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Successful Collaboration between U.S. Army and Intercell Towards a Novel Vaccine Against Japanese Encephalitis for Military and Travelers

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Washington, DC and Vienna, Austria, December 20,
2007 - Today, December 20, 2007 Intercell AG (VSE, "ICLL") announced 
the finalization of the submission of a Biologics License Application
(BLA) with the U.S. Food and Drug Administration (FDA) for 
Intercell´s investigational Japanese Encephalitis (JE) vaccine.
Intercell´s JE vaccine was developed for over 10 years under a 
Collaborative Research and Development Agreement (CRADA) with the 
Walter Reed Army Institute of Research (WRAIR). As JE is a 
significant and serious public health threat in Asia, the initial 
target for use of Intercell´s vaccine will be military personnel and 
adult civilian travelers who are deployed to or visit affected 
countries, including India, China, and Southeast / Southwest Asia. 
Assuming review and approval by the regulatory authorities in a 
timely manner, Intercell currently anticipates first market launch of
its JE vaccine during second half of 2008.
"The Army has enjoyed an excellent and successful collaboration with 
Intercell for several years towards development of this important JE 
vaccine," said William Howell, Acting Director of USAMRMC.  "We are 
extremely pleased that Intercell´s JE vaccine has progressed to the 
point of completion of the BLA submission process.  Furthermore, the 
timing of this FDA submission is good news because production has 
been halted for the only JE vaccine licensed in the United States 
today. The Army is hopeful that Intercell´s JE vaccine will be FDA 
approved and available for military use in the near future."
"Intercell is greatly appreciative of the expert technical support 
the Company has received from the Army during development," noted 
Gerd Zettlmeissl, Chief Executive Officer of Intercell.
"We would like to especially thank the many dedicated scientists at 
WRAIR for their outstanding efforts.  The success of our new JE 
vaccine is an excellent example what can be achieved when industry 
and government work together towards an important common goal.  
Intercell looks forward to the time when we will begin supplying the 
novel product for use in the military´s JE immunization program."
About Intercell´s investigational JE vaccine
Intercell´s novel investigational JE vaccine is a purified, 
inactivated vaccine for active immunization against the Japanese 
Encephalitis virus. With over 3 billion people living in endemic 
areas, Japanese Encephalitis, a mosquito-borne flaviviral infection, 
is the leading cause of childhood encephalitis and viral encephalitis
in Asia.
In successfully concluded pivotal non-inferiority Phase III trials, 
Intercell´s Japanese Encephalitis vaccine demonstrated a favorable 
safety and immunogenicity profile:
» The immunogenicity was comparable to that of the U.S. licensed 
product, JE-   VAX® » It demonstrated an overall clinical safety 
profile similar to placebo » Further, Intercell´s JE vaccine showed 
an excellent local tolerability   profile in this head-to-head study 
with JE-VAX®
Intercell´s novel investigational JE vaccine, manufactured in the 
company´s proprietary manufacturing facility, is prepared using 
tissue culture rather than live organisms and does not contain any 
stabilizers such as gelatin or preservatives in its formulation.
On June 13, 2006, Novartis and Intercell announced that the companies
had reached an agreement for Novartis to acquire marketing and 
distribution rights for Intercell´s Japanese Encephalitis Virus 
Vaccine in the United States, Europe and certain other markets in 
Asia and Latin America.
About U.S. Army Medical Research and Material Command
The US Army Medical Research and Materiel Command (USAMRMC) has the 
accountability to provide medical materiel and information in support
of the Army´s deployed force.  Infectious diseases are of significant
interest as endemic diseases in areas of potential deployment act as 
threats to military readiness.  Historical data clearly shows that 
infectious disease remains one of the primary sources of 
hospitalization for soldiers during times of war or military 
operations.  In response, the Walter Reed Army Institute of Research,
a subordinate command within USAMRMC, has worked vaccine constructs 
to several diseases found throughout the world, to include Japanese 
Encephalitis.  The USAMRMC is pleased that their initial work has led
to the maturation of the technology into the current vaccine being 
submitted for licensure.  With a successful approval of the 
submission, the services will again have a reliable source of vaccine
for their service members.
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Corporate Communications
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-303
Mail to: LMalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market

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