euro adhoc: Intercell AG / other / Intercell Submits Marketing Authorization Application (MAA) to EMEA for Licensure of Japanese Encephalitis Vaccine

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Company Information

06.12.2007

» Intercell submitted MAA for its lead product, a vaccine against
Japanese encephalitis » Product is intended to be licensed through
centralized regulatory procedure in Europe » Company expects
positive CHMP opinion in 2008

Vienna (Austria), December 6, 2007 - Intercell AG (VSE: ICLL)
announced the regulatory submission of the MAA (Marketing
Authorization Application) today for its lead product, a vaccine
against Japanese encephalitis (JE). After successful Phase III
clinical trials performed in Europe, the United States and Australia,
the new JE vaccine is intended to be licensed through the centralised
regulatory procedure by the EMEA (European Medicines Agency).

"It is a major achievement that we have been able to manage
Intercell´s first MAA submission according to our stated business
plans. Furthermore, we are on track for filing a license application
for our JE vaccine in the United States later this month. We are
encouraged and committed to further delivering on the next steps
towards product licensure and commercialization in the U.S., Europe,
and elsewhere", stated Thomas Lingelbach, Intercell´s Chief Operating
Officer.

Subject to EMEA´s validation of the submission, a review by the
rapporteurs (Germany) and co-rapporteurs (Norway) will be initiated
and the Company is expecting a positive opinion by the Committee for
Medicinal Products for Human Use (CHMP) in 2008.

About Intercell´s investigational JE vaccine (IC51)

Intercell´s novel investigational JE vaccine (IC51) 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. The JE virus remains virulent in this region and has
recently spread to countries not previously affected. In successfully
concluded pivotal Phase III non-inferiority trials, Intercell´s IC51
vaccine has demonstrated a favorable safety and immunogenicity
profile:

» The immunogenicity of IC51 was comparable to that of the U.S.
licensed product, JE-VAX® » IC51 demonstrated an overall clinical
safety profile similar to placebo » Furthermore, IC51 showed an
excellent local tolerability profile in this head-to-head study
with JE-VAX®

Intercell´s novel investigational JE vaccine, manufactured at the
Company´s proprietary GMP (Good Manufacturing Practice) manufacturing
facility in Scotland, 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.

About Intercell Biomedical Ltd.

In 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 Phase III
clinical trials. With major investments throughout the last years,
the Company has further increased its capacities and has established
a state-of the art, GMP commercial manufacturing facility to support
the future supplies of its Japanese encephalitis vaccine. Besides the
manufacturing facility, which is fully dedicated to these studies and
still has the potential for further expansion , the Livingston site
also has separate development and clinical manufacturing capacities.
With more than 70 employees, the organization operates under a
Manufacturing License from the MHRA (Medicines and Healthcare
products Regulatory Agency) for Investigational Medicinal Products
(IMP, Investigational Medicinal Products)) and is in the process of
becoming for commercial manufacturing.

end of announcement euro adhoc 06.12.2007 17:20:00
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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
Börsen: Wiener Börse AG / official market


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