Crucell corporate brochure (PDF)
Crucell corporate brochure (PDF)
Crucell corporate brochure (PDF)
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Bringing innovation to global health<br />
<strong>Crucell</strong> 2010<br />
www.crucell.com
Contents<br />
Research and development – see page 12<br />
Technologies – see page 20<br />
Products – see page 26<br />
Our mission<br />
<strong>Crucell</strong>’s mission is to protect human lives<br />
from infectious diseases by bringing meaningful<br />
innovation to global health.<br />
<strong>Crucell</strong> is a global biopharmaceutical company focusing on the research<br />
and development, production and marketing of vaccines and antibodies<br />
against infectious disease worldwide. Currently we are combating<br />
twelve major infectious diseases with our range of marketed vaccines<br />
in the paediatric, travel and endemic, and respiratory fields.<br />
In this report you can read all about our mission, vision, strategic pillars<br />
and our commitment to the principles of Corporate Social Responsibility.<br />
For inquiries, please contact Corporate Communications.<br />
Email: communications@crucell.com.<br />
Overview<br />
<strong>Crucell</strong> at a glance 02<br />
<strong>Crucell</strong>: A global perspective 06<br />
Message from our CEO 08<br />
Our business<br />
Research and development, technologies and products 10<br />
Research and development 12<br />
Technologies 20<br />
Products 26<br />
<strong>Crucell</strong>’s commitment to the world<br />
Taking responsibility 32<br />
CSR highlights in 2010 35<br />
Our CSR policy 36<br />
Our CSR achievements, ambitions and targets 40
2010 key highlights<br />
Revenues and other operating income<br />
2010 Revenues and other operating income<br />
(€ million) 105+<br />
2010 Product sales<br />
(€290.6 million)<br />
61%<br />
25%<br />
7%<br />
7%<br />
Product sales 290.6<br />
License revenues 32.7<br />
Service fees 6.5<br />
Other operating income,<br />
e.g. grants 35.6<br />
Total 365.4<br />
Paediatric<br />
Travel and endemic<br />
Respiratory<br />
Other<br />
mln<br />
Vaccine doses distributed in 2010<br />
In more than 100 countries around the world.<br />
€100.0 mln<br />
Research and development investment in 2010<br />
Compared to €70.2 mln in 2009.<br />
€290.6 mln<br />
Product sales in 2010<br />
€365.4 mln<br />
Total revenues and other operating income in 2010<br />
Compared to €358.0 mln in 2009.<br />
01
02<br />
Overview<br />
<strong>Crucell</strong> at a glance<br />
www.crucell.com
Overview – <strong>Crucell</strong> at a glance<br />
<strong>Crucell</strong> is a global biopharmaceutical company<br />
dedicated to bringing meaningful innovation to<br />
global health. We do this by discovering, developing,<br />
manufacturing and marketing products that<br />
combat major threats to the health of people<br />
worldwide. Our specialty is fighting infectious<br />
diseases—a growing healthcare challenge.<br />
03
04<br />
Overview – <strong>Crucell</strong> at a glance<br />
Our Company<br />
Innovation is the driving force behind our strong research and development<br />
(R&D) pipeline, with promising products in pre-clinical and clinical<br />
development. In 2010 alone, <strong>Crucell</strong> distributed more than 105 million 1<br />
vaccine doses in more than 100 countries around the world, and<br />
invested €100.0 million in R&D.<br />
<strong>Crucell</strong> is deeply committed to being a good <strong>corporate</strong> citizen:<br />
a company that creates significant value for society. Our mission is<br />
to make a truly meaningful contribution to global health by directing<br />
our proven talent for innovation towards the fight against infectious<br />
diseases. An entrepreneurial mind-set and social responsibility go<br />
hand-in-hand at <strong>Crucell</strong>.<br />
In 2010, 1,400 dedicated and skilled <strong>Crucell</strong> employees worldwide<br />
worked to bring significant benefit to the lives of people worldwide. We<br />
are fully committed to the principles of <strong>corporate</strong> social responsibility<br />
(CSR) and place great value on doing more to benefit society than we<br />
strictly ‘must’ do. Our mission underlies everything we do, from our core<br />
business activities to the sharing of scientific knowledge and community<br />
outreach programs in countries where help is needed the most.<br />
The combination of our innovative technologies, our core values and<br />
creative minds drives <strong>Crucell</strong>’s success, which we measure in human<br />
and business terms.<br />
<strong>Crucell</strong> is headquartered in Leiden, the Netherlands, with offices in<br />
China, Indonesia, Italy, Korea, Malaysia, Spain, Sweden, Switzerland,<br />
UK, the USA and Vietnam.<br />
Our strategy<br />
Infectious diseases are a major cause of illness and death throughout<br />
the world. The number of infectious outbreaks is increasing for many<br />
reasons: higher population density raises exposure to infectious agents,<br />
an aging population is more susceptible to infection, and a rise in<br />
1 Figure based on <strong>Crucell</strong>’s top five vaccines in terms of sales volumes:<br />
Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V.<br />
www.crucell.com<br />
global travel boosts the potential for spreading diseases across<br />
borders. In addition, natural disasters can have a devastating impact<br />
on sanitation, hygiene, infrastructure and healthcare facilities.<br />
At <strong>Crucell</strong>, we are dedicated to saving lives and preventing illness around<br />
the world. We focus strongly on unmet medical needs in developing<br />
countries, where infectious diseases exert their greatest toll. At the<br />
same time, we work to protect travelers and vulnerable groups living<br />
in industrialized countries.<br />
We target major health threats that demand innovative solutions,<br />
striving to lead rather than follow. We focus on infectious diseases<br />
because these pose an increasingly serious threat to the health of people<br />
worldwide—and we have the expertise to make a real difference in<br />
this disease area.<br />
The combination of our scientific know-how, innovative technologies<br />
and quality products positions <strong>Crucell</strong> to become a major player in the<br />
biopharmaceutical arena.<br />
Our strategy is based on three business drivers:<br />
1. A strong R&D pipeline with promising products in a range<br />
of major disease areas.<br />
2. Cutting-edge technologies that enable the discovery,<br />
development and production of biopharmaceutical products.<br />
These proprietary technologies drive in-house innovation and<br />
generate licensing revenue.<br />
3. A broad range of marketed vaccine products that together<br />
combat 12 major infectious diseases.<br />
1. Our strong research and development pipeline<br />
Innovation is the driving force behind our strong and broad R&D<br />
pipeline, with promising products in pre-clinical and clinical development.<br />
Product candidates include flu-mAb, an antibody effective against a
Overview – <strong>Crucell</strong> at a glance<br />
broad range of influenza virus strains, tuberculosis and malaria vaccines,<br />
and a rabies monoclonal antibody combination – all produced on our<br />
unique PER.C6® human cell-line technology. Read more on page 12.<br />
2. Our cutting-edge technologies<br />
<strong>Crucell</strong>’s proprietary technologies offer unique advantages for<br />
biopharmaceutical innovation. This competitive edge is exemplified<br />
by our PER.C6® technology, which is ideally suited to the manufacture<br />
of vaccines and therapeutic proteins, such as antibodies. Compared to<br />
traditional production platforms, PER.C6® human cell-line technology<br />
provides higher yields at lower cost, as well as safety advantages.<br />
<strong>Crucell</strong> licenses its PER.C6® technology and other technologies to the<br />
biopharmaceutical industry. Important partners and licensees include,<br />
among others, Johnson & Johnson, DSM Biologics, Merck & Co.,<br />
Novartis, sanofi pasteur and Pfizer/Wyeth. Read more on page 20.<br />
3. Our broad range of innovative products<br />
Vaccines play a vital role in protecting against diseases and have<br />
contributed significantly to the improvement of global health. Currently<br />
we are combating twelve major infectious diseases with our range of<br />
marketed vaccines in the paediatric, travel and endemic, and respiratory<br />
fields. We are one of the major suppliers of vaccines to supranational<br />
organizations in the developing world, and the first manufacturer<br />
to launch a fully liquid pentavalent vaccine, called Quinvaxem®.<br />
This innovative combination vaccine protects against five important<br />
childhood diseases. Over 200 million doses have been sold since its<br />
launch in 2006 in more than 50 GAVI (the Global Alliance for Vaccines<br />
and Immunisation) countries. With this innovation, <strong>Crucell</strong> has become<br />
a major partner in protecting children in developing countries. Other<br />
products in <strong>Crucell</strong>’s core portfolio include Hepavax-Gene®, a vaccine<br />
against hepatitis B; Epaxal®, the only aluminum-free hepatitis A vaccine<br />
on the market; Vivotif® and Dukoral®, oral vaccines against typhoid<br />
and cholera, respectively; and Inflexal® V, a virosomal adjuvanted<br />
vaccine against influenza. Read more on page 26.<br />
Partners and licensees<br />
In addition to our own R&D activities, we have strategic partnerships<br />
with several leading healthcare companies, such as Johnson & Johnson,<br />
DSM Biologics, Merck, Novartis and sanofi pasteur. Through these<br />
agreements, our technologies play a vital role in the development<br />
of a vast number of vaccines and antibody products.<br />
05
06<br />
Overview<br />
<strong>Crucell</strong>: A global perspective<br />
www.crucell.com<br />
9<br />
1. China<br />
Marketing and sales.<br />
2. Italy<br />
Marketing and sales.<br />
3. Korea<br />
Marketing and sales<br />
+ Manufacturing.<br />
5<br />
8 4<br />
7<br />
2<br />
6<br />
4. Netherlands (Headquarters)<br />
Marketing and sales.<br />
5. Spain<br />
Marketing and sales<br />
+ Manufacturing.<br />
6. Sweden<br />
Marketing and sales<br />
+ Manufacturing.<br />
1<br />
7. Switzerland<br />
Marketing and sales<br />
+ Manufacturing.<br />
8. UK<br />
Marketing and sales.<br />
9. USA<br />
Marketing and sales.<br />
3
Overview – <strong>Crucell</strong>: A global perspective<br />
Research and development<br />
Vaccines in development:<br />
Flavimun® yellow fever vaccine.<br />
Influenza Seasonal cell-based seasonal vaccine.<br />
Universal Influenza cell-based<br />
universal vaccine.<br />
Tuberculosis recombinant AdVac®based<br />
vaccine.<br />
Malaria recombinant AdVac®based<br />
vaccine.<br />
Ebola and Marburg recombinant AdVac®based<br />
vaccine.<br />
Technologies<br />
PER.C6® human cell line for development<br />
and manufacturing.<br />
AdVac® used with PER.C6® to develop<br />
recombinant vaccines.<br />
MAbstract® to discover novel drug targets<br />
and identify human monoclonal antibodies.<br />
Products<br />
Paediatric:<br />
Quinvaxem® fully liquid vaccine to protect<br />
against five important childhood diseases.<br />
Hepavax-Gene® recombinant hepatitis B<br />
vaccine.<br />
Epaxal® Junior low dosage, aluminum-free<br />
hepatitis A vaccine.<br />
MoRu-Viraten® vaccine for protection<br />
against measles and rubella.<br />
HIV recombinant AdVac®-based vaccine.<br />
HPV recombinant AdVac®-based vaccine.<br />
RSV recombinant AdVac®-based vaccine.<br />
Human monoclonal antibodies<br />
in development:<br />
Rabies antibody combination.<br />
Influenza antibodies.<br />
Hepatitis C antibody combination.<br />
Details on page 12<br />
STAR® to enhance yields of recombinant<br />
human antibodies and proteins.<br />
Virosome a vehicle enabling the use of<br />
virus antigens in the making of vaccines.<br />
Details on page 20<br />
Travel and endemic:<br />
Epaxal® aluminum-free hepatitis A vaccine.<br />
Vivotif® oral typhoid vaccine.<br />
Dukoral® only internationally licensed<br />
oral vaccine against cholera (and ETEC).<br />
Respiratory:<br />
Inflexal® V virosomal adjuvanted<br />
influenza vaccine.<br />
Details on page 26<br />
07
08<br />
Overview<br />
Message from our CEO<br />
<strong>Crucell</strong>’s mission to bring meaningful<br />
innovation to global health reflects a deep<br />
commitment to improving the lives of people<br />
worldwide. This underpins everything we do<br />
as a global organization and as individuals<br />
united by a common purpose.<br />
1 Figure based on <strong>Crucell</strong>’s top five vaccines in terms of sales volumes: Quinvaxem®,<br />
Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V.<br />
2 Figures based on <strong>Crucell</strong>’s top 5 vaccines Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif®<br />
and Inflexal® V. Total 101,666,000 doses minus 2% waste (2,033,320 doses) = 99,632,680<br />
doses sold in 2010 / 525600 minutes in 2010 = 189.5598 doses administered per minute.<br />
www.crucell.com<br />
I am therefore delighted that talks held with Johnson & Johnson<br />
during 2010 have resulted in <strong>Crucell</strong> becoming the center of excellence<br />
for vaccines within the world’s largest and possibly most respected<br />
healthcare company. As a member of the Johnson & Johnson Family<br />
of Companies, we can do so much more to make the world we live in<br />
a healthier place. The combination of our two companies will enable<br />
<strong>Crucell</strong> to further accelerate growth, and our shared expertise and<br />
talent will help to make an even bigger difference in the lives of people<br />
worldwide. We are delighted by the prospect of pursuing our mission<br />
with the support of Johnson & Johnson that shares our passion for<br />
healthcare innovation, our values and our commitment to care for people.<br />
Protecting and contributing to society in the fullest possible sense<br />
and to the best of our ability is our core business, our passion<br />
and the essence of our company. Our commitment to the principles<br />
of <strong>corporate</strong> social responsibility is a logical extension of our mission<br />
to bring innovation to global health, focusing especially on the<br />
prevention of infectious diseases.<br />
During 2010, we distributed over 105 million 1 doses of vaccines<br />
to people around the world, with the majority going to infants in<br />
developing countries. The range of vaccines we have on the market<br />
prevents twelve major infectious diseases: childhood infections, travel<br />
and endemic illnesses, and respiratory disease. We estimate that a<br />
<strong>Crucell</strong> vaccine was given to 190 individuals 2 every minute during 2010,<br />
a thought that makes us very proud.<br />
However, I believe that the best measure of our impact on global health<br />
is not the number of doses we supply, but the number of deaths and<br />
cases of disease we prevent each year. In 2010, <strong>Crucell</strong>’s ‘top-five’<br />
vaccines prevented more than 3.6 million cases of infectious disease<br />
and 809,823 deaths. 1<br />
<strong>Crucell</strong>’s core business is the discovery, development and delivery<br />
of innovative solutions for major health threats. Our specialty is the<br />
creation of much-needed immunization products: vaccines that safely
Overview – Message from our CEO<br />
and effectively mobilize the body’s own immune defenses against<br />
infections, and antibodies that provide ‘ready-made’ immune protection<br />
against invading microbes. After clean water, immunization is believed<br />
to be the most cost-effective health intervention and its key role in<br />
promoting the socioeconomic development of countries is becoming<br />
increasingly clear.<br />
The world population is predicted to reach 7 billion in 2011 and<br />
protecting these billions of individuals from infectious diseases is more<br />
important and challenging than ever. Trends such as climate change,<br />
globalization, urbanization, wider travel and population aging are<br />
presenting new opportunities for infectious pathogens to thrive<br />
and spread. Doing our utmost to tackle this problem is our primary<br />
responsibility and our privilege. It lies at the heart of <strong>Crucell</strong>. More<br />
importantly, I see that we are expanding the boundaries of that reality,<br />
day by day. Innovation is the foundation on which <strong>Crucell</strong> was built,<br />
and the fuel driving us forward.<br />
“ <strong>Crucell</strong>’s core business is the discovery,<br />
development and delivery of innovative<br />
solutions for major health threats.”<br />
Our achievements so far are thanks to the tireless efforts and<br />
dedication of our loyal employees, <strong>Crucell</strong>’s most important asset.<br />
In 2010 hundreds of talented people were recruited in order to further<br />
boost our capacity to bring innovation to global health going forward.<br />
Ronald H.P. Brus<br />
President and Chief Executive Officer<br />
Leiden, the Netherlands, April 18, 2011<br />
Improving healthcare access<br />
The cover photograph of this<br />
booklet shows an Expanded<br />
Program on Immunization (EPI)<br />
session set up by the nongovernmental<br />
organization<br />
Friendship in collaboration with<br />
local governmental agents in<br />
Bangladesh. The mothers holding<br />
young babies are waiting in line<br />
for their infants to receive <strong>Crucell</strong>’s<br />
Quinvaxem® vaccine. With support from <strong>Crucell</strong>, Friendship has<br />
set up the cold chain to enable children in these remote char areas<br />
to be immunized. This initiative is one of many described in our<br />
<strong>corporate</strong> social responsibility (CSR) report in this booklet.<br />
The EPI was established by the World Health Organization (WHO)<br />
in 1974 with the aim of ensuring that all children in all countries<br />
benefit from life-saving vaccines. The first diseases targeted by the<br />
EPI were diphtheria, pertussis (whooping cough), tetanus, measles,<br />
poliomyelitis and tuberculosis. In 1977, the WHO established global<br />
policies for immunization and set the goal of universal immunization<br />
for all children by 1990, as an essential element of the WHO<br />
strategy to achieve health for all.<br />
In 2009, an estimated 82% of children globally had received<br />
at least three doses of diphtheria–tetanus—pertussis vaccine<br />
(DTP3) by one year of age, which has traditionally been used as an<br />
indicator of EPI coverage. Additional vaccines have progressively<br />
been added to the original six recommended by the WHO in 1974.<br />
The EPI remains committed to the goal of universal access to all<br />
relevant vaccines for all at risk.<br />
Information on the EPI was sourced from the WHO website.<br />
09
10<br />
Our business<br />
Research and development, technologies and products<br />
At <strong>Crucell</strong> we bring meaningful innovation to global<br />
health. We do this by discovering, developing,<br />
manufacturing and marketing products that combat<br />
major threats to the health of people worldwide. Our<br />
specialty is fighting infectious diseases—a growing<br />
healthcare challenge. In the following pages<br />
we highlight <strong>Crucell</strong>’s key innovations in the field<br />
of research and development, our cutting-edge<br />
technologies and robust product portfolio.<br />
€100.0 mln<br />
Invested in research and development in 2010.<br />
105+ mln<br />
Doses distributed in 2010.<br />
100 countries<br />
<strong>Crucell</strong> vaccines were distributed in more than 100 countries in 2010.<br />
www.crucell.com<br />
Research and development<br />
Technologies<br />
Products
Our business – Research and development, technologies and products<br />
Development stage Discovery/<br />
Pre-clinical<br />
Phase I Phase II Phase III Marketed Description<br />
Marketed products:<br />
Quinvaxem® Fully liquid vaccine for protection against five childhood diseases.<br />
Hepavax-Gene® Recombinant hepatitis B vaccine.<br />
Epaxal® Junior Low-dosage, aluminum-free hepatitis A vaccine (0.25ml).<br />
MoRu-Viraten® Vaccine for protection against measles and rubella.<br />
Epaxal® Aluminum-free hepatitis A vaccine.<br />
Vivotif® Oral typhoid vaccine.<br />
Dukoral® Only internationally licensed oral vaccine against cholera.<br />
Inflexal® V<br />
Vaccines in development:<br />
Virosomal adjuvanted influenza vaccine.<br />
Flavimun® Yellow fever vaccine.<br />
Tuberculosis Recombinant AdVac®-based tuberculosis vaccine. 1<br />
Malaria Recombinant AdVac®-based malaria vaccine. 2<br />
Ebola and Marburg Recombinant AdVac®-based Ebola and Marburg vaccine. 2<br />
HIV Recombinant AdVac®-based HIV vaccine. 3<br />
Cell-based Influenza Seasonal influenza vaccine produced on PER.C6.®<br />
Universal influenza Universal influenza vaccine produced on PER.C6.®<br />
HPV Recombinant AdVac®-based HPV vaccine. 4<br />
RSV Recombinant AdVac®-based RSV vaccine. 5<br />
Human monoclonal antibodies in development:<br />
Rabies antibody combination<br />
Mix of two monoclonal antibodies for post-exposure<br />
treatment of rabies. 6<br />
Influenza antibodies<br />
Hepatitis C antibody<br />
combination<br />
1 Partnered with Aeras.<br />
2 Partnered with NIH/NIAID, GSK.<br />
3 Partnered with Harvard.<br />
4 Human papilloma virus (HPV), partnered with Johnson & Johnson.<br />
5 Respiratory syncytial virus (RSV), partnered with Johnson & Johnson.<br />
6 Partnered with sanofi pasteur.<br />
Antibodies neutralizing a wide range of influenza subtypes,<br />
including H5 and H1.<br />
Neutralizing monoclonal antibody combination across all<br />
genotypes tested.<br />
11
12<br />
Our business<br />
Research and development<br />
www.crucell.com
Our business – Research and development<br />
<strong>Crucell</strong>’s research efforts focus on developing<br />
vaccines and antibodies that address infectious<br />
disease and unmet medical needs. In this section<br />
you can read more about the discovery and<br />
development of next-generation medical products<br />
facilitated by our range of innovative technologies.<br />
13
14<br />
Our business – Research and development<br />
Our strong research and development pipeline<br />
Innovation is the driving force behind <strong>Crucell</strong>’s future growth supported<br />
by a strong R&D pipeline. Our scientists focus on the discovery and<br />
development of much-needed solutions for major threats to human<br />
health—particularly vaccines and antibodies for the prevention and<br />
treatment of infectious diseases. This has resulted in a broad pipeline<br />
of investigational products with the potential to revolutionize the fight<br />
