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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 trial enrollment completed for single dose Pandemic ...
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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.
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.
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
cash flow (14,364) (12,578) (28,570) (25,386) (10,186)
Cash and marketable
end of period 154,390 258,287 154,390 258,287 190,865
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ots Originaltext: Intercell AG
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