euro adhoc: Intercell AG / other / Australia first country to receive positive recommendation for Intercell's Vaccine to Prevent Japanese Encephalitis

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New Products

12.12.2008

» Australian Drug Evaluation Committee (ADEC) has issued a positive
recommendation for Intercell's first product, a new vaccine against
Japanese Encephalitis
» Marketing approvals in Europe and USA are expected in December 2008
» New vaccine targets travelers to, and population in, endemic areas

Vienna/Austria, December 12, 2008 - Intercell AG (VSE: ICLL) today
announced that the Australian Drug Evaluation Committee (ADEC) has
issued a positive recommendation for the company´s new vaccine
against Japanese Encephalitis. Following the recommendation by ADEC,
approval of Intercell´s JE vaccine in Australia is subject to final
authorization by the Therapeutic Goods Administration (TGA), the
regulatory body responsible for the evaluation of new therapies in
Australia. The TGA considers the advice and recommendation provided
by ADEC when making its final decision. ADEC recommended the
Intercell JE vaccine for active immunization against Japanese
Encephalitis (JE) virus for persons 18 years of age and older.
JESPECT should be considered for use in persons who plan to reside in
or travel to areas where JE is endemic (common) or epidemic
(seasonal).

Intercell is successfully advancing parallel regulatory processes in
all key markets and marketing approval in the U.S. and Europe is also
expected before the end of the year.

Japanese Encephalitis is a deadly disease that kills as many as 30%
of symptomatic persons who develop encephalitis. Japanese
Encephalitis is becoming a larger risk for travelers. There is
increasing travel to rural areas where the disease is more common,
and climate change is extending the range of disease-carrying
mosquitoes.

"This is a major accomplishment for Intercell. The JE-vaccine
addresses a critical unmet need for effective and safe protection
against Japanese Encephalitis, not only for travelers, but also for
people living in endemic areas," said Gerd Zettlmeissl, Chief
Executive Officer of Intercell AG. "We are also still very optimistic
about positive decisions in the U.S. and Europe this year."

Intercell's vaccine is a purified, inactivated product for active
immunization against viral infections of Japanese Encephalitis. The
vaccine is manufactured in Intercell's proprietary manufacturing
facility in Scotland and is prepared using tissue culture rather than
live organisms.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes
30,000 to 50,000 a year, causing 10-15,000 deaths up to 50% of
survivors have persistent neurological sequelae. Japanese
Encephalitis is the leading cause of viral neurological disease and
disability in Asia, and is the most important viral encephalitis in
Asia. The disease is most common in several developing countries in
Asia. No treatment is currently available; only vaccination
effectively prevents the disease. Though other vaccines have been
available in the past, use of those products has been limited by
reports of neurological reactions.

About Intercell's JE vaccine

Intercell's novel 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. The vaccine
was developed for over 10 years under a Collaborative Research and
Development Agreement (CRADA) with the Walter Reed Army Institute of
Research (WRAIR).

Intercell's Phase III trials for the vaccine found that the vaccine
demonstrated excellent immunogenicity against Japanese Encephalitis
and an overall clinical safety profile similar to placebo combined
with an excellent local tolerability profile. That data was published
in The Lancet in December 2007: » The immunogenicity was comparable
to that of the U.S. licensed product, JE-VAX® » Intercell's vaccine
demonstrated an overall clinical safety profile similar to placebo
» Further, Intercell's JE vaccine had an excellent local tolerability
profile in the head-to-head study with JE-VAX®

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

Tel. +43 1 20620-1303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market