against diseases such as influenza, rabies, malaria and tuberculosis.<br />
Vaccine development: based on AdVac® technology<br />
AdVac® technology involves the use of novel adenoviral vectors, such<br />
as Ad35 and Ad26, in vaccines for diseases caused by viruses, bacteria<br />
or parasites. These vectors are harmless adenoviruses that have been<br />
disabled so that they cannot replicate. A vector functions as an efficient<br />
‘gene taxi’, delivering into the human body a fragment of DNA that<br />
carries the code for a protein of a specific pathogen. Once inside the<br />
body, the vectors express (produce) these proteins and present them<br />
to the person’s immune system, which mounts its protective response.<br />
Using this versatile vaccine vector platform in combination with our<br />
PER.C6® manufacturing technology, we are working with our partners<br />
to develop vaccines against major threats to human health, including<br />
tuberculosis, malaria, Ebola and Marburg, HIV, human papilloma virus<br />
(HPV) and respiratory syncytial virus (RSV). See page 17.<br />
Tuberculosis (Phase II)<br />
<strong>Crucell</strong> joined forces with the nongovernmental organization (NGO)<br />
Aeras Global TB Vaccine Foundation in 2004 to develop a safe, effective<br />
and affordable vaccine against tuberculosis (TB). The traditional TB<br />
vaccine developed more than 85 years ago, Bacille Calmette Guérin<br />
(BCG), does not reliably prevent pulmonary disease—the most common<br />
form of TB—so there is a great need for a better alternative.<br />
Together with Aeras, we are developing the novel TB vaccine candidate<br />
AERAS-402/<strong>Crucell</strong> Ad35. The vaccine is based on <strong>Crucell</strong>’s innovative<br />
AdVac® technology, which uses novel harmless adenoviruses as vaccine<br />
vectors (vehicles). We are using the adenovirus 35 (Ad35) vector for this<br />
particular vaccine.<br />
www.crucell.com<br />
AERAS-402/<strong>Crucell</strong> Ad35 is being designed as a ‘booster’ vaccine that<br />
will be given to people who have previously been vaccinated with<br />
the traditional TB vaccine or an improved, recombinant version of the<br />
BCG vaccine that is being developed by Aeras. The BCG vaccine will prime<br />
(prepare) the immune system to fight off TB infection and the AERAS-402/<br />
<strong>Crucell</strong> Ad35 will be given later to boost this initial immune response.<br />
Data from AERAS-402/<strong>Crucell</strong> Ad35 clinical trials (Phase I and II) support the<br />
immunogenicity and acceptable safety profile of the candidate TB vaccine.<br />
In 2009, an estimated 1.7 million people<br />
died of tuberculosis.<br />
Source: WHO, Global TB Control 2010 report.<br />
Tuberculosis<br />
Estimated new TB cases (all forms) per 100,000 population in 2009.<br />
0–24<br />
25–49<br />
50–99<br />
100–299<br />
>300<br />
No estimate
Our business – Research and development<br />
Malaria<br />
Countries or areas at risk of transmission in 2009.<br />
Transmission occurs<br />
Limited risk of transmission<br />
No report<br />
Source: WHO, World Malaria Report 2010.<br />
Malaria (Phase I)<br />
Malaria is one of the most prevalent infections in tropical and subtropical<br />
regions. Children and pregnant women are most severely affected.<br />
According to the World Health Organization (WHO), half of the world’s<br />
population is at risk of malaria, and an estimated 225 million cases led<br />
to 781,000 deaths in 2009. There is currently no licensed vaccine to<br />
protect people against malaria, a disease caused by infection with the<br />
Plasmodium parasite and transmitted by mosquitoes. Therapies are<br />
available for malaria patients, but the worsening problem of drug<br />
resistance in many parts of the world is making adequate treatment and<br />
control of malaria increasingly difficult. In addition, many insecticides<br />
are no longer useful against the mosquitoes that transmit the disease.<br />
<strong>Crucell</strong> is working in collaboration with a number of research groups<br />
to develop a safe, effective and affordable vaccine against Plasmodium<br />
falciparum, the most lethal of the four species of malaria parasite that<br />
infect humans. <strong>Crucell</strong>’s approach is based on our innovative AdVac®<br />
technology, which uses novel, harmless adenoviruses as vaccine<br />
delivery vehicles (vectors).<br />
In April, 2010, <strong>Crucell</strong> entered into an agreement with GlaxoSmithKline<br />
Biologicals (GSK) to collaborate on developing a second-generation<br />
malaria vaccine candidate. <strong>Crucell</strong> is contributing the recombinant<br />
malaria vaccine candidate Ad35-CS, based on <strong>Crucell</strong>’s PER.C6® and<br />
AdVac® technologies, while GSK is contributing its late-stage malaria<br />
vaccine candidate RTS,S/AS. The collaborative partners aim to advance<br />
this new vaccine candidate into human clinical studies with the support<br />
of the PATH Malaria Vaccine Initiative (MVI). Clinical efficacy challenge<br />
trials sponsored by the MVI will be initiated in 2011 at the US Walter<br />
Reed Army Institute of Research, providing all agreements are finalized.<br />
Pending the results of these Phase I/IIa trials, <strong>Crucell</strong> and GSK expect<br />
to advance the prime boost candidate in further clinical studies with<br />
the support of public or non-profit partners who are interested in<br />
accelerating the development of a malaria vaccine.<br />
In May 2010, <strong>Crucell</strong> announced the start of a new Phase I clinical study<br />
in Burkina Faso, West Africa. <strong>Crucell</strong> is developing its malaria vaccine<br />
vector, Ad35-CS, in collaboration with National Institute of Allergy<br />
and Infectious Diseases (NIAID)/ National Institutes of Health (NIH),<br />
the Centre National de Recherche et de Formation sur le Paludisme<br />
(CNRFP) in Burkina Faso, and the Noguchi Memorial Institute for Medical<br />
Research at the University of Ghana. Enrolment has been completed<br />
and boost vaccinations are ongoing. This is the first study evaluating<br />
the safety and immunogenicity of this AdVac®-based malaria vaccine<br />
vector candidate in a population living in a malaria endemic area.<br />
Ebola and Marburg (Phase I)<br />
Ebola and Marburg are among the world’s most lethal viral diseases.<br />
Both Ebola and Marburg are among the few viruses causing hemorrhagic<br />
fever, a severe, often fatal disease in humans. There are currently no<br />
vaccines or antiviral therapies available for either disease.<br />
<strong>Crucell</strong> is developing a multivalent filovirus vaccine against Ebola<br />
and Marburg in collaboration with the Vaccine Research Center of the<br />
US National Institute of Allergy and Infectious Diseases (NIAID),<br />
part of the National Institutes of Health (NIH).<br />
The candidate vaccine is based on <strong>Crucell</strong>’s proprietary adenoviral<br />
vector technology and is produced using <strong>Crucell</strong>’s PER.C6® technology.<br />
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Our business – Research and development<br />
HIV (Phase I)<br />
Human immunodeficiency virus (HIV) is a retrovirus that causes acquired<br />
immune deficiency syndrome (AIDS), a condition in which the immune<br />
system progressively fails, leading to life-threatening infections. Over the<br />
past 25 years, HIV infection resulting in AIDS has claimed millions of lives,<br />
devastated communities, and enormously frustrated efforts to fight<br />
poverty, improve global health and promote economic development.<br />
According to the 2010 Progress Report (a joint report by UNAIDS,<br />
Unicef and WHO), the HIV epidemic remains a major global public health<br />
challenge, with a total of 33.4 million people living with HIV worldwide.<br />
In 2008 alone, 2.7 million people were newly infected with HIV.<br />
1 Source: WHO, factsheet on rabies.<br />
www.crucell.com<br />
In August 2010, <strong>Crucell</strong> announced its participation in an international<br />
Phase I clinical trial in the United States and Africa of a combination<br />
of two AdVac®-based AIDS vaccine candidates, Ad26.ENVA.01 and<br />
Ad35-ENV, in healthy adults who are not infected with HIV. The clinical<br />
trial, which will be led by the International AIDS Vaccine Initiative (IAVI),<br />
represents a collaboration between IAVI, <strong>Crucell</strong>, the Ragon Institute,<br />
and Beth Israel Deaconess Medical Center (BIDMC), a major teaching<br />
hospital of Harvard Medical School.<br />
In 2008, an estimated 2.7 million people<br />
were newly infected with HIV.<br />
Source: WHO.<br />
Every 17,5 seconds one person dies of AIDS.<br />
Source: Stop Aids Now!<br />
The Ad26.ENVA.01 vaccine candidate used in this study is developed<br />
and manufactured by <strong>Crucell</strong>, while the Ad35-ENV vaccine is developed<br />
by IAVI. Both vaccines candidates are based on <strong>Crucell</strong>’s proprietary<br />
AdVac® technology. The planned Phase 1 trial of the vaccine combination<br />
represents a key step towards proof of concept studies to evaluate the<br />
efficacy of the vaccine combination in humans.<br />
HPV (Discovery/Pre-clinical)<br />
Genital infection with human papilloma virus (HPV) is very common in<br />
both men and women and usually spontaneously clears within one year<br />
after infection. In about 1% of individuals, however, HPV persists and<br />
ultimately results in genital neoplastic lesions.
Our business – Research and development<br />
In November 2010, <strong>Crucell</strong> announced the start of a discovery program<br />
leading to the development and commercialization of a therapeutic<br />
HPV vaccine. The discovery program is part of a strategic collaboration,<br />
signed in September 2009 with Johnson & Johnson, through its<br />
subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc., to develop<br />
innovative products, including antibodies for influenza prevention<br />
and treatment.<br />
RSV (Discovery/Pre-clinical)<br />
Respiratory syncytial virus (RSV) is the most important cause of viral<br />
lower respiratory tract illness in infants and children. RSV-induced disease<br />
is the last of the major paediatric diseases for which no preventive<br />
vaccine is available. Current prevention in developed countries is based<br />
on the administration of a costly RSV-neutralizing antibody, which is<br />
given to high-risk infants, in particular premature newborns. RSV also<br />
induces severe disease in immunocompromized adults and elderly<br />
people with weak immune systems, for whom the RSV antibody is<br />
not available.<br />
In June 2010, <strong>Crucell</strong> announced the start of a discovery program<br />
leading to the development and commercialization of a universal RSV<br />
vaccine. The vaccine will be designed to prevent severe infections with<br />
the most common RSV strains in infants and the elderly. This discovery<br />
program is part of a strategic collaboration with Johnson & Johnson,<br />
signed in September 2009.<br />
As an encouragement towards the RSV research community, <strong>Crucell</strong><br />
sponsored the VII Respiratory Syncytial Virus Symposium held in<br />
December 2010 and established the Innovation Award for RSV Research.<br />
This support highlights <strong>Crucell</strong>’s long-standing commitment to improve<br />
the health of people worldwide by advancing the fight against<br />
infectious diseases.<br />
Antibody development<br />
Antibodies are proteins made naturally by cells of the body’s immune<br />
system. They function as one of the body’s principal defense mechanisms<br />
against pathogens—disease-causing agents such as parasites, viruses<br />
or bacteria. As antibodies recognize and bind to invading pathogens,<br />
ultimately eliminating them, they play a crucial role in protecting<br />
humans against disease.<br />
Rabies antibody combination (Phase II)<br />
Rabies is a viral disease of mammals and is most often transmitted<br />
through the bite of a rabid animal. The virus infects the central nervous<br />
system, causing encephalitis (inflammation of the brain) and ultimately<br />
death if appropriate medical intervention is not given promptly. Every<br />
year, more than 15 million people worldwide receive a post-exposure<br />
preventive regimen to avert the disease. This is estimated to prevent<br />
327,000 rabies deaths annually. 1<br />
Nevertheless, an estimated 55,000 individuals exposed to rabies<br />
virus—mostly children—die each year. Most of those who die receive<br />
a rabies vaccine only, rather than the proper post-exposure treatment<br />
consisting of anti-rabies antibodies as well as a vaccine. Concerns<br />
about the availability and safety of the current, blood-derived<br />
antibody treatment have prompted the search for a safe, effective<br />
and affordable alternative.<br />
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Our business – Research and development<br />
An estimated 55,000 individuals exposed to<br />
rabies virus—mostly children—die each year.<br />
Source: WHO.<br />
<strong>Crucell</strong> scientists in collaboration with scientists from Thomas Jefferson<br />
University (TJU) in Philadelphia and the US Centers for Disease Control<br />
and Prevention in Atlanta, USA to discover a combination of human<br />
monoclonal antibodies (mAbs) for the post-exposure treatment of<br />
rabies. <strong>Crucell</strong>’s innovative MAbstract® and PER.C6® technologies played<br />
a crucial role in the discovery and development of this promising therapy.<br />
The candidate mAb product is designed to be used together with rabies<br />
vaccine. Preclinical studies conducted during 2004 indicated that the<br />
mAb combination could neutralize (inactivate) rabies virus at least<br />
as effectively as blood-derived human rabies immune globulin (HRIG),<br />
the current gold standard for providing immediate protection against<br />
rabies virus. Since then, the rabies mAb combination has successfully<br />
progressed through phase I clinical trials in the USA and India (in 2006–7)<br />
and phase II trials in the USA and the Philippines.<br />
1 Source: US National Library of Medicine, National Institute of Health.<br />
www.crucell.com<br />
Since January 2008, the route toward global availability of this<br />
next-generation, life-saving rabies biological has been facilitated by<br />
a strategic partnership between <strong>Crucell</strong> and sanofi pasteur, a world<br />
leader in rabies immunization. Under the terms of this agreement,<br />
<strong>Crucell</strong> will be responsible for manufacturing the commercial product<br />
and has retained exclusive distribution rights in Europe, co-exclusive<br />
distribution rights in China and the rights to sell to supranational<br />
organizations, while sanofi pasteur will have exclusive distribution<br />
rights for all other territories and co-exclusive distribution rights<br />
in China.<br />
A planned Phase II trial in India is expected to start in the first half<br />
of 2011. This study is designed to collect data on the safety and<br />
neutralizing activity of the rabies antibody combination plus vaccine<br />
in a simulated rabies post-exposure prophylaxis setting.<br />
The US Food and Drug Administration (FDA) has granted the rabies mAb<br />
combination Fast Track status, paving the way for priority handling<br />
of the regulatory dossier.<br />
Human monoclonal antibodies against a broad range of influenza<br />
strains (Pre-clinical)<br />
Imagine a single product that could solve all the problems currently<br />
limiting influenza control. It would have to reliably protect all subgroups<br />
of the population—especially the elderly—against serious illness<br />
and death, regardless of the causal viral strain. Ideally, it would both<br />
prevent and cure influenza.<br />
In December 2008, <strong>Crucell</strong> announced the discovery of a new class of<br />
mAbs with this extraordinary potential. <strong>Crucell</strong> also reported the results<br />
of preclinical studies involving a representative of this new mAb class,<br />
CR6261. The antibody was shown to neutralize a broad range of<br />
influenza viruses, including the currently circulating H1N1 seasonal<br />
flu strains (genetic descendants of the virus responsible for 40 million<br />
deaths during the pandemic of 1918–1919) and the highly pathogenic<br />
H5N1 (‘bird flu’) virus. More recent tests have shown that CR6261<br />
also combats the novel H1N1 virus that caused the 2009 pandemic.
Our business – Research and development<br />
In a pre-clinical study comparing CR6261 with the leading antiviral<br />
drug, oseltamivir, <strong>Crucell</strong>’s mAb strongly outperformed oseltamivir for<br />
influenza prevention and treatment. The study showed that CR6261<br />
provides immediate protection against influenza viruses, suggesting<br />
that it will be able to prevent disease spread and therefore ward off<br />
a threatening pandemic. In contrast, oseltamivir was less effective<br />
and in some cases, not effective at all.<br />
In September 2009, Johnson & Johnson, through its subsidiary<br />
Ortho-McNeil-Janssen Pharmaceuticals, Inc., entered into a strategic<br />
collaboration with <strong>Crucell</strong> for the development and commercialization<br />
of a universal mAb product (flu-mAb) for the treatment and prevention<br />
of influenza. An important recent step in the development of this<br />
flu-mAb has been the first production of this antibody product in a<br />
mobile and fully disposable FlexFactory®.<br />
Universal influenza vaccine (Discovery/Pre-clinical)<br />
The exciting flu-mAb research and development has laid the basis for<br />
the discovery and development of a vaccine that could protect against<br />
all subtypes of influenza virus.<br />
Hepatitis C antibody combination (Pre-clinical)<br />
Hepatitis C is a disease of the liver, caused by the hepatitis C virus (HCV).<br />
The virus can be transmitted by direct blood contact, for instance by<br />
sharing contaminated needles among drug users or by needle stick<br />
injuries in healthcare settings.<br />
Hepatitis C is a major global public health problem. A significant<br />
proportion of people (20–50%) develop progressive liver disease leading<br />
ultimately to liver cirrhosis, liver failure and hepatocellular carcinoma<br />
(HCC). 1 Most people who have been infected develop chronic disease.<br />
Symptomatic chronic HCV patients can be treated with antiviral agents<br />
(usually a combination of pegylated interferon and ribavirin), but with<br />
limited success. The only treatment option for end-stage liver disease<br />
is transplantation. HCV-induced cirrhosis is the leading cause for liver<br />
transplantation. It is estimated that up to 170 million people worldwide<br />
(3% of the world’s population) are infected with HCV. There is no<br />
available vaccine against HCV.<br />
In August 2009, <strong>Crucell</strong> obtained an exclusive license from Stanford<br />
University (Palo Alto, California) for the development of an antibody<br />
combination against HCV. A large panel of fully human mAbs against<br />
HCV is being evaluated by <strong>Crucell</strong> in a proof of concept phase. The mAbs<br />
have been found to neutralize the virus across all genotypes tested and<br />
each recognizes a different part of the HCV surface protein.<br />
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Our business<br />
Technologies<br />
www.crucell.com
Our business – Technologies<br />
<strong>Crucell</strong>’s strong research and development (R&D)<br />
pipeline is supported by a range of patented<br />
technologies. Our technologies open up new areas<br />
of research, speed our development programs<br />
and optimize production processes. In this section<br />
you can read about our technologies and the way<br />
<strong>Crucell</strong> continues to extend their applications.<br />
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Our business – Technologies<br />
Our cutting-edge technologies<br />
<strong>Crucell</strong>’s strong product portfolio is supported by a range of patented<br />
technologies. Our cutting-edge technology platforms enable the<br />
cost-effective discovery, development and production of a range<br />
of biopharmaceutical products, including innovative vaccines,<br />
therapeutic proteins and gene therapies. In therapeutic areas where<br />
<strong>Crucell</strong> does not plan to develop its own products, these proprietary<br />
technologies may be licensed out to other biopharmaceutical<br />
manufacturers or research groups.<br />
5 core platforms<br />
www.crucell.com<br />
Core proprietary technology platforms<br />
<strong>Crucell</strong> has five core proprietary technology platforms, and two<br />
support technologies developed by <strong>Crucell</strong> to facilitate<br />
biopharmaceutical innovation:<br />
1. PER.C6® technology: a comprehensive package of technology and<br />
know-how based on our PER.C6® human cell line. It provides a safe<br />
and cost-effective manufacturing system for high-yield, large-scale<br />
production of vaccines, recombinant proteins including monoclonal<br />
antibodies, and gene therapy products.<br />
2. AdVac® technology: a technology based on the development and<br />
production of novel adenovirus vectors. It can be used together<br />
with PER.C6® technology to develop recombinant vaccines against<br />
life-threatening diseases or to develop gene therapy products.<br />
3. MAbstract® technology: a human-based antibody phage display<br />
technology that facilitates the discovery of novel drug targets<br />
and the identification of human monoclonal antibodies against<br />
those targets.<br />
4. STAR® technology: a gene expression technology that enhances<br />
yields of recombinant human antibodies and therapeutic proteins<br />
on mammalian cells lines.<br />
5. Virosome technology: a virosome is a virus-like particle that<br />
acts as a vaccine adjuvant and carrier system. Vaccines based<br />
on virosome technology combine high efficacy with high purity,<br />
and therefore low potential for causing side effects.<br />
Support technologies<br />
A. Recombinant Paramyxovirus technology: a novel vaccine design<br />
technology based on recombinant measles vectors. These vaccine<br />
vectors can be manufactured economically in large quantities,<br />
and induce strong and sustained immune responses against the<br />
antigens they carry.<br />
B. Hansenula polymorpha technology: an innovative yeast-based<br />
production platform widely used for the manufacture of industrial<br />
proteins, food and feed additives, and highly immunogenic vaccines—<br />
such as <strong>Crucell</strong>’s Hepavax-Gene® vaccine against hepatitis B.
