la recherche avance, la vie progresse. medicine and health in the tropics plenary session 3 « the...
TRANSCRIPT
La recherche avance, la vie progresse.
MEDICINE AND HEALTH IN THE TROPICSMEDICINE AND HEALTH IN THE TROPICSPlenary Session 3Plenary Session 3
« The Pharmaceutical Industry’s « The Pharmaceutical Industry’s R&D Drive and the issue of R&D Drive and the issue of
Tropical diseases »Tropical diseases »
13 of September 200513 of September 2005
MEDICINE AND HEALTH IN THE TROPICSMEDICINE AND HEALTH IN THE TROPICSPlenary Session 3Plenary Session 3
« The Pharmaceutical Industry’s « The Pharmaceutical Industry’s R&D Drive and the issue of R&D Drive and the issue of
Tropical diseases »Tropical diseases »
13 of September 200513 of September 2005
Dr Pierre Le Sourd
Leem President
Dr Pierre Le Sourd
Leem President
La recherche avance, la vie progresse. 2
The issue of Tropical DiseasesThe issue of Tropical Diseases
Definition– « Neglected infectious diseases that disproportionately affect
poor and marginalized populations »(TDR – Special Program for Research and Training in Tropical Diseases)
Current disease portfolio
Source: World Health Report, 2004
* DALYs - Disability Adjusted Life Years (the number of healthy years of life lost due to premature death and disability)
Disease burden DALYs* (thousands)
Deaths (thousands)
TDR disease
category Total Male Female Total Male Female
African trypanosomiasis 1 1,598 1,029 568 50 32 18
Dengue 1 653 287 366 21 10 11
Leishmaniasis 1 2,357 1410 946 59 35 24
Malaria 2 42,280 20,024 22,256 1,124 532 592
Schistosomiasis 2 1,760 1081 678 15 11 5
Tuberculosis 2 36,040 22,629 13,411 1,644 1,075 569
Chagas disease 3 649 333 316 13 7 6
Leprosy 3 177 98 79 4 3 2
Lymphatic filariasis 3 5,644 4,317 1,327 0 0 0
Onchocerciasis 3 987 571 416 0 0 0
TDR Disease Category:
1 – « Emerging or uncontrolled disease »
2 – « Control strategy available, but disease burden persists »
3 – « Control strategy effective / Elimination planned »
La recherche avance, la vie progresse.
What is the Pharmaceutical Industry What is the Pharmaceutical Industry
doing about it ?doing about it ?
Drug Companies part of the solution Drug Companies part of the solution instead of the issueinstead of the issue
What is the Pharmaceutical Industry What is the Pharmaceutical Industry
doing about it ?doing about it ?
Drug Companies part of the solution Drug Companies part of the solution instead of the issueinstead of the issue
La recherche avance, la vie progresse. 4
Medicines existMedicines existbut don’t reach the patients in needbut don’t reach the patients in need
Vitamin A as a low cost food supplement
140 million childred at risk of blindness
Vitamin A deficiency
Praziquantel at 30 cents per year, incl.
distribution
200 million people affected
Schistosomiasis
Effective prevention and treatment tools
1.3 million deaths annually
Malaria
Oral rehydration therapy at 10 cents per
treatment
1.8 million deaths annually
Diarrhoeal Diseases
Effective, low cost vaccines
1.12 million deaths annually
Childhood Diseases
Existing TreatmentCurrent StatusDisease
Vitamin A as a low cost food supplement
140 million childred at risk of blindness
Vitamin A deficiency
Praziquantel at 30 cents per year, incl.
distribution
200 million people affected
Schistosomiasis
Effective prevention and treatment tools
1.3 million deaths annually
Malaria
Oral rehydration therapy at 10 cents per
treatment
1.8 million deaths annually
Diarrhoeal Diseases
Effective, low cost vaccines
1.12 million deaths annually
Childhood Diseases
Existing TreatmentCurrent StatusDisease
Source: IFPMA, Septembre 2004
• Most essential medicines are off-patent and inexpensive;however over 50 % of populations in Least Developed Countries lack regular access to these products
La recherche avance, la vie progresse. 5
What are the real barriers ?What are the real barriers ?
