Dr Pierre Le Sourd Leem President

1. MEDICINE AND HEALTH IN THE TROPICSPlenary Session 3« The Pharmaceutical Industry’s R&D Drive and the issue of Tropical diseases »13 of September 2005 Dr Pierre Le Sourd Leem President

2. The 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 TDR Disease Category: 1 – « Emerging or uncontrolled disease » 2 – « Control strategy available, but disease burden persists » 3 – « Control strategy effective / Elimination planned » Source: World Health Report, 2004 * DALYs - Disability Adjusted Life Years (the number of healthy years of life lost due to premature death and disability)

3. What is the Pharmaceutical Industry doing about it ?Drug Companies part of the solution instead of the issue

4. Medicines existbut don’t reach the patients in need • Most essential medicines are off-patent and inexpensive;however over 50 % of populations in Least Developed Countries lack regular access to these products Source: IFPMA, Septembre 2004

5. 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

6. Successful interventions supported 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

7. Successful interventions supported 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

8. Successful interventions supported 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

9. Successful interventions supported 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

10. New or improved treatments needed Source: IFPMA, Septembre 2004

11. Drug resistance is widespread:the example of Malaria

12. 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

13. 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.

14. Establishment ofDedicated Research Centers Source: IFPMA, Septembre 2004

15. Creation 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

16. Public-Private Partnerships development (1) • TDR – The Special Program for Research and Training in Tropical Diseases - and its Industry Partner: a long and fruitful collaboration

17. Public-Private Partnerships development (2) • Examples of Product Development PPPs for Neglected diseases Source: IFPMA, Septembre 2004

19. FAC Project: an innovative partnership 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

20. Results: a growing R&D pipeline Source: IFPMA, Septembre 2004

21. Conclusions • 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

22. Conclusions • 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