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Intercell Announces European Approval of New Vaccine, IXIARO(R), to Prevent Japanese Encephalitis
Date:4/2/2009

new vaccine is manufactured in Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.

In addition to the European approval, Intercell's vaccine was also approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia, and the U.S. Food and Drug Administration for the U.S. market.

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 an underestimate due to underreporting and other factors). 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 millions of travelers and military personnel who live in or travel to areas where the virus circulates.

About IXIARO

Intercell's novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. The total development time of this vaccine took 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 for the U.S. Department of Defense.

Intercell's Phase III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to placebo, combined with an excellent local tolerability profile. These data were published in The Lancet in December 2007:
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SOURCE Intercell AG
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