An update on Crucell s Corporate Social Responsibility program July 2012. Passion. for. protection. www.crucell.com



Similar documents
Crucell Operational Excellence: Healthy Ambition

HSA Consumer Guide. Understanding Vaccines, Vaccine Development and Production. November How a Vaccine Works.

CANADA S VACCINE INDUSTRY COMMITTEE

Bringing innovation to global health. Crucell 2010

Plan early - get your vaccinations in time for full protection. To prepare for your trip, schedule an appointment: (910) , option #2.

Vaccination: It s what your child would choose. Your guide to childhood vaccinations.

AB Volvo, Göteborg, Sweden. Ref No , August The Volvo Way

Tuberculosis OUR MISSION THE OPPORTUNITY

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

DEVELOPING WORLD HEALTH PARTNERSHIPS DIRECTORY

University Health Services Information Guide Student Services Building healthyhorns.utexas.edu

Preparing for and responding to influenza pandemics: Roles and responsibilities of Roche. Revised August 2014

GSK Vaccines: Easing Compliance with SAP Process Control

Caring, one person at a time.

Corporate Social Responsibility: Implications for Human Resources and Talent Engagement

We d like to do the same for you. Owen J. Sullivan CEO, Right Management President, Specialty Brands ManpowerGroup

Optimizing vaccine supply chains

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K. GEOVAX LABS, INC. (Exact name of registrant as specified in its charter)

Adult Vaccination Frequently Asked Questions: The Basics

Human Infl uenza Pandemic. What your organisation needs to do

Since achieving independence from Great Britain in 1963, Kenya has worked to improve its healthcare system.

Seven Key Reasons Why immunization must remain a priority in the WHO European Region

Pentavalent Vaccine. Guide for Health Workers. with Answers to Frequently Asked Questions

Strategic Plan. Creating a healthier world through bold innovation

Strategic Executive Coaching: An Integrated Approach to Executive Development

Policy on Philanthropic Donations and non-commercial Sponsorship

5/11/2015. Seven Benchmarks of a Successful Worksite Wellness Program. Benchmark #1 Capturing Senior Level Support

The. for DUKE MEDICINE. Duke University School of Medicine. People

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

2 P age. Babies from Birth to Age 2

THE UNIVERSITY ON NAIROBI STRATEGIC PLAN,

Multiple Choice Questions

Frequently asked questions about whooping cough (pertussis)

Join our scientific talent community

An Enterprise Resource Planning Solution (ERP) for Mining Companies Driving Operational Excellence and Sustainable Growth

Uncover the Best Ideas

2 months Diptheria; Tetanus; Whooping Cough; Hib & Polio 1st dose Pneumococcal Conjugate Vaccination

Vaccinations and Spina Bifida and Hydrocephalus

Solving for the Future: Addressing Major Societal Challenges Through Innovative Technology and Cloud Computing

Up to $402,000. Insight HIV. Drug Class. 1.2 million people in the United States were living with HIV at the end of 2011 (most recent data).

SIXTY-SEVENTH WORLD HEALTH ASSEMBLY. Agenda item May Hepatitis

Frequently Asked Questions (FAQs)

GENERAL INFORMATION. Hepatitis B Foundation - Korean Chapter Pg. 3

Crucell 2007 Combating infectious diseases

The Challenge of Whooping Cough:

2015 Annual Convention

Open Innovation: An Imperative for the Pharmaceutical Industry. Berkeley Innovation Forum

Health, history and hard choices: Funding dilemmas in a fast-changing world

cambodia Maternal, Newborn AND Child Health and Nutrition

Our communities. We engage our people to meaningfully contribute to our communities.

UNIVERSITY OF MIAMI SCHOOL OF BUSINESS ADMINISTRATION MISSION, VISION & STRATEGIC PRIORITIES. Approved by SBA General Faculty (April 2012)

Building on Success: A National Strategy to Save Lives

career in the Production

NO MORE MISSED MDG4 OPPORTUNITIES: OPTIMIZING EXISTING HEALTH PLATFORMS FOR CHILD SURVIVAL. Polio Campaigns

DRAFT. CUNY Pandemic Influenza Response Plan Incident Level Responsibilities

Business model innovation as a response to increased competition in the energy sector

