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: Investors/Analysts:
Barbara Mulder Oya Yavuz
Director Corporate Communications Director Investor Relations
Tel: 31-(0) 71 519 7346 Tel. +31-(0) 71-519 7064
press@crucell.com ir@crucell.com
www.crucell.com www.crucell.com
