euro adhoc: Intercell AG / other / Intercell Receives Manufacturer´s Licence for Future Commercial Manufacturing of its Vaccine Against Japanese Encephalitis

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16.01.2008

» Successfully passed inspection by the Medicines and Healthcare
products Regulatory Agency (MHRA)

» Intercell receives Manufacturer´s Licence for its site in
Livingston, Scotland

» Major milestone in bringing vaccine against Japanese Encephalitis
to the American (US) and European markets

Vienna (Austria), January 16, 2008 - Intercell AG (VSE: ICLL)
announced today that its fully owned manufacturing site in
Livingston, Scotland (Intercell Biomedical Ltd.), has been granted
the Manufacturer´s Licence for the commercial manufacturing of its
vaccine against Japanese Encephalitis. The issuance of the license is
following a GMP (Good Manufacturing Practice) inspection performed by
the Medicines and Healthcare products Regulatory Agency (MHRA).

The Manufacturer´s Licence is required to support the Marketing
Authorization Application (MAA) process in Europe which is being
coordinated by the European Medicines Agency (EMEA) and represents
the basis for future product release and export to the US.

"The issuance of the Commercial Manufacturer´s Licence is a key
achievement on Intercell´s path to bringing our new investigational
Japanese Encephalitis vaccine onto the market and should allow us to
produce a sufficient launch stock for product approvals in the
respective locations," states Gerd Zettlmeissl, Intercell´s Chief
Executive Officer.

"Receiving the Manufacturer´s Licence validates our ongoing
commitment to focus on quality compliance and execution for our
future commercial supplies," says Thomas Lingelbach, Intercell´s
Chief Operating Officer.

Intercell expects the pre-approval inspection by the US FDA (Food and
Drug Administration) in support of the US licensure process within
the forthcoming months.

About Intercell´s investigational JE vaccine (IC51)

Intercell´s novel investigational JE vaccine (IC51) 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. The JE virus remains virulent in this region and has
recently spread to countries not previous affected.

In successfully concluded pivotal Phase III trials, Intercell´s IC51
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, IC51 showed an excellent local tolerability profile in
this head-to-head study with JE-VAX®

Intercell´s novel JE vaccine is produced using tissue culture rather
than live organisms and does not contain any stabilizers such as
gelatin or preservatives in its formulation. Novartis will market and
distribute Intercell´s Japanese Encephalitis virus vaccine in the
United States, Europe and certain other markets in Asia and Latin
America. CSL is Intercell´s marketing and distribution partner in
Australia.

About Intercell Biomedical Ltd. (Livingston, Scotland)

In 2004, Intercell acquired a manufacturing plant in Livingston,
Scotland, which has enabled the Company to gain in-house GMP
manufacturing capabilities for its Japanese encephalitis vaccine and
to manufacture the investigational product used in the Phase III
clinical trials. With major investments in the last years, the
Company has further increased capacities and established a state-of
the art, GMP commercial manufacturing facility to support the future
supplies of its Japanese encephalitis vaccine. Besides the fully
dedicated and further expandable manufacturing facility, the
Livingston site has also separate development and clinical
manufacturing capacities.

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

Campus Vienna Biocenter 2, A-1030 Vienna

P: +43-1-20620-303

Mail to: LMalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market