Intercell AG : announces Q3 2011 results and provides an update on ongoing operations

• IXIARO®/JESPECT® net product sales of EUR 15.5m in the first nine months of 2011 - an increase of 65% compared to 2010
• Re-structuring measures successfully implemented - operating loss for the first nine months of 2011 reduced by 63% compared to 2010
• Development programs progressing according to plan
• Significant progress in net loss-reduction (minus 72% in Q3) and cash-conservation (EUR 68.8m liquid funds at quarter-end)

Vienna (Austria), November 8, 2011 - Today, Intercell AG (VSE: ICLL) announced its financial results for the third quarter of 2011 and provided an update on its operations.

The IXIARO®/JESPECT® sales revenues exceeded EUR 15m in the first nine months 2011 and showed a year-on-year revenue growth of 65% compared to the prior year. Hence, the product sales development is progressing towards the company´s expectations for a full year-on-year growth of 60-70% compared to 2010.
Intercell and its distribution partner, Novartis, will continue to employ its resources to increase penetration in key markets, the military sector, and expand into new territories. The approval for the Japanese Encephalitis vaccine was obtained for Hong Kong, and approval for Singapore is expected in the next few months. Furthermore, the first submission in Latin America has been filed, and other submissions are planned.

In September Intercell and its partner, Biological E. Ltd., announced the successful completion of a pediatric pivotal Phase II/III study for its vaccine to protect children from Japanese Encephalitis (JE). Analysis of the pivotal Phase III safety and immunogenicity data showed positive results, and the study met its primary endpoint. Because of a rolling submission process initiated during the course of 2010 as well as Biological E´s recent completion of submissions for licensure to the Indian authorities (DCGI), licensure is expected in the very near future. The launch preparations for the product are on track and launch is expected in H1 2012. Manufacturing of commercial launch batches at Biological E.'s facility in Hyderabad has already commenced.

The pediatric development program for IXIARO®/JESPECT® label extension for children traveling to endemic areas is progressing towards Phase III results and submission in early 2012. The pediatric approval is expected by the end of 2012 or beginning of 2013.

Following a batch-specific, voluntary recall of IXIARO® in May, Intercell is completing a comprehensive investigation and root cause analysis in order to reduce the risk for future potential recalls, regulatory actions or batch-specific measures. These activities as well as other relevant measures and clinical implications are overseen and governed by the EMA (European Medicines Agency) under a procedure in accordance with Article 20 of the Commission Regulation (EC) 726/2004. Intercell is working closely with the authorities to execute against the regulatory requirements.

In order to further improve operational and cost-effectiveness Intercell plans to fully license its Quality Control Operations at the Vienna site for assays used to test and release IXIARO®/JESPECT®. .As an important step to achieve this goal, Intercell successfully passed a pre-approval inspection by the U.S. Food and Drug Administration (FDA).

Following Intercell´s presentation of its renewal strategy the Company successfully implemented its key consolidation and cost reduction measures while maintaining focused R&D activities, key talents and capabilities.

The commercial operations at Intercell's U.S. site in Gaithersburg (MD) have been consolidated. The patch R&D activities have been successfully transferred to Vienna. Intercell is transitioning the residual R&D facility leases and selling the unused equipment, and hence, expects to deliver its objective to eliminate any remaining R&D costs from its U.S. operations as of 2012.

The Company's operating expenses have been reduced by 50.1% year-to date compared to 2010 - the majority gained through cost reduction implemented by R&D prioritization, consolidation and general rationalization.

In September Intercell received positive scientific advice from the European Medicines Agency (EMA) for an investigational Pseudomonas vaccine Phase II/III study. Intercell is preparing for the pivotal clinical efficacy trial of the Pseudomonas aeruginosa vaccine candidate in ventilated ICU (Intensive Care Unit) patients. The planned double-blind study is powered to show a clinically meaningful and statistically significant reduction in overall mortality between the vaccine and control group and expects to enroll approximately 800 subjects. Intercell obtained clearance from the EMA for the proposed key elements of the study design, i.e. size, population, and primary endpoint.

Based on the positive feedback, Intercell intends to initiate the confirmatory efficacy study in Q1/2012. First interim data are expected in mid 2013. The program is one of the development programs under the strategic alliance between Novartis and Intercell. The trial will be executed by Intercell.

Intercell received positive first data from a Phase I clinical trial with the Company's vaccine candidate, IC84, to prevent disease caused by the bacterium Clostridium difficile (C. difficile). The pathogen is one of the main causes of nosocomial diarrhea. Data showed good safety and immunogenicity of the vaccine candidate and indicates functionality of the induced antibodies.

The investigational vaccine induced antibodies which reacted with both native toxins, A and B, of C. difficile. A dose response to the vaccine candidate could be observed, and the non-adjuvanted candidates were at least as immunogenic as the adjuvanted candidates for both toxins.  Functionality of vaccine-induced antibodies could be shown in toxin-neutralizing assays. 

This Phase I trial is a first-in-man study to obtain safety and immunogenicity data. The first part of the study was conducted in a population of healthy adults up to 65 years. The second part will enroll healthy elderly subjects above 65 years of age, as this age group is considered to represent the main target population for a C. difficile vaccine.

Tuberculosis: The start of a Phase II study is expected by the end of 2011. The Phase I clinical programs are proceeding according to schedule, and promising clinical data have been obtained in multiple other Phase I studies.

Pandemic Influenza Vaccine Enhancement Patch (VEP): The enrollment for the confirmatory Phase I trial is nearing completion, and a first safety analysis has been completed. The study will involve 300 healthy adults and will investigate various combinations of antigen and patch doses in one- and two-injection regimes to confirm the mode of action and the value of "external" adjuvantation. GSK's adjuvanted and licensed H5N1 vaccine will be used to provide a positive control for the patch. Final data are expected by mid 2012.

IC31® adjuvant: The Phase I clinical trial (undisclosed indication) with Intercell's adjuvant IC31®, initiated by Novartis, is ongoing. In 2007, Novartis acquired a non-exclusive license for the use of IC31® in selected new vaccines.

Hepatitis C: Romark is still awaiting regulatory clearance for study initiation of a combination Phase II trial which is expected to start in H2 2011. In the absence of receipt of regulatory clearance in the near future, the trial will not proceed as expected. Intercell and Romark joined forces in 2010 in combining therapies against Hepatitis C for a trial fully funded by Romark.

In September Intercell announced that it is part of the collaborative research program - Advanced Immunization Technologies (ADITEC). The program started in order to accelerate the development of novel and powerful immunization technologies for the next generation of human vaccines.  ADITEC is co-funded with EUR 30m by the European Commission to establish a robust platform for innovation in this key strategic area with a high socio-economic impact. Scientists from 42 research partners in 13 countries will collaborate in this new program.

Please click on the link to download the full report: