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Research & Development
» 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
» 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
» 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.
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