Parent s Guide to CHILDHOOD IMMUNIZATIONS

Link Sustainability to Corporate Strategy Using the Balanced Scorecard

HUMAN SERVICES MANAGEMENT COMPETENCIES

IKEA case study SWOT analysis and sustainable business planning

Procurement must be more than just cost cutting

The NIH Roadmap: Re-Engineering the Clinical Research Enterprise

Influenza Vaccine Frequently Asked Questions. Influenza Control Program

_experience the commitment TM. We deliver. responsibly

Chapter 3. Immunity and how vaccines work

Medical Management Plan Togo

What is whooping cough. (pertussis)? Information and Prevention. Ocument dn

Immunization Infrastructure: The Role of Section 317

Information on Measles and Whooping Cough: Vaccination and Disease

Case Study. Reduction Story. Clay Nesler Vice President, Global Energy & Sustainability. Steve Thomas Manager, Energy & Sustainability Communications

The EU role in global health QUESTIONNAIRE: Question 1 Question 2 Question 3: Question 4: Question 5:

Targeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia EXECUTIVE SUMMARY. New England Healthcare Institute

MSD Information Technology Global Innovation Center. Digitization and Health Information Transparency

Renault-Nissan CSR Guidelines for Suppliers

Editorial. Yves Levy, Executive Director

It takes a planet: global implications/consequences of local vaccine refusal

UCSF Clinical Enterprise Strategic Plan

PARTICIPATORY ANALYSIS

Immunity and how vaccines work

Health in the 2030 Agenda for Sustainable Development

Key Facts about Influenza (Flu) & Flu Vaccine

Viral hepatitis. Report by the Secretariat

SCP Issues for Business and Industry

NEA Leadership Competencies Guide

Recruitment and Selection

Valneva Reports Preliminary FY 2013 Revenues of EUR 36.0m and Cash Position of EUR 40.2m at End of 2013

Vaccination against pertussis (Whooping cough) for pregnant women Information for healthcare professionals

Early Lessons learned from strong revenue cycle performers

Polio and the Introduction of IPV

THE L ORÉAL SUSTAINABILITY COMMITMENT

Introduction. 1. General outline. 1) Position of the Healthcare Policy. 2) Basic principles of the Healthcare Policy (Article 2 of the Promotion Act)

Attribute 1: COMMUNICATION

HEALTH SYSTEM. Introduction. The. jurisdictions and we. Health Protection. Health Improvement. Health Services. Academic Public

Max Foundation plan

Helene D. Gayle, President and CEO, CARE USA

Best Practices in Strategic Planning

2019 Healthcare That Works for All

INVESTORS IN PEOPLE REVIEW REPORT

SYRACUSE UNIVERSITY: ACADEMIC STRATEGIC PLAN

School of Project Management

Transcription:

An update on Crucell s Corporate Social Responsibility program July 2012 Passion for protection www.crucell.com

2 Passion for Protection: Crucell s Corporate Social Responsibility Program

3 Contents About Crucell 6 Our CSR policy 8 Performance 12 People 25 Planet 32 Philanthropy 36 Images of hope 46 Appendix 51 Crucell welcomes feedback on this report and issues related to our CSR activities. Reactions can be sent to csr@crucell.com Our social responsibility Crucell has always been a company with a deep commitment to society. Our mission is to protect people from infectious diseases by bringing innovative vaccines and antibodies to all who need them. At the same time, we work in other ways to help make the world a better place. Crucell strives to be a good employer and business partner, to respect the planet and to reach out to communities with knowledge and expertise as well as material support. Our commitment Several years ago, Crucell set up a special global program focusing on good corporate citizenship. We call it our corporate social responsibility (CSR) program. Its goal is to maximize our contribution to society and minimize our impact on the environment. Employee engagement, accountability and transparent reporting are key elements of this initiative. In this report, we share highlights from our CSR program during 2011 and outline the way forward this year. An ongoing journey Those of you who have seen our previous annual CSR reports will notice a new approach this year. We have opted for a more informal style of reporting. As the center of excellence for vaccines within the Janssen Pharmaceutical Companies of Johnson & Johnson, we anticipate that the ways we measure CSR progress may change in the future. What will remain is the spirit that has inspired this initiative and, indeed, everything we do as a company dedicated to bringing innovation to global health.

