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

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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.

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
lmalfent@intercell.com

end of announcement euro adhoc 06.12.2007 17:20:00
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emitter: Intercell AG
Campus Vienna Biocenter 6
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes:
stockmarkets: official market: Wiener Börse AG
language: English

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