EANS-News: Intercell AG Intercell and Biological E. Ltd. announce approval for
Japanese Encephalitis vaccine in India
--------------------------------------------------------------------------------
Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
--------------------------------------------------------------------------------
Company Information
Wien (euro adhoc) - -
» Indian authorities granted approval for Japanese Encephalitis (JE) vaccine in
endemic region
» Important milestone towards introduction of Intercell´s modern,
cell culture-derived technology based vaccine in endemic countries
Vienna (Austria)/Hyderabad (India), November 10, 2011 - Intercell AG and its
partner Biological E. Ltd. today announced the approval of their vaccine to
protect children and adults from Japanese Encephalitis (JE) by the Drugs
Controller General of India (DCGI).
As previously announced, the analysis of the pivotal Phase III safety and
immunogenicity data showed positive results and the study met its primary
endpoint. Through a rolling submission process initiated in 2010 and an external
"Expert Committee" review in October 2011 as well as recognized disease burden
in endemic regions in India, the Indian authorities were able to facilitate the
review and grant approval. The launch of the product, which will be known as
JEEV®, is on track and expected for H1 2012, following the manufacturing and
release of commercial launch batches at Biological E.´s facility in Hyderabad.
"The approval by the Indian authorities represents an important milestone in our
strategy to roll out our Japanese Encephalitis vaccine in endemic countries with
high medical need and to protect children and adults against this terrible
disease. Without a local strategic partner like Biological E. however, this
success wouldn´t have been possible", states Thomas Lingelbach, Chief Executive
Officer of Intercell AG.
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®).
Dr. Vijay Kumar Datla, Chairman & Managing Director of Biological E. said, "This
is a significant milestone and has tremendous relevance for India. We are
pleased that we are able to now manufacture this important vaccine, (JEEV®)
locally and will begin discussion with key stakeholders to see how this vaccine
can play in role in supporting India´s on-going fight against the dreadful
disease."
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
--------------------------------------------------------------------------------
company: 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
stockmarkets: official market: Wien
language: English