4 Passion for Protection: Crucell s Corporate Social Responsibility Program

5 A meaningful difference We are proud to present this report on Crucell s CSR program during 2011. As relative newcomers to Crucell, we are struck by the breadth and depth of the program, and impressed by the way employees are bringing it to life. One example is Crucell s community outreach initiative called Footprint. This is a program that gives teams of Crucell volunteers the chance to visit disadvantaged communities where Crucell is helping to make a difference to people s lives. The photo reportage on pages 46 50 shares the experience of one of these teams. In this reportage, we follow the volunteers to the remote areas of Bangladesh, where they learn what vaccines and clean water mean to people who had been living without these basic necessities. We see the same spirit at work in Korea, where teams of Crucell volunteers give up free time to create clean, safe homes for people living in urban squats not far from the Crucell factory in Incheon. Meanwhile, our Government Affairs & Public Health representatives are working with policy makers at the national, regional and global levels to improve access to essential healthcare. On page 43 you can read about what they have been doing to address the cholera crisis in Haiti, for example. Crucell s worldwide team of Environment, Health and Safety (EHS) managers is making good progress with raising safety awareness in our organization, as well as aligning with Johnson & Johnson standards. The appointment of a Crucell Health Care Compliance Officer, supported by Johnson & Johnson s extensive resources in this field, will help to safeguard good business conduct as we grow. During 2011, Crucell employees achieved important advances in discovery and product development, several of which are highlighted in this report. Significant investments in Crucell s research and development capabilities, quality assurance systems and production facilities were initiated. The full social significance of these investments will only be felt years down the track, as Crucell brings a new generation of vaccines to market. Crucell s CSR program is a natural extension of Crucell s mission to make a meaningful difference to global health. We dream of helping to eradicate polio. Of transforming the prevention and treatment of influenza. Of contributing to the prevention of HIV/AIDS. Of helping the world deal with tuberculosis and malaria. Joining the Johnson & Johnson Family of Companies in February last year has given us additional resources and support to try to realize at least some of these dreams. The seeds of this future are being sown now, day after day, by Crucell employees around the globe. This report testifies to their passion and commitment to make the world a better place. That is what Crucell s CSR program is all about. Johan Van Hoof and Bart van Zijll Langhout, Managing Directors of Crucell

6 Passion for Protection: Crucell s Corporate Social Responsibility Program Business with a warm Crucell is a global biopharmaceutical company heart dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from major health threats. Crucell s specialty is fighting infectious diseases a growing healthcare challenge. Crucell strives to do business with a warm heart and a cool head, generating sustainable profit in order to continue to innovate and give back to society. Our corporate mission reflects a deep sense of responsibility to the people who live on our planet more than 7 billion today, and counting. Protecting the health and well-being of these billions of individuals is more important and difficult than ever before. That s because trends such as climate change, globalization, urbanization, wider travel and population aging are presenting new opportunities for viruses and bacteria to thrive and spread. Vaccines and antibodies Vaccines and antibody products are complementary approaches to immunization. A vaccine can induce lasting protection sometimes for a lifetime against an infectious threat, whereas an injection of antibodies provides immediate protection but only for a limited period of time (weeks or months). Different infectious diseases or different circumstances call for different approaches. For example, a universal influenza vaccine could protect a person against the flu for life, whereas an influenza antibody product would be invaluable in a pandemic situation. The antibody approach would also help the elderly, who are especially hard hit by flu and less well protected by the flu vaccine than younger people. That s because the immune system deteriorates with age. Immunization is one of the most promising strategies for tackling this problem. It comes in two main forms: vaccines that safely and effectively mobilize the body s own immune defenses against infections, and antibodies that provide ready-made immune protection against invading microbes. Each has its own special role (see box). Crucell s vaccine and antibody researchers are working on innovative immunization products to fight tuberculosis, malaria, HIV/AIDS, influenza, rabies, polio and several other diseases that are high on the list of global health problems. Meanwhile, we are already combating a dozen major infectious threats with our range of marketed vaccines against paediatric, respiratory, and travel or endemic infections. Though infectious diseases don t stop at borders, they home in on poverty and congregate in underdeveloped communities. So the tools to fight them must be afford able and accessible for all. After clean water, immunization is believed to be the most cost-effective health intervention there is, and its key role in promoting socioeconomic development is increasingly being documented. 1 Crucell wants to take this benefit further. That is one reason why we have invested in innovations such as our proprietary PER.C6 human cell-line technology, which promises to enable vaccines and therapeutic proteins (such as antibodies) to be produced in virtually unlimited quantities, much faster and more cheaply than traditional manufacturing methods allow. 1 See references cited on the GAVI Alliance website: http://www.gavialliance.org/about/value

