EANS-News: Intercell AG /Intercell announces positive results from two clinical Phase III studies supporting pediatric label extension of JE vaccine for children traveling to endemic areas

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Research & Development

Wien (euro adhoc) - - » Japanese Encephalitis (JE) vaccine showed to
be highly immunogenic in children aged 2 months to <18 years with a
safety profile comparable to other licensed pediatric vaccines

» Compilation of Phase III clinical data package supporting pediatric
licensure applications for IXIARO®/JESPECT® completed - regulatory
submissions to major agencies expected for Q2 2012

Vienna (Austria), February 01, 2012 - Intercell AG (VSE; 'ICLL')
today announced the successful completion of a pivotal Phase III
trial in 1869 children conducted in the Philippines and favorable
interim data from a second Phase III trial in EU, US and Australia.
Analysis of both studies showed that the vaccine was well tolerated
and immunogenic in children aged 2 months to <18 years. Based on
these data, Intercell will submit applications for the approval of an
IXIARO®/JESPECT® pediatric label extension to major regulatory
agencies in Q2 2012.

The pivotal study in the Philippines was designed as a safety,
immunogenicity and dose confirmation trial. The multi-center,
randomized and active-controlled study enrolled 1,869 children aged 2
months to <18 years. 1,411 children received IXIARO®/JESPECT® at
doses of either 0.25 ml / 3µg (half of an adult dose, ages below 3
years) or 0.5ml / 6µg (full adult dose, ages 12 years and older). For
ages 3 to <12 years the full adult dose was found appropriate in a
dose-confirmation component of the trial. In the control group, 64
children received Prevnar® and 394 children received Havrix®. In this
pivotal study, the safety profile with overall adverse event rate up
to Day 56 of 84.0% (<1 year) and 62.0% (>= 1 year) was comparable to
the control vaccines Prevnar® (87.5%, <1 year) and Havrix® (59.6%,
>=1 year).

The second study is an ongoing multi-center, open label, single arm
trial in which 100 children from US, EU and Australia who are
travelling to JEV-endemic areas are planned to receive
IXIARO®/JESPECT®. The overall adverse event rate up to Day 56 in the
interim analysis was 66.7%.

In both studies, more than 99% of children who received the
appropriate dose of IXIARO®/JESPECT® achieved neutralizing antibody
titers above the WHO-recognized protective titer.

"We are very pleased about the positive pivotal data in support of
our label extension to protect also traveling children against
Japanese Encephalitis - a key element of the further growth for
Intercell´s first commercial product", states Thomas Lingelbach,
Chief Executive Officer of Intercell AG.

Following the approval and launch of Intercell's vaccine against
Japanese Encephalitis for adult travelers and military personnel in
Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia
(JESPECT®), the development of a vaccine to protect children
traveling to endemic areas from Japanese Encephalitis has been a
major goal of the Company.

The vaccine is manufactured by Intercell AG´s wholly-owned subsidiary
Intercell Biomedical Ltd. at our cGMP facility in Livingston,
Scotland. The pediatric approval is expected by the end of 2012 or
beginning of 2013.

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

end of announcement euro adhoc
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company: 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
stockmarkets: official market: Wien
language: English