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 |   
 
  --------------------------------------------------------------------------------   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 --------------------------------------------------------------------------------
 
  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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