euro adhoc: Intercell AG / other / Intercell Finalizes Submission of US Biological License Application (BLA) To FDA For Licensure of Japanese Encephalitis Vaccine » Intercell delivers next import

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20.12.2007

Vienna (Austria), December 20, 2007 - Intercell AG (VSE: ICLL)
announced today that after having submitted the Market Authorization
Application in Europe earlier this month it has now also completed
the submission process of its Biological License Application (BLA)
with the US Food and Drug Administration (FDA) for the use of its
vaccine to prevent Japanese encephalitis (JE).

Because JE is a significant and serious public health threat in Asia,
the initial target for use of Intercell´s vaccine will be adult
civilian travellers and military personnel who visit or a deployed to
affected countries, including India, China, and Southeast / Southwest
Asia.

"It is a major achievement that, following our successful clinical
development, we have also been able to conclude all key
industrialization steps in time for regulatory submissions in the
United States and Europe. We are confident to be able to deliver on
the next steps towards respective product approvals", states Thomas
Lingelbach, Intercell´s Chief Operating Officer.

Earlier this month, Intercell also announced the submission for MAA
(Marketing Authorization Application) regulatory filing with the EMEA
(European Medicines Agency). The company has successfully completed
the clinical phase-III pivotal efficacy and safety trials for its
lead product and, subject to the validation of the most recent
submissions, expects licensures in the US and the EU in 2008. Filing
in Australia is planned for early in 2008.

"The completion of the submissions with both the FDA and the EMEA is
a key regulatory milestone for Intercell. To be able to
simultaneously manage the company´s first BLA and MAA reflects our
commitment to company goals, our business strategy, and to delivering
on the next steps towards commercialization in Europe and the US
together with our partner Novartis," explains Intercell´s Chief
Executive Officer, Gerd Zettlmeissl.

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 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.

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 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