Crucell Announces Collaboration with GlaxoSmithKline Biologicals on Second Generation Malaria Vaccine Candidate

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Tue Apr 6, 2010 1:57am EDT

  LEIDEN, NETHERLANDS, Apr 06 (MARKET WIRE) -- 


 Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ:
CRXL) (SWISS: CRX) today announced that it has signed a binding letter of
agreement with GlaxoSmithKline Biologicals (GSK) to collaborate on
developing a second generation malaria vaccine candidate. Pre-clinical
data from earlier studies indicated significantly enhanced immune
responses against the malaria parasite (circumsporozoite stage of the
Plasmodium falciparum) when Crucell's Adenovirus (AdVac(R)) technology
and GSK's RTS,S/AS technology are used in combination, versus either
component alone.


 
 Under the terms of the letter of agreement, Crucell
will contribute its recombinant malaria vaccine candidate, Ad35-CS, based
on Crucell's AdVac(R) technology and PER.C6(R) manufacturing platform and
GSK will contribute its late stage malaria vaccine candidate RTS,S/AS.
Financial details of the agreement were not disclosed.


 
 In October
2003 Crucell announced a program with the Walter Reed Army Institute of
Research and GSK. The parties entered into a Cooperative Research and
Development Agreement (CRADA) to evaluate Crucell's malaria vaccine
candidate in pre-clinical studies. Crucell's vaccine candidate was tested
as a stand- alone and in combination with GSK's malaria vaccine candidate
RTS,S/AS. The tests conducted were designed to assess whether a
combination of the GSK vaccine candidate with Crucell's vaccine candidate
could lead to improved results. These pre-clinical studies showed
significant enhancement of the immunological response when both vaccines
were used in combination[1].


 
 This collaboration now intends to
progress this concept into human clinical studies. The companies will
seek third party funding to advance the Ad35- CS and RTS,S/AS prime-boost
candidate into a Phase I/IIa clinical challenge trial in the United
States. Pending the results of the Phase I/IIa trial, the companies
expect to advance the prime boost candidate in further clinical studies
with the support of public or non-profit partners who are interested in
accelerating the development of a malaria vaccine.


 
 "We are very
excited about this collaboration with GSK, which brings new impulse to
the potential of eradicating malaria as one of the top three killers in
the world," said Ronald Brus, Chief Executive Officer at Crucell. "Malaria
currently represents one of the most prevalent infections in tropical and
subtropical areas, causing close to 900,000 deaths every year, mostly
amongst children. I am confident a partnership of this kind will allow us
to take a vital step towards our goal of bringing meaningful innovation
to global health."


 About AdVac(R) technology

    AdVac(R) technology is a vaccine technology developed by Crucell and is
considered to play an important role in the fight against emerging and
reemerging infectious diseases, and in biodefense. The technology
supports the practice of inserting genetic material from the
disease-causing virus or parasite into a 'vehicle' called a vector, which
then delivers the immunogenic material directly to the immune system.
Most vectors are based on an adenovirus, such as the virus that causes
the common cold.

    The AdVac(R) technology is specifically designed to manage the problem of
preexisting immunity in humans against the most commonly used recombinant
vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-
scale production capabilities or the immunogenic properties of Ad5.
AdVac(R) technology is based on adenoviruses that do not regularly occur
in the human population, such as Ad26 and Ad35. In contrast to Ad26 and
Ad35 antibodies, antibodies to Ad5 are widespread among people of all
ages and are known to lower the immune response to Ad5-based vaccines,
thereby impairing the efficacy of these vaccines. All vaccine candidates
based on AdVac(R) are produced using Crucell's PER.C6(R) production
technology.


 
 About PER.C6(R) technology

    Crucell's PER.C6(R) technology is a cell line developed for the large-
scale manufacture of biopharmaceutical products including vaccines. The
production scale potential of the PER.C6(R) cell line has been
demonstrated in an unprecedented successful bioreactor run of 20,000
liters. Compared to conventional production technologies, the strengths
of the PER.C6(R) 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(R) technology the biopharmaceutical
production technology of choice for Crucell's current and potential
pharmaceutical and biotechnology partners.


 
 About Crucell's malaria
vaccine

    Crucell is developing a recombinant malaria vaccine, Ad35-CS, based on the
company's AdVac(R) technology and PER.C6(R) manufacturing platform. The
vaccine candidate is made by inserting the gene for the CSP from the P.
falciparum malaria parasite into adenoviral vectors, which act as a
'vehicle' for vaccination delivery. This prime vaccine candidate is
currently being tested in a phase I study in partnership with the
National Institute of Allergy and Infectious Diseases (NIAID).


 About
Malaria

    Malaria is one of today's top three killers among communicable diseases.
The disease currently represents one of the most prevalent infections in
tropical and subtropical areas causing severe illness in approximately 250
million individuals worldwide and causing close to 900,000 deaths every
year. Most of these deaths occur among children under the age of five and
pregnant women in sub Saharan Africa. Unfortunately, mortality associated
with severe or complicated malaria still exceeds 10-30 percent. Malaria
is caused by the Plasmodium parasite and transmitted person-to-person
through the bite of a female Anopheles mosquito. Although the
overwhelming majority of illness and death associated with malaria occurs
in the developing world, this disease also affects travelers.


 About
Crucell

    Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a
global biopharmaceutical company focused on research development,
production and marketing of vaccines, proteins and antibodies that
prevent and/or treat infectious diseases. Crucell is one of the major
suppliers of vaccines to UNICEF and the developing world. Crucell was the
first manufacturer to launch a fully-liquid pentavalent vaccine called
Quinvaxem(R). Quinvaxem(R) protects against five important childhood
diseases and over 130 million doses have been sold since its launch in
2006 in more than 50 GAVI countries. Through Quinvaxem(R) and its
innovation, Crucell has become a major partner in protecting children in
developing countries. Crucell's core portfolio also includes a vaccine
against hepatitis B and a virosome-adjuvanted vaccine against influenza.
Crucell also markets travel vaccines, such as an 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(R) production
technology. The Company licenses its PER.C6(R) technology and other
technologies to the biopharmaceutical industry. Important partners and
licensees include Johnson & Johnson, DSM Biologics, sanofi-aventis,
Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in
Leiden, the Netherlands, with subsidiaries in Argentina, China, Italy,
Korea, Spain, Sweden, Switzerland, UK and the USA. The Company employs
over 1200 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 US
Securities and Exchange Commission on April 22, 2009, in the section
entitled 'Risk Factors'. The Company prepares its financial statements
under International Financial Reporting
Standards
(IFRS).




Financial Calendar

11 May 2010            Q1 Results 2010

4 June 2010             Annual General Meeting of Shareholders

17 August 2010        Q2 Results 2010

9 November 2010      Q3 Results 2010

15 February 2011      Q4/FY Results 2010

For further information please contact Crucell:

Oya Yavuz

Vice President Corporate Communications & Investor Relations

Tel. +31 (0)71 519 7064

ir@crucell.com

www.crucell.com

    


[1] Stewart et al. Infection and Immunity, May 2007, p. 2283-2290,
Vol. 75, No. 5


 
 [HUG#1400552]


 
 
 
  PDF file:
http://hugin.info/132631/R/1400552/355844.pdf

    



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