Intercell finalizes submission of US Biological License Application (BLA) to FDA for licensure of Japanese ...

Intercell finalizes submission of US Biological License Application (BLA) to FDA for licensure of Japanese Encephalitis Virus vaccine

Intercell finalizes submission of US Biological License Application (BLA) to FDA for licensure of Japanese Encephalitis Virus vaccine

» Intercell delivers next important step towards product licensure in the United States

(Vienna, 20. 12. 2007) Intercell AG (VSE: ICLL) announced today that after having submitted the Market Authorization Application in Europe earlier this month it has now also completed the submission process of its Biological License Application (BLA) with the US Food and Drug Administration (FDA) for the use of its vaccine to prevent Japanese encephalitis (JE).

Because JE is a significant and serious public health threat in Asia, the initial target for use of Intercell’s vaccine will be adult civilian travellers and military personnel who visit or a deployed to affected countries, including India, China, and Southeast / Southwest Asia.

“It is a major achievement that, following our successful clinical development, we have also been able to conclude all key industrialization steps in time for regulatory submissions in the United States and Europe. We are confident to be able to deliver on the next steps towards respective product approvals”, states Thomas Lingelbach, Intercell´s Chief Operating Officer.

Earlier this month, Intercell also announced the submission for MAA (Marketing Authorization Application) regulatory filing with the EMEA (European Medicines Agency). The company has successfully completed the clinical phase-III pivotal efficacy and safety trials for its lead product and, subject to the validation of the most recent submissions, expects licensures in the US and the EU in 2008. Filing in Australia is planned for early in 2008.

"The completion of the submissions with both the FDA and the EMEA is a key regulatory milestone for Intercell. To be able to simultaneously manage the company’s first BLA and MAA reflects our commitment to company goals, our business strategy, and to delivering on the next steps towards commercialization in Europe and the US together with our partner Novartis,” explains Intercell´s Chief Executive Officer, Gerd Zettlmeissl.

About Intercell’s investigational JE vaccine

Intercell´s novel investigational JE 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 U.S. 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.

On June 13, 2006, Novartis and Intercell announced that the companies had reached an agreement for Novartis to acquire marketing and distribution rights for Intercell’s Japanese Encephalitis Virus Vaccine in the United States, Europe and certain other markets in Asia and Latin America.

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 capability. 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. The 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 which is in Phase II and a broad pipeline of vaccine and antibody candidates focused on infectious diseases in pre- development.
Intercell is listed on the Vienna stock exchange under the symbol “ICLL”.

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 Investigational medicinal products (IMP) and is in the process to be licensed for commercial manufacturing For more information please visit:

Contact Intercell AG:

Intercell AGLucia MalfentHead of Corporate CommunicationsCampus Vienna Biocenter 2, A-1030 ViennaP: +43-1-20620-303Mail to: LMalfent(at)

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.

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

As a life sciences organization based in Vienna, would you like us to promote your news and events? If so, please send your contributions to news(at)