Our business – Technologies<br />
PER.C6® technology: an innovative package<br />
The PER.C6® human cell line is the cornerstone on which <strong>Crucell</strong> was<br />
built. It was originally developed for making antibodies against cancer<br />
and for gene therapy, but around 2002 researchers in the company<br />
discovered that a wide range of viruses also grow very well on<br />
PER.C6®. This meant that PER.C6® could be developed as a platform<br />
for producing the new viral vaccines the world needs—classical as<br />
well as adenovirus-based vaccines.<br />
PER.C6® technology offers major advantages over other platforms used<br />
for manufacturing biological products and is uniquely positioned<br />
to meet the key challenges in the industry. These include the need to<br />
produce larger volumes of product more quickly and cost-effectively,<br />
while meeting increasingly stringent safety requirements.<br />
The heart of PER.C6® technology is the PER.C6® human cell line.<br />
This is a continuously dividing set of cells derived from a single<br />
human cell, immortalized using recombinant DNA technology. Like<br />
other continuous cell lines, PER.C6® cells can replicate indefinitely—<br />
but that is where the comparison ends.<br />
One of the great advantages of PER.C6® cells is that they grow to much<br />
higher density than other continuous cell lines. This is due to inherent<br />
characteristics of the PER.C6® cells themselves, which are further<br />
enhanced by the intensified manufacturing process and special growth<br />
media developed as part of the PER.C6® technology package.<br />
The ability of PER.C6® cells to grow to exceptionally high densities<br />
means that much more biological product can be harvested from<br />
much smaller bioreactors. For example, PER.C6® cells infected with<br />
virus for manufacturing purposes produce at least 10 times more virus<br />
per milliliter than any other cell line does. The same yield can therefore<br />
be obtained from a 500-liter bioreactor using PER.C6® as a 5000-liter<br />
or larger bioreactor using another cell line. This translates into<br />
significant savings in capital expenditure and production costs, as well<br />
as shorter production times. PER.C6® technology is an ideal companion<br />
for other innovative <strong>Crucell</strong> technologies, such as the virosome<br />
(a vaccine design technology combining high efficacy with low side<br />
effects) and AdVac® technology (which focuses on the development<br />
of novel adenovirus vectors and is used with PER.C6® to develop<br />
recombinant vaccines).<br />
27 g/L<br />
Record-level titer achieved at harvest for an antibody<br />
product using PER.C6® human cell line technology.<br />
10 times<br />
More virus per millimeter are produced by<br />
PER.C6® infected cells.<br />
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Our business – Technologies<br />
The PERCIVIA PER.C6® Development Center<br />
is designed to further develop the PER.C6®<br />
cell line and to provide turnkey solutions for<br />
licensees utilizing the PER.C6® human cell<br />
line to produce pharmaceutical proteins.<br />
PERCIVIA PER.C6® Development Center<br />
In September 2010, <strong>Crucell</strong> and Royal DSM announced the expansion<br />
of activities in their existing joint venture, the PERCIVIA PER.C6®<br />
Development Center (Cambridge, Massachusetts, US), to transform<br />
the company from a development center into a full biopharmaceutical<br />
company for the development of PER.C6®-based biobetter proteins<br />
and monoclonal antibodies as well as global licensing of the PER.C6®<br />
human cell line for production of third party monoclonal antibodies<br />
and other proteins. The joint venture, in which DSM and <strong>Crucell</strong> each<br />
hold an equal equity share, will be known as PERCIVIA LLC. The joint<br />
venture will broaden its scope and will focus on proprietary development<br />
of PER.C6®-based biobetter proteins and monoclonal antibodies,<br />
initially to early clinical stages.<br />
AdVac® technology<br />
AdVac® technology involves the development and manufacture<br />
of novel vectors (gene transport vehicles) made from adenoviruses<br />
(harmless cold viruses) that very rarely infect humans, such as Ad35.<br />
Genetic material encoding for viruses, parasites or bacteria can be<br />
inserted into these vectors to make novel vaccines against a broad<br />
range of human pathogens, or the vectors can be used to make<br />
gene therapy products.<br />
www.crucell.com<br />
AdVac® technology is a powerful vector system, especially when<br />
coupled with <strong>Crucell</strong>’s PER.C6® technology, which unlike any other<br />
cell line does not allow replication-competent adenoviruses to form<br />
during the production of replication-deficient vectors.<br />
AdVac® technology is based on adenoviruses that very rarely infect<br />
humans, whereas other adenovirus vectors are based on viruses that are<br />
widespread in human populations—and therefore much more likely to<br />
encounter pre-existing immunity. By circumventing pre-existing immune<br />
responses against the adenovirus vector, AdVac®-based vaccines allow<br />
accurate dose control and are potentially more effective than other<br />
adenoviral vector vaccines.<br />
AdVac®-based vectors share the advantages of the widely used<br />
adenovirus vectors, such as scalable production, high yields and the<br />
ability to mediate a strong T-cell immune response.
Our business – Technologies<br />
MAbstract® technology<br />
MAbstract® technology is a human antibody-based phage display<br />
system, which facilitates the discovery of novel drug targets and the<br />
identification of human monoclonal antibody against those targets.<br />
A phage (or ‘bacteriophage’) is a virus that can infect and multiply in<br />
bacteria. In phage display technology, phages are genetically engineered<br />
to expresses the pathogen-binding part of a human antibody on their<br />
surfaces. In the application of MAbstract® technology, a library of<br />
phages exposing a wide variety of human antibody fragments on their<br />
surfaces is brought into contact with disease-causing microorganisms<br />
(pathogens) or parts of pathogens in order to identify human antibodies<br />
that selectively bind to targets of interest.<br />
MAbstract® technology is an efficient method for the discovery of<br />
human antibodies to be applied for the prevention, diagnosis and<br />
therapy of diseases.<br />
STAR® technology<br />
STAR® technology is a gene expression technology. Acquired by <strong>Crucell</strong><br />
in 2004, it has proved extremely valuable for increasing production<br />
of recombinant antibodies and therapeutic proteins on mammalian<br />
cell lines. STAR® technology uses well-established mammalian cell banks<br />
for protein and antibody production, thereby eliminating the need<br />
for specially engineered mammalian cells. It allows for very rapid,<br />
stable mammalian cell clone generation and typically generates stable<br />
mammalian cell clones that produce 5 to 10 times more antibody or other<br />
therapeutic protein than cell clones generated without STAR® technology.<br />
Virosome technology<br />
Virosome technology is a tool for developing novel vaccines against<br />
infectious and chronic diseases. A virosome is a virus-like particle that<br />
acts as a vaccine carrier and adjuvant (immunity enhancing) system.<br />
Vaccines based on virosome technology combine high efficacy with<br />
high purity, which means they are effective and safe to use even<br />
in infants and individuals with a weakened immune system.<br />
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Our business<br />
Products<br />
www.crucell.com
Our business – Products<br />
<strong>Crucell</strong> focuses on developing and marketing<br />
vaccines and antibodies against a range of<br />
infectious diseases in the paediatric, travel and<br />
endemic, and respiratory fields. We currently have<br />
a product portfolio of vaccines against twelve<br />
major infectious diseases, such as influenza,<br />
hepatitis A, hepatitis B and typhoid fever.<br />
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Our business – Products<br />
Our broad range of innovative products<br />
Vaccines play a vital role in protecting against disease and have<br />
contributed significantly to the improvement of global public health.<br />
Smallpox was eradicated through the use of vaccines. Significant<br />
advances include the introduction of combination vaccines and<br />
the development of new vaccine technologies.<br />
In 2010, a <strong>Crucell</strong> vaccine was given to 190 people every minute. 1 Over<br />
the full year, more than 105 million doses of vaccines were distributed<br />
in more than 100 countries, thereby preventing more than 3.6 million<br />
cases of infectious diseases and over 809, 000 deaths that would<br />
otherwise have occurred.<br />
1 Figures based on <strong>Crucell</strong>’s top 5 vaccines Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif®<br />
and Inflexal® V. Total 101,666,000 doses minus 2% waste (2,033,320 doses) = 99,632,680<br />
doses sold in 2010 / 525600 minutes in 2010 = 189.5598 doses administered per minute.<br />
www.crucell.com<br />
In this section, you will find information about <strong>Crucell</strong>’s marketed<br />
products and comprehensive information about the diseases each<br />
of these vaccines is designed to prevent.<br />
Quinvaxem®<br />
Quinvaxem® fully liquid pentavalent (five-in-one) vaccine protects<br />
infants against five deadly childhood infections: diphtheria (D),<br />
tetanus (T), pertussis (P, whooping cough), hepatitis B (HepB), and<br />
Haemophilus influenzae type b (Hib).<br />
Combination vaccines help to simplify and harmonize vaccination<br />
schedules, leading to increased vaccine coverage and greater costeffectiveness.<br />
As the first fully liquid pentavalent DTwP–HepB–Hib<br />
vaccine brought to the market, Quinvaxem® further simplified vaccine<br />
delivery because it is ready to use as soon as the vial is opened.<br />
This makes it an ideal choice for protecting babies in developing<br />
countries with infrastructure and hygiene problems. Quinvaxem®<br />
remains the only fully liquid pentavalent vaccine that offers these<br />
advantages in a preservative-free formulation.<br />
Since the launch of Quinvaxem® in 2006, over 200 million doses of<br />
this life-saving vaccine have been delivered to developing countries,<br />
including 50 GAVI-supported countries. Most were low-income<br />
countries supplied through Unicef and the Pan American Health<br />
Organization (PAHO). With this innovation, <strong>Crucell</strong> has become<br />
a major partner in protecting children in under-resourced countries.
Our business – Products<br />
Cases of disease prevented by Quinvaxem®<br />
< 5,000<br />
5,000–10,000<br />
10,000–100,000<br />
> 100,000<br />
No report<br />
Hepavax-Gene®<br />
Hepavax-Gene® is a recombinant vaccine against hepatitis B virus<br />
infection, providing long-term protection. With a track record of more<br />
than 800 million doses administered worldwide since the launch<br />
of this vaccine in 1997, it is also one of the established WHO<br />
pre-qualified vaccines.<br />
190 people<br />
Were given a <strong>Crucell</strong> vaccine every minute during 2010.<br />
105+ mln<br />
Doses of vaccines were distributed in more than<br />
100 countries in 2010.<br />
3.6 mln<br />
Cases of infectious diseases were prevented in 2010.<br />
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Our business – Products<br />
MoRu-Viraten®<br />
MoRu-Viraten® is a safe, well-tolerated and effective vaccine for<br />
protection against measles and rubella in children, adolescents<br />
and adults. As MoRu-Viraten® is free of egg proteins and antibiotics,<br />
it can be safely used in children with allergies to these substances.<br />
The vaccine has been marketed since 1986 and is on the WHO list<br />
of vaccines for purchase by UN agencies.<br />
Epaxal® and Epaxal® Junior<br />
Virosomal adjuvanted Epaxal®is the only aluminum-free hepatitis A<br />
vaccine on the international market. The absence of aluminum reduces<br />
the pain associated with injection, making this vaccine especially<br />
suitable for children. A virosome is a biodegradable adjuvant system<br />
and provides a more natural presentation of the antigens than<br />
traditional adjuvants. Epaxal® induces protective antibody levels<br />
within 10 days after the initial injection. A second dose prolongs<br />
effective protection for an estimated 30 years or more. The booster<br />
dose is preferably injected 6–12 months after the first dose but<br />
may be given up to 10 years later.<br />
www.crucell.com<br />
Epaxal® is approved for use in adults and children from 1 year of age.<br />
The vaccine is currently licensed in more than 35 countries under the<br />
brand names Epaxal®, HAVpur®and VIROHEP-A.<br />
Vivotif®<br />
Vivotif® is a live attenuated oral vaccine for immunization of children and<br />
adults against typhoid fever. It is available as gastro-resistant capsules for<br />
oral administration. It is the only oral vaccine approved for protection<br />
against typhoid fever. The most common cause of this bacterial disease<br />
is Salmonella serotype Typhi (S. Typhi). The protective action starts<br />
about 10 days after the last dose is taken. Vivotif® is remarkably well<br />
tolerated, with post-marketing experience over more than 20 years<br />
confirming that adverse events are rare. Vivotif® typhoid fever vaccine is<br />
currently licensed in more than 30 countries, including the United States.<br />
Dukoral®<br />
Dukoral® oral inactivated cholera vaccine provides safe, effective<br />
and convenient protection against cholera for people living in at-risk
Our business – Products<br />
areas as well as visitors to these regions. Outbreaks of severe disease<br />
in regions where cholera is endemic put local populations at risk<br />
of serious illness and death. Travelers’ diarrhea caused by cholera is<br />
generally not life-threatening but is distressing and debilitating, spoiling<br />
many holidays and business trips. This preventable diarrheal infection<br />
is now the most common travel illness but remains an under-recognized<br />
problem. Dukoral® was first licensed in 1992 and is now registered in<br />
65 countries for the prevention of cholera, with additional indications<br />
(ETEC, travelers’ diarrhea) in some of these countries. It is an oral<br />
inactivated vaccine approved for use in adults and children from<br />
two years of age. Dukoral® drinkable vaccine is easy to use and offers<br />
84–86% protection against cholera, as demonstrated in field clinical<br />
trials on various continents. Dukoral® also has a reassuringly favorable<br />
safety profile, with an adverse event rate comparable to placebo<br />
reported in clinical trials. The vaccine’s safety and tolerability has<br />
been confirmed over many years of use around the world.<br />
Inflexal® V<br />
Inflexal® V virosomal adjuvanted vaccine offers protection against<br />
influenza thanks to its virosome technology—one of <strong>Crucell</strong>’s patented<br />
innovations. Virosomes are reconstituted influenza virus envelopes,<br />
constructed without the genetic information of the virus so that they<br />
are unable to replicate or cause infections. In the context of vaccines,<br />
virosomes serve as both a carrier system and an adjuvant.<br />
Inflexal® V is the only adjuvanted influenza vaccine licensed for all<br />
age groups (from 6 months upwards).<br />
Since its launch in 1997, Inflexal® V has been licensed in 38 countries<br />
with over 60 million doses distributed. Extensive experience in<br />
the market has confirmed its efficacy and favorable safety profile.<br />
The vaccine’s unique design and manufacturing process eliminate the<br />
need for thiomersal (a vaccine preservative) or formaldehyde (commonly<br />
used to inactivate influenza viruses) and minimize residual traces of<br />
antibiotics, detergent and hen’s egg protein compared with other<br />
influenza vaccines.<br />
The vaccine’s antigen composition changes in accordance with annual<br />
recommendations issued by the World Health Organization (WHO)<br />
on the basis of data on the circulating influenza virus strains.<br />
Other products<br />
We also distribute a variety of other products, such as Gardasil®<br />
(Merck) and Prolastin® (Talecris).<br />
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<strong>Crucell</strong>’s commitment to the world<br />
Taking responsibility<br />
www.crucell.com
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
<strong>Crucell</strong>’s mission to bring innovation to global<br />
health reflects a deep commitment to improving<br />
the lives of people worldwide. We see this as part<br />
of our <strong>corporate</strong> social responsibility (CSR)—a<br />
responsibility that underpins everything we do as<br />
a global organization and as individuals united by<br />
a common purpose. For several years we have been<br />
working to develop our approach to CSR, with the<br />
goal of maximizing our contribution to society and<br />
minimizing our environmental impact. This report<br />
highlights the recent steps we have taken on our<br />
journey and outlines the road ahead.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Taking responsibility for a better world<br />
<strong>Crucell</strong> is making great strides with the<br />
implementation of a comprehensive policy<br />
for integrating sustainability practices in our<br />
organization. In 2009, we outlined our CSR 4P<br />
policy framework incorporating the four ‘Ps’<br />
of Performance, People, Planet and Philanthropy.<br />
In 2010, we focused on bringing this policy to life<br />
in our global organization, with substantial success.<br />
A first step in this process was to establish a CSR Working Group, which<br />
is responsible for driving continuous progress in the four P-categories.<br />
With strong support from <strong>Crucell</strong>’s Management Board and many <strong>Crucell</strong><br />
employees worldwide, this group has risen to the challenge of introducing<br />
a consistent approach to CSR development, information management<br />
and reporting. Despite the complexity of harmonizing data and<br />
definitions across departments and sites, close to full data coverage has<br />
been achieved. This will enable us to measure our progress and further<br />
improve both target setting and reporting in the years ahead.<br />
At the same time, we have been seizing opportunities for increasing<br />
our contribution to society right here and now. The rapid evolution<br />
of ‘Footprint’, our community outreach program, is one exciting<br />
example of this. The introduction of global learning and development<br />
programs for <strong>Crucell</strong> employees is another. Wherever possible, we<br />
have achieved quick wins regarding our environmental impact, while<br />
working towards a more comprehensive approach in the longer term.<br />
Looking to the future, we are delighted that talks we held with Johnson<br />
& Johnson during 2010 have resulted in <strong>Crucell</strong> becoming the center<br />
of excellence for vaccines within the world’s largest and possibly most<br />
respected healthcare company. As a member of the Johnson & Johnson<br />
Family of Companies, we can do so much more to make the world we<br />
live in a healthier and safer place. This is our core business, our passion<br />
and a key component of our CSR program.<br />
www.crucell.com<br />
On the threshold of this new era, we have compiled this report in order<br />
to update our stakeholders on the current status of our CSR program, the<br />
contribution we made to society during 2010 and our plans for the future.<br />
About this report<br />
The information in this report covers the global <strong>Crucell</strong> organization<br />
during the full calendar year 2010, unless otherwise stated. <strong>Crucell</strong> has<br />
not sought external verification of the information presented here as<br />
our current priority is to facilitate the smooth working of our newly<br />
implemented systems for CSR development.<br />
Contents<br />
CSR highlights in 2010 35<br />
Our CSR policy 36<br />
Performance 40<br />
People 51<br />
Planet 58<br />
Philanthropy 62<br />
Appendix 70
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
CSR highlights in 2010<br />
y A CSR Working Group was established in the first quarter of 2010<br />
and has driven the implementation of <strong>Crucell</strong>’s global policy for<br />
evidence-based CSR development and reporting.<br />
y The initial set of ambitions, targets and key performance indicators<br />
in the CSR 4P framework categories of Performance, People, Planet<br />
and Philanthropy have been reviewed, revised and expanded<br />
where necessary.<br />
y A centralized system for CSR information management has been<br />
developed and rolled out worldwide, and company-wide data<br />
collected for baseline assessments.<br />
y For the second successive year, <strong>Crucell</strong> was listed on the Dow Jones<br />
Sustainability Index (DJSI) in 2010 and showed strong progress on<br />
the Dutch ‘Transparency Benchmark’.<br />
y <strong>Crucell</strong> CEO Ronald Brus was nominated by the vaccine industry<br />
of industrialized countries to represent the constituency on the<br />
Board of the GAVI Alliance, a public-private partnership dedicated<br />
to improving access to new and underused vaccines in the world’s<br />
poorest countries.<br />
y Hundreds of talented people were recruited and further operational<br />
