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

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Company Information

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."

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 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