Sanofi Pasteur Broadens Pandemic Preparedness With First Clinical Trial Of Novel PER.C6®-based H7N1 Vaccine

Tuesday, 19. September 2006 13:26



Lyon, France; Leiden, the Netherlands, September 19, 2006 - Sanofi
pasteur, the vaccines business of the sanofi-aventis Group, has
within the framework of FLUPAN, a collaborative research project
funded by the European Commission, generated the first clinical trial
lot of a new generation of H7N1 pandemic vaccine. This trial will
broaden sanofi pasteur's pandemic preparedness program initiated with
the development of H5N1 vaccines.

The H7N1 vaccine was produced at sanofi pasteur's Marcy l'Etoile
facility in France using Crucell's PER.C6® cell-based technology,
allowing an alternative production process expected to offer
advantages over traditional manufacturing methods.

This phase I clinical trial, initiated today in Bergen, Norway, is
the first to assess the safety and ability to generate an immune
response of a split, inactivated prototype pandemic H7N1 vaccine
produced on cells.

"The H7N1 vaccine strain was developed from an avian influenza virus
(bird flu) by the UK's National Institute for Biological Standards
and Control (NIBSC) and the University of Reading (UK). A highly
pathogenic H7N1 avian influenza virus which caused outbreaks in
Italian poultry in 1999 has been modified, so that it is safe to use
and grows well in mammalian cell culture," commented Dr John Wood,
FLUPAN Coordinator.

Two influenza subtypes, H5 and H7, have recently caused highly
pathogenic avian influenza. While most vaccine development has
focused on H5N1 strains, avian H7-containing viruses remain a
significant pandemic threat and have caused infections in humans in
Europe over the last three years [1].

"The FLUPAN coordinated study started today at the Haukeland
University Hospital, University of Bergen (Norway). A total of 60
healthy adults aged 20 to 40 will be vaccinated with one of four
formulations: two dosages (12 µg and 24 µg) with or without an
aluminum hydroxide adjuvant, an additive commonly used to increase
the immune response to vaccines," said Dr Lars R. Haaheim, Principal
Clinical Investigator, University of Bergen.

Sanofi pasteur selected PER.C6® cells for their high susceptibility
to influenza viruses, thereby making the production of large amounts
of influenza vaccine feasible for both pandemic and seasonal strains.

Pandemic Influenza Overview
Influenza is a highly infectious virus that spreads easily from
person to person, primarily when an infected individual coughs or
sneezes. An influenza pandemic is a global epidemic of an especially
virulent virus, newly infectious for humans, with the potential to
cause severe morbidity and mortality. According to the World Health
Organization (WHO), the next pandemic is likely to result in 1 to 2.3
million hospitalizations and 280,000 to 650,000 deaths in
industrialized nations alone. Its impact is expected to be even more
devastating in developing countries. In an attempt to minimize the
impact of a pandemic, many countries are developing national and
transnational plans against an eventual influenza pandemic situation.

Several strains of influenza virus are potentially pandemic. An H7N7
strain was responsible for a large outbreak of fowl plague in the
Netherlands in 2003 that spread to 89 humans. While symptoms were
mostly mild, one case died from pneumonia in combination with acute
respiratory distress syndrome as a result of the infection. The virus
was also seen to be transmitted to family contacts[1, 2].

About FLUPAN,
FLUPAN is a European Union (EU) funded collaboration, intended to
improve the level of pandemic preparation in the EU. There are six
European partners in FLUPAN: National Institute for Biological
Standards and Control (NIBSC), UK; University of Reading, UK;
Istituto Superiore di Sanita, Italy; Health Protection Agency, UK;
University of Bergen, Norway; and sanofi pasteur, the vaccines
business of the sanofi-aventis Group, France. For more information,
please visit www.nibsc.ac.uk/spotlight/fluplan.htlm.

About sanofi pasteur and Crucell exclusive agreement
Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
entered into a strategic and exclusive agreement with Crucell N.V. on
December 31, 2003 to further develop, manufacture and market
cell-based novel influenza vaccine products based on Crucell's
proprietary PER.C6® cell line technology. The agreement covers both
pandemic and seasonal influenza vaccines. Crucell retains commercial
rights to the vaccine in Japan.

Crucell's PER.C6® technology is a cell line developed for the
large-scale manufacture of biological products including vaccines.

About sanofi-aventis
The sanofi-aventis Group is the world's third-largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular disease, thrombosis,
oncology, metabolic diseases, central nervous system, internal
medicine, and vaccines. The sanofi-aventis Group is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi pasteur, the vaccines business of the sanofi-aventis Group,
sold more than a billion doses of vaccine in 2005, making it possible
to protect more than 500 million people across the globe. The company
offers the broadest range of vaccines, providing protection against
20 bacterial and viral diseases. For more information, please visit:
www.sanofipasteur.com.

About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a
biotechnology company focused on research, development and worldwide
marketing of vaccines and antibodies that prevent and treat
infectious diseases. Its vaccines are sold in public and private
markets worldwide. Crucell's core portfolio includes a vaccine
against hepatitis B and a virosome-adjuvanted vaccine against
influenza. Crucell also markets travel vaccines, such as the only
oral anti-typhoid vaccine and the only aluminum-free hepatitis A
vaccine on the market. The Company has a broad development pipeline,
including both early-stage products and products almost ready to go
to market. Several Crucell products are based on its unique PER.C6®
production technology. The Company licenses this and other
technologies to the biopharmaceutical industry. Important partners
and licensees include DSM Biologics, sanofi aventis, GSK and Merck &
Co. Crucell is headquartered in Leiden (the Netherlands), with
subsidiaries in Switzerland, Spain, Italy and Korea. The Company
employs about 900 people. For more information, please visit
www.crucell.com.

References
[1] Fouchier RA, Schneeberger PM, Rozendaal FW, et al. Avian
influenza A virus (H7N7) associated with human conjunctivitis and a
fatal case of acute respiratory distress syndrome. Proc Natl Acad Sci
U S A 2004 Feb 3;101(5):1356-61.

[2] Tweed SA, Skowronski DM, David ST, et al. Human illness from
avian influenza H7N3, British Columbia. Emerg Infect Dis 2004 Dec;
10(12):2196-9.

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 U.S. Securities and Exchange Commission on July 6,
2006, and the section entitled "Risk Factors". The Company prepares
its financial statements under generally accepted accounting
principles in the United States (US GAAP) and Europe (IFRS).

For further information please contact:


Crucell N.V. For Crucell in the US
Paul Vermeij Redington, Inc.
Director Investor Relations and Corporate Thomas Redington
Communications Tel. +1 212-926-1733
Tel. +31-(0)71-524 8718 tredington@redingtoninc.com
p.vermeij@crucell.com


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Hugin
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