Intercell AG

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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 -------------------------------------------------------------------------------- ots Originaltext: Intercell AG Im Internet recherchierbar: http://www.presseportal.ch 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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