euro adhoc: Intercell AG / other / Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States - Approvals in United States, Europe and Australia remai

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Company Information

20.10.2008

» Intercell receives positive feedback from the US Food and Drug
Administration (FDA) towards earliest possible product approval

» Discussion on Japanese Encephalitis vaccines is expected to take
place at the meeting of the Advisory Committee for Immunization
Practices (ACIP) on October 22

» The European centralized procedure approval process also is
advancing according to plan targeting a positive opinion from the
Committee for Medical Products for Human Use (CHMP) by end 2008

» In Australia, following Therapeutic Goods Administration's (TGA)
earlier decision to accelerate the approval process, a positive
approval decision is expected in 2008

Vienna (Austria), October 20, 2008 - Following the positive feedback
from the FDA, Intercell announced today an update on the regulatory
approval processes for its Japanese Encephalitis vaccine in the
United States, Europe and Australia.

In the US, Intercell has concluded all submissions requested by the
FDA towards licensure. The remaining final formal alignment steps on
Product Insert leaflet and Product Release protocol have been
initiated. Intercell and the FDA are now jointly working towards the
product approval, which should follow as soon as possible. Given this
positive and encouraging feedback from the authority, Intercell has
focused its manufacturing efforts on a timely product delivery to the
US military still in 2008 and to its distribution partners Novartis
and CSL Limited.

Furthermore, Intercell looks forward to the forthcoming ACIP
discussion on Japanese Encephalitis vaccines scheduled for October
22, 2008. ACIP is the leading vaccine policy-making group in the
United States.

For the European Marketing Authorization Application (MAA) Intercell
expects to conclude its application submission process by responding
to the final list of outstanding issues from the EMEA (European
Medicines Agency) within the next few weeks. This plan has been
agreed upon with the European authorities and exactly follows the
roadmap towards a positive CHMP opinion expected by end of year 2008.

Intercell has received an evaluation report by the licensing
authority (TGA) in Australia and plans to conclude all supplementary
submissions in the very near future. Intercell is looking towards the
next possible advisory meeting and is expecting an approval decision
in Australia also before the end of the year.

"We view the recent regulatory feedback from the FDA as extremely
positive. It is an outstanding achievement for our company to
successfully advance parallel regulatory processes in all key markets
for travellers and military personnel", states Gerd Zettlmeissl,
Chief Executive Officer of Intercell AG. "Based on the important
progress made recently we are very confident that we will obtain
approval for our Japanese Encephalitis vaccine in the United States,
Europe and Australia during 2008. Although we have not yet received
the US approval at this point the current regulatory progress fully
supports our strategy and all of our commercial plans."

Novartis AG holds marketing and distribution rights for Intercell´s
Japanese Encephalitis vaccine, trade named IXIARO®, in the United
States, Europe and certain other markets in Asia and Latin America.

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 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