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EANS-Adhoc: Intercell AG Announces Q3 2009 Results and Updates on R&D Progress and Management:

Geschrieben am 09-11-2009


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ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide
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announcement.
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9-month report

09.11.2009

» Progress on Japanese Encephalitis vaccine (IXIARO®/JESPECT®)
business and global reach - approval in Canada obtained - Phase III
study start in India for JE-vaccine for endemic countries imminent
» Start of the Phase III study for Travelers' Diarrhea Vaccine Patch
in October » Phase II data for single-dose Pandemic Influenza
vaccine with Vaccine Enhancement Patch expected before end 2009 »
First interim data from Phase II for Pseudomonas vaccine expected
before end of 2009 » Net loss for the first nine months increased
to EUR 25.9m - Revenues increased by 16.6% in the same period -
Lower than anticipated sales increase for IXIARO® with Q3 sales
revenues of EUR 2.7m » Strong Q4 revenues anticipated from expected
partnering of future commercialization of Travelers' Diarrhea
Vaccine and of certain aspects of Patch Technology » Lower than
anticipated IXIARO® sales revenues and significant investments in
strongly progressing late-stage development programs likely to result
in full year net loss » Management Board appointed for the next three
years; Alexander von Gabain to transition from Management Board
(Chief Scientific Officer) into a new strategic role within the
Company

Vienna (Austria), November 9, 2009 - Today, Intercell AG (VSE: ICLL)
announced its financial results for the third quarter of 2009 and
presented an update on the Company's key R&D programs as well as
changes to the Management Board.

Japanese Encephalitis vaccine: Progress on IXIARO®/JESPECT® business
and global reach

The market preparation and launch activities in the 30 countries
where IXIARO®/JESPECT® is approved have been slower than anticipated,
with more than 50% of the countries still awaiting product launch.
Significant efforts are needed to create national recommendations for
JE-vaccination, to build awareness and hence optimize product uptake
in the markets. Some countries have successfully reached vaccination
rates that are already now in reach of the anticipated business
opportunity and hence we are optimistic that others can achieve
similarly over time. First deliveries of IXIARO® to the U.S. military
were concluded in September under the exclusive Supply Agreement
signed earlier this year. As sole supplier for the U.S. military,
Intercell is working closely with the Army's health representatives
on recommendations towards an increased use of the novel,
cell-culture vaccine to prevent Japanese Encephalitis (JE). Recently
Intercell reported that Health Canada granted product approval for
IXIARO®. This decision of the Canadian authorities represents another
important milestone for the product's global reach. Intercell's
vaccine has already been successfully approved and launched in the
USA, Europe, and Australia. The vaccine will be available for the
Canadian market by the end of the year and will be distributed and
marketed to travelers by Novartis Pharmaceuticals Canada Inc. and to
the military personnel by Intercell.

Additionally Intercell has initiated regulatory licensure processes
in other, small territories where there is an attractive market
segment for a product already approved in highly regulated
environments. Intercell AG and its partner Biological E. Ltd. are
expecting an imminent start of a pivotal Phase III study for the
investigational vaccine to protect children and adults from JE. The
investigational vaccine is manufactured in India by Biological E. and
is based on Intercell's technology, which was successfully used to
gain product licensure of the adult vaccine in Europe, the United
States, and Canada (IXIARO®) as well as in Australia (JESPECT®). The
randomized and controlled study will be the key pivotal Phase III
trial in an endemic region towards licensure of the JE vaccine. The
planned Phase III trial will investigate safety and immunogenicity
compared to JenceVacTM, the locally licensed, Korean-made,
inactivated, mouse brain-derived JE vaccine. The approval of the
vaccine in India is expected by the end of 2010 with WHO
pre-qualification planned to follow in 2011.

Strong performance on late-stage patch-based vaccine pipeline

In October, Intercell's investigational Travelers' Diarrhea (TD)
Vaccine Patch entered clinical Phase III development. This pivotal
efficacy field study started with the first subjects vaccinated in
the United Kingdom. The randomized and placebo-controlled study with
1,800 travelers from Europe to Mexico and Guatemala will evaluate the
efficacy of the TD Vaccine Patch to actively immunize against
moderate to severe enterotoxigenic E. coli (ETEC) disease in a field
setting. The investigational TD vaccine system consists of a
self-adhesive patch containing the vaccine antigen, the heat-labile
toxin (LT) from E. coli, and a single-use device used to prepare the
skin at the site of patch administration, the Skin Preparation System
(SPS). Intercell combines the classical toxin approach to vaccination
with its innovative patch-based, needle-free delivery system. The SPS
partially disrupts the stratum corneum of the skin. The dry patch
contains the antigen in a stabilizing excipient formulation and
delivers the antigen through the skin.

Phase II data for an investigational Vaccine Enhancement Patch to
potentially enable single application for Pandemic Influenza
prevention is expected before the end of 2009.

