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Intercell: Swiss authorities grant product approval for IXIARO® Intercellʹs vaccine to help prevent Japanese Encephalitis now available inSwitzerland
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(Vienna, July 13, 2010) – Intercell AG (VSE: ICLL) announces that Swissmedic has approved IXIARO®, its vaccine against Japanese Encephalitis. IXIARO®, which is distributed and marketed by Novartis, is now available in Switzerland The decision by the Swiss authorities represents another important milestone for the licensure process initiated for selected attractive market segments. Intercellʹs vaccine, which helps to prevent Japanese Encephalitis, has already been approved and launched in the USA, Europe, Canada and Australia. ʺThe Swissmedic approval is great news and another important step in the productʹs global reachʺ, states Thomas Lingelbach, Chief Operating Officer of Intercell. IXIARO® is a modern purified, inactivated vaccine for active immunization of adults against infections caused by the Japanese Encephalitis Virus. IXIARO® is manufactured at Intercellʹs proprietary manufacturing facility in Scotland using tissue culture rather than live organisms.
About Japanese Encephalitis Japanese Encephalitis is a mosquito‐borne infection that strikes 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths (both probably underestimate due to underreporting and misdiagnosis). Up to 50 percent of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia, including India and China. As there is no specific treatment for JE, health care experts recommend vaccination as the only highly effective protection for the travelers and military personnel who live in or travel to areas where the virus circulates.
About IXIARO® Intercellʹs novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus. The total development time of this vaccine was more than 10 years. The vaccine was developed under a Collaborative Research and Development Agreement with the Walter Reed Army Institute of Research, a biomedical research laboratory of the U.S. Department of Defense. Intercellʹs Phase III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to the control arm, combined with an excellent local tolerability profile. These data were published in The Lancet in December 2007: » The immunogenicity was comparable to that of the U.S. licensed product, JE‐VAX®. » Intercellʹs vaccine demonstrated an overall clinical safety profile similar to the control arm. Further, Intercellʹs Japanese Encephalitis vaccine had a more favorable local tolerability profile in the head‐to‐head study with JE‐VAX®. Please refer to the Product / Prescribing information (PI) / Medication Guide approved in your respective countries for complete information including safety about this vaccine.
About Intercell AG Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercellʹs vaccine to prevent Japanese Encephalitis is the Companyʹs first product on the market. The Companyʹs technology platform includes an antigen‐discovery system and human antiinfective monoclonal antibody discovery system, adjuvants and a novel patch‐based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., sanofi‐aventis, and Pfizer (formerly Wyeth). The Companyʹs pipeline of investigational products includes a Travelersʹ Diarrhea Vaccine Patch (Phase III), a Pseudomonas vaccine candidate (Phase II), a vaccine to prevent Pandemic Influenza combining our Vaccine Enhancement Patch with an injected vaccine (Phase II), a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, further products focused on infectious diseases are in pre‐clinical development. Intercell is listed on the Vienna stock exchange under the symbol ʺICLLʺ (U.S. level one ADR symbol ʺINRLYʺ).
Contact Intercell AG Lucia Malfent Global Head of Corporate Communications Campus Vienna Biocenter 3, A‐1030 Vienna P: +43‐1‐20620‐1303 LMalfent@intercell.com www.intercell.com |
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