7 Our stakeholders Crucell s efforts to bring significant benefit to the lives of people worldwide involve constructive interaction with many different stakeholders. Here is a short list of examples.* Crucell employees: almost 1700 individuals worldwide, united by a shared dream for global health. Colleagues in other Janssen Pharmaceutical Companies. Legislators such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and national regulatory authorities. Policy makers: World Health Organization (WHO), Pan American Health Organization (PAHO), GAVI Alliance, and many more. Business partners: DSM Biologics, Novartis, GlaxoSmithKline and Pfizer. Non-profit and academic organizations and government institutions such as Aeras, US National Institutes of Health, IAVI, Harvard University and PATH. Customers: Supranational purchasing organizations such as UNICEF (on behalf of developing countries); public and/or private health organizations in developed countries; physicians and pharmacists. Consumers: All the people worldwide who use our products and participate in clinical trials of our candidate products. *Status at the end of 2011

8 Passion for Protection: Crucell s Corporate Social Responsibility Program Crucell s CSR policy is a natural extension of our mission to bring innovation to global health in ways that make a meaningful difference to the lives of people worldwide.

9 Taking responsibility Social responsibility is built into the DNA of our organization. But we are conscious of the need to nurture this spirit. As our business expands in line with our ambitions, our impact on the world will increase. Achieving the optimal balance between the benefits we bring to society and the resources we consume will be an ongoing challenge. Crucell s CSR program is a concerted effort to meet that challenge through proactive planning and review. Crucell recognizes four key responsibilities to society and has drawn up a global CSR policy to help all employees work together to meet these responsibilities. The policy is built around a structure we call the 4P framework. This defines the four main ways in which Crucell strives to be a good corporate citizen and contribute to society. Performance First and foremost, we see a responsibility to perform at our best as a business bringing innovation to global health. People We want to take care of the people we work with, inside and outside the company. Planet We strive to care for the planet by minimizing our environmental footprint while maximizing our beneficial impact on global health. Philanthropy We take on the responsibility to do more for society than we must do from a business point of view. The four categories of Performance, People, Planet and Philanthropy are each further subdivided into a number of related themes or responsibilities. These are shown in the figure on the next page.

10 Passion for Protection: Crucell s Corporate Social Responsibility Program Performance Saving lives Innovation Responsible supply chain Transparency People Responsible employer Health & safety Business conduct Planet Philanthropy Contributing to science Access to healthcare NGO partnerships Community outreach Emissions to air Emissions to water Consumption Recycling

11 A dynamic framework Themes can be added or subtracted over time, as this is a dynamic framework. For example, participating in CSR-related sector initiatives such as the Dow Jones Sustainability Index was a priority for Crucell when it was listed on the stock exchange. We are no longer participating in such initiatives independently but as the center of excellence for vaccines within the Janssen Pharmaceutical Companies of Johnson & Johnson. Intersections The 4P classification system is somewhat artificial, as there is considerable overlap and interdependence among the P-categories and their component themes. However, it serves as a useful reminder of the many different facets of our CSR program and provides a clear overview of what Crucell stands for, as a socially responsible company. Adding value A practical advantage of the 4P framework is that it breaks the task of CSR development and reporting into manageable portions. Early in 2010, one or more leaders ( P-owners ) were appointed for each P-category. They have taken real ownership for progress in their area, providing crucial inspiration and direction as well as coordinating the flow of information. This approach fosters transparency, clarity and focus, which helps the P-owners in consultation with top-level management to define realistic but challenging targets for the coming years. This step is vital for achieving the continuous progress we strive for and ensuring that our CSR strategy delivers tangible benefits for society. Adding real value is our goal. Social responsibility is built into Crucell s DNA. Our CSR program is designed to bring this to full expression. Measuring outcomes Key performance indicators (KPIs) have been defined for each of the four P-categories and their component themes. Coupled to targets, they serve as measures of how well we are living up to our corporate social responsibilities and goals. Like the 4P framework itself, the KPIs can change over time to reflect the evolution of the company and our approach to CSR. The KPIs and targets used in 2011 are shown in the Appendix. Organization A CSR Working Group comprising the P-owners and several Crucell employees with a special advisory role was established in the first quarter of 2010. It is a diverse group of senior managers from different functional areas and Crucell sites. Members of the CSR Working Group gather information from all levels and parts of the organization. They also initiate improvements with support and advice from Crucell s Management Committee. The CSR Working Group meets quarterly to discuss progress and formulate plans for the future. These meetings are chaired by Crucell s top management, reflecting the importance we place on good corporate citizenship.

