Licensure application for Japanese Encephalitis vaccine submitted to Canadian Division of Biologics and Genetic Therapies Directorate of Health
» Intercell submitted application to launch Japanese Encephalitis vaccine in Canada
» Intercell confirms plans for market launch (Europe, US, Australia) within committed timelines – production process fully on track
Vienna (Austria), June 19, 2008 – Intercell AG (VSE: ICLL) announced today the submission of application to register Intercell's investigational Japanese Encephalitis vaccine in Canada to the Division of Biologics and Genetic Therapies Directorate of Health Canada. This submission has been based on the Market Authorization Application (MAA) with the European Medicines Agency (EMEA) and the Biological License Application (BLA) with the US Food and Drug Administration (FDA), submitted in December 2007.
Intercell confirms that the regulatory approval process in US, EU and Australia as well as its manufacturing operations are proceeding according to plan and in-line with communicated time lines for market launches in the respective territories.
The production of the vaccine for the Canadian market will be performed at Intercell's state-of-the-art vaccine manufacturing facility in Livingston, Scotland. "We are pleased to announce that the committed timelines regarding the planned manufacturing operations and regulatory approvals in the US, Europe and Australia in 2008 can be confirmed," explained Intercell's Chief Operating Officer, Thomas Lingelbach.
With over three billion people living in endemic areas, Japanese Encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia. The JE virus remains virulent in this region and has recently spread to countries not previously affected. Furthermore, the virus is a consistent threat to millions of travelers visiting the highly populated far eastern countries, including China and India.
As previously announced Intercell's investigational vaccine against Japanese Encephalitis shows excellent safety and immunogenicity in Phase II trials in children. These results fully support Intercell's development plan for endemic regions and pave the way towards late stage development and licensure.
About Intercell's investigational JE vaccine
Intercell's novel investigational Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. With over 3 billion people living in endemic areas, Japanese Encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia.
In successfully concluded pivotal non-inferiority Phase III trials, Intercell's Japanese Encephalitis vaccine demonstrated a favorable safety and immunogenicity profile:
» The immunogenicity was comparable to that of the US licensed product, JE-VAX®
» It demonstrated an overall clinical safety profile similar to placebo
» Further, Intercell's JE vaccine showed an excellent local tolerability profile in this head-to-head study with JE-VAX®
Intercell's novel JE vaccine, manufactured in the company's proprietary manufacturing facility, is prepared using tissue culture rather than live organisms and does not contain any stabilizers such as gelatin or preservatives in its formulation.
About Intercell AG
Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and adjuvants which are derived from its proprietary technology platforms, and has in-house GMP manufacturing capabilities. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, sanofi pasteur, Kirin and the Statens Serum Institut. The Company's leading product, a prophylactic vaccine against Japanese Encephalitis, successfully concluded pivotal Phase III clinical trials in 2006. The Market Authorization Application (MAA) in Europe as well as the Biological License Application (BLA) with the US Food and Drug Administration (FDA) for the use of the vaccine to prevent Japanese encephalitis were submitted in December 2007. The company's broad development pipeline includes a Pseudomonas vaccine in Phase II, a therapeutic vaccine for Hepatitis C in Phase II, partnered vaccines for Tuberculosis (Phase I) and Staphylococcus aureus (Phase II), and five products focused on infectious diseases in preclinical development.
As announced in May 2008, Intercell and the US-based Iomai Corporation have entered into a definitive agreement pursuant to which Intercell will acquire Iomai. Intercell will gain full rights to Iomai’s late stage Travelers' Diarrhea vaccine which is based on Iomai’s proprietary needle-free patch delivery vaccine technology.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
For more information please visit: www.intercell.com
About Intercell's manufacturing facility in Scotland – Intercell Biomedical Ltd.
In March 2004, Intercell acquired a manufacturing plant in Livingston, Scotland, which has enabled the company to gain in-house GMP manufacturing capabilities for its Japanese Encephalitis vaccine and to manufacture the investigational product used in the clinical phase III trials. With major investments in the last years the company has further increased capacities and established a state-of the art GMP commercial manufacturing facility to support the future supplies of its Japanese Encephalitis vaccine. Besides the fully dedicated and further expandable manufacturing facility the site has also separate development and clinical manufacturing capacities. The more than 70 employees organization is operating under a Manufacturing License from MHRA.
For more information please visit: www.intercell.com
Contact Intercell AG
Intercell AGLucia MalfentHead of Corporate CommunicationsCampus Vienna Biocenter 2, A-1030 ViennaP: +43-1-20620-303Mail to: LMalfent(at)intercell.com