euro adhoc: Intercell AG / other / Licensure application for Japanese Encephalitis vaccine submitted to Canadian Division of Biologics and Genetic Therapies Directorate of Health

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Company Information

19.06.2008

» Intercell submitted application to launch Japanese Encephalitis
vaccine in Canada

» Intercell confirms plans for market launch (Europe, US, Australia)
within committed timelines - production process fully on track

Vienna (Austria), June 19, 2008 - Intercell AG (VSE: ICLL) announced
today the submission of application to register Intercell's
investigational Japanese Encephalitis vaccine in Canada to the
Division of Biologics and Genetic Therapies Directorate of Health
Canada. This 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.

Intercell confirms that the regulatory approval process in US, EU and
Australia as well as its manufacturing operations are proceeding
according to plan and in-line with communicated time lines for market
launches in the respective territories.

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

"We are pleased to announce that the committed timelines regarding
the planned manufacturing operations and regulatory approvals in the
US, Europe and Australia in 2008 can be confirmed," explained
Intercell's Chief Operating Officer, Thomas Lingelbach.

With over three 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. The
JE virus remains virulent in this region and has recently spread to
countries not previously affected. Furthermore, the virus is a
consistent threat to millions of travelers visiting the highly
populated far eastern countries, including China and India.

As previously announced Intercell's investigational vaccine against
Japanese Encephalitis shows excellent safety and immunogenicity in
Phase II trials in children. These results fully support Intercell's
development plan for endemic regions and pave the way towards late
stage development and licensure.

About Intercell's investigational JE vaccine

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 US 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.

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

Further inquiry note:

Intercell AG

Lucia Malfent

Head of Communications

Tel. +43 1 20620-303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market