Intercell AG

EANS-Adhoc: Intercell AG
Intercell and Biological E. Ltd. announce successful completion of investigational Japanese Encephalitis vaccine pivotal Phase II/III study in India


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Research & Development

16.09.2011

* Positive results from first pivotal immunogenicity Phase II/III trial in
  endemic region to prevent Japanese Encephalitis (JE) in children 
* Primary study endpoint of non-inferiority of Biological E´s investigational
  vaccine compared with an inactivated JE comparator vaccine was met 
* Important development step towards a modern, cell culture-derived product in 
  endemic countries - licensure submission to Indian DCGI expected shortly

Vienna (Austria)/Hyderabad (India), September 16, 2011 - Intercell AG and its
partner Biological E. Ltd. today announced the successful completion of a
pediatric Phase II/III study for the vaccine to protect children from Japanese
Encephalitis (JE). Analysis of the pivotal Phase III safety and immunogenicity
data showed positive results and that the study met its primary endpoint.  

The clinical study was designed to compare the immunogenicity and safety of
Biological E´s investigational cell culture-derived vaccine with the mouse brain
derived vaccine produced by the Korean Green Cross Corporation, Korea, in a
multicentre, open label, parallel, randomised Phase II/III study design. The
study, conducted across 8 study sites in India and including 456 randomized
subjects, was designed to lead to licensure in India. 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®).

"We are very pleased to have reached this important milestone in our
collaboration with Biological E. which moves us one step closer towards being
able to provide a vaccine to protect children living in endemic areas threatened
by this terrible disease. The successful completion of this Phase II/III study
is a major step towards making our modern cell culture-derived product available
in Asia, and supports our global territory expansion ", states Thomas
Lingelbach, Chief Executive Officer of Intercell AG. 

Dr. Vijay Kumar Datla, Chairman and Managing Director of Biological E. Limited
added: "We are excited about the successful completion of our Phase II/III
clinical study which should enable us to offer this novel and safe vaccine to
combat Japanese Encephalitis not only in India but also across Asia. There is an
urgent need to respond to the JE epidemic throughout India and Asia where
large-scale immunization is of high importance. Through our strategic
partnership with Intercell, licensure of this modern JE vaccine will allow us to
ensure the vaccine reaches those who need it most."

In March 2011, an independent data and safety monitoring board evaluated data
from 160 subjects having completed their day 7 visit and concluded that the
safety assessment was favorable, thus allowing the study to proceed into Phase
III.

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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issuer:      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, ATX
stockmarkets: official market: Wien 
language:   English
 

 

 



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