improvements were made in order to boost <strong>Crucell</strong>’s capacity to<br />
bring innovation to global health.<br />
y A range of global initiatives were launched to foster employees’<br />
learning and development, which has been identified as the CSR<br />
priority with respect to human resources.<br />
y <strong>Crucell</strong> made important advances towards responsible supply<br />
chain management.<br />
y <strong>Crucell</strong> partnered the International Pediatric Association,<br />
the nongovernmental organization (NGO) Friendship and other<br />
organizations in their great efforts to support national vaccination<br />
programs in developing countries, as well as other NGOs such as<br />
the Max Foundation.<br />
y ‘Footprint’, <strong>Crucell</strong>’s community outreach program, expanded in<br />
scope and impact. Two field trips made an indelible impression on<br />
the lives of participating employees from different <strong>Crucell</strong> offices<br />
around the world, as well as the people living in disadvantaged<br />
communities in South Africa and Bangladesh.<br />
y The success of <strong>Crucell</strong>’s collaboration with Johnson & Johnson on<br />
research and development (R&D) projects during 2010 prompted both<br />
parties to explore the possibility of closer ties. This led to <strong>Crucell</strong><br />
joining the Johnson & Johnson Family of Companies in February 2011,<br />
in what we see as an exciting advance for world health.<br />
“ Our CSR program is a concerted effort<br />
to ensure that we maximize the benefits<br />
we bring to society while minimizing<br />
our environmental footprint.”<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Our CSR policy<br />
Because we care<br />
To protect, care for and contribute to society in the fullest possible sense<br />
and to the best of our ability: that is the essence of <strong>Crucell</strong>’s CSR policy.<br />
These principles of protection, care and contribution are a logical<br />
extension of our mission to bring innovation to global health, focusing<br />
especially on the prevention of infectious diseases.<br />
<strong>Crucell</strong>’s core business is the discovery, development and delivery<br />
of innovative solutions for major health threats. Our specialty is the<br />
creation of much-needed immunization products: vaccines that safely<br />
and effectively mobilize the body’s own immune defenses against<br />
infections, and antibodies that provide ‘ready-made’ immune protection<br />
against invading microbes. After clean water, immunization is believed<br />
to be the most cost-effective health intervention and its key role in<br />
promoting the socioeconomic development of countries is becoming<br />
increasingly clear.<br />
The world population is predicted to reach 7 billion in 2011 and protecting<br />
these billions of individuals from infectious diseases is more important<br />
and challenging than ever. Trends such as climate change, globalization,<br />
urbanization, wider travel and population aging are presenting new<br />
opportunities for infectious pathogens to thrive and spread.<br />
Doing our utmost to tackle this problem is our primary responsibility<br />
and our privilege. It lies at the heart of our approach to CSR. At the<br />
same time, we recognize that <strong>Crucell</strong>—as a global business with many<br />
stakeholders—has wider social responsibilities.<br />
As our business expands in line with our ambitions, our impact on<br />
the world around us will increase. Our CSR program is a concerted effort<br />
to ensure that we maximize the benefits we bring to society while<br />
minimizing our environmental footprint. Achieving the optimal balance<br />
is a challenge that calls for a proactive approach and ongoing, careful<br />
evaluation of our activities and their effects.<br />
www.crucell.com<br />
Our stakeholders<br />
<strong>Crucell</strong> works to bring significant benefit to the lives of people<br />
worldwide. This requires constructive interaction with a large<br />
number of stakeholders, including employees, legislators,<br />
investors, policy makers, business partners, licensees, suppliers,<br />
customers and organizations dedicated to sustainability issues.<br />
Our external stakeholders are far too numerous to mention, but<br />
in the interests of transparency here is a shortlist of key examples.<br />
y Legislators: US Food and Drug Administration, European<br />
Medicines Agency, and national regulatory authorities.<br />
y Policy makers: World Health Organization (WHO),<br />
Pan American Health Organization (PAHO), GAVI Alliance.<br />
y Business partners: Johnson & Johnson, DSM Biologics,<br />
Merck, Novartis, sanofi pasteur, Wyeth and MedImmune.<br />
y Customers: Supranational purchasing organizations such<br />
as Unicef (on behalf of developing countries); public and/or<br />
private health organizations in developed countries.<br />
y Sustainability organizatons: Dow Jones Sustainability Index,<br />
Carbon Disclosure Project.<br />
Stepwise progress<br />
<strong>Crucell</strong> sees CSR development as a continuous process and aims<br />
for steady progression. When we launched our global CSR program<br />
in 2008, our priority was to raise awareness and support for this<br />
initiative throughout our own organization, as well as starting<br />
a dialogue with our external stakeholders about our ambition to<br />
focus more on CSR performance and transparency.<br />
In 2009, we made the transition from this ambition to a strategy for<br />
CSR development, and outlined the 4P framework for a global CSR<br />
policy (see page 40) based on the four categories of Performance,<br />
People, Planet and Philanthropy. An initial set of ambitions, targets
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
and key performance indicators (KPIs) was formulated for each<br />
category. Of these, five were earmarked for special effort: CSR<br />
information management improvement, transparency objectives,<br />
responsible supply chain, CO 2 footprint and water use. Ambitious<br />
longer-term objectives were set for several of these indicators<br />
(see table 1).<br />
In 2010, we embarked on the implementation of our global CSR<br />
policy, including the roll-out of systems that will enable us to monitor,<br />
evaluate and improve our CSR performance and report on this in<br />
a transparent way.<br />
“ To protect, care for and contribute to<br />
society in the fullest possible sense and<br />
to the best of our ability: that is the<br />
essence of <strong>Crucell</strong>’s CSR policy.”<br />
Table 1: <strong>Crucell</strong>’s ‘top-five’ ambitions for CSR development<br />
KPI Target achieved in 2010 Target for 2011 Target for longer term<br />
CSR information<br />
management improvement<br />
Roll out Reporting Manual<br />
Transparency objectives Remain in DJSI 2<br />
Report based on 100% company coverage<br />
Improve CSR web page<br />
Set action plans for long term and set<br />
quantitative targets for EHS 1<br />
Further improve CSR web page and continue<br />
to develop reporting practices<br />
Responsible supply chain Extend global procurement policy Train all relevant employees<br />
80% of top 100 vendors sign Supplier Code<br />
of Conduct (CSR declaration) and take part<br />
in CSR assessment<br />
Define in 2011<br />
2015: GRI 3 A rating<br />
Monitor and maintain training level<br />
100% supplier coverage and monitoring<br />
of target group in 2011<br />
CO2 footprint Baseline setting Quantitative ambition setting 2020: 15% relative reduction 4<br />
Water use Baseline setting (100% company coverage) Quantitative ambition setting 2020: 10% relative reduction 4<br />
1 EHS–environment, health and safety.<br />
2 DJSI–Dow Jones Sustainability Indexes.<br />
3 GRI–Global Reporting Initiative.<br />
4 Relative to workforce size expressed in full-time equivalents.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
The 4P framework of <strong>Crucell</strong>’s CSR Policy<br />
Performance<br />
Saving lives<br />
Innovation<br />
Responsible supply chain<br />
Transparency<br />
Emissions to air<br />
Emissions to water<br />
Consumption<br />
Recycling<br />
Planet<br />
www.crucell.com<br />
People<br />
Responsible employer<br />
Health & safety<br />
Business conduct<br />
Sector sustainability<br />
initiatives<br />
Contributing to science<br />
Access to healthcare<br />
NGO partnerships<br />
Community outreach<br />
Philanthropy<br />
Clarity and leadership<br />
<strong>Crucell</strong>’s CSR policy 4P framework (see left) summarizes the main ways<br />
we strive to make a positive difference to society:<br />
y by performing at our best as a business dedicated to healthcare<br />
innovation;<br />
y by taking the best possible care of the people we work with,<br />
inside and outside the company;<br />
y by doing whatever we can to preserve and protect the earth’s<br />
precious resources;<br />
y and by contributing even more than we are required to do as<br />
a company with an intrinsically CSR-oriented mission.<br />
The four categories of Performance, People, Planet and Philanthropy<br />
are each further subdivided into a variety of themes, which represent<br />
a range of related responsibilities. Themes can be added over time<br />
to reflect our evolving responsibilities, as this is a dynamic framework.<br />
This classification system is somewhat artificial, as there is considerable<br />
overlap and interdependence among the P-categories and their<br />
component themes. However, it serves as a useful reminder of the<br />
many different facets of our CSR strategy and provides a clear overview of<br />
what we, as a socially responsible company, stand for and strive towards.<br />
A practical advantage of the 4P framework is that it breaks the enormous<br />
task of CSR development and reporting into manageable portions. Early in<br />
2010, one or more leaders (‘P-owners’) were appointed for each P-category.<br />
They have taken real ownership for progress in their area, providing crucial<br />
inspiration and direction as well as coordinating the flow of information.<br />
This approach fosters transparency, clarity and focus, which helps<br />
the P-owners—in consultation with top-level management—to define<br />
realistic but challenging targets for the coming years. This step is vital<br />
for achieving the continuous progress we strive for and ensuring that<br />
our CSR strategy delivers tangible benefits for society. Adding real<br />
value is our goal.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Organization and governance<br />
A CSR Working Group comprising the P-owners and several <strong>Crucell</strong><br />
employees with a special advisory role was established in the first quarter<br />
of 2010. It is a diverse group of senior managers representing a wide<br />
range of disciplines and different <strong>Crucell</strong> sites. Members of the CSR<br />
Working Group gather information from all levels and parts of the<br />
organization. They also initiate improvements with support and<br />
advice from the Management Board. Overall ownership of CSR has<br />
been taken on by Chief Executive Officer Ronald Brus, ensuring<br />
top-level support for its ongoing development.<br />
The CSR Working Group meets on a quarterly basis to discuss progress<br />
and formulate plans for the future. Cees de Jong, <strong>Crucell</strong>’s Chief<br />
Operating Officer, chaired these meetings in 2010 and reported<br />
on their outcomes at meetings of the Management Board. This<br />
participation reflects the importance <strong>Crucell</strong>’s top management<br />
places on CSR, and ensures governance of the program at<br />
Management Board level.<br />
Bringing our CSR policy to life<br />
While strong leadership is essential for driving our CSR program, its<br />
success will depend on how firmly it can be embedded in the fabric<br />
of our organization and brought to life. That was our priority over<br />
the past year.<br />
In the next section of this report, we focus on each of the P-categories<br />
in turn, describing our current level of achievement, the actions<br />
undertaken in 2010, our progress relative to the targets and<br />
ambitions formulated in 2009, and our priorities for the future.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Performance<br />
The P-category we call ‘Performance’ embraces four social responsibilities<br />
that we see as being central to our core business and our mission:<br />
innovation, saving lives, responsible supply chain management and<br />
transparency, by which we mean the responsibility to evaluate and<br />
report on our CSR activities in a comprehensive and systematic way.<br />
Transparency is, of course, an overarching principle in our CSR program<br />
and applies equally to all categories in the 4P policy framework.<br />
We have chosen to include it in the category most closely allied with<br />
our core business because we see transparency as a tool for strategic<br />
decision making, as well as a key responsibility towards our<br />
stakeholders. As a company dedicated to making a meaningful<br />
difference to people’s lives, we want the fullest possible understanding<br />
of our impact on society and our planet.<br />
Under the leadership of the Performance P-owner, whose function in the<br />
organization is Director Global Procurement, a large number of <strong>Crucell</strong><br />
employees have contributed to the gathering and analysis of information<br />
relevant to the initial set of key performance indicators (KPIs), targets<br />
and ambitions that were defined for this P-category in 2010 (see table 2).<br />
The P-owner’s expertise in the field of Procurement was especially<br />
valuable for developing a strategy for responsible supply chain<br />
management, which is one of five KPIs for which we have set<br />
particularly ambitious objectives.<br />
Besides a responsible supply chain, the other KPIs we have selected to<br />
measure our contribution in the Performance category are: prevention<br />
of illness and deaths, the number of pipeline products, research and<br />
development (R&D) expenses, animal welfare, CSR management<br />
improvement, and transparency objectives (relating to benchmarks<br />
such as the Dow Jones Sustainability Index, the Carbon Disclosure<br />
Project and the Transparency Benchmark). These indicators form the<br />
basis of the following discussion of activities and outcomes in the<br />
Performance category during 2010.<br />
1 Figures based on <strong>Crucell</strong>’s top 5 vaccines Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif®<br />
and Inflexal® V. Total 101,666,000 doses minus 2% waste (2,033,320 doses) = 99,632,680<br />
doses sold in 2010 / 525600 minutes in 2010 = 189.5598 doses administered per minute.<br />
2 Figure based on <strong>Crucell</strong>’s top five vaccines in terms of sales volumes:<br />
Quinvaxem®, Hepavax-Gene®, Epaxal®, Vivotif® and Inflexal® V.<br />
www.crucell.com<br />
Saving lives<br />
During 2010, <strong>Crucell</strong> delivered 105 million doses of vaccines to people<br />
around the world, with the majority going to infants in developing<br />
countries. Together, the vaccines we have on the market prevent<br />
twelve major infectious diseases: childhood infections, travel and<br />
endemic illnesses, and respiratory disease. Allowing for the fact<br />
that some vaccines inevitably go to waste, we can estimate that<br />
a <strong>Crucell</strong> vaccine was given to 190 individuals every minute during<br />
2010 1 —a thought that makes us proud.<br />
However, we believe that the best measure of our impact on global<br />
health is not the number of doses we supply, but the number of deaths<br />
and cases of disease we prevent each year. In other words, how many<br />
people would have become sick or died if they had not received our<br />
vaccine? This can be estimated by combining sales figures with data<br />
on vaccine efficacy (how well a vaccine works), disease incidence<br />
(the expected number of new cases in a population) and case fatality<br />
(the death rate among infected patients).<br />
Based on the best available evidence for these parameters, and<br />
assuming a 2% vaccine waste rate, <strong>Crucell</strong>’s ‘top-five’ vaccines prevented<br />
more than 3.6 million cases of infectious disease and 809,823 deaths in<br />
2010 2 . This was similar to our health impact in 2009, when we prevented<br />
more than 3.6 million cases of disease and over 819,000 deaths.<br />
We did not meet our target of continuous improvement in the prevention<br />
of illness and deaths, as overall product sales were slightly lower in<br />
2010 than 2009. Higher sales of travel and endemic vaccines were more<br />
than offset by lower sales of our seasonal influenza vaccine (due to the<br />
limited availability of flu antigen and weaker overall demand) as well<br />
as the temporary suspension of Quinvaxem® shipments, as explained<br />
on page 46.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Innovation<br />
While we are already preventing an estimated 3.6 million cases<br />
of infectious disease and saving over 809,000 lives with our existing<br />
portfolio of marketed vaccines, we want to do much more. Ongoing<br />
innovation is the key to realizing this ambition.<br />
<strong>Crucell</strong>’s broad research and development (R&D) pipeline currently<br />
includes twelve investigational products, of which nine are candidate<br />
vaccines and three are antibody-based immunization products. All are<br />
based on <strong>Crucell</strong>’s innovative proprietary technologies, which provide<br />
unique opportunities for combating major threats to human health.<br />
These threats include some of the world’s most powerful and elusive<br />
killers, such as tuberculosis, HIV/AIDS and malaria. The first two were<br />
responsible for 1.7 and 1.8 million deaths, respectively, in 2009, while<br />
malaria affected 225 million people in 2009 and claims almost one million<br />
lives annually. These enormous numbers highlight the importance and<br />
urgency of our promising vaccine research in these disease areas.<br />
Table 2: Performance KPIs and targets going forward<br />
KPI Quantitative/Qualitative Target<br />
Prevention of illness and death Continuous improvement<br />
Report annually<br />
Number of pipeline products Report annually<br />
Animal welfare Continuous improvement 3Rs 1<br />
R&D expenses Report annually<br />
CSR information management improvement 2011: Set action plans and set quantitative targets for EHS 2<br />
Responsible supply chain 2011: Train all relevant employees in responsible supply chain management<br />
2011: 80% of top 100 vendors sign Supplier Code of Conduct (CSR declaration)<br />
and take part in CSR assessment<br />
Beyond 2011: Full coverage and monitoring of supplier target group<br />
Transparency objectives 2011: Further improve CSR web page and continue to develop reporting practices<br />
1 3Rs–Reduce, Refine and Replace.<br />
2 EHS–Environment, health and safety.<br />
3 GRI–Global Reporting Initiative.<br />
Quantitative<br />
Qualitative<br />
2015: GRI 3 A rating<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
In the influenza field, our research teams are working on a trio of programs<br />
aimed at registering a better seasonal flu vaccine by 2014 and<br />
developing products that will revolutionize the approach to influenza<br />
prevention and treatment in the longer term. Influenza currently kills<br />
an estimated 345,000 people annually and imposes a heavy burden<br />
on society in terms of lost productivity and healthcare costs. The<br />
emergence of a lethal influenza virus with pandemic potential could<br />
push the death toll into tens of millions.<br />
For the 55,000 people—especially children—who die of rabies each year,<br />
we are developing a monoclonal antibody (mAb) product in partnership<br />
with sanofi pasteur. People who are bitten by a rabid animal can be<br />
saved by immediate injection of rabies antibodies and vaccine, both of<br />
which exist, but the blood-derived antibodies now available are in short<br />
supply and too expensive for most developing countries, where the<br />
need is greatest. Our rabies mAb product is poised to enter a large<br />
Phase II clinical trial in India in the first half of 2011, after showing<br />
very promising results in other clinical settings and populations.<br />
These are just some examples of the ways in which <strong>Crucell</strong> is working<br />
on medical solutions that really matter. A full overview of our pipeline<br />
products is given on page 13, and more information is available on<br />
the R&D section of our website.<br />
Animal welfare<br />
Before any candidate medical product can be given to humans, it<br />
must be rigorously tested in pre-clinical (non-human) models. <strong>Crucell</strong><br />
performs animal testing to the minimum extent that is required by<br />
law. We conduct essential safety studies in animals in accordance with<br />
the highest international standards, which are designed to prevent or<br />
minimize any suffering of the animals tested. Simultaneously, we apply<br />
the 3R principles—Reduce, Refine and Replace—to pre-clinical studies<br />
involving animals. <strong>Crucell</strong> has been working over many years to replace<br />
animal tests with cell-based assays, and these efforts have already<br />
resulted in the significant reduction of animal testing.<br />
www.crucell.com<br />
€100.0 mln<br />
Research and development investment in 2010<br />
compared to €70.2 mln in 2009.<br />
“ <strong>Crucell</strong> invested heavily in the<br />
advancement and expansion of<br />
pipeline programs in 2010.”
