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Intercell Announces FDA Approval of IXIARO(R), a Vaccine Against Japanese Encephalitis
Date:3/31/2009

and and is prepared using modern tissue culture rather than live organisms.

Intercell will directly distribute and market IXIARO to the U.S. military, while such functions will be handled by Novartis Vaccines USA to the private market.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes approximately 50,000 persons per year and causes 15,000 deaths (both probably an underestimate due to underreporting and other factors). The disease is most common in several developing countries in Asia, including India and China. JE causes death in one out of every three people with overt encephalitis and one-half of survivors develop permanent brain damage. No treatment is currently available for JE and only vaccination effectively prevents the disease. Though another JE vaccine was available in the past, use of that product was limited by reports of adverse reactions; furthermore, this vaccine is no longer being produced for the United States market and supplies will soon be exhausted.

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:

  • The immunogenicity was comparable to that of the U.S. licensed product, J
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SOURCE Intercell AG
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