Poverty
Lack of public health infrastructure
Lack of human resources
Lack of manufacturing capability
High tariffs on medicines
Political denial
La recherche avance, la vie progresse. 6
Successful interventions supported Successful interventions supported by Drug Companies (1)by Drug Companies (1)
In last decade, global companies have become critical contributors to numerous programs and initiatives targeting health needs of the poor
In 2003, the value of donations by major companies matched the US AID Global Budget for Health
– 3,7$ billion over last 5 years
La recherche avance, la vie progresse. 7
Successful interventions supported Successful interventions supported by Drug Companies (2)by Drug Companies (2)
Examples of concrete actions– Malaria
In 2001, Novartis formed a partnership with WHO to provide Coartem at no profit in developing countries
Sanofi-Aventis launched a Specific Program: « Impact Malaria » to develop new treatments, new therapeutic strategies, educational campaign and to provide drugs at price, « not loss, not profit »
Achievements: Pilot projects in South Africa resulted with outstanding health outcomes:
Malaria cases reduced by 86% Hospital admissions for malaria reduced by 82% Malaria deaths decreased by 87%
– Tuberculosis In South Africa, a huge involvement of Sanofi-Aventis
• Rifafour – a combination of 4 medicines –commercialized to enable better compliance
• A specific training program of 15$ million developed – DOT Supporters (DOT: Directly Observed Treatment) for Health agents
Ambitions: Building of 9 Training centers 100,000 Health agents trained
La recherche avance, la vie progresse. 8
Successful interventions supported Successful interventions supported by Drug Companies (3)by Drug Companies (3)
Examples of concrete actions– Leishmaniasis
Ampules of Glucantime (Sanofi-Aventis) provided at no profit– Onchocerciasis
40 million doses of Mectizan (Merck) donated annually in 34 countries– Trachoma
16 million treatments donated in 11 countries More than 80$ million of Zithromax (Pfizer) donated
– Leprosy 35$ million donated in multi-drug treatment (Novartis) Achievements:
• About 13 million people cured over the past 15 years, while some 2-3 million people have been protected from developing deformities
– Lymphatic Filariasis 6 billion treatments of albendazole (GSK) planned to be donated 20 million treatments of Mectizan (Merck) donated Achievements:
• 80 million people have received treatment
La recherche avance, la vie progresse. 9
Successful interventions supported Successful interventions supported by Drug Companies (4)by Drug Companies (4)
HIV/AIDS reference– To increase access to ARVs in developing countries, a huge
involvement of the Pharmaceutical Industry 564$ million in 2002 Involvement in International Programs
ONUSIDA ACCESS: thanks to significant price discounts, more than 330,000
patients in developing countries received ARVs by the end of September 2004
Pharmaceutical Initiatives
Determine Donation Program (Abott), Secure the Future (BMS), African Comprehensive HIV/Aids Partnership (Merck&Co), International HIV/Aids Health Literacy Grants Program (Pfizer)…
Health agents Training, equipments supply, prevention technical aids, health education
La recherche avance, la vie progresse. 10
New or improved treatments neededNew or improved treatments needed
Long 6-9 month course of treatmentComplianceResistance
YESTuberculosis
ComplianceCostResistance
YESMalaria
N.A.NODengue fever
SafetyDosage form (injectable)CostPossible Resistance
YESLeishmaniasis
Active only in acute stageSafety
YESChagas disease
Efficacy and safetyDosage form (injectable)CostPossible resistance
YESAfrican
trypanosomiasis
Limitations of Current Medicines
Existing Medicines
Disease
Long 6-9 month course of treatmentComplianceResistance
YESTuberculosis
ComplianceCostResistance
YESMalaria
N.A.NODengue fever
SafetyDosage form (injectable)CostPossible Resistance
YESLeishmaniasis
Active only in acute stageSafety
YESChagas disease
Efficacy and safetyDosage form (injectable)CostPossible resistance
YESAfrican
trypanosomiasis
Limitations of Current Medicines
Existing Medicines
Disease
Source: IFPMA, Septembre 2004
La recherche avance, la vie progresse. 11
Drug resistance is widespread:Drug resistance is widespread:the example of Malariathe example of Malaria
Chloroquine resistance
Sulfadoxine-Pyrimethamine resistance
Chloroquine resistance
Sulfadoxine-Pyrimethamine resistance
Chloroquine resistance
Sulfadoxine-Pyrimethamine resistance
La recherche avance, la vie progresse. 12
What about new drugs and vaccines ? (1)What about new drugs and vaccines ? (1)
Quantum leap in Research is coming
– R&D is at a crossroad
– Development of Biotech Products… 2003: 40% of New Molecular Entities 2010: around 100 New Molecular Entities
expected
– … could deliver major breakthroughs…
– … leading to new hope for Tropical Diseases
La recherche avance, la vie progresse. 13
What about new drugs and vaccines ? (2)What about new drugs and vaccines ? (2)
New dynamics in R&D for Neglected Diseases
– Establishment of dedicated research centers by major companies and increasing not-for-profit approach to R&D for neglected diseases
– Creation of a R&D efforts database of IFPMA members
– Growing number of product development public private partnerships (PPPs)
– Proliferation of R&D players, including public research institutes, academia, major pharma companies, small specialized biopharmaceutical companies from developed and developing countries, etc.