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
R&D progress<br />
<strong>Crucell</strong> invested heavily in the advancement and expansion of pipeline<br />
programs in 2010. In line with our guidance to the financial market,<br />
R&D expenses increased by more than a third to €100.0 million,<br />
compared to €70.2 million in 2009. The rise was predominantly due<br />
to an increase in clinical development spending, reflecting progress<br />
in clinical trials and significant investments in our in-house product<br />
development capabilities.<br />
Development of our pipeline during 2010 was accelerated by a strategic<br />
collaboration with Johnson & Johnson, signed in September 2009. Under<br />
the terms of this agreement, Johnson & Johnson will finance a significant<br />
part of <strong>Crucell</strong>’s existing R&D program aimed at discovery, development<br />
and commercialization of a monoclonal antibody product for the universal<br />
prevention and treatment of influenza. This program is based on <strong>Crucell</strong>’s<br />
discovery of a new class of antibodies with the unprecedented ability<br />
to neutralize a broad range of influenza virus strains.<br />
The strategic collaboration also provided funding for four new discovery<br />
programs in areas where <strong>Crucell</strong>’s innovative science and technologies<br />
show significant potential to make an important difference to global<br />
health. One of these was specified at the time the agreement was<br />
signed, and two others were decided jointly by the collaboration<br />
partners on the basis of exploratory work by <strong>Crucell</strong>’s Innovation<br />
& Discovery Laboratory (I&DL) teams in the course of 2010.<br />
In the first of the new discovery programs, <strong>Crucell</strong> scientists are using<br />
the knowledge generated in our flu antibodies program to design<br />
a vaccine with the potential to provide lifelong protection against<br />
influenza, regardless of the causal virus strain. A universal flu vaccine<br />
would eliminate the need to formulate new flu vaccines year after year,<br />
and would at last provide a defense against a lethal new influenza<br />
virus with pandemic potential. Work started on this exciting project<br />
at the beginning of 2010.<br />
The second discovery program, launched in June, focuses on the design<br />
of a vaccine to prevent severe respiratory infections caused by all of the<br />
most common strains of respiratory syncytial virus (RSV). Infants and<br />
the elderly are especially vulnerable to life-threatening illness caused<br />
by RSV, which currently claims an estimated 160,000 lives annually.<br />
RSV-induced disease is the last major childhood illness for which no<br />
preventive vaccine is available.<br />
The third new discovery program, announced in November, targets the<br />
development and commercialization of a therapeutic vaccine against<br />
human papillomavirus (HPV). Around 250,000 men and women with<br />
chronic HPV infection die each year.<br />
Another R&D highlight during 2010 was the launch of <strong>Crucell</strong>’s in-house<br />
FluCell program: a new frontier for seasonal influenza vaccines. Inflexal®<br />
V, our current flu vaccine, is both highly effective and very well tolerated<br />
thanks to its underlying virosomal technology. Now we are working<br />
to combine this innovative approach to vaccine design with our highdensity<br />
PER.C6® cell–based production system. This will enable us<br />
to manufacture unlimited supplies of high-quality flu vaccine more<br />
efficiently, more cost-effectively and starting earlier in the flu season.<br />
The traditional production method grows the viruses used for flu vaccines<br />
in chicken eggs—a slow and laborious method that does not lend itself<br />
to high-volume manufacturing, as we saw during the recent pandemic.<br />
The fact that we now have three influenza programs in the pipeline<br />
illustrates <strong>Crucell</strong>’s approach to innovation. We seize opportunities<br />
to make a difference in the near future while simultaneously working<br />
towards breakthrough products that will take considerably longer<br />
to develop, test and bring to market.<br />
Investigational vaccines we already have in clinical trials made<br />
important progress during 2010. For example, in May the recombinant<br />
malaria vaccine <strong>Crucell</strong> is developing in collaboration with the US<br />
National Institute of Allergy and Infectious Diseases entered a new<br />
phase I trial in Burkina Faso, Africa. This is the first trial of the vaccine<br />
in a population living in an area where malaria is endemic. In October,<br />
we were delighted to announce the start of a new phase II clinical trial<br />
of the tuberculosis vaccine we are developing together with the Aeras<br />
Global TB Vaccine Foundation. The trial will evaluate the safety and<br />
efficacy of this promising vaccine candidate in infants previously<br />
immunized with Bacille Calmette Guérin (BCG) vaccine. BCG is the<br />
only available TB vaccine, but has very limited efficacy.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Quinvaxem® in Uniject: simply better<br />
<strong>Crucell</strong> has embarked on a development project that will make<br />
Quinvaxem® pentavalent vaccine available in Uniject, an innovative<br />
vaccine injection system. The nonprofit organization PATH developed<br />
Uniject over 20 years ago with the aim of simplifying vaccine delivery,<br />
which the World Health Organization (WHO) sees as a key strategy<br />
for helping developing countries to improve their national<br />
immunization programs and reach populations in remote areas.<br />
The Uniject device is essentially a small plastic bubble attached to a<br />
fine, short needle and fitted with an auto-disable mechanism so that<br />
it can be used only once. The bubble will be filled with a single dose of<br />
Quinvaxem® at <strong>Crucell</strong>’s new manufacturing facility in Korea, where<br />
a state-of-the-art filling and inspection line will be created for this<br />
purpose. From there, the factory-filled devices will be shipped to the<br />
growing number of countries that are choosing <strong>Crucell</strong>’s five-in-one<br />
vaccine to protect their children against diphtheria, tetanus, pertussis,<br />
hepatitis B and Haemophilus influenzae type B (Hib), a leading cause<br />
of severe pneumonia and meningitis.<br />
Because the Uniject device needs no assembly or preparation in<br />
the field, it is ideal for countries with limited healthcare resources<br />
and a poor infrastructure. It is much faster and easier to use than the<br />
standard needle and syringe system, delivering the correct vaccine<br />
dose with a simple squeeze of the bubble. Medical staff can therefore<br />
administer more vaccines during an immunization session, with less<br />
risk of error, and even non-traditional healthcare workers can safely<br />
administer the vaccine after a short training. The auto-disable feature<br />
is important for preventing the spread of HIV and other infectious<br />
diseases. Uniject also reduces the vaccine wastage associated with<br />
multi-dose vials. Finally, its light weight and compact size facilitate<br />
transport to hard-to-reach areas. These benefits are proven, as Uniject<br />
has already been used to deliver hepatitis B and tetanus vaccines to<br />
over 73 million women and children in developing countries. Beckton-<br />
Dickinson (BD), with whom <strong>Crucell</strong> collaborates on the Uniject<br />
project, continues to further develop and improve the device.<br />
www.crucell.com<br />
Prototype Uniject device<br />
<strong>Crucell</strong>’s commitment to the Uniject project reflects the breadth<br />
of our efforts to bring innovation to global health. We know that<br />
improving access to lifesaving vaccines depends on programmatic<br />
innovations as well as new vaccines.<br />
<strong>Crucell</strong> developed Quinvaxem®to meet the specific immunization<br />
needs of the world’s poorest countries, where delivering the WHOrecommended<br />
package of vaccines to all children under five is a<br />
major challenge. When it was introduced in 2006, the only other<br />
available pentavalent vaccine came in two vials and had to be<br />
reconstituted in the field. The Quinvaxem® fully liquid formulation<br />
simplified vaccine delivery because it is ready for use as soon as<br />
the vial is opened. Putting Quinvaxem® into Uniject will make<br />
delivery simpler again, further improving vaccine coverage and<br />
cost-effectiveness. The introduction of one of the key EPI 1 vaccines<br />
in BD Uniject also brings environmental advantages: no need for<br />
separate transport of syringes and vials, ease of disposal and reduction<br />
of toxic substance emissions during burning of waste. This development<br />
is the next logical step in an ongoing process of innovation.<br />
“PATH is thrilled that <strong>Crucell</strong> is making this significant commitment,”<br />
Steve Brooke from PATH told key opinion leaders at the International<br />
Pediatric Association (IPA) Congress in South Africa last August.<br />
<strong>Crucell</strong> announced its Uniject plans at the conference and invited<br />
feedback from potential users. This followed a meeting of the WHO<br />
group focusing on new and underutilized vaccines implementation<br />
(NUVI) in June, where stakeholders were surveyed on the benefits<br />
and constraints for pentavalent vaccine in Uniject. The WHO<br />
consultation at Technet, which explores technological innovations,<br />
provided another opportunity for dialogue and debate in December.<br />
Participation in such meetings helps us to understand and meet<br />
local needs, for example regarding packaging.<br />
1 EPI stands for Expanded Program on Immunization, the WHO strategy<br />
for making vaccines available to all children worldwide.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Recruitment and operational improvements in our R&D groups were a high<br />
priority during 2010. Dr Jerald Sadoff, a veteran of vaccine development<br />
and former director of the Aeras Global TB Vaccine Foundation, joined<br />
<strong>Crucell</strong> as Chief Medical Officer & Head of Development in March 2010.<br />
He brings with him a wealth of experience and enthusiasm to take<br />
<strong>Crucell</strong>’s pipeline products to market in the shortest possible time.<br />
While working on the discovery and development of new vaccines<br />
and antibody products, <strong>Crucell</strong> also invests in programs that will<br />
increase the value and reach of existing products. A prime example<br />
of this sort of lifecycle development is our project to make Quinvaxem®<br />
available in Uniject, an ingenious vaccine delivery device designed<br />
to meet the immunization needs of developing countries (see box).<br />
Other examples are our efforts to launch Epaxal® hepatitis A vaccine<br />
on the US market and our R&D program to add a sixth vaccine to<br />
the Quinvaxem® combination.<br />
Success and setback<br />
A total of 68.9 million doses of Quinvaxem® vaccine, <strong>Crucell</strong>’s lead<br />
product, were delivered to developing countries in 2010, compared to<br />
64.3 million in 2009. Quinvaxem® is a fully liquid pentavalent (five-inone)<br />
vaccine that protects against five major childhood diseases. It<br />
was developed specifically to meet the needs of countries with limited<br />
resources and is making a major contribution towards achieving the<br />
United Nations Millennium Development Goal of reducing the mortality<br />
rate among children under five by two-thirds between 1990 and 2015.<br />
In 2010, Vietnam joined the growing number of recipient countries<br />
after the Vietnamese health authorities registered Quinvaxem® for use<br />
in the national immunization program. The first shipment was sent to<br />
Vietnam in April 2010—a month in which we shipped a record number<br />
of Quinvaxem® doses.<br />
Fill and finish operations started at our new Korean production facility mid-2010.<br />
Quinvaxem® vaccines sold<br />
(Doses in million units)<br />
6.3<br />
21.9<br />
39.6<br />
64.3 68.9<br />
2006 2007 2008 2009 2010<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Unfortunately, this success was followed by a setback later in the year.<br />
Despite our stringent quality and safety procedures, a microbiological<br />
contamination occurred at the Shingal plant in Korea where we<br />
manufacture Quinvaxem®, leading us to temporarily suspend all<br />
shipments of vaccines from this facility at the end of October 2010 and<br />
launch a thorough investigation. Shipments of noncontaminated stock<br />
of Quinvaxem® were resumed in December 2010. Full-scale commercial<br />
production of the vaccine recommenced at the Shingal facility at the<br />
start of February 2011, after the Korean regulatory authorities<br />
inspected the plant and declared it to be safe.<br />
This experience emphasizes the challenges and dilemmas inherent<br />
in our industry. Suspending the delivery of lifesaving vaccines as<br />
a precautionary measure was a painful choice and had significant<br />
financial consequences, but the alternative was unthinkable. We are<br />
not prepared to accept the slightest risk that a <strong>Crucell</strong> vaccine could<br />
cause harm.<br />
www.crucell.com<br />
During 2010 we made excellent progress on the project to relocate<br />
<strong>Crucell</strong>’s Korean production facility from the Shingal site in Yongin City<br />
to the Incheon Free Economic Zone. Operational testing of the Incheon<br />
production facility began in March 2010 and progressed rapidly from<br />
simulated test runs to validation testing of the real production process,<br />
which generates data on product consistency for submission to the<br />
regulatory authorities. These consistency runs have been completed<br />
successfully and we expect to receive regulatory approval of the<br />
Incheon facility in the second half of 2011.<br />
With a capacity of over 100 million doses annually, the new facility will<br />
enable us to significantly increase production volumes and efficiency<br />
in order to meet anticipated further growth in demand for Quinvaxem®<br />
pentavalent vaccine and our hepatitis B vaccine Hepavax-Gene®,<br />
which is also produced in Korea.<br />
A new era<br />
The landmark event of 2010 was Johnson & Johnson making a<br />
recommended cash offer to acquire <strong>Crucell</strong> N.V. at a price of €24.75 per share.<br />
The offer was formally made on 8 December 2010, and was declared<br />
unconditional on 22 February 2011, after more than 95% of the issued and<br />
outstanding share capital of <strong>Crucell</strong> was tendered for the offered price.<br />
The agreement makes <strong>Crucell</strong> the center for vaccines within the Johnson<br />
& Johnson Family of Companies, ushering in an exciting new era for<br />
our organization and—above all—for human health. We are delighted<br />
by the prospect of pursuing our mission with the support of Johnson<br />
& Johnson, an organization that shares our passion for healthcare<br />
innovation, our values and our commitment to care for people.<br />
“We are an excellent fit and together we can make a much greater<br />
difference to the lives of people worldwide,” says <strong>Crucell</strong>’s CEO Ronald<br />
Brus. “Johnson & Johnson is fully committed to investing in <strong>Crucell</strong> in<br />
order to accelerate our programs. What’s more, its management clearly<br />
values and wants to foster <strong>Crucell</strong>’s innovative and entrepreneurial<br />
spirit. This trust and respect is the key to a successful relationship.”
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Responsible supply chain<br />
Responsible supply chain management was identified in 2009 as<br />
one of five priority areas for CSR development. <strong>Crucell</strong> wants to make<br />
sustainability issues an integral aspect of our choice of suppliers and<br />
our relationship with them, and we have charted a clear course towards<br />
this goal. The progress made in 2010 well exceeds our expectations.<br />
In 2009, we laid the basis for active management of our supply<br />
chain, from a CSR perspective, by professionalizing our procurement<br />
organization and introducing a global procurement policy. The main<br />
target set for 2010 was to in<strong>corporate</strong> industry best practices for<br />
responsible supply chain management, as defined by the Pharmaceutical<br />
Supply Chain Initiative (PSCI), into our procurement policy and practice.<br />
Rather than simply reproducing the PSCI best practices in <strong>Crucell</strong>’s<br />
procurement guidelines, a team led by <strong>Crucell</strong>’s Global Procurement<br />
director has developed a Suppliers’ Code of Conduct focusing on<br />
the PSCI principles that are most important and relevant for <strong>Crucell</strong><br />
and our vendors. This Code is a declaration of <strong>Crucell</strong>’s commitment<br />
to sustainability and what we expect of our suppliers. It is designed<br />
to encourage dialogue with suppliers, instead of a ‘checklist’ or<br />
compliancy mentality. For this reason, the Code in<strong>corporate</strong>s <strong>Crucell</strong>specific<br />
ambitions relating to sustainability as well as guidelines<br />
for best practice.<br />
Working together<br />
Over the past year, this focus on dialogue has become central to our<br />
vision and strategy for responsible supply chain management. We want<br />
to engage our suppliers in an open conversation about sustainability<br />
practices, challenges and opportunities. By sharing our experiences<br />
and working together, we believe we can help the organizations<br />
that supply us with goods and services to make CSR improvements<br />
that benefit <strong>Crucell</strong>—and ultimately, of course, our planet.<br />
Two new initiatives were launched in 2010 to foster the kind of<br />
dialogue and improvements we aspire to. One focuses on supplier<br />
assessment, the other on supplier participation in <strong>Crucell</strong>-led<br />
efforts to promote good sustainability practices in line with our<br />
CSR objectives.<br />
Good things come in small packages<br />
During 2010, a multifunctional team at <strong>Crucell</strong> worked together<br />
with suppliers on a project to deliver our pentavalent paediatric<br />
vaccine Quinvaxem® in smaller glass vials. The new vials contain<br />
the same volume of vaccine and are made of the same glass as<br />
before, so this change raises no regulatory or health issues. Each<br />
vial is 1 gram lighter and we expect to fit 17% more vials in the<br />
containers used for shipping. This significantly reduces energy<br />
used for transportation and makes more efficient use of the cold<br />
chain, which in developing countries is particularly limited. Smaller<br />
vials also mean less raw material and less waste. The wide range<br />
of benefits associated with this development highlights the<br />
breadth of <strong>Crucell</strong>’s CSR efforts and the overlap among the 4P<br />
categories. We will start shipping Quinvaxem® in the new vials<br />
in September 2011.<br />
“ With a capacity of over 100 million<br />
doses annually, the new facility will<br />
enable us to significantly increase<br />
production volumes and efficiency<br />
in order to meet anticipated further<br />
growth in demand for our Quinvaxem®<br />
pentavalent vaccine and our hepatitis B<br />
vaccine Hepavax-Gene®, which is also<br />
produced in Korea.”<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
In order to conduct our business in a responsible way, we need to know<br />
more about the social and environmental impact of the companies in<br />
our supply chain. This will enable us to make the best choices and support<br />
our suppliers who may need help to develop their own sustainability<br />
practices. An online tool for gathering information about our vendors’<br />
practices and aspirations with respect to CSR was developed in 2010<br />
and will be implemented in 2011.<br />
In March 2011, <strong>Crucell</strong> held the first of a series of CSR workshops for<br />
core groups of <strong>Crucell</strong> suppliers in three regions: Korea, Switzerland and<br />
the Netherlands. These are the three major locations in terms of <strong>Crucell</strong>’s<br />
manufacturing and procurement volumes. Our aim is to bring the<br />
groups together annually to explore green ideas and work together<br />
www.crucell.com<br />
on developing sustainability practices. From our supply base, we<br />
have selected those suppliers that seem most willing and able to work<br />
with us on improvements that will deliver real benefit. The innovative<br />
concept for the workshop includes inspiring speakers, organic catering,<br />
and full CO 2 compensation for the event, including associated travel.<br />
As our ideas about responsible supply chain management have evolved<br />
during 2010, we have decided to refine our initial target (set in 2009)<br />
to achieve 100% supplier coverage and monitoring in 2011. Sending<br />
a Supplier Code of Conduct and questionnaire to each and every one<br />
of our thousands of suppliers is unlikely to lead to more than superficial<br />
communication, whereas we are aiming for real engagement and<br />
follow-up. Our revised target is to start rolling out the Suppliers’ Code<br />
of Conduct and the vendor assessment questionnaire to a sample of<br />
around 100 key suppliers in 2011. The feedback we receive should give<br />
us a good indication of the impact our CSR program can have. We will<br />
report on our findings in 2012.<br />
There is an interesting story behind the substantial results delivered<br />
in 2010. Students from Hogeschool Rotterdam, a Dutch tertiary college,<br />
were invited to work with the Global Procurement department on<br />
development of the Suppliers’ Code of Conduct, vendor assessment tool<br />
and Supplier Day program. This arrangement was mutually beneficial,<br />
giving the students valuable experience in a <strong>corporate</strong> environment<br />
while enabling <strong>Crucell</strong> to make faster progress towards our goal of<br />
responsible supply chain management.<br />
Training our people<br />
Having made great strides in 2010, we are well on track to train all<br />
relevant <strong>Crucell</strong> employees in best practices for responsible supply<br />
chain management in 2011, as targeted. In preparation for this next<br />
step, the people in our Procurement organization were given an<br />
update on <strong>Crucell</strong>’s CSR ambitions at a global event held in 2010.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Responsible choices<br />
Our successful cool-box recycling program in Sweden is an example<br />
of how smart supply chain management can combine environmental<br />
and financial benefits. This local initiative encourages vaccine customers<br />
to return the cool boxes in which they receive the products. Normally,<br />
these temperature-controlled boxes are thrown away after a single use.<br />
<strong>Crucell</strong> pays for the return transport, which costs about 50% of the new<br />
box price, and reuses each container up to four times before disposing<br />
of it responsibly. The average monthly return rate in 2010 was 89%—<br />
a great response and much higher than the 60% expected when the<br />
program was launched in 2009. Our Swedish organization sent out<br />
around 30,000 boxes of vaccines last year and purchased only around<br />
6,700 replacements, so the program substantially cuts down on both<br />
waste and expenses.<br />
CSR information management<br />
The better we understand the impact our organization has, the better<br />
choices we can make as a business that is committed to delivering<br />
sustainable profit, measured in human and financial terms.<br />
Comprehensive and reliable information about our global activities<br />
and effects is essential in order to run <strong>Crucell</strong> with ‘a warm heart and<br />
a cool head’ and communicate transparently with our stakeholders.<br />
Therefore, improving CSR information management was identified<br />
in 2009 as one of our top-five priorities for the coming years.<br />
