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euro adhoc: Intercell AG / other / Licensure application for Japanese Encephalitis vaccine submitted to Therapeutic Goods Administration (TGA) in Australia

Geschrieben am 29-02-2008


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Disclosure announcement transmitted by euro adhoc. The issuer is responsible
for the content of this announcement.
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29.02.2008

Vienna (Austria), February 29, 2008 - Intercell AG (VSE: ICLL)
announced today the submission of application to register Intercell's
investigational Japanese Encephalitis vaccine in Australia to the
Therapeutic Goods Administration (TGA). The submission process was
executed by Intercell's partner CSL Biotherapies Pty Ltd.

This TGA submission has been based on the Market Authorization
Application (MAA) with the European Medicines Agency (EMEA) and the
Biological License Application (BLA) with the US Food and Drug
Administration (FDA), submitted in December 2007.

In Australia Intercell cooperates with CSL Biotherapies Pty Ltd., who
has the exclusive right for marketing and distribution of Intercell's
novel cell culture based Japanese Encephalitis vaccine in Australia,
New Zealand, Papua New Guinea and Pacific Islands.

Japanese Encephalitis is a significant and serious public health
threat in Asia but increasingly also in Australia, where the disease
is endemic. The initial target for use of Intercell's vaccine will be
adult civilian travellers and military personnel who visit or are
deployed to affected countries, including India, China, and Southeast
/ Southwest Asia, and consequently also people living in endemic
regions.

The production of the vaccine for the Australian market will be
performed at Intercell's state-of-the-art vaccine manufacturing
facility in Livingston, Scotland.

"The submission of licensure applications with three major
governmental authorities is a key milestone for Intercell. With this
we are fully on track for the future global commercialization of our
vaccine against Japanese Encephalitis," explains Intercell's Chief
Executive Officer, Gerd Zettlmeissl.

About Intercell's investigational vaccine against Japanese
Encephalitis

Intercell's novel investigational Japanese Encephalitis 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 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.

About CSL Limited

CSL Limited is a global, specialty biopharmaceutical company that
develops, manufactures and markets products to treat and prevent
serious human medical conditions; Headquartered in Melbourne
Australia, CSL Limited includes CSL Bioplasma, CSL Behring,
incorporating ZLB Plasma Services, and CSL Biotherapies Pty. Ltd. CSL
Limited has over 7,000 employees working in 25 countries, with major
facilities in Australia, Germany, Switzerland, US and Japan; CSL
Biotherapies Pty. Ltd. markets a comprehensive range of Children's
vaccines, Travel Vaccines, Respiratory Vaccines Adult Vaccines and
Antivenoms. For more information please visit www.csl.com.au

About Intercell's manufacturing facility in Scotland - Intercell
Biomedical Ltd.

In March 2004, Intercell acquired a manufacturing plant in
Livingston, Scotland, which has enabled the company to gain in-house
GMP manufacturing capabilities for its Japanese Encephalitis vaccine
and to manufacture the investigational product used in the clinical
phase III trials. With major investments in the last years the
company has further increased capacities and established a state-of
the art GMP commercial manufacturing facility to support the future
supplies of its Japanese Encephalitis vaccine. Besides the fully
dedicated and further expandable manufacturing facility the site has
also separate development and clinical manufacturing capacities. The
more than 70 employees organization is operating under a
Manufacturing License from MHRA. For more information please visit:
www.intercell.com


end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

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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