Study to Test New Tuberculosis Vaccine in Infants


Leiden,  The  Netherlands  /  Rockville,  MD,  USA  (September 22, 2010) - Dutch
biopharmaceutical  company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange:
CRX)  and the Aeras Global TB Vaccine  Foundation today announced the start of a
Phase  II clinical trial  in infants of  the jointly developed tuberculosis (TB)
vaccine candidate, AERAS-402/Crucell Ad35.

The  main objective of  the trial is  to test the  safety and efficacy of the TB
vaccine   candidate   in   infants   previously   vaccinated  with  the  Bacille
Calmette-Guérin  (BCG) vaccine, which is currently  the only vaccine licensed to
help  prevent TB. The first part of this clinical trial, which will be conducted
in  Kenya, will establish the optimal  dosing regimen. The selected regimen will
then  be tested in  the second part  of the trial,  which is planned to begin in
2011 in Kenya, Mozambique, South Africa and Uganda.

The  Phase II study of  AERAS-402/Crucell Ad35 is being  led in Kenya by a joint
research  project of the Kenya Medical Research Institute and the US Centers for
Disease  Control and Prevention, called the KEMRI/CDC Research and Public Health
Collaboration.  Participants  from  the  Siaya  District  in  Nyanza Province of
Western Kenya will be enrolled.

"Despite  the  availability  of  the  BCG  vaccine,  two  million men, women and
children die from tuberculosis every year.  We urgently need a new TB vaccine to
ensure  long-term and effective TB protection," said Jim Connolly, President and
CEO  of the Aeras Global TB  Vaccine Foundation. "This clinical trial represents
an important step in our collaboration among a global network of researchers and
the people of Kenya, who continue to be at high-risk for TB infection."

In 2004, Aeras and Crucell began jointly developing this vaccine candidate using
Crucell's AdVac(®) vaccine technology and PER.C6(®) manufacturing technology.

"I  am  extremely  pleased  at  the  pace  in  which  our work to develop a next
generation  vaccine against TB is progressing. Our successful collaboration with
Aeras,  enabling the initiation of  yet another Phase II  study, is an important
step  towards our ambition of reducing the global burden of this fatal disease,"
said Jaap Goudsmit, Crucell's Chief Scientific Officer.

Kenya  is ranked 13th on a list of 22 high-burden TB countries, according to the
World  Health Organization.  In 2007, 24,000 Kenyans died from TB and there were
132,000 new cases.

"The  communities in  which we  work are  hard hit  by both TB and HIV/AIDS, two
leading   courses   of  mortality,"  said  Videlis  Nduba,  MD,  MPH,  Principal
Investigator   for   the   trial   at   KEMRI/CDC  Research  and  Public  Health
Collaboration.  "We are pleased to apply our research expertise at this stage in
the  development  of  this  vaccine-a  vaccine  which has undergone considerable
early-stage safety testing."
fAERAS-402/Crucell  Ad35 has  been tested  in seven  early-stage clinical trials
including a phase I clinical trial in infants in South Africa.  A Phase II trial
to  test its safety and  efficacy in adults living  with HIV is ongoing in South
Africa.  To date,  the candidate  has been  shown to  have an  acceptable safety
profile in these populations.

About Tuberculosis
Tuberculosis  is the  world's second  deadliest infectious  disease, with nearly
9.3 million   new  cases  diagnosed  in  2007. According  to  the  World  Health
Organization  (WHO),  an  estimated  1.8 million  people  died from TB in 2007.
One-third  of the world's population has been  infected with the TB bacillus and
current   treatment   takes   6­-9 months.   The  current  TB  vaccine,  Bacille
Calmette-Guérin  (BCG), developed over 85 years ago,  reduces the risk of severe
forms of TB in early childhood but is not very effective in preventing pulmonary
TB  in adolescents  and adults  - the  populations with  the highest rates of TB
disease. TB  is  changing  and  evolving,  making  new vaccines more crucial for
controlling  the pandemic. Tuberculosis  is now  the leading  cause of death for
people  living  with  HIV/AIDS,  particularly  in Africa. Multidrug-resistant TB
(MDR-TB)  and extensively drug-resistant TB (XDR-TB) are hampering treatment and
control efforts.

About AdVac(®) technology and Ad35
AdVac® technology is a vaccine technology developed by Crucell and is considered
to  play  an  important  role  in  the  fight  against  emerging and re-emerging
infectious  diseases, and in biodefense. The technology supports the practice of
inserting  genetic material  from the  disease-causing virus  or parasite into a
'vehicle' called a vector, which then delivers the immunogenic material directly
to  the immune  system.  Most  vectors are  based on  an adenovirus, such as the
virus that causes the common cold.

The  AdVac®  technology  is  specifically  designed  to  manage  the  problem of
pre-existing  immunity  in  humans  against  the  most commonly used recombinant
vaccine  vector, adenovirus  serotype 5 (Ad5),  without compromising large-scale
production  capabilities or the immunogenic properties of Ad5. AdVac® technology
is  based on  adenoviruses that  occur less  frequently in the human population,
such as Ad35. In contrast to for instance Ad35 antibodies, antibodies to Ad5 are
widespread  among people of all ages and  are known to lower the immune response
to  Ad5-based vaccines,  thereby impairing  the efficacy  of these vaccines. All
vaccine  candidates  based  on  AdVac®  are  produced  using  Crucell's  PER.C6®
production technology.

