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EANS-Adhoc: Intercell AG announces Q2 and H1 2009 results and business update: » Realizing IXIARO®'s commercial potential through global launch activities and market expansion » Phase II tri

Geschrieben am 17-08-2009


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announcement.
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6-month report

17.08.2009

Vienna (Austria) August 17, 2009 - Today, Intercell AG (VSE: ICLL)
announced its financial results for Q2 and H1 2009.

Increasing IXIARO's commercial potential through global territory
expansion

IXIARO is now launched in Europe, USA, and Australia. The vaccine
offers protection against Japanese Encephalitis for adults who travel
to, or reside in, endemic areas. At the end of June, the U.S. Centers
for Disease Control and Prevention (CDC) Advisory Committee on
Immunization Practices (ACIP) updated and strengthened its previous
recommendations regarding Japanese Encephalitis Vaccination.
Vaccination is now recommended for travelers to Asian countries where
the disease is endemic, as well as for U.S. citizens living in such
high-risk areas.

An exclusive, multi-year contract has been executed between Intercell
and the U.S. Department of Defense (DoD) for the purchase of IXIARO.
Intercell will directly distribute and market IXIARO to the U.S.
military. First product deliveries into the military supply chain are
on track. Approvals in other markets (i.e. Canada, Switzerland) and
Phase IV/post marketing studies are expected to commence soon. Phase
III pediatric clinical studies in the USA, Europe, and Asia are
expected to be initiated in H2 2009. The first pediatric licensure is
expected in India at end of 2010, and the IXIARO pediatric label
extension for travelers older than six months of age is expected in
2012.

Completed enrollment in a Phase II trial for an investigational
Vaccine Enhancement Patch to enable a single dose of Pandemic
Influenza vaccine, together with the U.S. Department of Health and
Human Services (HHS)

Phase II randomized and blinded clinical trial investigating the
effectiveness of Intercell's Vaccine Enhancement (VE) Patch in
combination with an injectable H5N1 Pandemic Influenza vaccine in
approximately 500 subjects has completed enrollment. The study is
being conducted at six study sites in the U.S. The study is
completely funded by the U.S. Department of Health and Human Services
(HHS) and represents the second clinical study conducted under a
5-year USD 128m contract with the HHS. Intercell's VE Patch is
designed to reduce the vaccine dosage and to improve protection
against an H5N1 Pandemic Influenza outbreak with a single dose
vaccine application resulting in a significant advantage in future
Pandemic Influenza vaccination strategies.

Start of first Phase III clinical study for Travelers' Diarrhea
Vaccine Patch is now planned for beginning of Q4 2009 - Development
of the global H1N1 Flu situation still being monitored, but expected
to allow study start in Mexico and Guatemala

The start of the first pivotal Phase III clinical study for the
Traveler's Diarrhea Vaccine Patch is planned for the beginning of Q4
2009. Due to the H1N1 Pandemic Influenza outbreak earlier this year,
Intercell postponed its planned Phase III trial in Mexico and
Guatemala. In close alignment with the relevant regulatory bodies,
Intercell has started preparatory activities for the trial start,
still subject to close monitoring of the further development of the
H1N1 Flu situation. The planned randomized, placebo-controlled Phase
III study will include approximately 1,800 people traveling from
Europe to Mexico and Guatemala, and will evaluate the prevention of
Diarrhea in a pivotal efficacy setting. In parallel, additional Phase
II trials with subjects from the USA and Europe will be conducted in
the USA and Asia to strengthen the development towards global
licensure with the broadest indication and label claim possible.
Earlier Phase II clinical trials showed that travelers who were
vaccinated were significantly less likely to suffer from clinically
significant Diarrhea.

Update for investigational S. aureus vaccine (V710) clinical program

Collaborator Merck & Co., Inc. informed Intercell that study
recruitment in the Phase II/III proof of concept clinical trial of
the investigational S. aureus vaccine is progressing. However, the
first critical interim analysis (surpassing futility) will be delayed
beyond 2009 due to slower than anticipated enrollment and accrual of
S. aureus infections to date. The Phase II/III clinical study is
designed to evaluate investigational vaccine efficacy/safety in
patients undergoing cardiothoracic surgery. 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.

Update for investigational Pseudomonas aeruginosa vaccine

Phase II study to prevent infections with the bacterium Pseudomonas
aeruginosa, which was started at the end of 2008, is progressing on
schedule. The study is conducted at 48 study sites in nine countries
(Europe and South America). The first target indication is active
immunization against Pseudomonas aeruginosa in Intensive Care Unit
(ICU) patients to prevent Ventilator-Associated Pneumonia (VAP) and
Bacteremia. First data expected by the end of 2009.

Pipeline vaccines - development according to plan

Streptococcus pneumoniae vaccine: In April, Intercell announced the
start of a clinical Phase I trial with the Company's protein-based
vaccine. Initial results are expected by the end of 2009. The program
is financially supported by PATH.

Therapeutic Hepatitis C vaccine - the strategic partnering process is
ongoing.

Tuberculosis vaccine - Phase I/II clinical programs are proceeding
according to plan. These programs are based on a partnership among
Intercell, Statens Serum Institut, Sanofi Pasteur, and the AERAS
Global Tuberculosis Foundation.

Other/Management Board

In June, Intercell was awarded the prestigious European Mediscience
Award granted by Piper Jaffray, and was named "Company of the Year"
by the British Bio Industry Association in London. In July, the City
of Vienna awarded Alexander von Gabain, Chief Scientific Officer of
Intercell, the City's Prize for Natural and Technical Sciences 2009
honoring his achievements in science and translational research. In
August 2009, Intercell's ADRs began trading on the OTCQX
international market in the United States under the symbol INRLY.
Investors can find current financial disclosure and real-time Level 2
quotes for the Company on www.otcqx.com and www.pinksheets.com.

Financial Statement

First product sales in Europe and the USA - totaling EUR 2.9m in H1
2009. Intercell's aggregate revenues for the first half year
increased to EUR 20.3m, an increase of 15.2% as compared to the same
period in 2008. Strong cash position with EUR 154.4m.

Key Financial Figures


in EUR thousands 3 months 6 months Year
ended ended ended
June 30, June 30, Dec 31,
2009 2008 2009 2008 2008

Revenues 14,897 9,018 20,321 17,642 55,763

Net profit/(loss) (3,078) (4,032) (11,254) (8,650) 17,175

Net operating
cash flow (14,364) (12,578) (28,570) (25,386) (10,186)


Cash and marketable
securities,
end of period 154,390 258,287 154,390 258,287 190,865


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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