EANS-Adhoc: Intercell AG / Intercell Announces FDA Approval of IXIARO®, a Novel Vaccine to Prevent Japanese Encephalitis

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30.03.2009

» U.S. FDA approves Intercell's first marketed product, a new vaccine
against Japanese Encephalitis for travelers and military personnel
» Commercial product launch in the U.S. planned for Q2 2009

Vienna, Austria, March 30, 2009 - Intercell AG (VSE: ICLL) today announced that
the U.S. Food and Drug Administration (FDA) approved IXIARO®, a new vaccine for
the prevention of Japanese Encephalitis (JE). The initial target for use of
Intercell's vaccine - the only such product currently manufactured for the U.S.
market - will be adult travelers and military personnel who visit or are
deployed to affected countries, including India, China, and other parts of Asia.

"This approval is a major achievement for Intercell, and it marks a significant
milestone in this company´s history. The approval of IXIARO by the FDA - part of
a regulatory process that included parallel filings in Europe and Australia -
puts us in a select group of biotechnology companies with both an FDA-approved
product and an outstanding pipeline of promising vaccine candidates," said
Intercell's Chief Executive Officer, Gerd Zettlmeissl. "With this decision,
Americans - both civilians and military personnel - will have an efficacious and
safe way to protect themselves from the devastating and deadly effects of
Japanese Encephalitis."

JE is a deadly infectious disease found mainly in Asia. Approximately 30,000 to
50,000 cases of JE are reported in Asia each year, and the actual number of
cases are likely much higher due to underreporting in rural areas. JE is fatal
in approximately 30 percent of those who show symptoms and leaves half of
survivors with permanent brain damage. As there is no specific treatment for JE,
vaccination is the only highly effective protection for the millions of
travelers and military personnel who live in or travel to areas where the virus
circulates.

Intercell's vaccine is a purified, inactivated product for active immunization
against viral infections of Japanese Encephalitis. IXIARO is manufactured at
Intercell's proprietary manufacturing facility in Scotland and is prepared using
tissue culture rather than live organisms. Novartis AG holds marketing and
distribution rights for IXIARO in the United States, Europe, Japan, South Korea
and certain other markets in Asia and Latin America. Intercell will directly
distribute and market IXIARO to the U.S. military.

Prior to approval, the vaccine was tested in a series of large-scale clinical
trials with around 5,000 individuals. The total development time of this vaccine
from research to approval took more than 10 years. The vaccine was developed
under a Collaborative Research and Development Agreement with the Walter Reed
Army Institute of Research in the U.S. The vaccine was also approved by the
Australian Therapeutic Goods Administration (TGA) in January 2009 and is
expected to be approved in Europe shortly following a positive CHMP-opinion.

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
[email protected]

end of announcement euro adhoc
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emitter: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: [email protected]
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime, ATX
stockmarkets: official market: Wiener Börse AG
language: English

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