Offices
RDC
WHO/TDR (permanent observer)
3
  • 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

4
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
5
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
6
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
7
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.
8
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.
9
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
10
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

11
PDPs new RD business modela non-threatening
niche or a transformational force?
12
The Artesunate-Amodiaquine Fixed-Dose
Combination ASAQ 
13
Rationale for the ASAQ 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)

14
  • 2006, WHO
  • strengthens
  • recommendations.
  • ACTS should be
  • first-line treatment for falciparum malaria
    everywhere
  • in fixed-dose combinations when possible

www.who.int/malaria/docs/TreatmentGuidelines2006.p
df
15
DNDi ASAQ Partnership
Industrial Partner Sanofi-Aventis
Funding DNDi, MSF, TDR, EUs INCODEV, DFID,
Farmanguinhos, AFD-France, DGIS Netherlands
Scientific Coordination Project Management
DNDi/TDR
Ellipse Pharma Tropival of Uni Bordeaux,
France pharmaceutical development
CNRFP, Burkina Faso phase III clinical trial
Contractual Partners Comips, Rottendorf Pharma,
Unitox, Genotox, Créapharm, Cardinal Systems
Uni Sains, Malaysia development of analytical
methods, human animal PKs, phase I study
Center for Tropical Med Univ Oxford, UK PK/PD,
in vitro and molecular studies
Farmanguinhos, Brazil Pharmaceutical
development, animal toxicity
- - - - - - Sharing information ----------
Sharing info/data/methods/products
AS/AQ Artesunate/Amodiaquine PK/PD
Pharmacokinetics/Pharmacodynamics
16
ASAQ DNDi and sanofi-aventis An Innovative
Partnership
  • Since 2002, DNDi partners have ensured the
    pharmaceutical and clinical development
  • DNDi licensed the product to s-a in Dec 2004
  • Patent free arrangement
  • Public price  at cost 
  • target ltUS1 for adult, US0.50 for children
  • Pediatric strenghts available
  • Drug registered in Morocco
  • Production in Morocco ? good science in the south
    for south

17
Advantages of the AS-AQ Fixed-Dose combination
  • Optimized ASAQ ratio
  • to prevent over- and under-dosing
  • Taylor WRJ, et al. Bulletin of the WHO. 2006
    84 956-964.
  • Easy to use fewer tablets in once-a-day
    treatment regimen
  • gt drugs taken together and in correct
    proportions
  • Affordable lt1 for adult, 0.50 for children
  • Available no patent taken

18
Simplified 3-Day Dose Regimen of ASAQ
Co-blistered non-fixed ASAQ Artesunate-amodiaquin
e
NEW Fixed-dose ASAQ Artesunate/amodiaquine
AS 50 mg AQ 153 mg
3 dosage strengths available
Infants (4.5-8 kg)
AS 25 mg AQ 67.5 mg
Young Children (8-17 kg)
AS 50 mg AQ 135 mg
Children (17-35 kg)
AS 100 mg AQ 270 mg
Adults (36 kg)
AS 100 mg AQ 270 mg
19
Coarsucam Artesunate Amodiaquine Winthrop
Differentiated packagings
TM
TM
Pharmacies CAP program
Public market
Artesunate Amodiaquine Winthrop
COARSUCAM Impact Malaria
Private market
COARSUCAM
20
Population in millions in 31 countries where ASAQ
could be considered as 1st line treatment for
uncomplicated malaria in Africa 497.3M
1st priority countries where ASAQ is adopted as
1st line where ASAQ is one of 1st-line
treatments 2nd priority countries where ASAQ can
be of benefit
Reference RBM-WHOAfro, 2006.
21
Registration FileInternational standards
  • Approved in Morocco, February 2007
  • Submitted to the WHO prequalification process,
    March 2007
  • Registered in 12 sub-Saharan African countries
  • Benin, Togo, Mauritania, Burkina-Faso, Guinea,
    Mali, Gabon, Congo, DRC, Madagascar

22
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 for Cooperation, 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
  •  

23
G8 promises from Okinawa (2000) to Rostock
(2007)
  • The conditions are right for a step change in
    international health outcomes (G8 Com. 2000)
  • we therefore committo urgently deliver three
    critical targets
  • - 25 reduction of HIV/AIDS infected young
    people by 2010
  • - reduce TB deaths and disease prevalence by
    50 by 2010
  • - reduce malaria burden of disease by 50
    by 2010

24
The G8 partnership agenda
  • Mobilising addditional resources to prevention
    and treatment of infectious diseases
  • Promoting political leadership in health
  • Working to making existing cost-effective
    interventions more universally available and
    affordable in developing countries
  • Addressing the issue of access to medicines.and
    assessing obstacles being faced by developing
    countries in that regard
  • Strenghtening co-operation in the area of
    research and development of new drugs, vacines
    and other international public goods

25
Still a long way to go which direction to take ?
  • WHO IGWG provides a historic opportunity
  • to increase governments ownership about the
    requirements linked to essential health
    innovation
  • political leadership is key to grant innovation
    access
  • to project WHO/ government commitments, well
    beyond the mid-term framework defined by WHA
    59.24
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