Crucell Presents Indian Phase I Rabies Antibody Cocktail Study,
Positive Results Enable Prompt Progression Towards Phase II Studies
Leiden, The Netherlands, 30 November 2007 - Dutch biotechnology
company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX)
today announced the results of the second clinical evaluation of
their rabies monoclonal antibody cocktail. Data for the Phase Ib
study conducted in India which started in April 2007 indicate that
the cocktail is well tolerated, provides the expected neutralizing
activity and that it can be safely administered in combination with a
rabies vaccine. The results are presented today, by Dr. Christophe
Python, at the Joint International Tropical Medicine Meeting 2007 in
Bangkok, Thailand.
The clinical trial was a randomized, double-blinded, placebo
controlled study in healthy volunteers that tested the human
monoclonal antibody cocktail against rabies alone, in a dose
escalation design, as well as in combination with a 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 both dose levels that were administered. In the
second, open, part of the study, in which the rabies antibody
cocktail was administered in combination with a rabies vaccine, all
volunteers seroconverted within 14 days upon the initiation of
treatment. A level of rabies virus neutralizing activity (i.e. > 0.5
IU/mL) was achieved that is considered to provide protection against
the deadly virus, thus proving that the antibody cocktail can be
safely co-administered in line with standard therapy.
The data from the Indian study confirm and extend the results of the
first-in-human Phase I study conducted in the US, which was presented
on 3 October 2007 at the XVIII Rabies in the Americas RITA conference
in Mexico. The combined data from both Phase I studies prompt the
progression towards Phase II studies which are expected to start in
the first half of 2008 in the US and the Philippines.
"The positive results from both studies, together with the Fast Track
designation for this antibody cocktail which we were awarded just
recently, supports our commitment to moving as fast as possible to
address the unmet medical need that exists for rabies," said Dr. Jaap
Goudsmit, Chief Scientific Officer.
On 13 November 2007, Crucell announced that it had been granted Fast
Track designation for its rabies antibody cocktail by the Food and
Drug Administration's (FDA) Department of Health and Human Services.
The Fast Track program facilitates the development and expedites the
review of new drugs that are intended to treat serious or
life-threatening diseases and that demonstrate the potential to
address unmet medical needs.
Crucell is developing the rabies antibody cocktail for the
post-exposure prophylaxis of rabies. The antibody cocktail is a
combination of two human monoclonal antibodies and is produced with
the use of Crucell's MAbstract® and PER.C6® technologies. Based on
market needs, peak sales for Crucell's rabies antibody cocktail are
expected to exceed US$ 300 million.
Crucell has already 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.
About Crucell's rabies antibody cocktail program
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 used for the
treatment of rabies. Based on market needs, peak sales for Crucell's
cocktail are expected to exceed US$ 300 million.
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the
large-scale manufacture of biopharmaceutical products such as
recombinant proteins including monoclonal antibodies. 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.
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 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
aluminium-free hepatitis A vaccine on the market. The Company has a
broad pipeline, with several products based on its unique PER.C6®
production technology in development. The Company licenses this and
other technologies to the biopharmaceutical industry. Important
partners and licensees include DSM Biologics, sanofi aventis,
Novartis, Wyeth 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 June 13,
2007, and the section entitled "Risk Factors". The Company prepares
its financial statements under International Financial Reporting
Standards (IFRS) with reconciliation to the generally accepted
accounting principles in the United States (US GAAP).
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