Crucell Announces Start of Rabies Antibody Product Clinical Trial
12:36 13.12.06
Leiden, The Netherlands, December 13, 2006 - Dutch biotechnology
company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX)
today announced that the rabies monoclonal antibody product it is
currently developing has entered a Phase I clinical study in the
United States. Crucell has developed a human monoclonal antibody
product, a combination of two monoclonal antibodies for the
post-exposure prophylaxis (PEP) of rabies, using its MAbstract® and
PER.C6® technology. The pre-clinical evaluation of the antibody
product was performed in collaboration with the Rabies Program of the
Centers for Disease Control and Prevention (CDC) in Atlanta.
The Crucell-funded US clinical trial, will be a randomized,
double-blind, placebo controlled study in 60 healthy volunteers that
will test the antibody product alone in a dose escalation study as
well as in combination with a rabies vaccine. The main parameters
under investigation will be safety, tolerability and (rabies virus)
neutralizing activity.
"The entry of the rabies antibody product into the clinic is an
important achievement for Crucell since it is the first innovative
PER.C6®-based protein product that offers a potential solution to the
problems of cost, availability and safety that currently curtail the
success of rabies immune globulin (RIG)," said Jaap Goudsmit, Chief
Scientific Officer at Crucell.
Dr. Charles E. Rupprecht, head of the Rabies Program in the Division
of Viral and Rickettsial Diseases of the CDC added: "The development
of a human monoclonal antibody product opens up a novel era in the
global fight against rabies. After several decades of pioneering
activities in the rabies scientific community, this product offers
the opportunity to replace RIG derived from human or horse blood.
These are traditional products that are in short supply and can
differ from lot to lot.''
Additional details regarding the product and the Phase I trial design
will be presented today by Crucell's project director, Dr. Alexander
Bakker at the IBC Antibody Engineering conference in San Diego at
10.30 a.m. PST.
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 PEP via the combined administration of
a rabies vaccine and RIG following the bite of a rabid animal. The
vaccine and RIG must be given together to prevent rabies. Neither
vaccine nor RIG is effective if independently applied. Current supply
and quality of rabies vaccine is sufficient, but RIG is in short
supply and carries certain safety risks.
Crucell has conceived an antibody product that is produced using its
PER.C6® technology, which offers large-scale manufacturing
capabilities and production under serum-free conditions. Crucell's
rabies monoclonal antibody product offers the potential for replacing
the traditional serum-derived products that are currently still in
use for the treatment of rabies.
Rabies is prevalent in all the continental regions of Europe, Asia,
America and Africa. Globally, approximately 10 million people a year
are vaccinated after exposure to rabies. Some 40,000 to 70,000 people
are thought to die of the disease each year, mainly in Asia and
Africa.
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.
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, a fully-liquid vaccine against five important
childhood diseases, and a virosome-adjuvanted vaccine against
influenza. Crucell also markets travel vaccines, such as the only
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 Crucell products 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, Sweden, Korea and the
US. The Company employs over a 1000 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 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:
Leonard Kruimer Redington, Inc.
Chief Financial Officer Thomas Redington
Tel. +31-(0)71-524 8722 Tel. +1 212-926-1733
Leonard.Kruimer@crucell.com tredington@redingtoninc.com