12 Passion for Protection: Crucell s Corporate Social Responsibility Program Optimizing performance The P-category we call Performance embraces four social responsibilities that we see as being central to our core business and our mission: saving lives, innovation, responsible supply chain management and transparency, by which we mean the responsibility to evaluate and report on our CSR activities.

Performance 13 Saving lives Crucell s licensed vaccines protect people around the world from a range of serious infectious diseases. They prevent illness, suffering and lasting disability. They save lives. Marketed products in 2011 Quinvaxem Fully liquid vaccine for protection against five childhood diseases Hepavax-Gene Recombinant hepatitis B vaccine Epaxal Junior Low-dosage, aluminium-free hepatitis A vaccine (0.25ml) MoRu-Viraten 2 Vaccine for protection against measles and rubella Epaxal Aluminium-free hepatitis A vaccine Vivotif Oral typhoid vaccine Dukoral Oral vaccine against cholera Inflexal V Virosomal adjuvanted influenza vaccine Every year, tens of thousands of babies born in the developing world have a much better chance of a future because they receive our combination vaccine against five serious childhood infections: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type B (Hib), a leading cause of severe pneumonia and meningitis. Meanwhile, Crucell s vaccines against hepatitis A, hepatitis B, typhoid fever and cholera safeguard children and adults living in areas where these diseases are endemic, as well as travelers to these regions. And year after year, our influenza vaccine helps at-risk people of all ages from as young as 6 months to avoid a disease with potentially life-threatening respiratory complications. In 2011, Crucell sold well over 107 million vaccine doses to protect people in more than 100 countries around the world. 1 Allowing for the fact that some vaccines inevitably go to waste, we can estimate that a Crucell vaccine was 1 Based on 2011 sales of all Crucell s marketed products. 2 MoRu-Viraten is no longer marketed. Global distribution of Crucell s Quinvaxem pentavalent vaccine in 2011

14 Passion for Protection: Crucell s Corporate Social Responsibility Program given to 200 1 individuals every minute during 2011. That s a thought that makes us proud though we are determined to reach even more people in the coming years. Expanding our reach Joining the Janssen Pharmaceutical Companies of Johnson & Johnson in February 2011 has opened up new opportunities for Crucell to deliver life-saving vaccines to all the people who need them. Janssen s commercial organization is truly global, with a presence in virtually every country around the world. To take advantage of this worldwide network, Crucell s local marketing and sales teams are progressively being integrated into the Janssen commercial organization. The transition began in Canada in September 2011. This marriage of Crucell s vaccine expertise with Janssen s commercial strength expands the reach of our vaccines within existing and new markets. This will enable us to save more lives and prevent more cases of serious disease. Increasing supply In order to meet growth in demand for Crucell vaccines, we need to build supply. Our goal is to produce more vaccine doses more quickly and efficiently, so that more people worldwide can receive the vaccines they need, when they need them. For several years, we have been working to expand 1 Number reflects sales volume of all Crucell s marketed products (minus 2% estimated wastage) divided by total minutes in 2011: 105,579,320 doses/526,600 minutes = 200 doses per minute. 107+ mln doses of Crucell vaccines were distributed in more than 100 countries in 2011. production capacity, boost productivity, reduce scrap and tighten quality assurance. Becoming part of the Janssen group has given Crucell access to additional expertise and financial support to step up these efforts. Looking ahead, Janssen resources will also be directed towards helping our organization solve supply constraints relating to raw materials, build capabilities for high-scale manufacturing and perform clinical studies to support the development of new markets. New packaging line takes shape Crucell s oral typhoid fever vaccine Vivotif comes in capsules, which are sealed in blister packs, boxed and packed for shipping at one of our production sites in Switzerland. Throughout 2011, a project team has been working on an investment project that will replace the current blistering and packaging equipment and transfer these operations to another Swiss site by 2013. All three packaging steps will be combined in a single line, greatly increasing speed and efficiency. Stateof-the-art automation and control features will improve operational safety and quality.

