1. Facilitating Vaccine Innovation and Access to Address Global Health Needs Mark Feinberg, MD, PhD Merck Vaccines Global Vaccines 202X: Access, Equity, Ethics May 4, 2011

2. Merck’s commitment to vaccine access in GAVI-eligible countries We will provide our vaccines as affordably as we can, with a focus on public health benefit and not profit in GAVI countries* We will work to lower the price of our vaccines as much as we can, and to optimize the presentation of the vaccine to best meet the needs and implementation realities of low income countries* We will work in close partnership with countries, donors, international organizations, NGOs and others to demonstrate the feasibility of introduction, to document the attendant public health impact and to communicate the value of new vaccine introduction* * We cannot achieve any of these goals by ourselves. For us to be able to contribute most successfully, we need strong partner engagement, clarity concerning donor support, and meaningful vaccine demand projections

3. Merck is committed to addressing key unmet global health needs Licensed products that directly address: Rotavirus gastroenteritis HPV infection and cervical cancer Examples of developmental programs: Pneumococcal pneumonia Dengue HIV Malaria Novel and Optimized Vaccines Specifically Designed to Meet Developing World Needs: MSD-Wellcome Trust Hilleman Laboratories

4. The Challenges Facing New Vaccine Introduction Efforts Far too many children die each year in developing countries from vaccine preventable illnesses Historically, new vaccines have reached those living in developing nations only after unacceptably long delays Immunization rates even for older, now inexpensive vaccines are undesirably low in many countries—a marker of insufficient infrastructure Lack of knowledge about specific link between a specific pathogen and associated country-level morbidity and mortality Competing health needs Insufficient political will Need to provide evidence for what is possible, and for the benefits to be realized by new vaccine introduction

5. Global Rotavirus Mortality Legend: 1 2 3 4 >10 Deaths / 1000 Births 5-10 Deaths / 1000 Births 1-5 Deaths / 1000 Births <1 Death / 1000 Births Latin America and the Caribbean Rotavirus deaths: 16,000 Sub-Saharan Africa Rotavirus deaths: 189,000 South Central Asia Rotavirus deaths: 179,000 Source: Estimate based on 2005 birth cohort and rotavirus mortality estimates from “Global Illness and Death Caused by Rotavirus Disease in Children," Emerging Infectious Diseases, 5 /03. Glass R.I. Bresee J.S., Parashar U.D., Miller M.A., Hummelman, Erik G. Pacific Rim Rotavirus deaths: 55,000 ~ 600,000 children die each year from rotavirus gastroenteritis

6. Merck – Nicaraguan Ministry of Health RotaTeq Partnership Objectives –Demonstrate the public health impact of implementing a full rotavirus vaccination program in Nicaragua –Reduce the delay in introducing a new vaccine into a GAVI- eligible country Time frame –November 2006 – November 2009 Merck’s role –Supplied RotaTeq for 3 years (~1.3 million doses) at no cost –Provide assistance in administrative, training and logistical aspects related to an expansion of the national immunization calendar, strengthening local rotavirus surveillance networks, and assess public health benefit post-vaccine introduction RotaTeq® shown to be highly effective in routine use in Nicaragua (in PAHO/CDC and Merck-NIC Ministry of Health vaccine effectiveness studies), and Nicaragua promptly achieved highest rates of rotavirus vaccination in the world http://www.homefront.tv/media/I0033/video/I0033_Rotavirus_Davos_2010_0125.wmv

7. Bangladesh Vietnam 1136 Subjects 900 Subjects Ghana Mali 1960 Subjects 2200 Subjects Kenya 1309 Subjects Worldwide >527,000 deaths/year due to rotavirus, predominantly in Africa & Asia Merck’s rotavirus vaccine (RotaTeq) shown to be highly efficacious in industrialized countries WHO recommended that efficacy data in Africa & Asia be generated prior to introduction Clinical trials to assess efficacy, safety & immunogenicity of RotaTeq in GAVI countries in Africa & Asia initiated in 2007 Study results provided support for global WHO pre-qualification and SAGE recommendation for rotavirus vaccine Rotavirus Vaccine Program: Clinical Trials in Africa and Asia

8. Global Cervical Cancer Mortality Latin America and the Caribbean Cervical cancer deaths: 25,000 Africa Cervical cancer deaths: 26,000 South Central Asia Cervical cancer deaths: 87,000 Whosis Statistical Database, 2002. South East / East Asia Cervical cancer deaths: 56,000 Legend: 1 2 3 4 > 15 deaths / 1000 births 10-15 deaths / 1000 births 5-10 deaths / 1000 births < 5 deaths / 1000 births Cervical Cancer Deaths: ~270,000 per year

9. Consequences of a 10 year delay in HPV vaccine introduction 3 -5 million more cervical cancer cases *, most resulting in death 10 million or more children will lose their mothers, and 1-3 million would under age 18 Lost productivity costs approach 5 billion dollars Missed opportunity to build platform for delivering other live- saving and life-improving adolescent health services Sue J. Goldie et al, 2010, submitted * Depending on vaccination coverage rates achieved

