EANS-News: Intercell Announces Pediatric Approval of its Japanese Encephalitis Vaccine in the U.S.

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Company Information

Wien (euro adhoc) - Vienna (Austria), May 21, 2013 - Intercell AG
(VSE; "ICLL") announced today that the pediatric indication for
IXIARO®, a vaccine to protect against Japanese Encephalitis (JE), was
approved by the U.S. Food and Drug Administration (FDA). In Europe,
the pediatric label extension was granted in February 2013.

"We are very pleased that the FDA has now approved IXIARO® for use in
in children from the age of 2 months. For the first time in nearly 2
years, a licensed vaccine will now be available to vaccinate also
traveling children and those children of forward deployed military
personal in Asia, against JE. This important step is a key element of
the further growth for Intercell's first commercial product and
another milestone in the fight against this potentially deadly
disease with a licensed vaccine", says Thomas Lingelbach, Chief
Executive Officer of Intercell AG.

Intercell submitted applications for pediatric licensure of the JE
vaccine to major regulatory agencies in late Q2 2012 based on data
from a Phase III clinical study conducted in the Philippines and
favorable interim data from a second Phase III trial in EU, U.S. and
Australia. In both studies, the JE vaccine was shown to be highly
immunogenic in children/adolescents aged 2 months to less than 18
years with a safety profile comparable to pediatric vaccines licensed
for other diseases.

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

Intercell's next-generation vaccine to protect travelers against
Japanese Encephalitis (JE) is currently licensed in more than 35
countries worldwide, and is the Company's first product on the
market. Extension of the approved indication to include the pediatric
age segment in the U.S. allows IXIARO® to be administered to both
adults and children aged 2 months and above who travel to, or live
in, JEV endemic areas of Asia. Intercell and its marketing and
distribution partners are committed to introducing a new product
presentation for IXIARO®, suitable for administration in all approved
age groups, as soon as possible. Product which is currently available
on the market in the U.S. can be used in accordance with the approved
dosage and administration in individuals aged 3 years and above.

The vaccine is manufactured by Intercell AG's wholly-owned subsidiary
Intercell Biomedical Ltd. at its cGMP facility in Livingston,
Scotland.

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