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Intercell Announces FDA Approval of IXIARO(R), a Novel Vaccine to Prevent Japanese Encephalitis
Date:3/30/2009

nactivated product for active immunization against viral infections of Japanese Encephalitis. IXIARO is manufactured at Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms. Novartis AG holds marketing and distribution rights for IXIARO in the United States, Europe, Japan, South Korea and certain other markets in Asia and Latin America. Intercell will directly distribute and market IXIARO to the U.S. military.

Prior to approval, the vaccine was tested in a series of large-scale clinical trials with around 5,000 individuals. The total development time of this vaccine from research to approval took more than 10 years. The vaccine was developed under a Collaborative Research and Development Agreement with the Walter Reed Army Institute of Research in the U.S. The vaccine was also approved by the Australian Therapeutic Goods Administration (TGA) in January 2009 and is expected to be approved shortly by the European Union following a positive CHMP-opinion.

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 fo
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SOURCE Intercell AG
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