EANS-News: Intercell announces start of pivotal Phase II/III study in India for vaccine to protect children from Japanese Encephalitis

-
» First pivotal Phase II/III trial in endemic region towards
licensure of a
novel pediatric vaccine to prevent Japanese
Encephalitis (JE), manufactured
by Intercell's partner, Biological
E.

» Important development step towards a modern, cell
culture-derived product in
endemic countries – first country
approval expected for end 2011

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Corporate news transmitted by euro adhoc. The issuer/originator is solely
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Research & Development

Subtitle: - » First pivotal Phase II/III trial in endemic region
towards licensure of a novel pediatric vaccine to prevent Japanese
Encephalitis (JE), manufactured by Intercell's partner, Biological
E.

» Important development step towards a modern, cell culture-derived
product in endemic countries – first country approval expected for
end 2011

Vienna (Austria)/Hyderabad (India), February 21, 2011 - (euro adhoc)
- Intercell AG and its partner Biological E. Ltd. today announced the
start of a pediatric Phase II/III study for the vaccine to protect
children from Japanese Encephalitis. 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 and Hong Kong (IXIARO®) as well
as in Australia (JESPECT®).

This randomized and controlled study will be the first pivotal Phase
II/III study in an endemic region towards licensure of the pediatric
JE vaccine. The study will enroll healthy children aged one to below
three years across multiple sites in India. This Phase II/III trial
aims at investigating safety and immunogenicity compared to a
licensed competitor Japanese Encephalitis vaccine.

"We are very pleased with the progress in our collaboration with
Biological E. which undertakes the development of this vaccine to
protect children living in endemic areas threatened by this terrible
disease. The start of the current Phase II/III study is a major step
towards making our modern cell culture-derived product available in
Asia, and supports our global vision for our Japanese Encephalitis
franchise", states Thomas Lingelbach, Chief Operating Officer of
Intercell AG.

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.

Vijay Kumar Datla, Chairman and Managing Director of Biological E.
Ltd., added: "The start of this pivotal Phase II/III study is a
significant milestone in our program. We hope to make the product
available at the earliest possible time in order to best protect the
vulnerable population living in JE-endemic regions."

Data from a previous Phase II study conducted in 2007 in India by
Biological E. with vaccine manufactured at Intercell´s Scottish
manufacturing site suggested that the vaccine has a comparable
excellent immunogenicity and safety profile in young children (one to
below three years of age) as in adults, even if only half of the
adult dose is applied.

In 2010, Biological E. conducted a trial in 20 healthy adults,
confirming the safety profile seen in that previous Phase II trial
with product manufactured at Biological E.'s facility.

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.

end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market