12.02.2013 – 08:04

Intercell AG

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