About PER.C6(®) technology
Crucell's  PER.C6(®) technology  is a  cell line  developed for  the large-scale
manufacture  of  biopharmaceutical  products  including vaccines. The production
scale  potential  of  the  PER.C6(®)  cell  line  has  been  demonstrated  in an
unprecedented   successful   bioreactor   run   of  20,000 liters.  Compared  to
conventional  production technologies, the strengths of the PER.C6(®) technology
lie  in  its  excellent  safety  profile,  scalability  and  productivity  under
serum-free  culture conditions. These characteristics, combined with its ability
to   support  the  growth  of  both  human  and  animal  viruses,  make PER.C6(®
)technology  the biopharmaceutical production technology of choice for Crucell's
current and potential pharmaceutical and biotechnology partners.

About Aeras
The  Aeras Global TB Vaccine Foundation (www.aeras.org) is a non-profit research
organization  developing new  tuberculosis vaccines  and ensuring  that they are
distributed  to all who need them around the world. Aeras is funded primarily by
private  foundations and government  aid agencies. Aeras  is based in Rockville,
Maryland,  where  it  operates  a  state-of-the-art manufacturing and laboratory
facility, and Cape Town, South Africa.

About KEMRI/CDC
The  KEMRI/CDC Research and Public Health Collaboration in Kenya was established
in  1979 by the Kenya  Medical Research Institute  (KEMRI) and the United States
Centers  for Disease Control and Prevention (CDC).  KEMRI is a parastatal in the
Kenyan  Ministry of Health  and is responsible  for conducting research into the
major  public  health  problems  of  the country.  Until 2000, KEMRI/CDC focused
mostly  on malaria research, but  today HIV and TB  research activities are also
primary  focuses. The KEMRI/CDC field site in Kisumu  is one of few sites in the
world  capable  of  conducting  large?scale  late  phase  TB vaccine trials. The
KEMRI/CDC  Research and Public Health  Collaboration has well-developed malaria,
HIV,  microbiology,  and  tuberculosis  laboratories  that  perform  a  range of
standard  diagnostic  procedures.  KEMRI/CDC  is  well  positioned  to  play  an
important  role in  global surveillance  to monitor  infectious diseases, assess
problems  of  public  health  importance  such  as  the  spread of antimicrobial
resistance,  and provide a basis for evaluating interventions designed to reduce
the  burden of  disease among  vulnerable groups.  For more  information, please
visitwww.kemri.org and www.cdc.gov.

About Crucell
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global
biopharmaceutical company focused on research development, production and
marketing of vaccines, proteins and antibodies that prevent and/or treat
infectious diseases. In 2009 alone, Crucell distributed more than 115 million
vaccine doses in more than 100 countries around the world, with the vast
majority of doses (97%) going to developing countries. Crucell is one of the
major suppliers of vaccines to UNICEF and the developing world. Crucell was the
first manufacturer to launch a fully-liquid pentavalent vaccine. Called
Quinvaxem(®), this innovative combination vaccine protects against five
important childhood diseases. Over 130 million doses have been sold since its
launch in 2006 in more than 50 GAVI countries. With this innovation, Crucell has
become a major partner in protecting children in developing countries. Other
products in Crucell's core portfolio include a vaccine against hepatitis B and a
virosome-adjuvanted vaccine against influenza. Crucell also markets travel
vaccines, such as an oral anti-typhoid vaccine, an oral cholera vaccine and the
only aluminum-free hepatitis A vaccine on the market. The Company has a broad
development pipeline, with several product candidates based on its unique
PER.C6(®) production technology. The Company licenses its PER.C6(®) technology
and other technologies to the biopharmaceutical industry. Important partners and
licensees include Johnson & Johnson, DSM Biologics, sanofi-aventis, Novartis,
Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the
Netherlands, with offices in China, Indonesia, Italy, Korea, Malaysia, Spain,
Sweden, Switzerland, UK, the USA and Vietnam. The Company employs over 1300
people. For more information, please visit www.crucell.com.

Forward-looking statements
This press release contains forward-looking statements that involve inherent
risks and uncertainties.  We have identified certain important factors that may
cause actual results to differ materially from those contained in such
forward-looking statements. For information relating to these factors please
refer to our Form 20-F, as filed with the US Securities and Exchange Commission
on April 7, 2010, in the section entitled 'Risk Factors'. The Company prepares
its financial statements under International Financial Reporting Standards
(IFRS).


For further information please contact:

Crucell N.V.                                  Aeras Global TB Vaccine Foundation

Oya Yavuz                                     Annmarie Leadman
Vice President Corporate Communications &     Director of Communications
Investor Relations                            Tel: +1 240 599 3018
Tel: +31 71 519 7064                          aleadman@aeras.org
ir@crucell.com                                www.aeras.org
www.crucell.com


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