Intercell AG

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Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States - Approvals in United States, Europe and Australia remain on track for 2008

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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.

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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.ch

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



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