La recherche avance, la vie progresse. 14
Establishment ofEstablishment ofDedicated Research CentersDedicated Research Centers
$122 million research institute with 100 scientists working on research and discovery of new drugs form TB and Dengue fever.
NovartisNovartis Institute for Tropical Diseases
This research facility covers necessary expertise, human resources and capacities to assess disease targets and identify candidate compounds for malariaand TBThis is a principal location for discovery projects within the joint GSK/MMV portfolio.
GlaxoSmithKlineTres Cantos Centre for Diseases of the Developing World Drug Discovery
$40 million drug discovery facility with 100 scientists working on new drug candidates for TBFirst drug candidates are expected in 3 years
AstraZenecaBangalore Research Institute
$122 million research institute with 100 scientists working on research and discovery of new drugs form TB and Dengue fever.
NovartisNovartis Institute for Tropical Diseases
This research facility covers necessary expertise, human resources and capacities to assess disease targets and identify candidate compounds for malariaand TBThis is a principal location for discovery projects within the joint GSK/MMV portfolio.
GlaxoSmithKlineTres Cantos Centre for Diseases of the Developing World Drug Discovery
$40 million drug discovery facility with 100 scientists working on new drug candidates for TBFirst drug candidates are expected in 3 years
AstraZenecaBangalore Research Institute
Source: IFPMA, Septembre 2004
La recherche avance, la vie progresse. 15
Creation of a R&D efforts databaseCreation of a R&D efforts database
In September 2005, launch of a database collecting all the health initiatives involving the pharmaceutical industry to benefit the Developing countries
– A comprehensive list of both R&D and Access Initiatives
– Accessible on the Internet (via the IFPMA website) by the general public
– Create an overall vision for industry activities in addressing developing countries needs
– Build a central depositary used to create new collaborations and partnerships
La recherche avance, la vie progresse. 16
Public-Private Partnerships Public-Private Partnerships development (1)development (1)
TDR – The Special Program for Research and Training in Tropical Diseases - and its Industry Partner: a long and fruitful collaboration
ACF BeheerBayer AG
Biobras-BioquimicaCiba Geigy (currently Novartis)
Daiichi PharmEli Lilly
Genetic InstitutesGlaxoSmithKline
Hoffmann – La RocheIharabras
Janssen PharmaceuticaJomaa Pharmaka
Laboratorios Gador
Merck and Co., IncE. Merck Pharma
Novo NordiskPasteur-Merieux-Connaught.
Pharmacia FarmitaliaRhône-Poulenc Rorer Doma
(currently Aventis)Shin Poong
VestarWyeth
Wanxing PharmaceuticalsZeneca Pharmaceuticals
Zentaris
ACF BeheerBayer AG
Biobras-BioquimicaCiba Geigy (currently Novartis)
Daiichi PharmEli Lilly
Genetic InstitutesGlaxoSmithKline
Hoffmann – La RocheIharabras
Janssen PharmaceuticaJomaa Pharmaka
Laboratorios Gador
Merck and Co., IncE. Merck Pharma
Novo NordiskPasteur-Merieux-Connaught.
Pharmacia FarmitaliaRhône-Poulenc Rorer Doma
(currently Aventis)Shin Poong
VestarWyeth
Wanxing PharmaceuticalsZeneca Pharmaceuticals
Zentaris
ACF BeheerBayer AG
Biobras-BioquimicaCiba Geigy (currently Novartis)
Daiichi PharmEli Lilly
Genetic InstitutesGlaxoSmithKline
Hoffmann – La RocheIharabras
Janssen PharmaceuticaJomaa Pharmaka
Laboratorios Gador
ACF BeheerBayer AG
Biobras-BioquimicaCiba Geigy (currently Novartis)
Daiichi PharmEli Lilly
Genetic InstitutesGlaxoSmithKline
Hoffmann – La RocheIharabras
Janssen PharmaceuticaJomaa Pharmaka
Laboratorios Gador
ACF BeheerBayer AG
Biobras-BioquimicaCiba Geigy (currently Novartis)
Daiichi PharmEli Lilly
Genetic InstitutesGlaxoSmithKline
Hoffmann – La RocheIharabras
Janssen PharmaceuticaJomaa Pharmaka
Laboratorios Gador
Merck and Co., IncE. Merck Pharma
Novo NordiskPasteur-Merieux-Connaught.
