euro adhoc: Intercell AG / other / Positive results for Intercell’s Japanese Encephalitis virus vaccine in pivotal clinical trial - Phase III meets primary endpoint

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31.05.2006

» First results for Intercell’s Japanese Encephalitis virus vaccine
in the pivotal immunogenicity clinical trial are positive » In a
preliminary statistical analysis, the primary endpoint of non-
inferiority of Intercell’s investigational vaccine compared with
JE-VAX® was met » With these results, the filing process with the
United States Food and Drug Administration (FDA) will start
shortly to prepare for the market launch in the United States
expected in 2007

Vienna (Austria), May 31, 2006 - Intercell AG (VSE, "ICLL") announced
today that a first analysis of the pivotal immunogenicity phase III
clinical data of its investigational Japanese Encephalitis virus
(JEV) vaccine showed positive results and met its primary endpoint.
The primary endpoint in this clinical trial comprised both the amount
of antibodies in the blood (expressed as geometric mean titer or GMT)
and the percentage of subjects reaching protective antibody titers
(known as the seroconversion rate).

The clinical trial was designed to compare the immunogenicity of
Intercell’s investigational vaccine with the mouse brain derived JE
VAX® (distributed by Sanofi Pasteur SA, produced by Biken) in a
multicenter, multinational, observer-blinded, randomized controlled
trial. The pivotal immunogenicity phase III clinical trial was
conducted at study sites in the United States, Austria, and Germany
and included 868 randomized subjects. The pivotal Phase III clinical
trial program is designed to meet the regulatory requirements of
Intercell´s JEV vaccine in the United States, Europe and Australia.
The first market launch is expected to take place in the United
States in 2007, if the company obtains timely approvals from the
regulatory authorities.

The full phase III clinical trial program consists of several
additional clinical trials including a pivotal safety trial, a single
shot trial and a co-vaccination trial for travelers, which are all
expected to be completed by early 2007. To date, more than 4,800 of
the approximately 5,370 trial participants have been enrolled and
vaccinated in these clinical trials. Preparations for the submission
of a BLA (Biologics License Application) to the FDA have commenced.

In January 2006, an independent data and safety monitoring board
concluded that it observed no safety concerns in its first
evaluation. In addition, Intercell´s JEV vaccine was granted orphan
drug status by the European Commission, resulting in ten years of
market exclusivity in the European Union upon product registration.

"Based on the positive immunogenicity and safety profile observed so
far, we believe that our innovative product will replace the
mouse-brain derived products currently available on the market and
that we will be able to expand the market for this traveler vaccine
significantly. We are very proud that we are one of the few companies
in the rapidly growing vaccine market that is running a globally
successful phase III clinical program, states Intercell’s Chief
Executive Officer, Gerd Zettlmeissl.

Full clinical trial data will be presented at the Annual Meeting of
the American Society of Tropical Medicine and Hygiene (ASTMH), which
is scheduled to take place from November 12 to 16, 2006, in Atlanta.

About Intercell’s investigational JEV vaccine

Intercell´s novel investigational JEV vaccine is a purified,
inactivated vaccine for active immunization of adults against the
Japanese Encephalitis virus. With over three 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.

In a former phase II head-to-head comparison with JE-VAX®, the only
JEV vaccine licensed in the United States, Intercell’s
investigational vaccine was shown to be:

» Less reactogenic - both in frequency and intensity » More potent -
higher antibody levels at all doses studied one month after the
immunizations » More convenient - 2 doses versus 3 doses and liquid
versus freeze-dried format » More persistent - higher persistence
of antibodies two years after primary immunization

Intercell’s JEV vaccine, manufactured in the Company’s propriety
manufacturing facility in Scotland, is novel as it is based on tissue
culture rather than live organisms and does not contain any
stabilizers or preservatives in its formulation.

About Intercell AG

Intercell AG is a biotechnology company focused on the research,
development, manufacturing and future commercialization of innovative
vaccines for the prevention and treatment of infectious diseases, for
which there exists a substantial unmet medical need. The Company
develops antigens and immunizers (adjuvants), which are derived from
its proprietary technology platforms and has in-house GMP
manufacturing capability. Intercell has strategic partnerships with a
number of global pharmaceutical companies, including Sanofi Pasteur
S.A., Merck & Co., Inc., SciGen Ltd., the Statens Serum Institut and
Kirin Brewery Co., Ltd.. The Company has a broad development pipeline
with a vaccine product candidate for Japanese Encephalitis in phase
III, a vaccine product candidate for Hepatitis C in phase II,
partnered vaccine candidates for tuberculosis and S. aureus, which
are in Phase I, and more than five other product candidates focused
on infectious diseases in pre-clinical development. Intercell is
listed on the Vienna stock exchange under the symbol "ICLL". For more
information, please visit: www.intercell.com

end of announcement euro adhoc 31.05.2006 17:05:00
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market