euro adhoc: Intercell AG / Joint Ventures/Cooperation/Collaboration / Intercell's investigational vaccine against Japanese Encephalitis shows excellent safety and immunogenicity in Phase II trials in

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Research & Development

15.04.2008

» Japanese Encephalitis (JE) Vaccine meets primary endpoints in Phase
II trials in children » The results fully support Intercell's
development plan for endemic regions and pave the way towards late
stage development and licensure - planned for late 2009 / early
2010

Vienna (Austria), April 15, 2008 - Intercell AG and its partner
Biological E. Ltd. (Hyderabad, India) today announced the analysis of
Phase II data for its investigational pediatric vaccine against
Japanese Encephalitis.

The randomized and controlled study shows an excellent safety and
immunogenicity profile amongst children in endemic areas. The study
which started in 2007 enrolled 60 healthy children at the age of one
to three years.

The seroconversion rate of the test vaccine (given in two doses at
days 0 and 28) in the IC51-3mcg dose group ("half adult dose") was 96
% and thus comparable to seroconversion rates observed in adults in
former pivotal Phase III clinical trials.

Also the geometric mean titers (GMT of about 200) observed at day 56
after the first vaccination for recipients in the "half adult dose"
group were in a similar range to the ones recorded in the pivotal
Phase III trials for adults. The safety profiles of IC51 in children
were very favorable and are fully in line with the data obtained from
the broad Phase III safety studies in adults.

In summary the data suggest that IC51 in young children (one to three
years of age) has a comparable excellent immunogenicity and safety
profile as in adults even if only half of the adult dose is applied.
This allows Intercell and its partner Biological E. to enter into
late stage development towards the licensure of the vaccine for the
use in children in India and other parts of South East Asia. Start of
Phase III clinical trials in India are planned for end 2008/early
2009.

"These results clearly confirm our straight forward development
process and leadership for our Japanese Encephalitis vaccine for
children, which are living in endemic areas and are threatened by
this terrible disease. We are now even more encouraged to enforce all
necessary activities to make our novel product also available to the
children in Asia in the fastest possible way.", states Gerd
Zettlmeissl, Chief Executive Officer of Intercell AG.

Vijay Kumar Datla, Chairman and Managing Director of Biological E.
Ltd added: "The success of this Phase II study is a significant
milestone in our program. With these encouraging study results we
hope to accelerate the program and make the product available at the
earliest for the protection of vulnerable pediatric and adult
population living in JE endemic regions."

Besides the approval and launch of Intercell's investigational
vaccine against Japanese Encephalitis for adult travelers and
military personnel in Europe, USA and Australia, the development of a
vaccine to prevent children in endemic areas from Japanese
Encephalitis, is a major goal.

About Japanese Encephalitis

Japanese encephalitis is the most important cause of viral
encephalitis in Asia. The Japanese encephalitis virus (JEV) is
estimated to cause at least 50 000 cases of clinical disease every
year, mostly in children younger than 10 years. The disease is
endemic in Southeast Asia, a region with more than 3 billion
inhabitants. Only within 1 month in the year 2005, Japanese
encephalitis killed more than 1200 children during an epidemic
outbreak in Uttar Pradesh, India, and Nepal.

About Biological E. Ltd

Over the last 50 years, Biological E. Ltd. (BE) has been a leading
vaccine and pharmaceutical company. The company produces a range of
critical vaccines and has been an active partner in the National
Immunization Program of India. The company is currently commissioning
large scale cGMP facilities in order increase its capacities and
product range to offer these vaccines on a global basis. In addition
to its current pipeline of combination vaccines that are entering
pivotal trials, BE has R&D programs to develop novel vaccines for
both vector borne and enteric diseases. The company has entered into
a number of strategic collaborations with leading biotech companies
and research institutes for basic R&D. Biological E. is a privately
held company. Biological E will manufacture Intercell´s JE vaccine
for the Asian markets and will exclusively market and distribute the
product in India, Nepal, Bhutan and Bangladesh. For more information
please visit: www.biologicale.com

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

Head of Communications

Tel. +43 1 20620-303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market


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