Bridging the Gap in Global Health: Innovation for Malaria Management and Access to Medicines

1. Oxford Conference on Innovation and Technology Transfer for Global HealthBridging the Gap in Global Health Innovation – From Needs to AccessUniversity of Oxford9-13 September 2007 Robert L. Mallett Senior Vice President Pfizer Inc Worldwide Public Affairs & Policy

2. A Comprehensive Approach to Malaria Management – Targeted and Needs Driven Private/Public Research Collaboration (TDR) Training and Capacity Building (IDI) Cross Disciplinary People Resources and Expertise (Global Health Fellows) Quality Manufacturing / Secure Distribution Process – Senegal Targeted Development (Zithromax / Chloroquine FDC) Public Health Interventions (Africa)

3. Compounds Access to over 3 million compounds Libraries of interesting drugs Antiparasitic classes Known drugs and mechanistic actives Medicinal Chemistry and Biology Expertise Selecting the best compounds for follow up – AH parasitology + HH Directing lead optimisation, e.g., input on likely toxicity, pharmacokinetics, etc. Support for HTS development Genomics and targetselection expertise Training and supervision forpost-Docs Pfizer / WHO – Tropical DiseaseResearch Partnership What WHO-TDR Brings What Pfizer Brings • Expertise • Tropical parasitology • Desired target product profiles • Screening Capability • Whole organism in vitro and lab animal in vivo screens • New mechanistic targets for high throughput screens • Funding for FTE Support • Chemists to follow up hits and lead optimisation • Biologist for HTS development and implementation • Genomic work aimed at new target identification

4. Medicines in the Pipeline: Zithromax/Chloroquine: Targeting Preventive Therapy in Africa Phase 2 Conclusions Burkina Faso Mali Ghana India • Regional efficacy differences observed • Excellent response in Africa • Dose-response seen in India and Colombia • Combination well tolerated Suriname Colombia Kenya Zambia Uganda Indonesia * Submit for Regulatory Review Submit for Regulatory Review Confirmatory Adult Treatment Trialin Africa Pediatric Treatment Trial in Africa + + * * Clinical Trial: Intermittent Preventive Therapy in Pregnancy (IPTp) Clinical Trial: Intermittent Preventive Therapy in Infants and Children (IPTi/c) * With External Consultation

5. Manufacturing & Distribution Program • Pfizer Facility, 100% owned by Pfizer • Location: Dakar, Senegal in the Free Tax Area (ZFID) • Exclusively dedicated to Anti-Malarial products • Ensures secure distribution chain/All products distributed to Private Wholesalers and the Public Sector (through tenders) in 19 countries • Now being upgraded and awaiting WHO PQS inspection • GMP certified by Senegal authorities

6. Infectious Disease Institute • Joint Uganda Malaria Training Program (JUMP) • An AAF/IDI and ExxonMobil Malaria Initiative • JUMP was established as a partnership between the Infectious Diseases Institute (IDI) and the Uganda Malaria Surveillance Project (UMSP). UMSP is a collaboration between academic institutions and the Ministry of Health in Uganda with the aim to create a scalable training model for Uganda and other countries. • JUMP takes an innovative approach to training healthcare professionals in improved malaria prevention, diagnosis and treatment, by working directly with entire treatment teams at the health facility level and by building the skill sets of all clinic professionals, from medical officers to data entry clerks.

7. Summary of Malaria Epidemiology inGhana, Senegal and Kenya Ghana: Malaria is the LeadingCause of Death Senegal: Malaria is the Largest Contributor to Mortalityand Morbidity Kenya: #1 Killer Among Children, Concentrated in the Coast andin the West • Malaria accounts for 44.5% of all out patient illness • 100% of the population is atendemic risk • Malaria incidence is 170/1,000 population, the highest among the three assessed countries • Deaths under 5: at 33%, the highest among the three assessed countries • ACTs were introduced in Ghana in 2006, and the rollout is lagging behind GFATM targets • Transmission is seasonal in most of the country, and lasts throughout the year in the south eastern part ofthe country • Accounts for 35% of patient visits • 20% of cases reported are severe • Wide epidemiological diversity across environments (Northern Sahel, North Coast, Senegal river valley, Southern Sudan-Sahel) • Deaths have been previously documented at 8,000 per year, though current estimates dropped to 3,000 per year • Senegal has led West Africa intrials of IPT in children for seasonal malaria • 20 million people at risk of malaria • 30% of outpatient visits and 19%of hospital admissions attributed to malaria • #1 killer among children • Highly variable risk of malaria across diverse environments: • Endemic • Highland • Arid • Low-risk

8. Public Health Interventions –Pfizer’s “Mobilize Against Malaria” Initiative

9. Metrics to Determine Progress and Success • Principal Evaluation Partner: London School of Hygiene and Tropical Diseases • Reduction in the rate of malaria morbidity and mortality by improving malaria symptom recognition, treatment and referral • % increase of children who took anti-malarial drugs • % increase in number of caretakers seeking treatment for feverish child • % increase of informal outlet providers who supply adequate treatment • % increase of informal outlet providers who provide correct diagnosis, malaria treatment compliance information and referrals (in case of severe malaria) • # of patients adhering to treatment • Infrastructure Strengthening • Sustainable programs • Strengthening a substrate relevant for other disease interventions • Positive reinforcement from patients in Kenya, Senegal and Ghana

10. Familiar Challenges ofHealthcare in the Developing World • Lack of government commitment for effectivehealthcare delivery • Lack of healthcare capacity and healthcare worker training • Lack of financial sustainability of healthcare systems • Weak medical and regulatory systems • Lack of technical capacity for clinical trials • Concerns re. placebo-controlled clinical trials inepidemic situations • Public distrust of the clinical trials process • Private sector still not viewed as a natural partner

11. Practical Realities of Private Sector Health Interventions in Developing Countries • Difficult to Identify Clusters of Trained Investigators for Clinical Trials • Getting Physicians to Encourage Patient Participation • Patient Consent Issues/Maintaining Patient Participation • Quality Records Retention and Management • Understanding the Need for Double Blind Placebo Based Studies • Assuring the Integrity of the Supply Chain for Medicines • Weak Point of Sale Quality Regulation • Limited Regional Program Evaluation Capacity • Continuing Distrust of the Role of the Private Sector in Healthcare Delivery Across the Continuum • Balancing Shareholder Fiduciary Responsibilities with Social Obligations