Performance 15 200 people received a Crucell vaccine every minute during 2011. New Korean facility fully commissioned Crucell s new manufacturing facility in Korea s Incheon Free Economic Zone started commercial manufacturing of Quinvaxem pentavalent vaccine on September 26, 2011, after the Korean Food and Drug Administration (KFDA) gave the green light. Later that month, the KFDA also approved the facility for production of Hepavax-Gene TF, Crucell s thiomersal-free hepatitis B vaccine. The new plant offers significantly greater production capacity and efficiency compared with its predecessor in Yongin City, Korea. The Incheon facility was approved by the regulatory authorities less than three years after construction work started a feat that testifies to the extraordinary commitment of Crucell employees.

16 Passion for Protection: Crucell s Corporate Social Responsibility Program What innovation means to us While our marketed vaccines are already making a significant difference to global health, we want to do much more. Ongoing innovation is the key to realizing this ambition. Crucell s broad research and development (R&D) pipeline currently includes 13 candidate vaccines and antibody products. All are based on Crucell s innovative proprietary technologies, which provide unique opportunities for combating major threats to human health. These threats include some of the world s most powerful and elusive killers, such as HIV/AIDS, tuberculosis and malaria. According to the latest statistics from the World Health Organization, 2.7 million people were newly infected with HIV and there were 1.8 million AIDS deaths in 2010. Tuberculosis was responsible for 1.4 million deaths and a staggering 8.8 million new cases of illness in that same year, while malaria afflicted 216 million people and caused 655,000 deaths mainly among children under five. 1 These enormous numbers highlight the importance and urgency of our vaccine research in these disease areas. Influenza is another field where we see a great need and potential for innovation. Every year, flu viruses make millions of people severely ill, claim between 250,000 and 500,000 lives, and burden society with considerable economic losses and healthcare costs. 2 The emergence of a lethal flu virus with pandemic potential could push the death toll into tens of millions. We are tackling these challenges by developing a new-generation seasonal flu vaccine based on our PER.C6 technology, which will overcome the many drawbacks of egg-based vaccine 133.0 mln R&D investment in 2011, up from 100.0 mln in 2010. production, while simultaneously working on revolutionary approaches to influenza prevention and treatment in the longer term. For the 70,000 people 3 (mostly children) who die of rabies each year, we are developing a monoclonal antibody (mab) product. A person bitten by a rabid animal can be saved by immediate injection of rabies antibodies and vaccine, both of which exist, but the blood-derived antibodies now available are in short supply and too expensive for most developing countries, where the need is greatest. Similarly, we are working with a great sense of urgency to develop a polio vaccine that will support the WHO s efforts to wipe out this ancient disease. Mass vaccination campaigns over the past 20 years have dramatically reduced the number of polio victims worldwide, but the poliovirus is fighting back. The WHO sounded the alarm in May 2012, warning that the world will see an explosive resurgence of polio cases undoing all the progress made unless the job of eradication can be finished. This cannot be achieved with the oral polio vaccine used in developing countries, which contains live-attenuated virus that can revert to a disease-causing form. Crucell s PER.C6 technology holds the key to delivering what the world needs: an inexpensive IPV (inactivated polio vaccine) in large quantities. Using this high-density cell culture process, we hope to be able to grow poliovirus cheaply enough to make IPV available to every child in the world. We don t stop innovating after bringing a new product to market. We look for opportunities to create further value, for example by simplifying administration. Our project to put one of our vaccines into Uniject is an example of this approach. (See page 21) 1 Source: World Health Organization reports for the year 2010. 2 Influenza (Seasonal) Fact Sheet, World Health Organization, 2009. 3 Global Alliance for Rabies Control, press release September 2011.

Performance 17 336 patents were granted to Crucell in 2011, compared with 220 in 2010 and 146 in 2009. Animal welfare These are just some of the ways in which Crucell is working on medical innovations that really matter for individuals and for the world. We strive to lead rather than follow, directing our energies and expertise towards finding and delivering creative solutions for tough health challenges. More information is available on the R&D section of our website. Healthy investment Crucell s investment in R&D climbed to 133.0 million euro in 2011, one-third higher than the 100.0 million invested in 2010. The increase continues the sharp upward trend seen since 2009, when R&D expenditure was 70.2 million. This healthy injection of funds to drive discovery and product development reflects Crucell s focus on innovation as a key driver for the advancement of global health, as well as the commitment of our new parent organization, Janssen. Before any candidate medical product can be given to humans, it must be rigorously tested in preclinical (non-human) models, in compliance with the regulations governing the development of new pharmaceutical products. Crucell performs animal testing to the minimum extent that is required by law and in accordance with the highest international standards, which are designed to prevent suffering and minimize any discomfort in the animals tested. Crucell applies the 3R principles Reduce, Refine and Replace to preclinical studies involving animal testing. For example, our scientists have been working for many years to replace animal tests with cellbased assays and these efforts have resulted in a significant reduction of animal testing. Cholera vaccine Crucell researchers in Sweden have substantially improved our ability to deliver Dukoral, Crucell s oral cholera vaccine. Thanks to innovation and the introduction of robust manufacturing processes, average yields of the active ingredient rctb increased by 20% in 2011. The higher productivity is sustainable in the long term. 589 employees were involved in R&D in 2011 compared with 440 in 2010.