The main targets set for 2010 were to roll out the Reporting Manual—<br />
an information tool custom-built to fit <strong>Crucell</strong>’s organization and CSR<br />
policy—and achieve 100% company coverage regarding data collection.<br />
We have reached this goal for nearly all indicators, thanks to a<br />
tremendous effort from <strong>Crucell</strong> people at all levels and parts of<br />
our organization.<br />
The senior managers who shouldered responsibility for each of the 4P<br />
policy areas (P-owners) at the global level have shown real ownership<br />
and leadership. They, in turn, have received great support from a<br />
growing band of enthusiastic CSR supporters from the local affiliates.<br />
The active involvement of the Chief Operating Officer in <strong>Crucell</strong>’s CSR<br />
Working Group sessions (held four times in 2010) has been invaluable<br />
for ensuring the alignment of this program with the Management<br />
Board’s vision and strategy for <strong>Crucell</strong>.<br />
“ The better we understand the impact our<br />
organization has, the better choices we<br />
can make as a business that is committed<br />
to delivering sustainable profit, measured<br />
in human and financial terms.”<br />
‘Rolling out’ a Reporting Manual may sound easy and effortless,<br />
but it was far from that. People grappled with the challenge of finding<br />
consistent definitions for key performance indicators (KPIs) and<br />
meaningful parameters for measuring outcomes. Training sessions<br />
and data collection had to be fitted into our employees’ already busy<br />
work days. However, by the end of 2010 a system for consistent and<br />
comprehensive reporting of information relevant to our CSR ambitions<br />
was in place, and company-wide data collection was on track.<br />
This establishes a 2010 baseline for our CSR performance, against<br />
which progress towards our ambitions can be evaluated over time.<br />
The insights we gain in the process will help us to refine and develop<br />
our CSR activities and ambitions. We see this as a continuous<br />
feedback loop enabling steady improvement.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Our fledgling system for CSR information management has its teething<br />
problems, of course. Looking at the 2010 data, we see some gaps<br />
and surprising differences across sites, which need to be investigated<br />
further. This uneven or uncertain quality of reporting mainly applies<br />
to specific quantitative KPIs in the categories of People and Planet.<br />
More intensive training may be required in these areas to ensure these<br />
KPIs mean the same thing to everyone contributing data. We are also<br />
thinking about the creation of incentive schemes to encourage and<br />
improve reporting. We will continue to develop, refine and improve<br />
our data collection methodology, scope and KPI set as we grow as<br />
an organization.<br />
As targeted, we will move on to formulating quantitative ambitions<br />
for environment, health and safety (EHS) parameters in 2011.<br />
Transparency<br />
A commitment to transparent communication with all stakeholders<br />
is fundamental to <strong>Crucell</strong>’s CSR policy. We measure our performance<br />
in this regard against external benchmarks and our own targets for<br />
CSR development. In line with our ambitions, <strong>Crucell</strong> continued to<br />
show good performance and progress on major external benchmarks<br />
of transparency and sustainability in 2010.<br />
We are especially proud that <strong>Crucell</strong> was relisted on the Dow Jones<br />
Sustainability Index (DJSI) on September 9, 2010, for the second successive<br />
year. This significant achievement is in line with our target, expressed in<br />
2009, to remain in the DJSI family of indexes—the leading benchmarks<br />
for sustainable investment. The Dow Jones Sustainability Indexes<br />
were introduced in 1999 to indicate international corporations that<br />
have made sustainability an integral part of their business strategy.<br />
Companies are included on the basis of best-in-class performance.<br />
To find out more about the DJSI, go to www.sustainability-index.com.<br />
www.crucell.com<br />
<strong>Crucell</strong> participated in the Carbon Disclosure Project (CDP) in 2010,<br />
as in the previous year. This project is a worldwide, investor-driven<br />
initiative encouraging multinational corporations to report on their<br />
environmental impact, specifically in relation to carbon emissions<br />
and climate change. Our participation reflects our ambition to<br />
measure and manage <strong>Crucell</strong>’s carbon footprint. For more information<br />
about the CDP, go to www.cdproject.net.<br />
In the Netherlands, where <strong>Crucell</strong> has its global headquarters, <strong>Crucell</strong><br />
is listed on the Transparantiebenchmark (Transparency Benchmark),<br />
an index published by the Dutch Ministry of Economic Affairs, Innovation<br />
and Agriculture. The Transparency Benchmark criteria were changed<br />
considerably in 2010 compared with the previous years, the index was<br />
expanded to include the country’s 500 largest companies and the rating<br />
scale was increased from 100 to 200 points. The Ministry expected the<br />
new criteria to have a negative impact on scores. Nevertheless, <strong>Crucell</strong><br />
showed good progress on the benchmark in 2010, scoring 96 out of<br />
200 points compared with 38 out of 100 points in 2009. This substantial<br />
growth continues the trend seen since 2008.<br />
<strong>Crucell</strong> continues to make progress towards the goal of reporting<br />
on our CSR activities in accordance with Global Reporting Initiative<br />
(GRI) criteria and verified by external audit. The improvements in<br />
CSR information management implemented in 2010 take us a step<br />
further in this direction.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
People<br />
<strong>Crucell</strong> is committed to conducting business with integrity, in a way<br />
that respects the rights and needs of our large network of stakeholders,<br />
inside and outside the company. As a company dedicated to bringing<br />
innovation to global health, we recognize the importance of creating<br />
a working environment that attracts and retains talented people<br />
and fosters their ongoing development.<br />
In this section we describe what <strong>Crucell</strong> is doing to live up to its<br />
responsibilities towards people, focusing on three main themes:<br />
being a responsible employer, health and safety, and good<br />
business conduct.<br />
<strong>Crucell</strong>’s VP Global Human Resources has taken on ownership of<br />
the ‘People’ category within the CSR policy framework. He has driven<br />
<strong>Crucell</strong>’s efforts to improve CSR performance and reporting in the<br />
area of people and organization during 2010. In consultation with<br />
the Management Board, the CSR Working Group has refined and<br />
expanded the initial set of key performance indicators (KPIs) for the<br />
People category (see table 3) and formulated qualitative targets<br />
corresponding to these indicators.<br />
Thanks to efforts from <strong>Crucell</strong> employees worldwide, the ambition<br />
to collect relevant People KPI data from all parts of the organization<br />
was achieved in 2010, giving us a better overview of our global<br />
organization and a baseline to evaluate further progress.<br />
Being a responsible employer<br />
<strong>Crucell</strong> can only fulfill its mission through the concerted efforts of the<br />
people making up our global organization. With their creativity, passion<br />
and drive, <strong>Crucell</strong> employees make a difference that matters—especially<br />
to the millions of individuals who lead healthy and productive lives<br />
because of the innovative products we deliver. Taking the best possible<br />
care of <strong>Crucell</strong>’s employees is therefore a responsibility with wide<br />
implications, and one we embrace.<br />
1 Excluding insourced staff in China.<br />
In line with <strong>Crucell</strong>’s growing ambitions, recruitment was a high priority<br />
over the past year. We are determined to accelerate our pipeline programs<br />
in order to bring new products to market faster, thereby increasing our<br />
impact on global health. The total workforce expanded to 1398 1 in 2010,<br />
representing a 12% increase from 2009. Most of the new employees<br />
are based in the Netherlands and Switzerland, where <strong>Crucell</strong>’s research<br />
and development (R&D) activities are located. <strong>Crucell</strong> remains an<br />
organization of relatively young people, with the average employee<br />
age being 40.<br />
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Table 3: People KPIs and targets going forward<br />
KPI Quantitative/Qualitative Target<br />
Number of employees by gender Continue focus on equal-opportunity human resource management worldwide<br />
Average age of employees Report annually<br />
Number of women in management Fair and equitable representation<br />
Number of nationalities Focus on cross-cultural teams<br />
Total number of accidents 2011: LTC rate of 0.4 or less<br />
Of the people who joined <strong>Crucell</strong> in 2010, 250 were recruited through<br />
referral and the strong employer’s reputation on the labor market.<br />
We actively encourage our employees to talk to their contacts about job<br />
opportunities at <strong>Crucell</strong> or recommend suitable candidates. As talent<br />
attracts talent, this has proven to be an efficient and effective means<br />
to develop <strong>Crucell</strong>’s capabilities in specialist areas. We also see it as an<br />
indicator of employee satisfaction, the key prerequisite for achieving our<br />
ambition to become an ‘employer of choice’. For this reason, the number<br />
of ‘own recruits’ has been added to the list of People KPIs and will be<br />
reported annually. <strong>Crucell</strong> aims to maximize the number of ‘own recruits’.<br />
Another new KPI is absenteeism: the percentage of days missed from<br />
work (apart from planned leave). Our first experience with collecting<br />
www.crucell.com<br />
2015: LTC rate below 0.2<br />
Employee turnover Voluntary turnover rate no more than 10% of workforce, excluding temporary staff<br />
% employees receiving regular<br />
performance reviews<br />
> 95%<br />
Number of own recruits 1 Report annually<br />
Absenteeism 1 Set criteria in 2011<br />
1 New KPI added in 2010.<br />
Quantitative<br />
Qualitative<br />
Report annually<br />
these data in 2010 has pointed to the need to sharpen definitions,<br />
which we will do in 2011. We are interested in this parameter<br />
as a global measure of our employees’ health, well-being and<br />
job satisfaction.<br />
Voluntary employee turnover in 2010 was 12.93%. We aim to work<br />
proactively to minimize the number of people who choose to leave<br />
the company, with a target of less than 10% voluntary turnover.<br />
To achieve this, <strong>Crucell</strong> will continue to focus on creating the sort<br />
of working environment that not only inspires and empowers our<br />
employees, but also provides ample opportunities for learning<br />
and development within the organization.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Developing talent<br />
<strong>Crucell</strong> is investing heavily in the skills and competencies of its people.<br />
Our Global Human Resources (HR) team has developed a long-term<br />
strategy for people development and identified this as a key CSR priority<br />
for taking <strong>Crucell</strong> where it wants to go.<br />
Implementation of this strategy started in 2010 and great strides have<br />
been made. A Global Manager Learning & Development was appointed<br />
in May, reflecting the importance we attach to building a ‘continuous<br />
learning’ culture at <strong>Crucell</strong>. In collaboration with other key stakeholders,<br />
the Global HR team has launched two global training programs for<br />
<strong>Crucell</strong> managers at various levels. One program focuses on developing<br />
people’s project management skills, the other on helping managers to<br />
develop financial and business acumen. <strong>Crucell</strong> employees have asked<br />
for this kind of support and this dovetails with the company’s<br />
strategic goals.<br />
With a view to providing a gateway to learning and development<br />
opportunities for all <strong>Crucell</strong> employees, the Global HR department launched<br />
an online People Development Portal in July 2010. The basic launch<br />
version will be progressively enriched and expanded over the coming<br />
years. The idea is to offer our people a toolkit that will help them to reflect<br />
on their learning potential and seize opportunities for development.<br />
<strong>Crucell</strong> ran a leadership training for managers in Switzerland and the<br />
Netherlands in 2010, as part of an ongoing program established in 2008.<br />
We see a vital role in our organization for good leaders who can inspire<br />
and empower their teams of people to excel.<br />
An essential aspect of this leadership role is conducting regular<br />
performance reviews, which when done well provide people with feedback<br />
that will enable them to achieve their full potential. In 2010, about 95%<br />
of <strong>Crucell</strong> employees received regular performance reviews. Our aim<br />
is to ensure all employees receive regular performance reviews, and to<br />
increase their added value for both the employee and the company.<br />
Diversity and equal opportunity<br />
<strong>Crucell</strong> sees the value of diversity and strives to foster this through<br />
our recruitment practices and organizational structure, for example<br />
by building cross-functional and cross-site teams. Our site in the<br />
Netherlands employs people of 24 nationalities, closely followed by<br />
Switzerland with 23. This rich cultural mix fosters the cross-fertilization<br />
of ideas, as well as fun.<br />
Looking at the numbers of male and female employees in 2010, we see<br />
that <strong>Crucell</strong> has a reasonably balanced workforce in terms of gender<br />
(more than 47% females in 2010, compared with 45% in 2009). There<br />
was a substantially greater year-on-year increase (20% versus 10%)<br />
in the number of women compared with men.<br />
In our 2009 report, we noted the relatively low number of women in<br />
senior management positions as a point for attention. It is encouraging<br />
to see that the number of female employees with senior management<br />
roles increased by 45% in 2010 compared with 2009, bringing the total<br />
number to 84.<br />
<strong>Crucell</strong> is an equal-opportunity employer. We are committed to<br />
recruiting and promoting employees on the basis of talent and ability,<br />
without negative or positive discrimination on the basis of gender,<br />
race or age.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
We value both gender and ethnic diversity and accordingly act as an equal opportunity employer.<br />
The characteristics of our workforce are as follows:<br />
2010<br />
www.crucell.com<br />
China Italy Korea Netherlands Spain Sweden Switzerland UK USA Total<br />
Number of male employees 8 9 172 216 34 34 245 9 14 741<br />
Number of female employees 35 8 49 222 49 71 184 26 13 657<br />
Total number of employees 43 17 221 438 83 105 429 35 27 1,398<br />
Average age of employees 28 47 35 37 45 46 40 38 45 40<br />
Number of women in management 3 2 6 42 3 5 18 0 5 84<br />
Number of nationalities per location 1 1 4 24 2 1 23 3 7 n/a<br />
2009<br />
Number of male employees 9 10 169 181 33 43 218 6 12 681<br />
Number of female employees 41 8 50 177 40 78 151 15 7 567<br />
Total number of employees 50 18 219 358 73 121 369 21 19 1,248<br />
Average age of employees 30 46 36 36 45 45 40 40 44 40<br />
Number of women in management 1 2 5 27 3 4 14 0 2 58<br />
Number of nationalities per location 1 1 4 20 2 7 20 3 5 n/a<br />
2008<br />
Number of male employees 9 12 167 139 30 45 225 n/a 11 638<br />
Number of female employees 26 10 44 114 39 88 159 n/a 8 488<br />
Total number of employees 35 22 211 253 69 133 384 n/a 1 19 1,126<br />
Average age of employees 31 44 35 36 46 45 42 n/a 43 40<br />
Number of women in management 3 3 4 23 2 10 10 n/a 3 58<br />
Number of nationalities per location 2 1 3 19 2 4 10 n/a 5 n/a<br />
1 Not applicable, as <strong>Crucell</strong>’s UK organization was launched in October 2009.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Male/female ratio of <strong>Crucell</strong> employees in 2010<br />
53%<br />
Male<br />
Female<br />
47%<br />
Number of nationalities per <strong>Crucell</strong> office in 2010<br />
China 1<br />
Italy 1<br />
Korea 4<br />
Netherlands 24<br />
Spain 2<br />
Sweden 1<br />
Switzerland 23<br />
UK 3<br />
USA 7<br />
Health and safety<br />
<strong>Crucell</strong> invests in protecting the health, safety and well-being of our<br />
employees. This is both a moral obligation and essential for building<br />
a strong and sustainable business.<br />
For several years, <strong>Crucell</strong> has been working systematically to enhance<br />
workplace safety, focusing especially on accident prevention and<br />
preparedness. To ensure a coordinated approach, we have created the<br />
position of Global Head of Environment Health & Safety (EHS) and<br />
introduced a global EHS policy based on international standards and<br />
certification requirements. Safety officers have been appointed at our sites<br />
worldwide and sent to DuPont safety training, the gold standard in the<br />
chemicals and biopharmaceuticals industry. They take responsibility at the<br />
local level for introducing best practices and monitoring workplace safety.<br />
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Safety improvement: a case study<br />
In January 2011, a <strong>Crucell</strong> technician had a serious accident while<br />
handling glassware in one of our production facilities. The worker<br />
was pushing a tray of bottles sprayed with antiseptic under the<br />
laminar flow hood (air-control barrier) of a sterile handling unit.<br />
The bottles toppled and fell, and the technician suffered a deep<br />
cut as he tried and failed to catch them in his gloved hands.<br />
His colleagues had received safety training and responded<br />
appropriately, most probably saving his life.<br />
If we examine the risk factors in this situation—the wet and<br />
slippery glassware, the laminar hood, the sterile gloves, the tray<br />
and handling method—we see that they are all related to Good<br />
Manufacturing Practice (GMP) in our industry. Biopharmaceutical<br />
production must be conducted under highly sterile and controlled<br />
conditions in order to ensure the safety of the people who receive<br />
our products. However, this can potentially create unsafe<br />
conditions for production workers. The challenge we face is<br />
to safeguard both our employees and products.<br />
Our safety and process experts meet this sort of challenge by<br />
analyzing the precise circumstances in which accidents occur and<br />
looking for GMP-compliant technical workarounds, or ways to<br />
avoid unsafe process steps altogether. At the same time, they focus<br />
on raising employees’ awareness of workplace risks and how to<br />
respond if an accident does occur.<br />
1 The OSHA defines the LTC as the number of accidents resulting in at least one whole<br />
shift absence, per hours worked by 100 employees in 12 months (200,000 hours).<br />
www.crucell.com<br />
One of the tasks of safety officers is to collect data on accidents,<br />
with the aim of gaining a better understanding of risk factors and how<br />
to manage them. In our 2009 CSR report, we published accident data<br />
collected independently at our five manufacturing and/or development<br />
sites (covering 90% of the workforce) but noted the limitations of these<br />
data. For example, countries used different definitions and ways<br />
of measuring accidents.<br />
In 2010, we focused on taking EHS information management to the next<br />
level by introducing a global reporting system based on harmonized<br />
criteria. Access to more detailed information, collected from our production<br />
and R&D facilities using the same definitions, will give us greater power<br />
to continuously improve safety, using a ‘plan-do-check-act’ approach.<br />
We are well on track towards this goal. A clear procedure for accident<br />
reporting, analysis and follow-up with corrective action has been<br />
introduced. An EHS Reporting Manual has been developed, local<br />
safety officers have been trained in its use and full-year data based<br />
on consistent criteria have been collected and analyzed. A reporting<br />
infrastructure has been established and is working well: local data<br />
are reported to the global EHS manager, who gives regular updates<br />
to the Chief Operating Officer (safety data on a monthly basis,<br />
other information quarterly).<br />
Accident reporting<br />
Agreeing on a consistent definition of reportable accidents was a<br />
challenge. After considerable debate, we have decided to adopt the<br />
United States’ Occupational Safety and Health Administration (OSHA)<br />
definition of lost time case rate (LTC) 1 , excluding accidents that occur<br />
on the way to or from work and excluding medical conditions (such<br />
as fainting at work). Using consistent definitions allow trends to<br />
be followed.<br />
Analysis of the LTC among <strong>Crucell</strong> employees at our five main sites over<br />
the period 2009–2010 (see graph) suggests that accident frequency has
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
been dropping. Whole-year LTC values<br />
decreased from 0.75 in 2009 to 0.40 in 2010.<br />
The target we have set for this KPI is to<br />
maintain or improve an LTC of 0.40 in 2011,<br />
which is the industry average. By 2015 we<br />
want to achieve a rate below 0.2.<br />
Increasing safety awareness<br />
<strong>Crucell</strong>’s approach to improving workplace<br />
safety starts with accident preparedness:<br />
anticipating accidents that could occur and<br />
making sure that people know what action<br />
to take if they do. The importance of this is<br />
highlighted by a serious accident that occurred<br />
recently in one of our production facilities<br />
(see box left).<br />
Accident frequency<br />
(in LTC values)<br />
0.75<br />
0.40<br />
2009 2010<br />
Our new reporting system provides a tool for<br />
understanding why accidents happen, so that we can take corrective<br />
action and prevent further occurrences. Ideally, we want to identify<br />
unsafe situations before any accident occurs. Reports of ‘near misses’<br />
(narrowly avoided accidents) are perhaps the most valuable information<br />
for managing risks and preventing accidents.<br />
Our accident data are classified into four groups according to the<br />
severity of their outcomes: near miss, first aid, medical treatment and<br />
fatality. On the basis of the assumed frequency of events in each<br />
category, we could expect to receive far more reports of near misses<br />
than serious accidents. Our data show the opposite pattern, suggesting<br />
that a relatively small proportion of near misses are being reported.<br />
We encourage every employee to report unsafe situations and near<br />
misses. With a view to raising the general level of safety awareness<br />
in the organization, we will hold a series of safety workshops for<br />
managers in 2011. They will be asked to act as role models and adopt<br />
a number of best practices in order to foster a culture of sustainable<br />
safety awareness.<br />
Other initiatives<br />
<strong>Crucell</strong> promotes the health and well-being of employees in other<br />
ways. Here are just a few examples of recent developments:<br />
y In Switzerland, improvements to the production line for Vivotif®,<br />
<strong>Crucell</strong>’s vaccine against typhoid fever, have made work more<br />
comfortable and pleasant for our people, as well as more efficient.<br />
y Our Spanish site has significantly improved security in order to<br />
