euro adhoc: Intercell AG / other / Intercell initiates regulatory process for its Japanese Encephalitis Vaccine to the U.S. Food and Drug Administration (FDA)

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12.10.2006

» Successful pre-BLA meeting with the FDA in September 2006 »
Intercell has now initiated the regulatory process towards a
Biologics License Application (BLA) for its Japanese Encephalitis
vaccine (IC51) » Intercell AG is on track to complete submission in
early 2007 with approval expected same year

Intercell AG (VSE, "ICLL") announced today that it has initiated the
regulatory process towards a Biologics License Application (BLA) for
its Japanese Encephalitis (JE) vaccine (IC51) to the U.S. Food and
Drug Administration (FDA).

This significant event follows a successful pre-BLA meeting held
between the FDA and Intercell on September 19, 2006, during which a
detailed plan for filing of the BLA was discussed and agreed upon.
Initially, full reports of the completed pivotal clinical studies
will be submitted to the FDA. Intercell announced earlier the
successful completion of the pivotal immunogenicity and pivotal
safety trials of IC51.In these Phase III trials, Intercell’s JE
vaccine demonstrated a favorable safety and immunogenicity profile: »
The immunogenicity of IC51 was at least as good as the U.S. licensed
product, JE VAX® » IC51 demonstrated an overall clinical safety
profile similar to placebo » Further, the local tolerability of IC51
appeared to be more favorable than JE-VAX® in a head-to-head study.

The pivotal Phase III clinical trial program is designed to meet
regulatory requirements in the United States, Europe and Australia.
Assuming approval of Intercell’s BLA by the regulatory authorities,
the first market launch for IC51 is anticipated for 2007.

About Intercell’s investigational JE vaccine(IC51):

Intercell´s novel investigational JE vaccine is a purified,
inactivated vaccine for active immunization of adults 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 successful concluded pivotal Phase III
trials, Intercell’s Japanese Encephalitis vaccine has demonstrated a
favorable safety and immunogenicity profile: » The immunogenicity of
IC51 was at least as good as the U.S. licensed product, JE-VAX® »
IC51 demonstrated an overall clinical safety profile similar to
placebo » Further, the local tolerability of IC51 appeared to be
more favorable than JE-VAX® in this head-to-head study Full clinical
results of the pivotal immunogenicity trial will be presented at the
Annual Meeting of the American Society of Tropical Medicine and
Hygiene (ASTMH), November 12-16, 2006 in Atlanta, Georgia, and full
clinical results of the pivotal safety trial are planned to be
presented at the 10th Conference of the International Society of
Travel Medicine, May 20-24, 2007 in Vancouver, Canada. Intercell’s
novel JE vaccine, manufactured in the Company’s proprietary
manufacturing facility in Scotland, is prepared using tissue culture
rather than live organisms and, unlike JE-VAX®, does not contain any
stabilizers or preservatives in its formulation. Novartis and
Intercell announced on June 13, that the companies had reached an
agreement for Novartis to acquire marketing and distribution rights
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 12.10.2006 06:26:34
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

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


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