euro adhoc: Intercell AG / other / First child vaccinated with Intercell Japanese Encephalitis (JE) Vaccine in India - Pediatric Phase II clinical trial started

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Research & Development

16.07.2007

» Development process for vaccine launch in endemic countries
accelerated - First child vaccinated with IC51 » First
administration of Intercell´s JE vaccine to children - Results of
Phase II trial are expected in late 2007 » Development plan for
endemic regions clearly defined - Market launch expected in 2009

Vienna (Austria), July 16, 2007 - Intercell AG and its partner
Biological E. Ltd. (Hyderabad, India) announced today that the
companies have started 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 available, Korean made mouse-brain Japanese Encephalitis
vaccine. The study will enroll 60 children at the age of one to three
years. It is the first step toward the licensure of a new cell
culture derived product in Asia, which is expected in 2009.

"The start of the pediatric clinical trials in India is a major step
forward to make our vaccine, which is based on a proven and safe
technology, available also 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, "With the spirit and energy of this partnership we aim to
make equitable access to this important intervention against JE
available in the endemic regions of the world. This trial will be
followed by a corresponding Phase III study in both children and
adults in India."

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) 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 16.07.2007 07:55:00
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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