The clinical trial is investigating Intercell's Vaccine Enhancement
(VE) Patch in combination with an injectable H5N1 Pandemic Influenza
vaccine (manufactured by Solvay Biologicals, B.V., The Netherlands)
and enrolled 500 subjects in the USA with serological analysis under
way. The study, as part of Intercell`s overall PanFlu program, is
fully funded by the U.S. Department of Health and Human Services
(HHS). In 2008, Intercell announced the results of a Phase I clinical
trial in a similar setting with the VE Patch combined with an
injectable H5N1 Influenza vaccine. The data revealed that a single
45-microgram dose of the H5N1 Influenza vaccine, when administered
with the Intercell VE Patch containing 50-microgram LT adjuvant, was
sufficient to provide an immune response seen to be protective in 73%
of the vaccinees. This was the first time that a single dose of H5N1
Pandemic Influenza vaccine met the level of protection suggested in
the U.S. Food and Drug Administration guidance. The U.S. Food and
Drug Administration considers a pandemic vaccine to be protective if
it achieves immune response levels in at least 70% of the vaccine
recipients.

Excellent progress for all other clinical programs

Staphylococcus aureus vaccine (V710) clinical program: First critical
interim analysis (surpassing futility) from the ongoing Phase II/III
trial in cardiothoracic surgery patients is expected in 2010. The
Phase II/III trial is designed to evaluate investigational vaccine
efficacy/safety in patients undergoing cardiothoracic surgery. To
date, the trial has experienced slower than anticipated enrollment
and accrual of individuals with S. aureus infections. The
double-blind, randomized, placebo-controlled trial utilizes an
adaptive (group-sequential) design incorporating several interim
analyses to evaluate accrued data and allow for objective assessment
of study progress. The study involves more than 90 centers in 18
countries, including the USA, Europe, South America, and Japan.
Collaborator Merck & Co., Inc. is responsible for clinical
development, manufacturing, and marketing.

Pseudomonas aeruginosa vaccine: First interim data on the Phase II
study are expected by the end of 2009. Intercell's investigational
prophylactic Pseudomonas aeruginosa vaccine aims to protect Intensive
Care Unit (ICU) patients against Ventilator-Associated Pneumonia
(VAP) and Bacteremia. For the current Phase II clinical trial, about
400 patients are enrolled in more than 50 ICUs in 11 countries in
Europe and Latin America.

Streptococcus pneumoniae vaccine: Initial results of the clinical
Phase I trial with the Company's protein-based vaccine are expected
at the beginning of 2010. The program is financially supported by
PATH.

Therapeutic Hepatitis C vaccine: the strategic partnering process is
progressing well and it is expected that a partnership will be closed
in the first half of 2010. The strategic aim is to combine
Intercell´s vaccine approach, which in a previous Phase II trial
showed a significant virus decline in chronic Hepatitis C patients,
with a small molecule treatment scheme of the potential partner.

Tuberculosis vaccine: Phase I/II clinical programs are proceeding
according to plan. These programs are based on a partnership between
Intercell, Statens Serum Institut, Sanofi Pasteur, and the AERAS
Global Tuberculosis Foundation. Further clinical data is expected for
2010.

Management Board

Intercell's Supervisory Board confirmed the existing Management Board
members Gerd Zettlmeissl as Chief Executive Officer and Thomas
Lingelbach as Chief Operating Officer for the next three years.

Reinhard Kandera, Chief Financial Officer since March 2009, has been
appointed for a term of three years as a new member of Intercell's
Management Board. Kandera, who joined Intercell in 2001, has served
the Company in different areas of responsibility - most recently as
Global Head of Investor Relations and Chief Financial Officer of
Intercell USA, Inc. He played a pivotal role in the Company's
multiple financing events, including the IPO in 2005, and contributed
significantly to the successful integration of Intercell's
subsidiaries in Scotland and the USA. Before joining Intercell,
Reinhard Kandera held various positions at the Deutsche Bank.

Alexander von Gabain, Intercell's Chief Scientific Officer,
co-founder and former Chief Executive Officer, has decided to
transition from his current Management Board role into a less
operational one. He commits himself for a three-year period and will
support the Company as Strategic Advisor to both the Management Board
and the Supervisory Board. In this role, he will continue to be fully
employed by Intercell. Alexander von Gabain will be strongly involved
in key research and development topics and will substantially
contribute to the Company by leveraging his excellent network in the
arena of academia, biotech and the pharmaceutical industry.

Eszter Nagy, Ph.D., M.D, who has been with Intercell since 1999, will
continue to be in charge of Intercell's pre-clinical research
activities and to lead Intercell's Research function as Senior Vice
President & Head Pre-clinical Research.

Corporate / Other

In September, Intercell was awarded the prestigious Triple-A Award
for outstanding annual reports and was named "Newcomer of the Year"
by the Austrian business magazine "Trend".

Key Financial Figures


EUR in thousands 3 months ended 9 months ended Year ended
Sept 30, Sept 30, Sept 30, Sept 30, Dec 31,
2009 2008 2009 2008 2008

Revenues 9,159 7,641 29,480 25,283 55,763

Net profit/(loss) (14,671) (5,140) (25,925) (13,789) 17,175

Net operating
cash flow (14,753) 24,956 (43,322) (430) (10,186)

Cash and available-


for-sale financial
assets, end of
period 139,746 208,952 139,746 208,952 190,865

The report can be downloaded at http://www.intercell.com/main/forinve
stors/downloads/quarterly-reports/


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 Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market


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