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

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New Products

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.

end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG

Lucia Malfent

Head of Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

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