EANS-Adhoc: Intercell announces next steps of development for Pseudomonas vaccine

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01.04.2011

Vienna (Austria), April 1, 2011 - Today Intercell AG (VSE: ICLL) announced that
it has agreed with Novartis to advance Intercell's investigational Pseudomonas
aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated ICU
(Intensive Care Unit) patients. The planned double blind study is powered to
show a clinically meaningful and statistically significant reduction in overall
mortality between the vaccine and control group and envisages enrolling about
800 subjects. The study is subject to final regulatory concurrence and its start
is planned for first half of 2012. Intercell will execute the trial and the
costs will be shared with Novartis.

Intercell's Pseudomonas aeruginosa vaccine program is one of the development
programs under the strategic alliance between Intercell and Novartis. Next
steps for the program will be decided based upon data from the planned efficacy
trial, taking into consideration the Novartis option rights and the Intercell
right to choose either profit-sharing or to receive milestones and royalties.
"Pseudomonas infections are a major cause of mortality in artificially
ventilated ICU patients. Our Phase II data showed a statistically significant
improved survival of patients vaccinated and we are happy that we will together
with Novartis move the program forward. This further strongly underlines our
leading position to develop vaccines against hospital acquired infections, one
of the major medical problems in global societies", states Gerd Zettlmeissl,
Chief Executive Officer of Intercell.

The trial is expected to be conducted in various countries, predominantly in the
EU, involving up to 50 study sites. Two study groups, both receiving standard of
care in addition to vaccine or placebo, will be compared. The subjects in the
vaccine group which will comprise about 400 ventilated ICU patients will be
vaccinated twice within a 7-day interval with the non-adjuvanted product
formulation that was found to most impact observed survival. Primary endpoint of
the trial will be mortality at day 28 after first vaccination in both study
groups. Secondary objectives are to investigate Pseudomonas aeruginosa
infections, infection-related mortality as well as immune response to the
vaccine candidate and its safety and tolerability.

Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
[email protected]
end of announcement euro adhoc
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issuer:      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: Wien
language: English

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