euro adhoc: Intercell AG / other / Positive results for Intercell’s Japanese Encephalitis Vaccine in pivotal Phase III Safety trial

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Disclosure announcement transmitted by euro adhoc.
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24.08.2006

» Results for Intercell’s Japanese Encephalitis virus vaccine in the
pivotal Phase III safety trial, which included 2,683 randomized
subjects, are positive » Intercell’s JE vaccine was well
tolerated, no critical adverse events were observed » With these
results, the preparations for the filing process with the United
States Food and Drug Administration (FDA) are fully on track for an
anticipated market launch in the United States in 2007

Intercell AG (VSE, "ICLL") announced today that the safety analyses
for the pivotal Phase III safety trial of its investigational
Japanese Encephalitis vaccine are positive.

The pivotal Phase III safety trial was conducted at 39 study sites in
Austria, Germany, Romania, Israel, Australia, New Zealand and in the
US, and included 2,683 randomized subjects. The study was designed to
analyze the safety and tolerability of Intercell’s investigational
vaccine in a multicenter, multinational, double-blind,
placebo-controlled randomized study.

Major endpoints of this study were the frequency of adverse events in
both test groups, as well as local tolerability findings in both
groups. First analyses of this trial show that Intercell’s
investigational Japanese Encephalitis vaccine was systemically and
locally well tolerated. Overall, the local tolerability and general
safety profile of the Intercell JE vaccine appeared to be comparable
with placebo.

The Phase III clinical trial program consists of several additional
clinical trials including a pivotal immunogenicity 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. The pivotal Phase III clinical
trial program is designed to meet regulatory requirements in the
United States, Europe and Australia. Assuming approval by the
regulatory authorities, the first market launch is anticipated for
2007. Preparations for the submission of a BLA (Biologics License
Application) to the FDA have commenced.

Full clinical results of the pivotal immunogenicity trial are planned
to be presented at the Annual Meeting of the American Society of
Tropical Medicine and Hygiene (ASTMH), November 12-16, Atlanta, and
full clinical results of the pivotal safety trial are planned to be
presented at the 10th Conference of the International Society of
Travel Medicine, May 20-24, 2007 in Vancouver, Canada.

end of announcement euro adhoc 24.08.2006 07:23:04
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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