DJ euro adhoc: Intercell AG / other / Licensure application for Japanese Encephalitis vaccine submitted to Canadian Division of Biologics and Genetic Therapies Directorate of Health

DJ euro adhoc: Intercell AG / other / Licensure application for Japanese Encephalitis vaccine submitted to Canadian Division of Biologics and Genetic Therapies Directorate of Health

Intercell AG / other 

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  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
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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
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(END) Dow Jones Newswires

June 19, 2008 02:03 ET (06:03 GMT)