EANS-News: Intercell AG / Intercell and Biological E. Ltd. announce approval for Japanese Encephalitis vaccine in India

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Wien (euro adhoc) - -

» Indian authorities granted approval for Japanese Encephalitis (JE)
vaccine in endemic region » Important milestone towards
introduction of Intercell´s modern, cell culture-derived technology
based vaccine in endemic countries

Vienna (Austria)/Hyderabad (India), November 10, 2011 - Intercell AG
and its partner Biological E. Ltd. today announced the approval of
their vaccine to protect children and adults from Japanese
Encephalitis (JE) by the Drugs Controller General of India (DCGI).

As previously announced, the analysis of the pivotal Phase III safety
and immunogenicity data showed positive results and the study met its
primary endpoint. Through a rolling submission process initiated in
2010 and an external "Expert Committee" review in October 2011 as
well as recognized disease burden in endemic regions in India, the
Indian authorities were able to facilitate the review and grant
approval. The launch of the product, which will be known as JEEV®, is
on track and expected for H1 2012, following the manufacturing and
release of commercial launch batches at Biological E.´s facility in
Hyderabad.

"The approval by the Indian authorities represents an important
milestone in our strategy to roll out our Japanese Encephalitis
vaccine in endemic countries with high medical need and to protect
children and adults against this terrible disease. Without a local
strategic partner like Biological E. however, this success wouldn´t
have been possible", states Thomas Lingelbach, Chief Executive
Officer of Intercell AG.

The vaccine is manufactured in India by Biological E. and is based on
Intercell's technology, which was successfully used to gain product
licensure of the adult vaccine in Europe, the United States, Canada,
Hong Kong (IXIARO®) and Australia (JESPECT®).

Dr. Vijay Kumar Datla, Chairman & Managing Director of Biological E.
said, "This is a significant milestone and has tremendous relevance
for India. We are pleased that we are able to now manufacture this
important vaccine, (JEEV®) locally and will begin discussion with key
stakeholders to see how this vaccine can play in role in supporting
India´s on-going fight against the dreadful disease."

In 2005, Intercell and Biological E. signed a contract for the
development, manufacturing, marketing and distribution in India and
the Indian subcontinent of Intercell's Japanese Encephalitis vaccine.
The vaccine's further regulatory approval route for other Asian
territories is expected through the World Health Organization -
Novartis will be responsible for the marketing and distribution in
these regions. Following the approval and launch of Intercell's
vaccine against Japanese Encephalitis for adult travelers and
military personnel in Europe, the USA and Australia, the development
of a vaccine to protect children in endemic areas from Japanese
Encephalitis has been a major goal of the Company.

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