Crucell presents Phase I results rabies antibody cocktail showing safety and ability to protect
LEIDEN, The Netherlands, October 3, 2007 - Dutch biotechnology
company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)
today announced the results of the first clinical evaluation of the
Rabies monoclonal antibody cocktail, a combination of two human
monoclonal antibodies.
Data from the First-in-Man Phase I study conducted in the US
indicates that the cocktail is well tolerated, provides the
expected neutralizing activity and that it can be administered in
combination with rabies vaccine. Crucell is developing this human
monoclonal antibody cocktail for the post-exposure prophylaxis of
rabies, using its MAbstract® and PER.C6®
technologies.
Details regarding the US Phase I trial data are presented today by
Dr. Alexander Bakker at the XVIII Rabies in the Americas RITA
conference in Guanajuato City, Mexico.
The clinical trial was a randomized, double-blind, placebo
controlled study in healthy volunteers that tested the human
monoclonal antibody cocktail against rabies alone, in a dose
escalation, as well as in combination with rabies vaccine. In the
first, blinded, part of the study, in which solely the antibody
cocktail was given, rabies virus neutralizing activity could be
demonstrated at all dose levels that were administered. In the
second, open, part of the study, in which the rabies antibody
cocktail was administered in combination with rabies vaccine, all
volunteers seroconverted within 14 days upon the initiation of
treatment, which means a level of rabies virus neutralizing
activity that is considered to provide protection against the
deadly virus (i.e. > 0.5 IU/mL) was achieved. This shows that
the antibody cocktail can be safely co-administered inline with
standard therapy.
"Given the unmet medical need in rabies, we are committed to move
as fast as possible; people deserve to be protected against
rabies," said Dr. Jaap Goudsmit, Chief Scientific Officer at
Crucell. "The continued progress of the phase I clinical
trial provides further validation of our PER.C6® and
MAbstract® technologies."
Data from the Phase I clinical trial in India, to assess safety and
efficacy, will be reported during the Joint International Tropical
Medicine Meeting 2007 on November 30, 2007 in Bangkok,
Thailand.
Crucell meanwhile has contracted DSM Biologics, its alliance
partner for the PER.C6® technology platform, for the process
validation and manufacturing of antibody batches for Phase III
clinical efficacy studies.
About Rabies
Rabies is a viral disease of mammals most often transmitted through
the bite of a rabid animal. The virus infects the central nervous
system, causing encephalitis (inflammation of the brain) and
ultimately death if medical intervention is not sought promptly
after exposure.
There is no proven treatment for rabies once symptoms of the
disease have appeared. Lethal rabies is prevented by post-exposure
prophylaxis (PEP) via the combined administration of a rabies
vaccine and RIG following the bite of a rabid animal. Current
supply and quality of rabies vaccine is sufficient, but RIG is in
short supply and carries certain safety risks.
Rabies is prevalent in Europe, Asia, North and South America as
well as Africa. Every year, approximately 10 million people are
vaccinated worldwide. With the exception of the US and Europe, most
of these people do not receive RIG due to shortages and are
therefore not adequately protected. As a result, an estimated
40,000 to 70,000 people die of the disease each year, mainly in
Asia. Based on market needs, peak sales for our cocktail are
expected to exceed $300 million.
Crucell develops the antibody cocktail using its PER.C6®
technology, which offers large-scale manufacturing capabilities and
production under serum-free culture conditions. Crucell's rabies
monoclonal antibody cocktail offers the potential for replacing the
traditional serum-derived products that are currently still in use
for the treatment of rabies.
About MAbstract® technology
Crucell's proprietary MAbstract® technology can be used to
discover drug targets, such as cancer markers or proteins from
infectious agents including bacteria and viruses, and identify
human antibodies against those drug targets.
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the
large-scale manufacture of biopharmaceutical products including
vaccines. 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.
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
June 13, 2007, 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:
Media:
Barbara Mulder
Director Corporate Communications
Tel: 31-(0) 71 519 7346
press@crucell.com
www.crucell.com
Investors/Analysts:
Oya Yavuz
Director Investor Relations
Tel. +31-(0) 71-519 7064
ir@crucell.com
www.crucell.com
