dr pierre le sourd leem president

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


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


Diarrhoeal Diseases

Effective, low cost vaccines


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


Malaria

Oral rehydration therapy at 10 cents per

treatment


Diarrhoeal Diseases

Effective, low cost vaccines


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


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


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



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



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



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


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



Drug resistance is widespread:Drug resistance is widespread:the example of Malariathe example of Malaria

Chloroquine resistance

Sulfadoxine-Pyrimethamine resistance






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


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.


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



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


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






Laboratorios Gador





VestarWyeth


Zentaris

ACF BeheerBayer AG






Laboratorios Gador

ACF BeheerBayer AG






Laboratorios Gador

ACF BeheerBayer AG






Laboratorios Gador





VestarWyeth


Zentaris





VestarWyeth


Zentaris





VestarWyeth


Zentaris

67 disease control tools developed

Of which 38 in use in disease control initiatives


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



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


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



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


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

dr pierre le sourd leem president

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