increase the protection of our people and our products.<br />
y Free vaccination against seasonal influenza is offered to employees<br />
and their families each year, in countries where this is feasible<br />
and appropriate. In Korea, employees identified as being at risk of<br />
hepatitis A were also offered free vaccination with <strong>Crucell</strong>’s Epaxal®<br />
vaccine in 2010, while <strong>Crucell</strong>’s travel vaccines were made available<br />
to employees and their families in the Netherlands and Switzerland.<br />
Good business conduct<br />
<strong>Crucell</strong> adheres to high standards of ethics and transparency in dealing<br />
with all stakeholders. We take our legal and ethical obligations very<br />
seriously. <strong>Crucell</strong>’s Code of Conduct guides employees in the high<br />
standards of behavior expected of them and their obligation to act<br />
with integrity at all times.<br />
The Code of Conduct urges employees to report any behavior or<br />
action that may be in breach of this code. A procedure for reporting<br />
non-compliance is in place and compliance offers have been<br />
appointed worldwide.<br />
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Planet<br />
As a company dedicated to fostering the health and well-being of<br />
people worldwide, <strong>Crucell</strong> is very conscious of its responsibility to care<br />
for the planet—our shared home. We are actively working to integrate<br />
environmental awareness into our strategic decision making and<br />
routine work practices so that we can live up to this responsibility.<br />
Our aim is to maximize our productivity—and thereby our health<br />
impact—while minimizing our environmental footprint.<br />
In 2009, we defined an initial set of KPIs for measuring our progress<br />
towards this goal. We also set targets for reducing energy and water<br />
consumption, minimizing our carbon footprint and improving waste<br />
management, basing these targets on the data then available in the<br />
organization. At the same time, we pointed out the need for more<br />
comprehensive and reliable data.<br />
Table 4: Planet KPIs and targets going forward<br />
KPI Quantitative/Qualitative Target<br />
Total water use<br />
Waste water<br />
www.crucell.com<br />
With the development and implementation of the CSR Reporting<br />
Manual in 2010, we now have what we aimed for: company-wide<br />
data on relevant Planet KPIs, collected for the full calendar year using<br />
consistent criteria. This gives us a solid baseline for future reporting<br />
and target setting.<br />
Reporting methodology<br />
As targeted, the findings reported here are based on 100% data coverage<br />
for our global organization in 2010. We took a pragmatic approach<br />
to achieving this target, focusing primarily on collecting data from our<br />
five manufacturing and/or development sites, which together employ<br />
over 90% of the total workforce and account for almost all of<br />
<strong>Crucell</strong>’s environmental impact. Solid data were also obtained from<br />
a representative marketing and sales office and extrapolated to<br />
cover the remaining offices in order to calculate our carbon footprint.<br />
Relative reduction 1 of 10% from 2010 baseline by 2020<br />
Monitor and minimize<br />
Total energy use See CO2 footprint<br />
CO2 footprint Relative reduction 1 of 15% from 2010 baseline by 2020<br />
Number, sort and impact of accidents 2011: LTC rate of 0.4 or less<br />
Amount and characteristics of waste<br />
and disposal method<br />
1 Relative to workforce size expressed in full-time equivalents (FTEs).<br />
Quantitative<br />
Qualitative<br />
2015: LTC rate below 0.2<br />
Develop and/or refine waste minimization programs on all sites
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Total energy consumption<br />
(in kWh, million)<br />
59.3<br />
62.7<br />
61.1<br />
88.4<br />
2007 2008 2009 2010<br />
Total water consumption<br />
(in m 3 )<br />
201,523<br />
231,834<br />
221,320<br />
312,259<br />
2007 2008 2009 2010<br />
<strong>Crucell</strong>’s marketing and sales offices were found to account for less<br />
than 1% of total CO 2 emissions, confirming the validity of the method<br />
used for data collection and the importance of focusing our Planet<br />
efforts on the five production-related sites.<br />
To safeguard the reliability of data, the managers responsible for data<br />
delivery have been trained in KPI definitions and CSR reporting rules.<br />
For example, they are instructed to report quantities and units<br />
as invoiced, without conversion. Any estimates must be indicated<br />
as such, and assumptions or algorithms must be documented.<br />
Pilot studies were conducted during 2010 to evaluate the quality<br />
of the data being collected, identify any problem areas and adapt<br />
the reporting methodology as needed. For example, the initial waste<br />
classification system was simplified in the course of the year to promote<br />
the consistency and value of reporting. We will report amounts of waste<br />
in three major categories: solid waste, special waste and recycled<br />
quantities. Waste water has been added to our KPI set.<br />
The EHS Reporting Manual has been developed progressively over the<br />
year and will continue to evolve as we learn by doing. We extend our<br />
thanks to all who have put so much time, energy and enthusiasm into<br />
this project. What they have produced, under the leadership of our<br />
global EHS director, is an indispensable tool for understanding and<br />
progressively improving <strong>Crucell</strong>’s relationship with the planet.<br />
Energy savings and safety: a dilemma<br />
A dilemma we face in our industry is that what makes sense from<br />
an environmental point of view can conflict with our responsibility<br />
to provide safe biopharmaceutical products. It seems logical to<br />
save energy by shutting down the air conditioning in our production<br />
facilities overnight or at the weekend. However, maintaining<br />
a constant and clean environment is essential for safeguarding<br />
against microbial contamination and ensuring the quality of the<br />
product. The energy gain from a temporary shutdown is outweighed<br />
by the energy that would be required to restore the correct<br />
environment and the time-consuming quality assurance tests<br />
that would be needed.<br />
Energy consumption<br />
<strong>Crucell</strong>’s global organization consumed a total of 88.4 million kilowatt<br />
hours (kWh) of energy in 2010. This represents a 44.6% increase<br />
compared to the previous year (see graph).<br />
Energy use includes electricity, natural gas, oil, and other fuels such<br />
as gasoline and diesel, all of which are converted to kWh. Electricity<br />
(from the grid) is <strong>Crucell</strong>’s primary source of energy. <strong>Crucell</strong>’s total<br />
energy consumption in 2010 was equivalent to that of approximately<br />
4,935 average households (consuming 17,906 kWh).<br />
Parallel operations in Korea account for most of the increase in total<br />
energy consumption in 2010 compared with 2009. Our new Korean<br />
manufacturing facility on the Incheon site became fully operational<br />
in validation mode in 2010, while commercial production continued<br />
at the facility on the Shingal site. The latter will be decommissioned<br />
once the Incheon facility receives regulatory approval.<br />
The Incheon vaccine plant has around twice the capacity of the<br />
Shingal facility and has been engineered for highly efficient production.<br />
Manufacturing larger volumes more efficiently translates into significant<br />
gains in eco-efficiency. That is exactly what <strong>Crucell</strong> strives for: greater<br />
output—and health impact—with lower energy use.<br />
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Higher occupancy at our sites in Switzerland and the Netherlands also<br />
played a role in the greater energy consumption.<br />
In Switzerland, total energy consumption increased by around a third in<br />
2010 versus 2009. This reflects the fact that two formerly decommissioned<br />
buildings were brought on line again in the summer to house groups<br />
working on product process development and activities related to<br />
taking our Epaxal® vaccine to the USA. Expansion of these groups is part<br />
of <strong>Crucell</strong>’s strategy for accelerating pipeline growth. This also explains<br />
rising energy use in the Netherlands, where we significantly increased<br />
our R&D capabilities and activities in 2010. An additional building was<br />
rented to accommodate the rapidly growing workforce and provide<br />
space for new laboratories.<br />
1,2 Relative to workforce size expressed in full-time equivalents (FTEs).<br />
www.crucell.com<br />
Water management<br />
<strong>Crucell</strong> has decided to measure both total water consumption and<br />
waste water.<br />
Total water consumption in 2010 was 312,259 cubic meters, which<br />
was 41.1% higher than in 2009. Water is sourced from the grid, except<br />
for Madrid, Spain, where we operate a well on our premises.<br />
In 2010 <strong>Crucell</strong> generated 156,643 cubic meters of waste water.<br />
The addition of this new parameter to our KPI set reflects the high<br />
potential we see to decrease overall water consumption by optimizing<br />
water management in our production facilities.<br />
The large increase in total water consumption during 2010 can<br />
be explained by the significant expansion of manufacturing and<br />
development operations, as discussed in the section on energy<br />
consumption. The observation that water consumption increased<br />
to a lesser extent than energy consumption might therefore reflect<br />
the success of recent efforts to improve water management,<br />
for example at facilities in Switzerland and Spain.<br />
At one of our production facilities in Switzerland, fresh water intake<br />
for plant steam generation has been cut substantially by optimizing the<br />
working of the steam and condensate system. The maximal amount<br />
of recoverable water is now being returned to the boiler. Besides saving<br />
water, this saves energy (as the recovered water requires less heating)<br />
and cuts down on water conditioning chemicals.<br />
<strong>Crucell</strong>’s production plant in Madrid installed a new system for purified<br />
water production in 2010. The old system supplied 50% purified water<br />
and 50% concentrate (water with impurities), which was used to water<br />
plants on the site. The output from the new system is 85% purified<br />
water, decreasing waste to 15%.<br />
Improving water use is one of the top-five ambitions relating to CSR<br />
that we identified in 2009. We are targeting a 10% relative reduction<br />
in water use by 2020. 1
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Waste<br />
Outcomes of our waste generation analysis for the global organization<br />
in 2010 are as follows:<br />
y Solid waste: 754,420 kilograms.<br />
y Special waste: 52,995 kilograms (representing 7% of total waste).<br />
y Recycled waste: 203,596 kilograms (representing 27% of total waste).<br />
Now that we have a good overview of the amounts and types of waste<br />
generated in our global organization, as well as the disposal method,<br />
we can start to develop and implement waste minimization programs.<br />
A workshop with EHS managers was held in March 2011 to spark ideas.<br />
Packaging<br />
<strong>Crucell</strong> continuously explores options for improving packaging, especially<br />
in ways that benefit both the environment and our customers. One of the<br />
success stories is our project to deliver <strong>Crucell</strong>’s Quinvaxem® pentavalent<br />
vaccine in smaller vials, which means less raw material, less weight<br />
to be transported and more efficient use of cold chain storage (for more<br />
details see the section on responsible supply chain management).<br />
In 2010 our regulatory team set out to reduce the size of the boxes carrying<br />
two vials of Dukoral® cholera vaccine, which are considerably oversized.<br />
Smaller volumes would facilitate transport and cold storage, as well<br />
as saving packaging material. The team was disappointed to hear from<br />
the Canadian regulatory authorities that they could not carry out their<br />
plan. The information printed on the boxes must be in both English and<br />
French, and of a specified font size. These regulatory requirements—<br />
designed to promote safe use of the product—could not be met using a<br />
smaller box. This dilemma is an example of the complexity of factors that<br />
must be taken into consideration in the highly regulated vaccines industry.<br />
Carbon footprint<br />
<strong>Crucell</strong>’s carbon footprint in 2010 was just over 21,000 tonnes CO 2<br />
(21,120.61 tonnes). The carbon footprint was calculated using the<br />
Greenhouse Gas Protocol and accompanying conversion factors<br />
(to account for different energy mixes) per country. The most recent<br />
conversion factors were sourced from the UK Department for<br />
Environment, Food and Rural Affairs (DEFRA). Reducing our carbon<br />
footprint is one of the top-five CSR ambitions formulated in 2009. We<br />
are targeting a 15% relative reduction 2 from the baseline set in 2010.<br />
Planting the seed<br />
For years, <strong>Crucell</strong>’s organization in Spain has taken a creative<br />
approach to recycling plastic packaging material that would<br />
otherwise go to waste. The large plastic containers in which<br />
syringes are delivered to <strong>Crucell</strong> are ideal for re-use as seedling<br />
trays. <strong>Crucell</strong> Spain sells the boxes to a nursery for this purpose.<br />
Though this is a relatively small-scale activity, it is a good<br />
example of the kind of CSR thinking <strong>Crucell</strong> wants to promote.<br />
A large volume of plastic is recycled in this way every year.<br />
<strong>Crucell</strong> Sweden shows the same spirit with its vaccine cool-box<br />
recycling program.<br />
“ <strong>Crucell</strong> continuously explores options<br />
for improving packaging, especially in<br />
ways that benefit both the environment<br />
and our customers.”<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Philanthropy<br />
Besides doing the very best we can to discover, develop, manufacture<br />
and market innovative products that protect people’s health and<br />
well-being, we look for extra ways to make a positive difference to<br />
the lives of people worldwide.<br />
For reporting purposes, we group these noncommercial efforts under<br />
the heading of ‘Philanthropy’. This is a broad category that embraces<br />
everything from community outreach projects and efforts to<br />
improve healthcare access to the sharing of scientific knowledge<br />
and participation in sector sustainability initiatives.<br />
www.crucell.com<br />
Community outreach<br />
Footprint<br />
<strong>Crucell</strong> encourages and facilitates employees’ involvement in<br />
philanthropic projects, in the belief that this benefits those who give<br />
help as well as those who receive it. This is the philosophy behind our<br />
global CSR outreach program ‘Footprint’, which gives <strong>Crucell</strong> employees<br />
an opportunity to visit disadvantaged communities where <strong>Crucell</strong> is<br />
working in partnership with local organizations to make a major<br />
difference to people’s lives.<br />
In last year’s report we introduced two of these partners: the South<br />
African Tuberculosis Vaccine Initiative (SATVI) and the nongovernmental<br />
organization (NGO) Friendship. SATVI conducts clinical trials of the<br />
tuberculosis vaccine <strong>Crucell</strong> is developing in collaboration with the Aeras<br />
Global TB Vaccine Foundation. Friendship is doing wonderful work—<br />
with <strong>Crucell</strong>’s support—to extend the reach of the government’s routine<br />
vaccination program in the remote northern districts of Bangladesh.<br />
Many children in this poor and inaccessible part of the country have<br />
been missing out on vaccinations prescribed by the national Expanded<br />
Program on Immunization (EPI).<br />
In the course of 2010, we enlarged the scope of these CSR outreach<br />
efforts to include support for the Max Foundation, a nonprofit<br />
organization that carries out small-scale projects to provide clean<br />
drinking water to communities in the southern part of Bangladesh.<br />
<strong>Crucell</strong> has so far sent three teams of <strong>Crucell</strong> volunteers to take part<br />
in these local projects and see for themselves the challenges faced<br />
by people living in the world’s poorest and most needy communities.<br />
The employees have returned to work with a new understanding of the<br />
devastating effect infectious diseases have on communities without
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
adequate access to childhood vaccines and clean water, as well as<br />
the importance of what they are doing in their daily work as <strong>Crucell</strong><br />
employees to give the people in these communities a future.<br />
A blog entry posted on our Global Intranet by the Footprint team<br />
during the latest field trip says it all: “We took the ambulance boat<br />
along the chars to an EPI session set up by Friendship in collaboration<br />
with local governmental agents. When we arrived there was a long<br />
queue of mothers with very young babies in their arms. And there<br />
we saw it, the babies were getting Quinvaxem®! With funding from<br />
<strong>Crucell</strong>, Friendship has set up a cold chain to enable children in these<br />
remote char areas to be immunized. Even though all these tiny babies<br />
had to cry when they were injected, we were thrilled to know that<br />
it would significantly increase their chances of growing up into<br />
healthy teenagers.”<br />
Table 5: Philanthropy KPIs and targets going forward<br />
KPI Quantitative/Qualitative Target<br />
Number of doses donated Report annually<br />
Global policy for disaster relief (donations)<br />
Support of sector sustainability initiatives Participation in DJSI 1 , CDP 2 and Transparency Benchmark to end due to delisting<br />
Continue participation in GRI 3<br />
NGO partnerships New Footprint field trips scheduled for 2011<br />
1 DJSI – Dow Jones Sustainability Indexes.<br />
2 CDP – Carbon Disclosure Project.<br />
3 GRI – Global Reporting Initiative.<br />
Quantitative<br />
Qualitative<br />
“ I went into this experience really not having<br />
a clue what to expect… and it was amazing!<br />
The cliché term of a ‘once in a lifetime<br />
opportunity’ is really the only way I can<br />
describe my experience in Bangladesh.”<br />
Further strengthen current NGO partnerships<br />
Explore potential new partnerships<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Whenever possible, the Footprint volunteers have provided practical help<br />
during these field trips, for example by painting the children’s ward of<br />
a hospital in South Africa or helping to dig a well in Bangladesh. They<br />
arrived with suitcases laden with small gifts—from coloring sets, jewelry,<br />
sweets and toys to large boxes of disinfectant solutions and plasters—<br />
which were received like treasures by excited children and parents.<br />
What the volunteers took away with them was equally treasured.<br />
One field trip member points out: “I went into this experience really<br />
not having a clue what to expect… and it was amazing! The cliché term<br />
of a ‘once in a lifetime opportunity’ is really the only way I can describe<br />
my experience in Bangladesh.”<br />
www.crucell.com<br />
All <strong>Crucell</strong> employees can apply to take part in the Footprint field trips,<br />
and teams are carefully chosen to include people with different job<br />
functions and from different countries. They share their experiences<br />
with their colleagues on their return, thereby creating a ripple-on<br />
effect that is helping to raise the overall level of CSR awareness and<br />
enthusiasm in our organization.<br />
Community outreach in Korea<br />
In 2010, our Korean colleagues continued their efforts to make life<br />
a bit brighter for children taking part in the ‘Dream Start’ program,<br />
a government health and welfare program targeting children from<br />
low-income families.<br />
Many of these children live in urban squats and lack access to even<br />
basic amenities like hot water, which means they are often teased and<br />
rejected at school. In 2009, <strong>Crucell</strong> volunteers were inspired to organize<br />
a ‘bath day’, combining a trip to the public baths with games, presents<br />
and a barbeque. This successful formula was repeated again in February<br />
2010, providing a day of warmth and fun in the middle of winter.<br />
Around 20 <strong>Crucell</strong> employees and 25 Dream Start children participated.<br />
In the heat and humidity of July 2010, <strong>Crucell</strong> volunteers took the Dream<br />
Start collaboration a step further by organizing a ‘clean-up day’ for two<br />
families living in Seongnam-si, one of the poorest neighborhoods in<br />
the city. The teams put up fresh wallpaper, renovated the floors and<br />
cleaned both houses. “It was a great joy to see the kids playing around<br />
in a clean and tidy home,” was how one volunteer summed up the day.<br />
“What my colleagues did might seem like a small contribution to<br />
improving the lives of people in this squalid area, but it is a great start<br />
and I am very proud of all of them,” said Sang Jeom Ahn, General<br />
Manager of <strong>Crucell</strong> Korea. This example highlights the importance<br />
of local as well as global CSR initiatives.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Runa Khan, Executive Director Friendship<br />
“Let me tell you a true story… On char Bhatiborial under Sundarganj,<br />
Gaibandha, a young girl is already a mother at the age of 16. Khadija<br />
Begum was 15 when she married Shomizuddin. She had never<br />
received medical treatment or visited a doctor and had not received<br />
her tetanus injection (TT). She was not even aware that adolescent<br />
girls should receive three doses of TT under the Government<br />
Expanded Program on Immunization (EPI) to minimize the risk<br />
of infection during delivery.<br />
To her knowledge, the government has never held an EPI session at<br />
Bhatiborial and she does not recall a health worker ever visiting the<br />
char for health education. The closest family welfare center was<br />
approximately 3 hours away. To get there, she would have to walk<br />
2 kilometers over sand, wait for a boat that may come only twice<br />
a week (and not even at a fixed time), and then take a van ride,<br />
making her journey both tiring and costly.<br />
In May 2010, when she was about 4 months pregnant, a team<br />
showed up on her island—not only to conduct an EPI session on the<br />
char itself but also to inform and educate the community through<br />
household visits and group meetings.<br />
Khadija’s son, Mohammad Khairul, is now 5 months old and under<br />
the Friendship–<strong>Crucell</strong> EPI Support Program has received his BCG<br />
(tuberculosis), Quinvaxem® 1 and 2 (pertussis, diphtheria, hepatitis B,<br />
tetanus and Haemophilus influenzae type B), and OPV 1 and 2 (polio)<br />
vaccine doses. More importantly, Khadija is aware of when his next<br />
dose is due and will be bringing him to the center for it. If by chance<br />
she forgets, she is secure in the knowledge that a Friendship health<br />
worker will come by to remind her.<br />
Khadija Begum’s story is one of thousands. This outcome is made<br />
possible by the joint efforts of <strong>Crucell</strong> and Friendship.”<br />
NGO partnerships<br />
<strong>Crucell</strong> and Friendship<br />
<strong>Crucell</strong>’s partnership with Friendship is a good example of how we<br />
work with NGOs to overcome barriers to healthcare access in developing<br />
countries. <strong>Crucell</strong> provides funding and scientific expertise, as well as<br />
practical support, to enable organizations that understand the local<br />
needs, culture and healthcare challenges to develop targeted solutions.<br />
