Vienna (Austria), February 01, 2012 – Intercell AG (VSE; “ICLL”) today announced the successful completion of a pivotal Phase III trial in 1869 children conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia. Analysis of both studies showed that the vaccine was well tolerated and immunogenic in children aged 2 months to <18 years. Based on these data, Intercell will submit applications for the approval of an IXIARO®/JESPECT® pediatric label extension to major regulatory agencies in Q2 2012.

The pivotal study in the Philippines was designed as a safety, immunogenicity and dose confirmation trial. The multi-center, randomized and active-controlled study enrolled 1,869 children aged 2 months to <18 years. 1,411 children received IXIARO®/JESPECT® at doses of either 0.25 ml / 3µg (half of an adult dose, ages below 3 years) or 0.5ml / 6µg (full adult dose, ages 12 years and older). For ages 3 to <12 years the full adult dose was found appropriate in a dose-confirmation component of the trial. In the control group, 64 children received Prevnar® and 394 children received Havrix®. In this pivotal study, the safety profile with overall adverse event rate up to Day 56 of 84.0% (<1 year) and 62.0% (≥1 year) was comparable to the control vaccines Prevnar® (87.5%, <1 year) and Havrix® (59.6%, ≥1 year).
The second study is an ongoing multi-center, open label, single arm trial in which 100 children from US, EU and Australia who are travelling to JEV-endemic areas are planned to receive IXIARO®/JESPECT®. The overall adverse event rate up to Day 56 in the interim analysis was 66.7%.

In both studies, more than 99% of children who received the appropriate dose of IXIARO®/JESPECT® achieved neutralizing antibody titers above the WHO-recognized protective titer. 

"We are very pleased about the positive pivotal data in support of our label extension to protect also traveling children against Japanese Encephalitis - a key element of the further growth for Intercell’s first commercial product", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.

Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.

The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at our cGMP facility in Livingston, Scotland. The pediatric approval is expected by the end of 2012 or beginning of 2013.

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• Intercell announces positive results from two clinical Phase III studies supporting pediatric label extension of JE vaccine for children traveling to endemic areas (.pdf, 150kB)

Vienna (Austria) / Copenhagen (Denmark), January 11, 2012 – Intercell AG (VSE; "ICLL") and Statens Serum Institut (SSI) today announced the start of the first Phase II study within their collaboration to develop vaccines against Tuberculosis (TB). The randomised, double-blind, clinical trial evaluating the immunogenicity and safety of two doses of an adjuvanted TB subunit vaccine candidate, H1IC (a combination of SSI’s Ag85B-ESAT-6 + Intercell’s IC31®), in HIV-positive individuals, will be conducted in South Africa and Tanzania. The study is funded by EDCTP (European and Developing Countries Clinical Trials Partnership) and conducted in collaboration with Aurum Institute, Ifakara Health Institute, Swiss Tropical and Public Health Institute, London School of Hygiene and Tropical Medicine and the South African TB Vaccine Initiative.

First results are expected in 2013. A second Phase II clinical study is being planned to assess the safety and immunogenicity of the vaccine candidate in healthy adolescents.

Previous Phase I clinical trials in Europe and Africa have demonstrated that SSI and Intercell’s collaborative novel investigational TB vaccine is safe and very immunogenic in different populations. The new H1IC vaccine candidate from SSI is a recombinant subunit vaccine based on two important TB antigens resulting from SSI’s research pipeline combined with Intercell’s proprietary adjuvant IC31® and ultimately targeted against adults and adolescents.

“We are very proud that the clinical evaluation of the H1IC vaccine is progressing so well and that this vaccine is playing a key role in the development of a much-needed novel efficient TB vaccine”, say’s Peter Lawætz Andersen, Vice President Vaccine R&D, SSI.

“The start of this Phase II clinical trial is not only a further validation of Intercell’s proprietary IC31® adjuvant technology, it is foremost an notable step towards addressing an important medical need with a novel vaccine against TB”, says Thomas Lingelbach, CEO of Intercell AG.
 
The collaboration between SSI and Intercell in the field of Tuberculosis currently includes three clinical vaccine candidates, all formulated with Intercell’s IC31® adjuvant: H1IC, now entering Phase II, H4IC, currently in Phase I (partnered with Sanofi and AERAS, “AERAS 404”), and H56IC, currently in a Bill and Melinda Gates Foundation-funded Phase I in partnership with AERAS and the South African Tuberculosis Vaccine Initiative.

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• Intercell and Statens Serum Institut (SSI) progress vaccine clinical development to fight Tuberculosis (.pdf, 150kB)

The new chairman Thomas Szucs has served as a member of Intercell’s Supervisory Board since June 2011. He gained extensive experience in the pharmaceutical and healthcare sector through several previous positions in acknowledged organizations and companies. In his new role he will work with the other Supervisory Board members to support the company in its business and scientific strategic planning.

