euro adhoc: Intercell AG / other / Product Development Update: Intercell starts Phase II clinical trial for Pseudomonas aeruginosa vaccine and FDA approval of IXIARO® expected in early 2009 (E)

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29.12.2008

» Initiation of a Phase II clinical trial in mechanically ventilated
intensive care patients - Study aims to investigate immunogenicity
and safety in intensive care patients and to assess Pseudomonas
aeruginosa infection rates - Initial results expected in H2 2009

» After recently achieving positive recommendations in EU and Australia,
U.S. approval of Japanese Encephalitis vaccine expected to move into
early 2009 - No impact on product launch plans expected

Vienna (Austria), December 29, 2008 - Intercell AG (VSE: "ICLL") today announced
that the Phase II clinical trial with the company's vaccine candidate to prevent
infections with the bacterium Pseudomonas aeruginosa is starting. Intercell's
vaccine (IC43) is a recombinant subunit vaccine consisting of two outer membrane
proteins of Pseudomonas aeruginosa.

In the Phase II clinical trial, mechanically ventilated intensive care patients,
who are at particular high risk of acquiring severe and often life-threatening
forms of Pseudomonas aeruginosa infections, such as ventilator-associated
pneumonia, sepsis or soft tissue infection, will be vaccinated with Intercell's
prophylactic Pseudomonas aeruginosa vaccine. Two different dosages will be used
in the trial. The dosages and vaccination schedule have been identified in a
Phase I study initiated earlier this year.

For the current Phase II clinical trial, about 450 patients will be enrolled in
more than 50 intensive care units in 11 countries in Europe and Latin America.
The study aims to show induction of protective antibody responses against
Pseudomonas aeruginosa. Antibodies are known to be the "primary line of defense"
of our immune system against the intruding bacteria and are therefore the
targeted immune response to be measured in the trial. Additionally, the patients
will be followed-up for infections caused by Pseudomonas aeruginosa, including
pneumonia, sepsis, wound infections, urinary tract infections or
tracheobronchitis. The overall benefit and quality of life will be assessed by
parameters such as length of ICU and hospital stay or number of antibiotic-free
days.

"The initiation of this Phase II trial strengthens Intercell's leading position
in the field of hospital acquired infections. Intercell's approach to develop
vaccines and antibodies against the major causes of nosocomial infections has
the clear potential to become the unique strategic solution for a dramatically
increasing medical need," comments Thomas Lingelbach, Chief Operating Officer of
Intercell AG.

In addition to the in-house development of the Pseudomonas vaccine, Merck & Co.
Inc., together with Intercell develops a vaccine against S. aureus infections,
which is currently being tested in extensive Phase II clinical trials.

Update on IXIARO® - vaccine candidate to prevent Japanese Encephalitis

Intercell also informed today that despite best collaborative efforts, it does
not expect the U.S. Food and Drug Administration (FDA) to complete all
administrative steps of the application for IXIARO®, a vaccine for the
prevention of Japanese Encephalitis, by the Company's target date of December
31, 2008 and now is looking forward to a U.S. approval in early 2009.

"After our recent excellent achievement obtaining both, the positive opinion in
Europe and the recommendation for approval in Australia, we have been in a
constant and very productive interaction with the FDA to finalize the license
application as quickly as possible," said Intercell´s Chief Executive Officer,
Gerd Zettlmeissl. "Although our year end target date for approval in the U.S.
will be missed we are very confident that we will be able to obtain approval in
time to provide this important vaccine to U.S. travelers and military personnel
according to our original timelines."

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com

end of announcement euro adhoc
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emitter: Intercell AG
Campus Vienna Biocenter 3
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: ATX Prime, ATX
stockmarkets: official market: Wiener Börse AG
language: English

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