Intercell AG (VSE: ICLL) announced today the submission of application to register Intercell's investigational Japanese Encephalitis vaccine in Australia to the Therapeutic Goods Administration (TGA). The submission process was executed by Intercell's partner CSL Biotherapies Pty Ltd.
This TGA 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.
In Australia Intercell cooperates with CSL Biotherapies Pty Ltd., who has the exclusive right for marketing and distribution of Intercell's novel cell culture based Japanese Encephalitis vaccine in Australia, New Zealand, Papua New Guinea and Pacific Islands.
Japanese Encephalitis is a significant and serious public health threat in Asia but increasingly also in Australia, where the disease is endemic. The initial target for use of Intercell's vaccine will be adult civilian travellers and military personnel who visit or are deployed to affected countries, including India, China, and Southeast / Southwest Asia, and consequently also people living in endemic regions.
The production of the vaccine for the Australian market will be performed at Intercell's state-of-the-art vaccine manufacturing facility in Livingston, Scotland.
"The submission of licensure applications with three major governmental authorities is a key milestone for Intercell. With this we are fully on track for the future global commercialization of our vaccine against Japanese Encephalitis," explains Intercell's Chief Executive Officer, Gerd Zettlmeissl.
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 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.
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.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
About CSL Limited
CSL Limited is a global, specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions; Headquartered in Melbourne Australia, CSL Limited includes CSL Bioplasma, CSL Behring, incorporating ZLB Plasma Services, and CSL Biotherapies Pty. Ltd.
CSL Limited has over 7,000 employees working in 25 countries, with major facilities in Australia, Germany, Switzerland, US and Japan; CSL Biotherapies Pty. Ltd. markets a comprehensive range of Children's vaccines, Travel Vaccines, Respiratory Vaccines Adult Vaccines and Antivenoms.
For more information please visit www.csl.com.au
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
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.