18 Passion for Protection: Crucell s Corporate Social Responsibility Program Innovation in action We are making progress towards our vision of a healthier world. Over the next few pages we share a small selection of innovation highlights from 2011. Promising results from our HIV vaccine program Crucell s HIV vaccine researchers and collaborators are encouraged by the results achieved by their novel vaccine regimens in recent preclinical tests. These findings provide strong support for starting trials in humans. In the first week of 2012, the prestigious journal Nature published promising results from a preclinical study of novel HIV vaccine regimens that are being developed by Crucell in collaboration with Harvard and the US Military HIV Research Program (MHRP). The study explored several prime-boost regimens designed to deliver the vaccine in two or three shots containing different immunity-stimulating components. Regimens including Crucell s adenovirus vectors (vaccine carriers) and the MHRP s MVA vector were shown to be highly immunogenic in an animal model. Further analysis of the stored samples provided evidence that the type of immunity elicited by these regimens could play a pivotal role in protecting people against HIV infection. They confirmed the presence of a specific immune response that has recently been identified as a potential correlate of protection against HIV in humans. We were delighted to learn that our best vaccine candidate induced this important immune response, said Maria Grazia Pau, leader of Crucell s HIV program. An HIV discovery team led by Hanneke Schuitemaker has started exploring ways to further boost this particular aspect of immunity. The study results pave the way for clinical testing of the novel HIV vaccine combinations. One of the planned clinical trial sites is the world-class CAPRISA center for AIDS prevention and research in Durban, South Africa. Crucell s Laura Digilio, clinical leader of the HIV program, and collaborating researcher Dan Barouch of Harvard visited the site together last November. They also visited a rural clinic west of Durban, in an area where 8 9% of teenage girls become infected with HIV. What we saw made us painfully aware of the devastation AIDS is causing in disadvantaged communities despite intervention efforts and made it very clear that a vaccine is needed to slow the spread of HIV, Digilio said. A step closer to saving people from rabies A phase II clinical trial of Crucell s rabies antibody combination started in India just before the end of 2011. This was good news for our clinical team, who have been working for several years to get the go-ahead from the Indian regulatory authorities. This takes us a step closer to our goal: saving around 70,000 people every year from a gruesome death, said Crucell s rabies program director Brad Duncan. An estimated 20,000 of these deaths occur in India, mainly among children. The trial will test our candidate antibody product (together with rabies vaccine) in a clinical setting that simulates its intended use: to provide immediate protection against rabies after exposure to the rabies virus. It will include 240 subjects and focus mainly on gathering a large amount of safety data. These findings will build on the data collected in smaller phase II trials in the USA and Philippines, and pave the way for a definitive phase III efficacy trial in patients exposed to rabies virus. Step by step, we are working to deliver life-saving innovations.