10. In 2007, Merck made a commitment to donate at least 3 million doses of GARDASIL ® to organizations and institutions in developing countries, where approximately 80% of the world's cervical cancer cases occur –The GARDASIL Access Program enables applicants from eligible lowest income countries to gain operational experience in the design and implementation of human papillomavirus (HPV) vaccination projects, with the goal of supporting the development of successful child and adolescent immunization models The program is managed by Axios Healthcare Development, a U.S. non-profit organization, with strategic guidance provided by the independent GARDASIL Access Program Advisory Board, comprised of international public health experts As of 1st April 2011: –The Advisory Board has recommended, and Axios subsequently approved, applications from 23 organizations and institutions in 20 countries. –More than 1M doses of GARDASIL have been approved by Axios for donation to these 23 participants, enough to vaccinate >349,000 girls –More than 665,600 doses of GARDASIL have shipped to 15 participants in support of their HPV vaccination projects in 14 countries: Bhutan, Bolivia, Cambodia, Cameroon, Georgia, Ghana, Haiti, Kiribati, Lesotho, Moldova, Nepal, Tanzania, Uganda and Uzbekistan GARDASIL ® Access Program

11. Bhutan Gardasil Immunization Program On May 5, 2010, Bhutan became the first GAVI country to implement a national HPV vaccination program Partnership between the Royal Government of Bhutan, Merck and the Australian Cervical Cancer Foundation Vaccine offered to all appropriate 12 to 18 year old girls and young women To date, > 90% of eligible girls have initiated vaccination series, and of these 3-dose series completion rates have been >97% Merck is working with the Royal Government of Bhutan to ensure that the program is sustained past the duration of the donation period http://www.merck.com/newsroom/news-release- archive/corporate-responsibility/2010_0505.html

12. Shared Vision: Reduce the burden of cervical cancer in developing countries with a comprehensive approach that integrates vaccination, screening and treatment First time a vaccine manufacturer and a molecular diagnostics company are collaborating on an integrated approach –Merck will provide at least 5 million doses of GARDASIL, and Qiagen will provide 1.5 million HPV DNA tests to support this initiative Leverages 2 breakthrough and complementary advances in health care, and promotes development of national comprehensive cervical cancer prevention programs –Merck’s cervical cancer vaccine –Qiagen’s HPV tests, the digene HPV test and a new test (CareHPV) developed for use specifically in resource-limited settings –Mobilization of resources to deliver treatment for women found to have cervical cancer or its precursors Partners have engaged the governments of select GAVI-eligible countries to explore their interest in and commitment to implementing national cervical cancer reduction programs Merck and Qiagen Collaboration Facilitating Comprehensive Cervical Cancer Prevention Programs

13. Rwanda Comprehensive Cervical Cancer Prevention Program On April 26, 2011, Rwanda became the first country in Africa to initiate a nationwide HPV vaccination program, and the first country in the world to have such a comprehensive, integrated cervical cancer prevention program (involving vaccination, screening and treatment) In support of the Government of Rwanda’s efforts, Merck will donate 2 million doses of GARDASIL over 3 years to vaccinate all appropriate girls aged 12-15, and Qiagen will donate 250,000 HPV DNA tests Exceptionally high rates of vaccination coverage achieved within the first week of the program Merck has worked with the Government of Rwanda to ensure sustainability of the program following completion of the donation period

14. MSD-Wellcome Trust Hilleman Laboratories: Working to Facilitate New Collaborative Models in Global Health R&D Many promising research concepts do not reach those who need them the most New models of public and private engagement are needed to meet the opportunities and challenges of product development for developing world populations Merck and the Wellcome Trust, working together and with other partners, can help meet these needs Leverage Merck’s strengths in vaccine discovery and product development Leverage the Wellcome Trust’s strengths in understanding the needs of the developing world and supporting research of relevance to the DW Attract a broad range of potential partners Encourage innovation, transparency and sustainability for a long term impact

15. MSD Wellcome Trust Hilleman Laboratories First of Its Kind JV to Develop Affordable Vaccines for Low-Income Countries Marks the first time a research charity and a pharmaceutical company have partnered to form a separate entity with equally shared funding and decision- making rights Create a sustainable R&D organization; operates like a business, but with a not- for-profit operating model, to specifically address the vaccine needs of low income countries –Linking the ingenuity of academic research with the know-how of industry The Wellcome Trust: strong track record in global public health and biomedical research Merck: expertise in the development and delivery of vaccines –Developing new vaccines to meet unmet medical needs in low income countries, as well as working on optimization of existing vaccines to be better suited for impact in resource- limited settings Merck and the Wellcome Trust will invest equally in the R&D JV –Combined cash contribution of 90MM GBP (~US$145MM) over the next seven years –A staff of ~60 researchers and developers Based in India, operations now underway

16. MSD Wellcome Trust Hilleman Laboratories Operating Model Responsible Research Institutions and Biopharmaceutical Companies Low Cost Manufacturers (LCM) Basic Research Target ► Lead Candidate Early Development Lead ► Proof of Concept Late Development, Manufacturing, and Distribution MSD Wellcome Trust Hilleman Laboratories DonorsAcademic Global HealthCivic Societies andDeveloping World InstitutionsAuthoritiesDelivery ExpertsResearch Institutions Vaccine Development Cycle Beyond providing technical expertise, Hilleman Laboratories will establish the strategies and partnerships needed to develop and deliver vaccines to low-income countries. Stage

17. Some concluding thoughts Merck is committed to developing vaccines for unmet medical needs worldwide, to working to ensure that our vaccines reach those who need them most, and to collaborating with capable partners to achieve these goals Unprecedented global attention to public health, philanthropic support and new financing mechanisms have created a more favorable environment for vaccine innovation, but barriers to access still remain Strong partnerships with NGOs, governments, donors and international organizations are vital to overcome these barriers and to: – Understand and anticipate global health priorities so that the right products at the right prices are developed and delivered where and when they are needed –Reduce barriers to new product development and market introduction –Enhance research and healthcare infrastructure –Provide reliable demand forecasts and stable financing to create predictable, sustainable vaccine markets, and realize economies of scale necessary to further improve vaccine affordability