Friendship is a value-based national organization dedicated to<br />
improving the lives of people living in the remote riverbank and char<br />
areas of northern Bangladesh. The chars (nomad islands) are isolated<br />
from the mainland in terms of physical distance, access to healthcare,<br />
and other basic resources. Rates of morbidity and mortality due to<br />
vaccine-preventable diseases are high, especially among children.<br />
The partnership between <strong>Crucell</strong> and Friendship is successfully tackling<br />
this problem by facilitating the government EPI program, which aims<br />
to deliver the WHO-recommended schedule of vaccines to all children<br />
under five. We focus on logistics and infrastructure, providing a riverbased<br />
health service system with floating hospitals, satellite clinics and<br />
community medics. The Friendship–<strong>Crucell</strong> program has purchased<br />
three boats, recruited staff who help the government healthcare<br />
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<strong>Crucell</strong> employees help locals dig a well in Bangladesh.<br />
Steven and Joke Le Poole, Directors of the Max Foundation<br />
“Both <strong>Crucell</strong> and the Max Foundation want to reduce child<br />
mortality. We use our privileged position to fund projects that<br />
provide high health value per euro spent. We are especially<br />
impressed that <strong>Crucell</strong> has the vision to support our<br />
non-pharmaceutical approach based on wells, latrines and<br />
hygiene training. We really value the cooperation with <strong>Crucell</strong><br />
as far too many children still die from water-borne infectious<br />
diseases. Together we can make the difference. <strong>Crucell</strong> not only<br />
supports us but also recently visited the project in Bangladesh<br />
where they could see first-hand the major impact their<br />
program had on the local community.”<br />
www.crucell.com<br />
workers to deliver the regular vaccine schedule and monitor delivery,<br />
trained community medics and leaders, and conducted community<br />
meetings to increase awareness about vaccine-preventable diseases<br />
and the importance of the EPI program.<br />
These efforts have greatly increased the rate of vaccination coverage<br />
in the target region. From May 2010, when the Friendship–<strong>Crucell</strong> EPI<br />
Support Program was inaugurated, to the end of the year, all but 50<br />
of the 704 planned EPI sessions were held; problems such as extreme<br />
rains account for the missed sessions. A total of 1809 babies received<br />
Quinvaxem® doses at 6, 10 and 14 weeks of age, in accordance with<br />
the EPI schedule. This gives them protection against five common<br />
and potentially deadly childhood infections. The infants were also<br />
vaccinated against tuberculosis, polio and measles, and received<br />
vitamin A, which reduces child mortality and the risk of river blindness.<br />
<strong>Crucell</strong> and the Max Foundation<br />
<strong>Crucell</strong> is proud to be supporting the Max Foundation in its work<br />
to save children’s lives through community-based water projects in<br />
Bangladesh. Since its foundation in 2004, over 200,000 people have<br />
been supplied with clean drinking water and sanitation. The 1,000th<br />
project was completed in March 2011.<br />
The foundation was set up by Dutch couple Steven and Joke Le Poole<br />
after their 8-month old son Max died from a rare viral infection.<br />
“They wanted to turn their loss into something positive,” says <strong>Crucell</strong>’s<br />
Chief Strategy Officer Arthur Lahr, who brought the Max Foundation<br />
to the attention of his Management Committee colleagues.<br />
For <strong>Crucell</strong>, partnering this NGO is a logical choice: “It is gratifying<br />
to be able to support a nonprofit organization that shares our drive to<br />
improve children’s lives. Immunization and clean water are the most<br />
cost-effective contributors to child health,” says CEO Ronald Brus.<br />
Every euro donated to the foundation goes towards microsanitation<br />
projects.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Bringing color to children’s lives<br />
<strong>Crucell</strong> employees gave generously to good causes in 2010. Here are<br />
two examples we particularly like.<br />
y Child ambassadors for Stichting Kinderpostzegels<br />
(Foundation for Childrens’ Stamps) sold a record number of<br />
stamps and cards during a lunchtime visit to <strong>Crucell</strong>’s Dutch<br />
site in October 2010, raising over €1,400 from employees.<br />
<strong>Crucell</strong> management doubled their contribution.<br />
y Employees in Switzerland donated money to purchase over 200<br />
coloring sets for the children in Bangladesh. The initiative was sparked<br />
by a presentation on Friendship during a general staff meeting.<br />
Access to healthcare<br />
<strong>Crucell</strong>’s work with Friendship is an example of a targeted community<br />
initiative to remove barriers to healthcare access. <strong>Crucell</strong> also works<br />
on this issue at the international and global level, through close and<br />
continuous engagement with a wide range of organizations. Here are<br />
the 2010 highlights.<br />
<strong>Crucell</strong> supported the International Pediatric Association (IPA) in its<br />
efforts to drive EPI development by empowering its members to take<br />
on an advocacy role. The IPA believes that pediatricians have a crucial<br />
role to play in advising their governments on the best vaccines and<br />
implementation strategies. <strong>Crucell</strong> gave the IPA an unrestricted grant<br />
to run an advocacy workshop during its latest international congress,<br />
held early August in Johannesburg, South Africa. <strong>Crucell</strong> also provided<br />
a follow-up grant to help in-country implementation of the best<br />
advocacy proposals.<br />
At the same conference, <strong>Crucell</strong> supported educational activities<br />
through the IPA. These focused on innovative strategies for simplifying<br />
vaccine delivery, which are seen to be key for reaching neglected<br />
populations. <strong>Crucell</strong>’s collaboration with the nonprofit organization<br />
PATH to make Quinvaxem® available in a Uniject device underlines<br />
our commitment to this type of innovation (see page 44).<br />
In November 2010, the launch of a global Coalition Against Typhoid<br />
(CaT) was announced by the Sabin Vaccine Institute in Washington,<br />
DC, which will serve as the secretariat. <strong>Crucell</strong> played a significant role<br />
in bringing together this worldwide collaboration of stakeholders in<br />
the field of typhoid fever. “Despite the availability of low-cost vaccines<br />
against typhoid and a WHO Strategic Advisory Group of Experts<br />
recommendation for their use, typhoid fever vaccination has been a<br />
low priority for many countries, including those most impacted by the<br />
disease,” said Dr Christopher Nelson, Director of the CaT secretariat.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
<strong>Crucell</strong> was the vaccine industry representative (for the third successive<br />
year) on the formal advisory Program & Policy Committee of the GAVI<br />
Alliance, a public-private partnership with the mission to improve access<br />
to vaccines in the world’s poorest countries. In 2010, the committee<br />
played an important role in the development of a new GAVI Alliance<br />
strategy and business plan for the 2011–2015 period. Other key issues<br />
were how to prioritize new vaccine applications in order to bridge<br />
a funding gap, a strategy for resources mobilization, and health<br />
system strengthening.<br />
<strong>Crucell</strong>’s innovative work with international organizations dedicated<br />
to immunization program development paved the way for our CEO<br />
Ronald Brus to be nominated by the vaccine industry in industrialized<br />
countries to represent the constituency on the Board of the<br />
GAVI Alliance.<br />
1 Including PERCIVIA events.<br />
www.crucell.com<br />
<strong>Crucell</strong> also worked on healthcare access improvements as a member of:<br />
y the IFPMA Biologicals & Vaccines Committee, which contributes to<br />
discussions with the World Health Organization (WHO) on general<br />
vaccination policies;<br />
y the advisory group for Project Optimize, a WHO/PATH collaboration<br />
aimed at developing innovative delivery systems to ensure that<br />
vaccines get to the right place, at the right time, in the right condition;<br />
y the European Vaccine Manufacturers (EVM), part of the European<br />
Federation of Pharmaceutical Industries and Associations, which is<br />
committed to working in partnership with EU institutions to support<br />
vaccine policy development and promote vaccine innovation.<br />
Vaccine donations<br />
In 2010, <strong>Crucell</strong> donated 321,000 doses of MoRu-Viraten® vaccine<br />
against measles and rubella to Unicef to assist earthquake victims<br />
in Haiti. The vaccines were shipped in August 2010. The donation<br />
was made as part of the emergency aid campaign organized by<br />
the International Federation of Pharmaceutical Manufacturers &<br />
Associations (IFPMA), of which <strong>Crucell</strong> is a member.<br />
Contributing to science<br />
<strong>Crucell</strong> contributes to the advancement of science and healthcare<br />
by sharing knowledge and expertise. In 2010, <strong>Crucell</strong> participated in 58 1<br />
international conferences and many more seminars, informal meetings<br />
and media presentations.<br />
Our leading scientists gave over 25 1 public lectures and presentations to<br />
their peers on a wide range of topics, including innovative technologies<br />
for vaccine and antibody discovery, design and manufacturing; novel<br />
approaches to fighting major infectious diseases; and results emerging<br />
from <strong>Crucell</strong>’s research and development programs.
<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
In 2010, <strong>Crucell</strong> once again sponsored events and symposia to facilitate<br />
information exchange among key opinion leaders and promote scientific<br />
development. One example is the Seventh Respiratory Syncytial Virus<br />
Symposium held in Rotterdam, the Netherlands, in December 2010.<br />
As well as sponsoring this meeting of leading RSV investigators, <strong>Crucell</strong>’s<br />
Innovation and Discovery Laboratories presented two researchers<br />
with a <strong>Crucell</strong> Innovation Award in recognition of their outstanding<br />
work in this field.<br />
A total of 15 scientific papers by <strong>Crucell</strong> researchers were published<br />
in peer-reviewed journals in 2010.<br />
Sector sustainability initiatives<br />
In 2010, <strong>Crucell</strong> participated in a number of initiatives that provide<br />
an objective measure of <strong>corporate</strong> performance on sustainability<br />
issues, including the Dow Jones Sustainability Index (DJSI), the Carbon<br />
Disclosure Project (CDP) and the Transparantiebenchmark (Transparency<br />
Benchmark), an index published by the Dutch Ministry of Economic<br />
Affairs, Innovation and Agriculture. See page 50.<br />
<strong>Crucell</strong> remains committed to making sustainability issues an integral<br />
part of strategic decision-making, with the aim of maximizing<br />
our contribution to a better world.<br />
Conclusion<br />
Corporate social responsibility (CSR) is an integral part of <strong>Crucell</strong>’s<br />
mission to conduct good business, for the good of humanity.<br />
<strong>Crucell</strong> is committed to continuous development of its approach<br />
to CSR reporting and the engagement of stakeholders in dialogue<br />
about sustainability issues. We are again pleased to have taken<br />
important steps in this direction during 2010.<br />
<strong>Crucell</strong> welcomes feedback on this report or any issues related<br />
to our CSR activities. Your opinion matters to us. Reactions can<br />
be sent to csr@crucell.com.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Appendix<br />
Performance overview<br />
What we said (2009 target setting) What we did (2010 actions) Where we are (2010 outcomes) Where we are going (2010 target setting)<br />
KPI: Prevention of illness and deaths<br />
Continuous improvement<br />
Report annually<br />
Number of pipeline products<br />
1 PSCI – Pharmaceutical Supply Chain Initiative.<br />
2 GRI – Global Reporting Initiative.<br />
3 DJSI – Dow Jones Sustainability Indexes.<br />
www.crucell.com<br />
Maintained similar levels of prevention<br />
compared with 2009<br />
Report annually Expanded and advanced our pipeline<br />
of investigational vaccines and antibodies<br />
Animal welfare<br />
Continuous improvement 3Rs<br />
(Reduce, Refine, Replace)<br />
R&D expenses<br />
Continued to apply 3R principles to animal<br />
testing for preclinical R&D<br />
Report annually Reported in press release (2010 financial results,<br />
February 7, 2011) and in this CSR report<br />
CSR information management improvement<br />
In 2010 roll out Reporting Manual<br />
In 2010 report with 100%<br />
company coverage<br />
In 2011 set action plans<br />
(quantitative targets)<br />
Responsible supply chain<br />
In 2010 in<strong>corporate</strong> PSCI 1 principles<br />
into procurement policy<br />
In 2011 train all relevant<br />
employees<br />
In 2011 100% supplier coverage<br />
& monitoring<br />
Transparency objectives<br />
GRI 2 A+ level CSR reporting in 2015<br />
Remain in DJSI 3<br />
In 2010 improve CSR web page<br />
Developed, finetuned and rolled out<br />
Reporting Manual<br />
Collected and analyzed company-wide data<br />
Produced Supplier Code of Conduct based<br />
on PSCI principles and incorporating<br />
<strong>Crucell</strong>-specific CSR ambitions and guidelines<br />
Created vendor assessment questionnaire<br />
to survey key suppliers<br />
Devised strategy and program for<br />
<strong>Crucell</strong> ‘supplier days’ (CSR workshops)<br />
Made substantial further progress with CSR<br />
reporting and performance, as measured by<br />
a range of external benchmarks (DJSI, CDP 4 ,<br />
GRI and Dutch ‘Transparency Benchmark’ 5 )<br />
Improved CSR page on <strong>Crucell</strong> website<br />
4 CDP – Carbon Disclosure Project.<br />
5 Transparantiebenchmark (Transparency<br />
Benchmark), an index published by the Dutch<br />
Ministry of Economic Affairs, Innovation<br />
and Agriculture.<br />
Prevented more than 3.6 million cases<br />
of infectious disease and 809,823 deaths<br />
<strong>Crucell</strong> has 12 candidate products in its<br />
R&D pipeline<br />
Essential safety studies are conducted<br />
to minimal extent required by law and in<br />
accordance with highest international standards<br />
Annual R&D expenses €100 mln in 2010 versus<br />
€70.2 mln in 2009<br />
A system for consistent and comprehensive<br />
reporting is in place<br />
Data coverage is 100%<br />
Areas where further training or reporting<br />
incentives are needed have been identified<br />
Strategy and tools are in place to engage<br />
key suppliers in constructive dialogue about<br />
<strong>Crucell</strong>’s CSR guidelines and ambitions<br />
Self-declared GRI level C; DJSI listing for second<br />
successive year; ‘Transparency Benchmark’<br />
score 96/200<br />
Web page outlines <strong>Crucell</strong>’s CSR ambition<br />
and strategy, and provides links for more<br />
information/contact<br />
Quantitative<br />
Qualitative<br />
Continuous improvement<br />
Report annually<br />
Report annually<br />
Continuous improvement 3Rs<br />
Report annually<br />
2011: Set action plans and set quantitative<br />
targets for environment, health and safety<br />
(EHS) indicators<br />
In 2011: train all relevant employees in<br />
responsible supply chain management<br />
In 2011: 80% of top 100 vendors to sign<br />
Supplier Code of Conduct (CSR declaration)<br />
and take part in CSR assessment<br />
Beyond 2011: full coverage & monitoring<br />
of supplier target group<br />
Hold supplier day with focus on CSR<br />
in three countries in 2011<br />
2011: Further improve CSR web page and<br />
continue to develop reporting practices<br />
2015: GRI A rating
<strong>Crucell</strong>’s commitment to the world – Taking responsibility – Appendix<br />
People overview<br />
What we said (2009 target setting) What we did (2010 actions) Where we are (2010 outcomes) Where we are going (2010 target setting)<br />
Number of employees by gender<br />
Formulate target in 2010 Achieved 100% data coverage<br />
and formulated target<br />
Average age of employees<br />
Report annually Achieved 100% data collection<br />
and formulated target<br />
Number of women in management<br />
Formulate target in 2010 Achieved 100% data collection<br />
and formulated target<br />
Number of nationalities<br />
Formulate target in 2010 Achieved 100% data collection<br />
and formulated target<br />
Total number of accidents<br />
Formulate target in 2010 Defined reporting criteria, achieved 100%<br />
data collection and formulated target<br />
Employee turnover<br />
Formulate target in 2010 Achieved 100% data collection, refined KPI<br />
definition and formulated target<br />
Strong and successful recruitment drive<br />
Learning & development (L&D) identified by<br />
global Human Resources department as key<br />
CSR priority; global L&D manager appointed<br />
and multiple L&D initiatives launched<br />
Percentage of employees receiving regular performance reviews<br />
Formulate target in 2010 Achieved 100% data collection and<br />
formulated target<br />
Added two new KPIs to initial set: Number of own recruits*<br />
Absenteeism*<br />
1 Excluding 31 insourced staff in China.<br />
2 US Occupational Safety and Health Administration (OSHA) definition.<br />
Quantitative<br />
Qualitative<br />
Total workforce 1,398 1<br />
(12% increase from 2009); ~47% women<br />
Average age 40 years Report annually<br />
84 women in senior management positions,<br />
45% increase versus 2009<br />
Teams show high cultural diversity, particularly<br />
in the Netherlands and Switzerland<br />
Continue focus on equal-opportunity<br />
human resource management worldwide<br />
Fair and equitable representation<br />
Focus on cross-cultural teams<br />
Lost time case (LTC) rate 2 of 0.40 2011: LTC rate of 0.4 or less<br />
2015: LTC rate below 0.2<br />
Voluntary turnover in 2010 was 12.93% Voluntary turnover rate no more than 10%<br />
of workforce, excluding temporary staff<br />
~95% > 95%<br />
250 new employees in 2010 were recruited<br />
by referral<br />
Wide variation in data across sites, suggesting<br />
need to sharpen definition of this new KPI<br />
Report annually<br />
Set criteria in 2011<br />
Report annually<br />
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Planet overview<br />
What we said (2009 target setting) What we did (2010 actions) Where we are (2010 outcomes) Where we are going (2010 target setting)<br />
Total water use<br />
Relative reduction 1 of 10% by 2020<br />
In 2010 achieve 100% coverage<br />
(i.e. baseline)<br />
Total energy use<br />
See CO2 footprint<br />
In 2010 achieve 100% coverage<br />
CO2 footprint<br />
Relative reduction 1 of 15% by 2020<br />
In 2010 set baseline<br />
In 2011 set action plans<br />
Number, sort and impact of accidents<br />
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Achieved significant water savings by installing<br />
a new purified water generation plant in Spain<br />
and improving steam boiler operations in a<br />
Swiss facility<br />
Initiated full operational testing at new Korean<br />
facility in addition to commercial operations<br />
at old site and increased activity at two<br />
Swiss facilities, leading to overall increase<br />
in water consumption<br />
Achieved 100% data coverage. Waste<br />
water was monitored and reported as an<br />
additional parameter<br />
Increased operations in Korea and Switzerland,<br />
leading to overall increase in energy<br />
consumption (see ‘water use’)<br />
The carbon footprint was calculated using the<br />
Greenhouse Gas Protocol and latest conversion<br />
factors sourced from the UK Department for<br />
Environment, Food and Rural Affairs (DEFRA)<br />
Formulate target in 2010 Defined reporting criteria, achieved 100%<br />
data collection and formulated target<br />
Amount and characteristics of waste and disposal method<br />
Implement waste minimization<br />
programs on all sites<br />
System for global data collection and analysis<br />
developed, piloted and refined; 2010 baseline<br />
established; recycling initiatives mapped<br />
Plan drawn up for workshop early 2011 to<br />
share best practices and develop waste<br />
minimization programs<br />
1 Relative to workforce size expressed in full-time equivalents (FTEs).<br />
Quantitative<br />
Qualitative<br />
312,259 m 3 (41.1% increase versus 2009<br />
due to operational increases)<br />
156,643 m 3 of waste water<br />
Total energy use: 88.4 million kWh<br />
(44.6% increase versus 2009 due to operational<br />
increases)<br />
Relative reduction 1 of 10% from 2010<br />
baseline by 2020<br />
Monitor and minimize waste water<br />
See CO2 footprint<br />
21,120.61 tonnes CO2 Relative reduction 1 of 15% from 2010<br />
baseline by 2020<br />
Lost time case (LTC) rate 2 of 0.40 2011: LTC rate of 0.4 or less<br />
2015: LTC rate below 0.2<br />
Solid waste: 754,420 kg<br />
Special waste: 52,995 kg (7% of total waste)<br />
Recycled waste: 203,596 kg (27% of total waste)<br />
Develop and/or refine waste minimization<br />
programs on all sites
<strong>Crucell</strong>’s commitment to the world – Taking responsibility – Appendix<br />
Philanthropy overview<br />
What we said (2009 target setting) What we did (2010 actions) Where we are (2010 outcomes) Where we are going (2010 target setting)<br />
Number of doses donated<br />
Report annually Donated 321,000 doses of MoRu-Viraten®<br />
vaccine against measles and rubella to Unicef<br />
to assist earthquake victims in Haiti<br />
Support of sector sustainability initiatives<br />
Further <strong>Crucell</strong> involvement Participated in a range of initiatives measuring<br />
sustainability and CSR transparency: DJSI 1 ,<br />
CDP 2 , GRI 3 and ‘Transparency Benchmark’ 4<br />
NGO partnerships<br />
Liaise with key NGOs and<br />
evaluate partnership yearly<br />
Conducted two Footprint field trips to<br />
Bangladesh and planned a third trip which<br />
was held early in 2011<br />
Strengthened and expanded partnerships<br />
with NGOs<br />
Evaluated partnerships<br />
1 DJSI – Dow Jones Sustainability indexes.<br />
2 CDP – Carbon Disclosure Project.<br />
3 GRI – Global Reporting Initiative.<br />
4 Transparantiebenchmark (Transparency Benchmark),<br />
an index published by the Dutch Ministry of Economic Affairs,<br />
Innovation and Agriculture.<br />
Quantitative<br />
Qualitative<br />
321,000 donated doses of MoRu-Viraten®<br />
vaccine were shipped in August 2010<br />
Self-declared GRI level C; DJSI listing<br />
for second successive year<br />
‘Transparency Benchmark’ score 96/200<br />
Participation in CDP<br />
Strong employee involvement in and<br />
support for community outreach activities<br />
<strong>Crucell</strong>–Friendship partnership is highly<br />
successful in helping Bangladeshi<br />
government to improve immunization<br />
coverage in remote areas<br />
In partnership with the Max Foundation<br />
(new partner in 2010) <strong>Crucell</strong> is supporting<br />
microsanitation projects in Bangladesh<br />
Report annually<br />
Global policy for disaster relief (donations)<br />
Participation in DJSI, CDP and Transparency<br />
Benchmark to end due to delisting<br />
Continue participation in GRI<br />
New Footprint fieldtrips scheduled for 2011<br />
Further strengthen current NGO partnerships<br />
Explore potential new partnerships<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
Field trips<br />
Impression photo’s taken by <strong>Crucell</strong> employees during Footprint<br />
field trips, <strong>Crucell</strong>’s CSR outreach program.<br />
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<strong>Crucell</strong>’s commitment to the world – Taking responsibility<br />
75
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