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Intercell AG

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 trial enrollment completed for single dose Pandemic ...

  ad-hoc disclosure transmitted by euro adhoc with the aim of a Europe-wide
  distribution. The issuer is solely responsible for the content of this
  announcement.
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

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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