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Licensure application for Japanese Encephalitis vaccine submitted to Canadian Division of Biologics and Genetic Therapies Directorate of Health

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
Company Information
19.06.2008
» Intercell submitted application to launch Japanese Encephalitis
  vaccine in Canada
» Intercell confirms plans for market launch (Europe, US, Australia)
  within committed timelines - production process fully on track
Vienna (Austria), June 19, 2008 - Intercell AG (VSE: ICLL) announced 
today the submission of application to register Intercell's 
investigational Japanese Encephalitis vaccine in Canada to the 
Division of Biologics and Genetic Therapies Directorate of Health 
Canada. This submission has been based on the Market Authorization 
Application (MAA) with the European Medicines Agency (EMEA) and the 
Biological License Application (BLA) with the US Food and Drug 
Administration (FDA), submitted in December 2007.
Intercell confirms that the regulatory approval process in US, EU and
Australia as well as its manufacturing operations are proceeding 
according to plan and in-line with communicated time lines for market
launches in the respective territories.
The production of the vaccine for the Canadian market will be 
performed at Intercell's state-of-the-art vaccine manufacturing 
facility in Livingston, Scotland.
"We are pleased to announce that the committed timelines regarding 
the planned manufacturing operations and regulatory approvals in the 
US, Europe and Australia in 2008 can be confirmed," explained 
Intercell's Chief Operating Officer, Thomas Lingelbach.
With over three 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. The 
JE virus remains virulent in this region and has recently spread to 
countries not previously affected. Furthermore, the virus is a 
consistent threat to millions of travelers visiting the highly 
populated far eastern countries, including China and India.
As previously announced Intercell's investigational vaccine against 
Japanese Encephalitis shows excellent safety and immunogenicity in 
Phase II trials in children. These results fully support Intercell's 
development plan for endemic regions and pave the way towards late 
stage development and licensure.
About Intercell's investigational JE vaccine
Intercell's novel investigational Japanese Encephalitis 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 non-inferiority Phase III trials, 
Intercell's Japanese Encephalitis vaccine demonstrated a favorable 
safety and immunogenicity profile:
» The immunogenicity was comparable to that of the US licensed 
product,   JE-VAX® » It demonstrated an overall clinical safety 
profile similar to placebo » Further, Intercell's JE vaccine 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, is prepared using tissue culture 
rather than live organisms and does not contain any stabilizers such 
as gelatin or preservatives in its formulation.
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market

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