EANS-Adhoc: Intercell provides update on clinical trials for the patch-based Travelers' Diarrhea vaccine

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12.12.2010

» Travelers' Diarrhea vaccine candidate failed to meet efficacy endpoints to
protect against enterotoxigenic E. coli (ETEC) (defined as cases in which
ETEC LT, LT/ST or ST toxins are detected in diarrheal stool samples) mediated
diarrheal infections in pivotal, randomized and placebo-controlled efficacy
studies (Phase II and Phase III)

» However, the studies support the continued investigation of the patch
technology as a suitable route of immunization for future potential vaccine
candidates. The pivotal studies confirm that the vaccine candidate induces
reproducible levels of protective antibodies against the LT toxin resulting
in a meaningful reduction of LT specific ETEC episodes, following
transcutaneous immunization.

» The projected year end loss for 2010 will be substantially higher than the
previously expected EUR 40m since milestone payments in connection with the
Travelers' Diarrhea program are not expected to be received, and the Company
expects to impair all or a substantial part of its respective intangible
assets.

» Intercell has taken the decision not to pursue further clinical
development of its Travelers' Diarrhea vaccine candidate

» Intercell will reduce R&D expenses by approximately 40% in 2011 compared to
2010 and will realign its organizational structures accordingly

» Management is focusing the Company's R&D strategy and resources on the other
projects in its well-balanced clinical stage portfolio, especially the
successful and highly attractive nosocomial programs including the
investigational vaccines against Pseudomonas and C. difficile as well as
S. aureus developed with Merck & Co., Inc., and Management will continue to
progress the positive trend of increasing sales of Intercell's Japanese
Encephalitis vaccine

Vienna (Austria) and Gaithersburg (USA), December 12, 2010 - Intercell AG (VSE:
ICLL) announced today preliminary clinical results on its investigational
Travelers' Diarrhea (TD) Vaccine Patch program and the decision not to pursue
further the development of this vaccine candidate. The decision was made
following the receipt of results of its randomized and placebo-controlled Phase
III study (ELT301) with 2036 travelers from Europe to Mexico and Guatemala as
well as the pilot efficacy Phase II trial (ELT209) with 723 travelers from
Europe to India.

Both trials were successfully conducted according to study design, met
statistical targets of enrollment, participation follow-up, subject and site
compliance, and produced a firm preliminary conclusion. The vaccine was
generally well tolerated and the safety profile was consistent with that
observed in earlier studies.

In an earlier randomized double blind placebo-controlled Phase II field trial
(ELT206) the TD vaccine candidate showed excellent immunogenicity and reduced
the risk of clinically significant diarrheal episodes in U.S. travelers to
Mexico and Guatemala. The Phase III trial was intended to confirm the efficacy
of the investigational TD Vaccine Patch for prevention of moderate to severe
diarrhea in a similar field setting.

The trials' primary endpoints, reduction of incidence of all types of
enterotoxigenic E. coli (ETEC) (defined as cases in which ETEC LT, LT/ST or ST
toxins are detected in diarrheal stool samples) and/or all cause diarrhea
(secondary endpoints) comparing the vaccine groups with the placebo group, were
not met. Thus, in the ELT301 study a non-significant vaccine efficacy for about
35% for all type ETEC and no apparent effect on the frequency of all-cause
moderate to severe diarrhea was observed. However, a statistically significant
reduction of duration of all-cause diarrheal episodes and total number of
unformed stools was observed, confirming observations from a previous Phase II
study.

In study ELT301, the vaccine protected most against LT positive ETEC (up to
60%). However, the study was not powered to demonstrate a statistically
significant efficacy against individual ETEC types. Furthermore the incidence of
LT positive ETEC in both trials was lower than expected, compared to previous
trials and published data.

The current trials have confirmed the previous Phase II observation of a
consistent induction of protective levels of antibodies against the LT-toxin
following transcutaneous immunization and using the Company's proprietary
delivery technology. This clearly supports and validates patch-based vaccination
as a suitable route of immunization for future potential product candidates.

Intercell is carrying out further analysis of the trial results. However,
subject to this analysis and further consultation with its partner, the Company
remains committed to expanding the development of the use of patch technology
for existing or novel vaccines as well as the development of the investigational
Vaccine Enhancement Patch (VEP) system for vaccination against Avian H5N1
Influenza.

Following the successful progression of the S. aureus vaccine candidate with
recent positive Phase II data reported by Intercell's partner Merck & Co., Inc.,
the encouraging Phase II data in the Pseudomonas vaccine program and the
imminent clinical entry of the Company's novel investigational C. difficile
vaccine, R&D resources will be even more focused on the development of the
nosocomial franchise. Hospital-acquired infections represent a major health need
and Intercell is well positioned with its portfolio to help address this medical
need.

Intangible assets pertaining to the TD vaccine program and other patch programs
represented a book value of EUR 167m at September 30, 2010. Intercell expects to
impair all or a substantial part of these assets following an impairment
analysis triggered by the study results. Such impairment will have a substantial
effect on the loss for the full year 2010. In addition, Intercell does not
expect to receive the previously expected milestone payments in connection with
the TD program in 2010 or going forward. Intercell has decided to substantially
reduce Research and Development expenses by approximately 40% in 2011 compared
to 2010 and will realign its organizational structures accordingly. The measures
are expected to be fully effective by mid 2011 and lead to further cost savings
in 2012 and forward.

"We are extremely disappointed with these unexpected Phase II and III outcomes
for our TD Vaccine Patch; however, we believe that we have a clear strategy to
further develop our strong product portfolio in a balanced way. Our Japanese
Encephalitis vaccine is on the market, and we have a world leading and highly
attractive nosocomial vaccine franchise in advanced development and a series of
promising vaccine and antibody pre-clinical candidates", states Gerd
Zettlmeissl, Chief Executive Officer of Intercell. "We have taken all necessary
managerial measures to fully realign the company's operations."

Given this unexpected situation, Intercell has decided to postpone its R&D Day
planned for Wednesday, December 15 in London and will replace it by an Analysts'
call to outline the data obtained and its strategic implications in more detail.

Further inquiry note:
Intercell AG
Corporate Communications
Tel. +43 1 20620-1222/-1116
[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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