“The election to chairman is a great honor for me. I am looking forward to working on the future success of the company, together with my fellow Supervisory Board colleagues and the Management of Intercell. I want to thank Michel Gréco for his great achievements in building this exciting company”, stated Thomas Szucs.

The Supervisory Board of Intercell now includes the following members: Thomas Szucs (Chairman), Ernst-Günter Afting (Vice-chairman), Michel Gréco, Alexander von Gabain, James Sulat and Hans Wigzell.

The Board of Directors would like to take this opportunity to thank Michel Gréco, who chaired Intercell’s Supervisory Board for more than five years, for his dedication and commitment to the company.

"It has been a privilege to work with my fellow Supervisory Board members and with an outstanding group of professionals in the Management Board. I trust that Thomas Szucs will lead the company into a new era of success”, says Michel Gréco.

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• Thomas Szucs elected new chairman of Intercell’s Supervisory Board (.pdf, 154kB)

Vienna (Austria)/Hyderabad (India), November 10, 2011 – Intercell AG and its partner Biological E. Ltd. today announced the approval of their vaccine to protect children and adults from Japanese Encephalitis (JE) by the Drugs Controller General of India (DCGI).

As previously announced, the analysis of the pivotal Phase III safety and immunogenicity data showed positive results and the study met its primary endpoint. Through a rolling submission process initiated in 2010 and an external “Expert Committee” review in October 2011 as well as recognized disease burden in endemic regions in India, the Indian authorities were able to facilitate the review and grant approval. The launch of the product, which will be known as JEEV®, is on track and expected for H1 2012, following the manufacturing and release of commercial launch batches at Biological E.’s facility in Hyderabad.

“The approval by the Indian authorities represents an important milestone in our strategy to roll out our Japanese Encephalitis vaccine in endemic countries with high medical need and to protect children and adults against this terrible disease. Without a local strategic partner like Biological E. however, this success wouldn’t have been possible”, states Thomas Lingelbach, Chief Executive Officer of Intercell AG.

The vaccine is manufactured in India by Biological E. and is based on Intercell's technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, Canada, Hong Kong (IXIARO®) and Australia (JESPECT®).

Dr. Vijay Kumar Datla, Chairman & Managing Director of Biological E. said, “This is a significant milestone and has tremendous relevance for India. We are pleased that we are able to now manufacture this important vaccine, (JEEV®) locally and will begin discussion with key stakeholders to see how this vaccine can play in role in supporting India’s on-going fight against the dreadful disease.”

In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell's Japanese Encephalitis vaccine. The vaccine's further regulatory approval route for other Asian territories is expected through the World Health Organization – Novartis will be responsible for the marketing and distribution in these regions. Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the Company.

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• Intercell and Biological E. Ltd. announce approval for Japanese Encephalitis vaccine in India (.pdf, 159kB)

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.

IXIARO®/JESPECT® – strong progress in line with full-year 2011 growth guidance

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).

Re-structuring measures successfully implemented

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.

Update on development programs – good progress

Pseudomonas aeruginosa infections – high unmet medical need

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.

Clostridium difficile vaccine candidate – leading cause of nosocomial diarrhea

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.

Additional candidate vaccines with high medical need progressing in development

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.

Corporate/Other

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.

Key Financial Figures

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• Intercell AG announces Q3 2011 results and provides an update on ongoing operations (.pdf, 396kB)

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Vienna (Austria), October 24, 2011 – Intercell AG (VSE: ICLL) today announced 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.
Intercell's vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from C. difficile. The toxins are known to be disease-causing and anti-toxin immunity can be protective.

This Phase I trial is a first-in-man study to obtain safety and immunogenicity data. The first part of the study is in a population of healthy adults up to 65 years. The second part is in  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.

The first part of the study has enrolled 60 healthy adults (18-65 years). Three different alum-adjuvanted vaccine candidate concentrations were tested in a 3 times–vaccination schedule; two of the three vaccine concentrations were additionally tested without adjuvant.
An independent Data Safety Monitoring Board (DSMB) reviewed safety as primary objective of the study and did not identify any safety concern in any of the IC84 treatment arms.

IC84 induced antibodies reacted with both native toxins A and B of C. difficile. A dose response to the vaccine candidate could be observed; the non-adjuvanted candidates were at least as immunogenic as the adjuvanted for both toxins, respectively. 

Functionality of IC84-induced antibodies could be shown in toxin-neutralizing assays. 

Based on the data form the first part of the study, the two higher doses will be carried forward to the second part of the study for dose-confirmation in elderly. Also, the necessity of the adjuvant will need to be confirmed in the elderly, who might respond differently to vaccination than the younger subjects due to immunosenescence.  Modification of the vaccination schedule will be implemented to potentially further optimize the immune response in elderly.

