Intercell AG Announces Q3 2010 Results and Updates on R&D Progress and Management

VIENNA, Nov. 9, 2010 /PRNewswire-FirstCall/ -- Today, Intercell AG (VSE: ICLL) announced its financial results for the third quarter of 2010 and presented an update on the Company's key R&D programs as well as changes to the Management Board.

Financial Results

• IXIARO and JESPECT sales revenues continue showing significant year-on-year growth – sales revenues totaled EUR 9.4m in the 9 months ended September 30, 2010, compared to EUR 5.6m in the same period of the previous year.
• Intercell's aggregate revenues decreased by 28.4% from EUR 29.5m in the 9 months ended September 30, 2009 to EUR 21.1m in the same period of 2010.
• Net loss for the first nine months of 2010 increased to EUR 50.9m mainly driven by increased R&D expenses for late stage development programs and non-cash currency effects.
• Solid cash position with EUR 107.1m.
• Outlook full year 2010: Net loss for the full year 2010 expected to reach approximately EUR 40.0m, at the high end of previously communicated range, and this assumes positive outcome of upcoming milestone events.

IXIARO®/JESPECT®

Intercell reports that the positive trend of increasing sales of IXIARO/JESPECT seen in Q2 2010 continued in Q3. Intercell's product is the only vaccine against Japanese Encephalitis licensed in Europe. It is manufactured for, and supplied into, the U.S., EU and Canada and the only vaccine being produced for the U.S. military. U.S. military sales in 2010 depend on further use of residual product stock of JE-Vax®. A significant increase in sales is possible for 2011, when leftover inventory of JE-Vax is expected to be exhausted or abandoned.

The Department of Health, Government of the Hong Kong Special Administrative Regions has approved Intercell's vaccine to prevent Japanese Encephalitis. The licensure process has been initiated for additional territories, and further recommendations are expected also for other key countries in Europe. These recommendations are essential to continue advancing product awareness and market growth.

The pediatric Phase III studies for IXIARO/JESPECT for use in children travelling to endemic areas are progressing according to plan, with data expected in 2012. These studies are the basis for a label extension to make the existing vaccine available for travelling children.

Based on Intercell's technology a novel JE vaccine candidate is also being developed for the endemic markets, where the WHO recommends that Japanese Encephalitis vaccination be integrated into national immunization programs. Clinical development in endemic areas is progressing, with a pivotal Phase III trial in children scheduled to start by the end of 2010 / early 2011 sponsored and managed by Intercell's partner, Biological E., in India.

Leading R&D portfolio in hospital infections

A Phase II clinical trial involving IC43, the vaccine candidate against infections with the bacterium Pseudomonas aeruginosa, met primary immunogenicity and safety endpoints; a statistically significant reduction in mortality compared to placebo was observed for the non-adjuvanted vaccine group. If confirmed by pivotal clinical trials, this could make IC43 an important vaccine for ICU patients who are subject to a particularly high mortality risk associated with hospital-acquired infections. The vaccine generated a good immune response and was well tolerated. Vaccine-related serious side-effects which would raise any safety concern were not observed. The results provide a strong basis for evaluation of further development options. Intercell and its partner Novartis will determine next steps.

Clostridium difficile program planned to enter clinic: After successful pre-clinical trials, Intercell is progressing its vaccine candidate to prevent infections with Clostridium difficile (C. diff). C. diff is the leading cause for nosocomial Diarrhea in Europe and the U.S. A Phase I clinical study is expected to start in 2010.

Staphylococcus aureus vaccine (V710) on track: The Phase II/III study conducted and funded by Merck & Co., Inc. in cardiothoracic surgery patients for the investigational S. aureus vaccine is progressing to plan. The first critical interim analysis (surpassing futility) is expected in 2011.

Good progress in development pipeline – programs progressing according to plan

• Recruitment for the pivotal Phase III study of approximately 2,000 travelers for Intercell's investigational Travelers' Diarrhea (TD) Vaccine Patch is completed. The first data from that trial, conducted in travelers to Mexico and Guatemala, is expected for end 2010/early 2011. The enrollment of a complementary 800-traveler Phase II study in those travelling to India has also been completed; first data is expected in Q4 2010. The trial in India is the first study outside South America and has the potential to demonstrate proof of concept for the vaccine in Asia.
• Intercell will pursue activities with GSK to prepare markets as soon as data on Phase II and Phase III trials becomes available. Diarrhea is the most common health problem among travelers from developed countries who visit developing areas and most of the diarrheal cases in travelers are caused by bacteria, primarily by ETEC strains (Escherichia coli).
• Intercell and GSK will continue development of the investigational Vaccine Enhancement Patch (VEP) system for Avian H5N1 Influenza vaccination as part of a collaborative agreement signed in December 2009. The initiation of a respective clinical trial is expected for end 2010/early 2011.
• Intercell and Romark joined forces in combining therapies against Hepatitis C. The companies are designing a treatment that combines Intercell's investigational Hepatitis C vaccine, IC41, with Romark's antiviral drug, nitazoxanide - a combination Phase II trial is expected to start in H1 2011.

Management

Effective October 1, 2010, Staph Leavenworth Bakali joined Intercell's Management Board as Chief Business Officer, with key responsibilities for the commercial aspects of the Company, directly leading Marketing & Sales, Corporate & Business Development, and Alliance Management.

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

This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE Intercell AG