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