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Australian Authorities (TGA) First to Grant Final Product Approval for Intercell's Vaccine to Prevent Japanese Encephalitis
Date:1/23/2009

New Zealand, Papua New Guinea and Pacific Islands (trade name JESPECT(R)). Intercell is committed to make JESPECT(R) available to the Australian market as soon as possible.

Intercell's vaccine is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. The vaccine is manufactured in Intercell's proprietary manufacturing facility in Scotland and is prepared 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. Up to 50% 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. No treatment is currently available; only vaccination effectively prevents the disease. Though other vaccines have been available in the past, use of those products was limited due to reports of neurological reactions.

About Intercell's JE vaccine

Intercell's novel JE vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. The vaccine was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).

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, JE-VAX(R)

-- Intercell's vaccine demo
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SOURCE Intercell AG
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