JP Paccaud
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Transcript of JP Paccaud
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Jean-Pierre Paccaud, PhD
European Parliament, May 30th 2012
New Drugs for
Neglected Diseases
New Hope forForgotten Patients
Breaking the disease-poverty cycle: Dopharmaceutical companies deliver on R&D for
Neglected Diseases in developing countries?
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NTDs, the PDP Model and DNDi
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Burden of Neglected Tropical Diseases
This map displays countries endemic for each of these diseasesbased on 2009-2010 data and international borders.(from: www.unitingtocombatntds.org)
Buruli UlcerChagas disease (Americantrypanosomiasis)CysticercosisDengue/Severe dengueDracunculiasis (guinea-worm disease)
EchinococcosisFascioliasisHuman African trypanosomiasisLeishmaniasisLeprosyLymphatic filariasisOnchocerciasisRabiesSchistosomiasis
Soil transmitted helminthiasisTrachomaYaws
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HIV/AIDS TB Malaria NTD Diarrhea Respiratory
Diagnostics
Microbicides &preventatives
Therapeuticproduct
Vaccine Human hookwormvaccine initiative
VaccineDevelopment
Program
PDPs work across different diseases and modalities
&Source:
Product Development Partnerships (PDPs)
http://www.sabin.org/http://www.dndi.org/http://www.sabin.org/http://www.dndi.org/http://www.oneworldhealth.org/http://www.iavi.org/http://www.meningvax.org/index.htmhttp://www.finddiagnostics.org/ -
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Malaria Leishmaniasis
Sleeping Sickness (HAT) Chagas Disease
Paediatric HIV
Helminth infections
Responding to the Needs of PatientsSuffering from Neglected Diseases
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Vision:
A collaborative, patients needs-driven, virtual,non-profit drug R&D organisation to developnew treatments against the most neglected
communicable diseases
DNDisVision & Objectives
Objectives:
Deliver 11 to 13 new treatments by 2018 for sleepingsickness, Chagas disease, leishmaniasis, malaria,
paediatric HIV and specific helminth infections Establish a robust pipeline for future needs
Use and strengthen existing capacity in disease-endemiccountries
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Easy to Use Affordable Field-Adapted Non-Patented
6 New Treatments Developed Since 2007
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DNDiPortfolio: A Mix of Existing Drugs & NCEs
December 2011
Discovery Pre-clinical Clinical Implementation
Nitroimidazole backup(HAT)Screening
ConsolidatedLead
Optimization
VL-2098 (VL)
Alternative formulationsof Amphotericin B (VL)
Nitroimidazole backup(VL)
Fenarimol series(Chagas)
K777 (Chagas)
Flubendazole -Macrofilaricide
(Helminth)
Improved PI for 1st-line Prodrugs of LPV/RTV New formulations of
LPV/r(Paed. HIV)
Fexinidazole (HAT)
Oxaborole SCYX-7158(HAT)
New VL treatmentsBangladesh
New VL treatments
Africa AmBisome Miltefosine
New VL treatments(Latin America)
HIV / VL
Azoles E1224& Biomarker (Chagas)
Benznidazole Paed.dosage form (Chagas)
NECT (Stage 2 HAT)Nifurtimox - Eflornithine
Co-administration
SSG/PMco-administration
VL in Africa
New VL treatmentsin Asia
(SD AmBisome,3 drug combinations)
ASMQFixed-DoseArtesunate/ Mefloquine
ASAQFixed-DoseArtesunate/ Amodiaquine
Oxaborole backup (HAT)
Major CollaboratorsSources for hit and leadcompounds:GSK, Anacor, Merck, Pfizer,Novartis (GNF, NITD), TBAlliance, ...Screening Resources:Eskitis, Institut Pasteur Korea,
SCYNEXIS, Univ. Dundee, ...Reference screeningcentres:LSHTM, Swiss Tropical &Public Health Institute,University of Antwerp
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Utilizing and Strengthening ResearchCapacities in Disease-Endemic Countries
Major Role of RegionalDisease Platforms:
Defining patients needs andtarget product profile (TPP)
Strengthening local capacities
Conducting clinical trials(Phase II/III studies)
Facilitating registration
Accelerating implementationof new treatments (Phase IV& pharmacovigilance studies)
HAT
VL
CHAGAS
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FACT Project budget: EUR 15.3 million, Public financing has been critical Project-specific funding provided through FP5
(EUR 1 Mio)
+ +
Industrial Partners:
Sanofi-AventisEllipse, Catalent
Cipla
Funding:
EUs INCODEV,France, Netherlands,
Spain, UK, MSF
Scientific coordination
& project management
DNDi/TDR
DNDis FACT Project
Development of Fixed-dose Artemisinin-based Combination Therapies
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Initial Objectives:
Responseto public health need Easyto use
Affordable
Available as public good
Today: support implementation ofASAQ (artesunate-amodiaquine) andASMQ (artesunate-mefloquine)
ASMQ (Farmanguinhos)
ASAQ (sanofi)
DNDis FACT Project
2 new treatments delivered
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ASAQ:
Transfer oftechnology
toZenufa
Tanzania
Implemented in Partnership with sanofi
Registered in 2007, prequalified by WHOin 2008
Registered in 30 sub-Saharan Africancountries, in India, and in Colombia
More than 120M Treatments Distributed
Only FDC with a 3 years shelf life
Ambitious risk management plan(Pharmacovigilance)
Available at 0.5$ for children, 1$ foradults
DNDis FACT Project
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PRND and Horizon 2020
M i Ch ll f S t i bl R&D
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Main Challenges for Sustainable R&D
for Neglected Patients
IP & OpenInnovation
RegulatoryBarriers
SustainableFinancing
R&DCoordination
Private SectorInvolvment
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How can EU help fill the gap for PRNDs?
Horizon 2020 Framework
Strengthen European Competitiveness
and EUs position in science
Promote industrial leadership in innovation
and support SMEs
IMI
Pre-competitive mechanism to
support outstanding science
between academia & industry
EDCTPPartnership to support Phase
IIb-III clinical trials for TB, HIV
and malaria
Strengthen capacities in
endemic countries
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Feature Global Health R&D into Horizon2020, and in particular poverty-relatedand Neglected Tropical Diseases
Increase funding for NDs
Improved mechanisms to support entiredevelopment process, from translationalresearch to implementation
Better coordination of research prioritiesat European level
More flexibility on public/privatecollaborations schemes
EDCTP 2 with wider scope (NTDs) andmore resources
How can EU help fill the gap for PRNDs?
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Thank You to All Our Partners & Donors
www.dndi.org
via the 4th Sector HealthProject implemented by AbtAssociates, Inc.
by
http://www.ge.ch/