euro adhoc: Intercell AG / other / Regulatory approval to start pediatric clinical trials for Japanese Encephalitis (JE) Vaccine in India obtained

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Research & Development

04.04.2007

» Development process for vaccine launch in endemic countries
accelerated - Approval for start of clinical trials in India
obtained

» First administration of Intercell’s JE vaccine to children - Start
of Phase II trial is expected within the next weeks

» Development plan for endemic regions clearly defined - Market
launch expected for late 2008/early 2009

Vienna (Austria), April 4, 2007 - Intercell AG and its partner
Biological E. Ltd. (Hyderabad, India) announced today that the
companies have obtained regulatory clearance to start a pediatric
Phase II clinical trial for Intercell’s novel Japanese Encephalitis
Vaccine in India.

The randomized and controlled study aims to demonstrate the dose,
safety and immunogenicity of Intercell’s JE vaccine compared to a
locally produced mouse-brain Japanese Encephalitis vaccine. The
study, which will start in late April/early May, will enroll children
at the age of one to three years. It is the first step towards the
licensure of a new cell culture derived product in Asia, which is
expected for late 2008/early 2009.

"We have clearly defined a straight forward development process for
our Japanese Encephalitis vaccine to enter endemic markets. It is our
priority to make the vaccine, which is based on proven and safe
technology, also available for the population and especially the
children in endemic regions", states Gerd Zettlmeissl, Chief
Executive Officer of Intercell AG.

Vijay Kumar Datla, Chairman and Managing Director of Biological E.
Ltd added: "We believe that this is a very important milestone in our
endeavor to bring a safe and efficacious vaccine to endemic regions."

About Intercell’s investigational JE vaccine (IC51)

Intercell´s novel investigational JE vaccine is a purified,
inactivated vaccine for active immunization against the Japanese
Encephalitis virus. With over 3 billion people living in endemic
areas, Japanese Encephalitis, a mosquito-borne flaviviral infection,
is the leading cause of childhood encephalitis and viral encephalitis
in Asia.

In successfully concluded pivotal Phase III trials, Intercell’s
Japanese Encephalitis vaccine (IC51) has demonstrated a favorable
safety and immunogenicity profile:

» The immunogenicity of IC51 was at least as good as the U.S.
licensed product, JE-VAX®

» IC51 demonstrated an overall clinical safety profile similar to
placebo

» Further, IC51 showed an excellent local tolerability profile in
this head-to head study with JE-VAX®.

Intercell’s novel JE vaccine, manufactured in the Company’s
proprietary manufacturing facility in Scotland, is prepared using
tissue culture rather than live organisms and, unlike JE-VAX®, does
not contain any stabilizers such as gelatin or preservatives in its
formulation.

On June 13, 2006, Novartis and Intercell announced that the companies
had reached an agreement for Novartis to acquire marketing and
distribution rights for Intercell’s Japanese Encephalitis Virus
Vaccine in the United States, Europe and certain other markets in
Asia and Latin America.

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 04.04.2007 07:09:46
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

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


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