Leiden, The Netherlands (July 7, 2011) - Dutch biopharmaceutical
company Crucell N.V. and The Scripps Research Institute today
published an article in the world's leading journal of original
scientific research Science describing Crucell's novel
anti-influenza antibody CR8020 and how it neutralizes group 2
influenza A viruses. Attempts to isolate broadly neutralizing
antibodies against group 2 viruses have not been previously
described. The broad neutralizing ability of the CR8020 makes it a
potentially groundbreaking therapy against seasonal and pandemic
flu.
"Influenza is an elusive enemy" said Jaap Goudsmit, Chief
Scientific Officer at Crucell. "The need for innovative approaches
to the control of seasonal influenza is highlighted by its death
toll - estimated at 500,000 annually. Having successfully
discovered these antibodies, Crucell is determined to develop an
antibody therapy for flu."
In February 2009, Crucell and The Scripps Research Institute
published a paper in Science, reporting the discovery of a panel of
human monoclonal antibodies showing neutralizing activity against
almost all influenza A group 1 viruses. The most potent of these
antibodies, called CR6261, prevents or cures influenza, in animal
tests, to deadly levels of the H5N1 and H1N1 viruses.
In this new study, Crucell reports that, by recognizing a novel
conserved epitope in the hemagglutinin stem, the antibody CR8020
shows broad neutralizing activity against most influenza A group 2
viruses, including the H3N2 and H7N7 viruses, which cause severe
human infection.
Crucell believes that a combination of these two antibodies may
be sufficient to neutralize most influenza A subtypes and, with
that, enable the development of a universal flu vaccine and a broad
spectrum of antibody therapies.
Attempts to isolate broadly neutralizing antibodies against
group 2 viruses have not been previously described. Antibodies,
such as CR6261 and CR8020, may protect against essentially all
influenza A viruses and would have undisputed benefits for
high-risk groups, such as the elderly and immunocompromised, and
for severe, life-threatening influenza infections.
Influenza and related medical complications result in an
estimated number of 500,000 annual deaths worldwide. Every year
more than 200,000 people in the United States are hospitalized from
flu complications and about 36,000 people die from flu[1].
Currently, two main countermeasures are used against flu.
Antivirals have been widely used and proven to be quite effective.
However, resistance to these antivirals has reduced their
effectiveness and mutations are widespread.
Vaccination is the other countermeasure. Each year circulating
strains of influenza virus subtypes, currently H1 and H3, change
the composition of the viral surface protein known as hemagglutinin
by mutation. Consequently, if one has had a vaccination against
influenza this year, the antibodies produced by the immune system
will most likely not protect against next years' flu. If an
antibody was able to recognize an invariable structure in the
hemagglutinin protein, such an antibody could be applied for the
prevention and therapy of influenza caused by a wide variety of flu
strains.
The unique property of the Crucell antibodies appears to be
related to its mechanism of action. The paper published in Science
entitled "A Highly Conserved Neutralizing Epitope on Group 2
Influenza A Viruses" shows the isolation and characterization of a
human monoclonal antibody CR8020 with broad neutralizing activity
against most group 2 viruses, including H3N2 and H7N7, which
sporadically cross from birds into humans and have the potential to
develop into a future pandemic.
"Influenza A viruses responsible for human pandemics have arisen
from both group 1 and group 2 viruses." says Dr Robert Friesen,
Crucell's Vice President Preclinical and Clinical Research.
"Therefore these results are a revolutionary discovery for the
potential development of an effective therapy of, and prevention
against, seasonal and pandemic influenza".
The results of this study will be presented by Dr Robert Friesen
at the 7(th) Annual European Antibody Congress taking place from
November 29(th) till December 1(st) in Geneva, Switzerland.
For both studies, Crucell collaborated with the Scripps Research
Institute in California, USA, which is a world leader in this type
of molecular- level research, the department of microbiology of the
Univeristy of Hong Kong in Hong Kong, and the Central Veterinary
Institute of the University of Wageningen in Lelystad, The
Netherlands.
This project has been funded in whole or in part with Federal
funds from the National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Department of Health and
Human Services, under Contract No. HHSN272200900060C.
[1] Source: Centers for Disease Control and Prevention.
Article reference: A Highly Conserved Neutralizing Epitope on
Group 2 Influenza A Viruses. Authors: Damian C. Ekiert,(1#) Robert
H. E. Friesen,(2#) Gira Bhabha,(1) Ted Kwaks,(2) Mandy
Jongeneelen,(2) Wenli Yu,(1) Carla Ophorst,(2) Freek Cox,(2) Hans
J.W.M. Korse,(2) Boerries Brandenburg,(2) Ronald Vogels,(2) Just
P.J. Brakenhoff,(2) Ronald Kompier,(2) Martin H. Koldijk,(2)
Lisette A.H.M. Cornelissen,(3) Leo L. M. Poon,(4) Malik Peiris,(4)
Wouter Koudstaal,(2*) Ian A. Wilson,(1,5) and Jaap Goudsmit(2)
(1) Department of Molecular Biology, The Scripps Research
Institute, 10550 North Torrey Pines Road, La Jolla, CA 92037, USA;
(2) Crucell Holland BV, Archimedesweg 4-6, 2301 CA Leiden, The
Netherlands; (3) Central Veterinary Institute, Wageningen
University, Lelystad, the Netherlands; (4) Department of
Microbiology, The University of Hong Kong, Queen Mary Hospital,
Hong Kong Special Administrative Region, People's Republic of
China; (5) The Skaggs Institute for Chemical Biology, The Scripps
Research Institute, 10550 North Torrey Pines Road, La Jolla, CA
92037, USA. # These authors contributed equally to this work.
About Crucell
Crucell N.V. 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 2010 alone, Crucell distributed more than 105 million
vaccine doses in more than 100 countries around the world. 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 200 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. Crucell has a broad development pipeline, with several
product candidates based on its unique PER.C6(®) production
technology. Crucell licenses its PER.C6(®) technology and other
technologies to the biopharmaceutical industry. Important partners
and licensees include DSM Biologics, sanofi-aventis, Novartis,
Pfizer/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. Crucell employs over 1300 people.
Johnson & Johnson completed the tender offer for Crucell
N.V. (Crucell) on 22(nd) February 2011 and declared the offer
unconditional. As a result, Crucell will now operate as the center
for vaccines within the Johnson & Johnson pharmaceuticals
group.
For more information, please visit www.crucell.com.
Forward-looking statements
(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown risks
or uncertainties materialize, actual results could vary materially
from the expectations and projections of Crucell N.V. and/or
Johnson & Johnson. Risks and uncertainties include, but are not
limited to, general industry conditions and competition; economic
factors, such as interest rate and currency exchange rate
fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; trends
toward health care cost containment; and increased scrutiny of the
healthcare industry by government agencies. A further list and
description of these risks, uncertainties and other factors can be
found in Exhibit 99 of Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended January 2, 2011. Copies of this
Form 10-K, as well as subsequent filings, are available online
atwww.sec.gov, www.jnj.com or on request from Johnson &
Johnson. Neither Crucell N.V. nor Johnson & Johnson undertake
to update any forward-looking statements as a result of new
information or future events or developments.)
PDF file: http://hugin.info/132631/R/1529318/464846.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants
that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Crucell N.V. via Thomson Reuters ONE
[HUG#1529318]
For further information please contact: Crucell: Oya Yavuz Vice
President Corporate Communications Tel. +31 (0)71 519 7064 Email
Contact www.crucell.com
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