Intercell AG

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Intercell Finalizes Submission of US Biological License Application (BLA) To FDA For Licensure of Japanese Encephalitis Vaccine » Intercell delivers next important step towards product licensure in the United ...

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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.

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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.ch

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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