Intercell AG

EANS-News: Intercell receives CHMP positive opinion for the pediatric indication of its Japanese Encephalitis vaccine in Europe

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Company Information

Wien (euro adhoc) - Vienna (Austria), December 19, 2012 - Intercell AG (VSE;
"ICLL") today announced that the CHMP of the European Medicines Agency (EMA) has
come to a positive opinion on the Marketing Authorisation for IXIARO® in
children, a vaccine to protect against Japanese Encephalitis (JE). The final
decision (approval) by the European Commission is expected in February or March

Intercell has submitted applications for the approval of a JE vaccine pediatric
label extension 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 showed to be highly immunogenic in children aged 2 months to <18
years with a safety profile comparable to pediatric vaccines licensed for other

"We are very pleased about the positive CHMP opinion on the pediatric indication
for our JE vaccine. This will be the first time European travelers of all ages
can be protected against this dreadful disease with a licensed vaccine", 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, 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
The vaccine to prevent Japanese Encephalitis (JE) is Intercell's first product
on the market. This is a next-generation vaccine used to help prevent infection
with the JE virus, and has been licensed in more than 30 countries. The vaccine
is a purified, inactivated vaccine and causes the body to produce its own
protection (antibodies) against this disease.
Upon approval of the new indication for the pediatric age segment in the EU, the
vaccine will offer protection against JE for adults and children aged 2 months
and above who travel to, or live in, endemic areas. In the U.S. the vaccine is
currently licensed for those above 17 years of age, and in Canada, Australia and
New Zealand it is licensed for persons above 18 years of age. 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 our cGMP facility in Livingston, Scotland.

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

end of announcement                               euro adhoc 

company:     Intercell AG
             Campus Vienna Biocenter  3
             A-1030 Wien 
phone:       +43 1 20620-0
FAX:         +43 1 20620-800
sector:      Biotechnology
ISIN:        AT0000612601
indexes:     ATX Prime
stockmarkets: official market: Wien 
language:   English

Weitere Meldungen: Intercell AG

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