LEIDEN, NETHERLANDS -- 05/13/08 --
Dutch biotechnology company
Crucell N.V. today announced that its rabies monoclonal antibody
combination product has entered a second phase II clinical study in
the Philippines. On 31 March 2008 the company announced the start of
a first phase II clinical study in the U.S.
At the beginning of the year, Crucell announced a collaboration and
commercialization agreement with sanofi pasteur for Crucell's rabies
monoclonal antibody combination product to be used in combination
with rabies vaccines for post-exposure prophylaxis against this fatal
disease. Crucell received an initial payment of EUR 10 million following
the execution of the agreement and will be eligible for milestone
payments of up to EUR 66.5 million. The first phase II study, as
announced in March 2008, marked an important milestone in the
collaboration agreement.
The second phase II clinical trial will be a randomized,
single-blind, controlled study in 48 healthy adolescents and
children. The study will test the rabies monoclonal antibody
combination product in association with sanofi pasteur's rabies
vaccine and will compare it to the human rabies immune globulin,
which is currently administered with the vaccine. The main parameters
under investigation will be safety, tolerability and (rabies virus)
neutralizing activity. This clinical trial aims to generate safety
data in children in Asia, complementing the safety data generated in
adult volunteers during a phase I trial conducted in India. Jointly,
the combined data allows a swift phase III clinical evaluation of the
monoclonal antibody combination in individuals exposed to rabies in
endemic areas like Asia.
"We are clearly on a fast track with the development of this new
rabies treatment", said Ronald Brus, Crucell's Chief Executive
Officer. "Our rabies antibody combination product is highly suitable
to replace the currently used serum-based products. This antibody
product can be produced in sufficient quantities to cover public and
private sectors needs by the use of our PER.C6® technology. Expanded
product availability would clearly help combat the supply
restrictions of serum-based immune globulin products. The continued
rapid development of our rabies antibody product in combination with
sanofi pasteur's rabies vaccine can therefore considerably reduce the
global burden of this fatal disease. "
Sanofi pasteur is the worldwide market leader in providing
biologicals for pre- and post-exposure prophylaxis against rabies. In
the last 20 years, over 20 million people in 100 countries have been
treated with sanofi pasteur's rabies products.
Peak sales for Crucell's rabies monoclonal antibody combination
product are expected to exceed US$ 300 million.
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
this fatal disease have appeared. Rabies is prevented by
post-exposure prophylaxis (PEP) with the combined administration of a
rabies vaccine and rabies immune globulin (RIG). Rabies is prevalent
in Europe, Asia, Africa, North America and South America. Every year
approximately 10 million people are vaccinated against the disease
worldwide. Rabies causes over 50,000 deaths each year, mainly in Asia
and Africa.
About Crucell's rabies monoclonal antibody program
Crucell's rabies monoclonal antibody product is a combination of two
human monoclonal antibodies, generated using Crucell's MAbstract®
technology and produced using Crucell's PER.C6® technology. Crucell's
rabies monoclonal antibody combination offers the potential to
replace the traditional serum-based products that are currently used
for rabies post-exposure prophylaxis. Phase I clinical trials
conducted in the United States and India demonstrated safety and the
ability to protect. The antibody combination is well tolerated,
provides the expected virus neutralizing activity and can be safely
administered in association with a rabies vaccine. The program has
been granted a Fast Track designation 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.
In December 2007, Crucell and sanofi pasteur signed an exclusive
collaboration and commercialization agreement for Crucell's rabies
monoclonal antibodies, next-generation rabies biologicals, to be used
with sanofi pasteur rabies vaccine for post-exposure prophylaxis
against this fatal disease. Under the terms of the agreement, Crucell
will continue to perform the development activities. Crucell will be
responsible for the manufacturing of the final product and will
retain exclusive distribution rights in Europe, co-exclusive
distribution rights in China and the rights to sell to supranational
organizations such as UNICEF.
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. The strengths
of the PER.C6® technology lie in its 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
global biotechnology company focused on research, development,
production and marketing of vaccines, proteins and antibodies that
prevent and treat primarily 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
product candidates based on its unique PER.C6® production technology.
The Company licenses its PER.C6® technology 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, Portugal, 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 May 7,
2008, and the section entitled "Risk Factors". The Company prepares
its financial statements under generally accepted accounting
principles in 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
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