Intercell AG

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Intercell initiates regulatory process for its Japanese Encephalitis Vaccine to the U.S. Food and Drug Administration (FDA)

-------------------------------------------------------------------------------- Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement. -------------------------------------------------------------------------------- 12.10.2006 » Successful pre-BLA meeting with the FDA in September 2006 » Intercell has now initiated the regulatory process towards a Biologics License Application (BLA) for its Japanese Encephalitis vaccine (IC51) » Intercell AG is on track to complete submission in early 2007 with approval expected same year Intercell AG (VSE, "ICLL") announced today that it has initiated the regulatory process towards a Biologics License Application (BLA) for its Japanese Encephalitis (JE) vaccine (IC51) to the U.S. Food and Drug Administration (FDA). This significant event follows a successful pre-BLA meeting held between the FDA and Intercell on September 19, 2006, during which a detailed plan for filing of the BLA was discussed and agreed upon. Initially, full reports of the completed pivotal clinical studies will be submitted to the FDA. Intercell announced earlier the successful completion of the pivotal immunogenicity and pivotal safety trials of IC51.In these Phase III trials, Intercell’s JE vaccine demonstrated a favorable safety and immunogenicity profile: » The immunogenicity of IC51 was at least as good as the U.S. licensed product, JE VAX® » IC51 demonstrated an overall clinical safety profile similar to placebo » Further, the local tolerability of IC51 appeared to be more favorable than JE-VAX® in a head-to-head study. The pivotal Phase III clinical trial program is designed to meet regulatory requirements in the United States, Europe and Australia. Assuming approval of Intercell’s BLA by the regulatory authorities, the first market launch for IC51 is anticipated for 2007. About Intercell’s investigational JE vaccine(IC51): Intercell´s novel investigational JE vaccine is a purified, inactivated vaccine for active immunization of adults 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 successful concluded pivotal Phase III trials, Intercell’s Japanese Encephalitis vaccine has demonstrated a favorable safety and immunogenicity profile: » The immunogenicity of IC51 was at least as good as the U.S. licensed product, JE-VAX® » IC51 demonstrated an overall clinical safety profile similar to placebo » Further, the local tolerability of IC51 appeared to be more favorable than JE-VAX® in this head-to-head study Full clinical results of the pivotal immunogenicity trial will be presented at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), November 12-16, 2006 in Atlanta, Georgia, and full clinical results of the pivotal safety trial are planned to be presented at the 10th Conference of the International Society of Travel Medicine, May 20-24, 2007 in Vancouver, Canada. Intercell’s novel JE vaccine, manufactured in the Company’s proprietary manufacturing facility in Scotland, is prepared using tissue culture rather than live organisms and, unlike JE-VAX®, does not contain any stabilizers or preservatives in its formulation. Novartis and Intercell announced on June 13, that the companies had reached an agreement for Novartis to acquire marketing and distribution rights Intercell’s Japanese Encephalitis Virus Vaccine in the United States, Europe and certain other markets in Asia and Latin America. end of announcement euro adhoc 12.10.2006 06:26:34 -------------------------------------------------------------------------------- ots Originaltext: Intercell AG Im Internet recherchierbar: http://www.presseportal.de Further inquiry note: Intercell AG Mag. Katharina Wieser Head of Corporate Communications Tel. +43 1 20620-303 kwieser@intercell.com Branche: Biotechnology ISIN: AT0000612601 WKN: A0D8HW Börsen: Wiener Börse AG / official market

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