Pharmacia FarmitaliaRhône-Poulenc Rorer Doma
(currently Aventis)Shin Poong
VestarWyeth
Wanxing PharmaceuticalsZeneca Pharmaceuticals
Zentaris
Merck and Co., IncE. Merck Pharma
Novo NordiskPasteur-Merieux-Connaught.
Pharmacia FarmitaliaRhône-Poulenc Rorer Doma
(currently Aventis)Shin Poong
VestarWyeth
Wanxing PharmaceuticalsZeneca Pharmaceuticals
Zentaris
Merck and Co., IncE. Merck Pharma
Novo NordiskPasteur-Merieux-Connaught.
Pharmacia FarmitaliaRhône-Poulenc Rorer Doma
(currently Aventis)Shin Poong
VestarWyeth
Wanxing PharmaceuticalsZeneca Pharmaceuticals
Zentaris
67 disease control tools developed
Of which 38 in use in disease control initiatives
La recherche avance, la vie progresse. 17
Public-Private Partnerships Public-Private Partnerships development (2)development (2)
Examples of Product Development PPPs for Neglected diseases
Drugs for Neglected Diseases Initiative (DNDi)Gates Foundation/Universtity of Carolina Partnership (GFUNC)Infectious Diseased Research Institiute (IDRI)Institute for One World Health (IOWH)
African trypanosomiasisLeishmaniasis
Chagas disease
Global Alliance for TB Drug Development (GATB)Global TB Vacine Foundation (Aeras)Foundation for Innovative New Diagnostics (FIND)
Tuberculosis
Medicines for Malaria Venture (MMV)
Malaria Vaccine Initiative (MVI)European Malaria Vaccine Initiative (EMVI)J apanese Pharmaceutical, Ministry of Health, WHO Malaria Drug Partnership (J PWM)Lapdap Antimalarial Product Development (Lapdap)
Malaria
Drugs for Neglected Diseases Initiative (DNDi)Gates Foundation/Universtity of Carolina Partnership (GFUNC)Infectious Diseased Research Institiute (IDRI)Institute for One World Health (IOWH)
African trypanosomiasisLeishmaniasis
Chagas disease
Global Alliance for TB Drug Development (GATB)Global TB Vacine Foundation (Aeras)Foundation for Innovative New Diagnostics (FIND)
Tuberculosis
Medicines for Malaria Venture (MMV)
Malaria Vaccine Initiative (MVI)European Malaria Vaccine Initiative (EMVI)J apanese Pharmaceutical, Ministry of Health, WHO Malaria Drug Partnership (J PWM)Lapdap Antimalarial Product Development (Lapdap)
Malaria
Source: IFPMA, Septembre 2004
La recherche avance, la vie progresse. 19
FAC Project: an innovative FAC Project: an innovative partnership against Malariapartnership against Malaria
For Malaria, new medicine needed to adress drug resistance– WHO recommands the development of 4 Artemisine Combination
Therapies (ACT) : – But, 2 combinations needed a new fixed-dose combination
FAC Project:– A scientific partnership, coordinated by DNDi, to develop fixed-
dose combination of Artesunate/Amodiaquine (AS/AQ) and Artesunate/Mefloquine (AS/MQ)
– A public-private Innovative partnership: Sanofi-Aventis & DNDi In 2006, a new medicine available
• Easy to use for adults and children• Less expensive: Target price 1$• Off patent
WHO estimations: 50 to 100 million of people could received this treatement
La recherche avance, la vie progresse. 20
Results: a growing R&D pipelineResults: a growing R&D pipeline
2218Tuberculosis
53121Malaria
125Dengue fever*
213Leishmaniasis
5Chagas disease
113African trypanosomiasis
Phase I I IPhase I IPhase IDiscovery & Preclinical
Development
2218Tuberculosis
53121Malaria
125Dengue fever*
213Leishmaniasis
5Chagas disease
113African trypanosomiasis
Phase I I IPhase I IPhase IDiscovery & Preclinical
Development
Source: IFPMA, Septembre 2004
La recherche avance, la vie progresse. 21
ConclusionsConclusions
Public-private partnerships prove to offer the most effective solution
Pharmaceutical companies increasing its commitment in:
– Developing dedicated R&D projects– Establishing many health partnerships– Bringing critical resources (products, money, people)– Contributing in valuable cross-country experience and
expertise in health care delivery– Introducing a private sector management philosophy
that helps achieve needed results
Significant and promising global awareness
La recherche avance, la vie progresse. 22
ConclusionsConclusions
Therefore, any successful initiatives must include:
– Political will– Partners– Infrastructure to get the medicines to patients– Physicians training and patient education– Proper diagnosis & dispensing– Quality control– Proper dispensing– Monitoring of outcomes