Performance 19 A cocktail of two antibodies like these may be sufficient to neutralize most influenza A subtypes says Robert Friesen, who heads Crucell s antibody discovery group. This paves the way for developing broad-spectrum antibody therapies that could save the thousands of people now dying from flu each year and help to stop a potential pandemic in its tracks. A revolutionary approach to flu Crucell is blazing a trail with its discovery and development of broad-spectrum antibodies against influenza. The ultimate goal is to deliver immunization products that will revolutionize the fight against seasonal and pandemic flu. Back in 2008, Crucell scientists were the first in the world to find antibodies that can neutralize a broad range of influenza viruses. The vast majority of antibodies our immune system makes in response to an invading flu virus (or vaccine) are quite specific: they won t protect against the next strain that comes along. So Crucell s discovery was a breakthrough that raised hopes of developing a completely new approach to combating flu: a one-shotfits-all antibody treatment or even a universal vaccine. Other research groups soon confirmed the importance of Crucell s finding by reporting the discovery of similar broadly neutralizing influenza antibodies. Like ours, these new antibodies were effective against a variety of influenza A group 1 viruses. Crucell researchers have since discovered broad-spectrum antibodies against influenza A group 2 viruses and type B viruses as well. This covers all the influenza viruses that make people ill. The novel broad-spectrum antibody against influenza A group 2 viruses was handed over to our development teams last year, after performing strongly in preclinical tests. These encouraging results were published in Science journal in August 2011. Similar results for Crucell s leading broadly neutralizing antibody against group 1 viruses were published in Science journal in February 2009. Protecting vulnerable groups The need for such a therapy is very clear. Current flu vaccination does not generate adequate protection in the people who need it most: those whose bodies are unable to mount a strong immune response. This includes the elderly (because the immune system deteriorates with age) and immunocompromized patients. More and more influenza strains are showing resistance to antiviral drugs such as oseltamivir, which are currently the only treatment option for influenza. And antivirals are useless once patients develop serious symptoms. Towards a universal flu vaccine Crucell also dreams of designing a vaccine that will protect people for life against virtually every future influenza virus those causing ordinary seasonal flu and those with pandemic potential. Crystal structure studies have provided molecular snapshots of these antibodies attached to influenza viruses, enabling researchers to locate and study their binding sites on the viral surface. We now know that ordinary influenza antibodies bind to parts of the virus that rapidly mutate and change shape, whereas the broadly neutralizing antibodies bind to stable sites that are not subject to mutation and change. Armed with this knowledge, Crucell researchers are trying to rebuild these stable binding domains in a form that can induce the production of broadly neutralizing antibodies. It s a very complex and difficult task, says Crucell s Katarina Radosevic, VP Immunology & Proof of Concept. But if we can make this work in preclinical models, we will be a step closer to a revolutionary flu vaccine. The significance of this work was highlighted in a Nature special on influenza in December 2011.

20 Passion for Protection: Crucell s Corporate Social Responsibility Program A new team at the vaccinology frontier Crucell launched an Innovation & Discovery Laboratory in La Jolla, San Diego, in July 2011. The new team is in the right place at the right time to help tackle some of the largest issues in global health. Vaccinologists have gone as far as they can go with the traditional approach to vaccine design, says Anthony Williamson, Senior Director of the La Jolla lab. The low-hanging fruit has already been picked and we re left with the difficult diseases. We can t develop the new vaccines we need using empirical ( trial and error ) methods. One example of rational vaccine design is the epitope-based vaccine. Researchers start with a library of monoclonal antibodies targeting specific pathogens, screen them to identify the best ones, define the structural epitopes (binding sites) these antibodies attach to, and then try to turn these molecular structures into vaccines. The problem is that these structural epitopes are often quite poorly immunogenic they don t trigger a strong immune response. We need to understand why. One of the key questions for the future of vaccine design is how to translate epitope structures into immunogenicity, says Williamson. He hopes his team will make a meaningful contribu tion to finding answers, and expects to attract high-quality collaborators. That won t be hard, because Crucell is looking to solve some of the largest issues in global health and is willing to invest in very high-quality basic science to underpin development, he said at the time of launch. The lab s location in San Diego s concentrated bioscience community will facilitate such collaboration. Acclaimed research centers like the Scripps Institute, University of California San Diego and La Jolla Institute for Allergy & Immunology are all virtually within walking distance, and Crucell already has excellent relationships with scientists at these institutes. Expanding horizons Jan Poolman (left) joined Crucell in August 2011 to build Crucell s capabilities for bacterial vaccine innovation. His appointment signals an upcoming expansion of our discovery and pipeline programs, which currently focus on vaccines and antibodies against viral diseases, and vaccines based on adenovirus-vector technology. These were established under the leadership of virologist Jaap Goudsmit (right). In the past, Crucell didn t have the money to do everything a big player can do, so we focused on our capabilities in the viral field. Now, with the support of Janssen, we can afford to widen our focus, says Goudsmit. To realize our ambition for global health, we need to deliver innovative vaccines against viral and bacterial diseases and ultimately noninfectious diseases as well. Goudsmit is already working towards that third level of expansion as director of the Crucell Vaccine Institute. The institute was established towards the end of 2011 to make Crucell s innovative vaccine technology platforms available to Janssen researchers in noninfectious disease areas, like cancer and neurology. Now, with the support of Janssen, we can afford to widen our focus.