EANS-News: Intercell AG / Intercell announces pediatric approval of its Japanese Encephalitis vaccine in Europe

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Company Information

Wien (euro adhoc) - Vienna (Austria), February 12, 2013 - Intercell
AG (VSE; "ICLL") announced today that the pediatric indication for
IXIARO®, a vaccine to protect against Japanese Encephalitis (JE), was
granted Marketing Authorisation by the European Medicines Agency
(EMA) and the European Commission (EC). The European Commission
Decision ratifies the positive opinion from the European Committee
for Human Medicinal Products (CHMP) in December 2012. The approval by
the European Union provides formal Marketing Authorisation for the
pediatric indication of IXIARO® in all 27 member states as well as
Norway, Liechtenstein and Iceland.

"We are delighted that our JE vaccine has been granted pediatric
licensure in Europe, which will now enable travelers of all ages to
obtain protection against this disease with a licensed vaccine. The
approval of IXARO® for children is based on additional clinical
studies that have once more confirmed the favorable safety and
immunogenicity profile of the 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, US 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 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) has been licensed in more than 30
countries world-wide, and is the Company's first product on the
market. Extension of the approved indications to include the
pediatric age segment in the EU, allows vaccine to be administered to
adults and children aged 2 months and above who travel to, or live
in, endemic areas. Intercell and its marketing and distribution
partners are committed to introducing the IXIARO® product for
administration in all approved age groups as soon as possible.
Product which is currently available on the market in Europe can be
used in accordance with the approved method of administration in all
people aged 3 years and above.

In the U.S. the pediatric label extension is currently under review
by the FDA.

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