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• Intercell announces first data from its Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections (.pdf, 173kB)

The trial follows a Phase II study in which a lower mortality rate was observed in the vaccine groups as compared to the control group. Based on the positive feedback Intercell intends to initiate the confirmatory efficacy study in Q1/2012. First interim data are expected mid 2013. The program is part of the Strategic Alliance between Novartis and Intercell – the trial will be executed by Intercell and cost will be shared between both parties.

The planned double blind study is powered to show a clinically meaningful reduction in overall mortality with statistical significance between the vaccine and control group and target enrollement is about 800 patients. The trial is expected to be conducted in various countries in the EU, involving up to 50 study sites. Two study groups, both receiving standard of care in addition to vaccine or placebo, will be compared. Subjects in the vaccine group which will comprise about 400 ventilated ICU patients will be vaccinated twice within a 7-day interval with the non-adjuvanted product formulation that was found to most impact observed survival in the previous Phase II clinical study. Primary endpoint of the trial will be mortality at day 28 after first vaccination in both study groups. Secondary objectives are to investigate Pseudomonas aeruginosa infections, infection-related mortality as well as immune responses to the vaccine candidate and its safety and tolerability.

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• Intercell receives positive scientific advice from EMA for Pseudomonas vaccine Phase II/III-study (.pdf, 323kB)

“We are at a unique point in vaccine history,” says Rino Rappuoli, coordinator of ADITEC and president of the Sclavo Vaccines Association (SVA) which is based in Siena /Italy . “Progress in science and technology makes it possible to achieve what was previously deemed impossible. New technologies are opening the door to fight those diseases for which new vaccines could not be developed so far. However, a single laboratory cannot tackle modern vaccine science in isolation. Therefore we have set up this project consortium with scientists from 42 research bodies to collaboratively produce the knowledge necessary for the development of novel and powerful immunization technologies for the next generation of human vaccines.”

ADITEC comprises a team of competitive European universities and research institutions next to top US groups on systems biology and adjuvants. The project is reinforced by a number of key European industries, both big pharmaceutical and smaller biotechnology companies -these corporations are focusing on specific innovative technologies that now allow making better and safer vaccines-. In addition, the World Health Organization is supporting the project as a senior partner, ensuring that cross-cutting global health aspects are duly considered.

From basic research to public health

This research program covers a wide range of crucial aspects of vaccination; from basic research or new technologies to clinical trials and public health. The high impact project will therefore lead to: improved potency and safety of vaccines and their components, novel routes and devices of administration, optimized vaccination strategies, optimized formulations and vaccination methods for different age groups, better insight in the effects of gender, chronic diseases and genetic variation on vaccination and widespread knowledge about the available new technologies.

Details of ADITEC project

Start date: 01/10/2011
End date: 30/09/2016
Project cost: €41 million
EU contribution: €30 million
Coordinator: Rino Rappuoli & Donata Medaglini, Sclavo Vaccines Association (SVA), Siena (Italy), email: info@associazionesclavo.org, Tel: + 39-0577-233307

Participants

Sclavo Vaccines Association, Italy
Statens Serum Institut, Denmark
St George University of London, United Kingdom
Max Planck Institute for Infection Biology, Germany
University of Siena, Italy
Institute Pasteur, France
University of Oxford, United Kingdom
University of Geneva, Switzerland
Novartis Vaccines and Diagnostics s.r.l., Italy
Intercell AG, Austria
University of Goteborg, Sweden
Leiden University and Medical Centre, The Netherlands
Emory University Atlanta, USA
Tuberculosis Vaccine Initiative, The Netherlands
Institute for Biomedical Aging Research, Austria
Infectious Disease Research Institute Seattle, USA
Utrecht University, The Netherlands
Fondazione Humanitas per la Ricerca, Italy
Fondazione per l’Istituto di Ricerca in Biomedicina, Switzerland
Istituto Superiore di Sanità, Italy
Kings College London, United Kingdom
World Health Organization, Switzerland
French Atomic Energy, France
Institut de Biologie et Chimie des Protéines, France
Erasmus Medical Center, The Netherlands
ALTA s.r.l.u, Italy
Medicine in need, France
deCODE Genetics, Iceland
Okairos, Italy
Sigmoid Pharma, Ireland
Vaccibody, Norway
Pevion Biotech, Switzerland
Duotol AB, Sweden
Crossbeta Biosciences, The Netherlands
Microbiotecsrl, Italy
ArenaVax, Switzerland
Xbrane Bioscience AB, Sweden
Bioneedle Group, The Netherlands
Novartis Vaccines Institute for Global Health s.r.l, Italy
National Institute for Biological Standards and Control, United Kingdom
Seattle Biomedical Research Institute, USA
Imperial College London, UK

Find out who we are and what we are working on. Be informed about the potential of our product and our existing development programs. Learn about partnerships and growth strategies. Stay up-to-date on Intercell.

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