FDA Approves Intercell's Vaccine Against Japanese Encephalitis

April 10, 2009

Intercell AG (Vienna, Switzerland) has received the US Food and Drug Administration?s approval for Ixiaro, a vaccine for the prevention of Japanese Encephalitis (JE).

Intercell AG (Vienna, Switzerland) has received the US Food and Drug Administration’s approval for Ixiaro, a vaccine for the prevention of Japanese Encephalitis (JE). The initial target for use of Intercell’s vaccine will be adult travellers and military personnel who visit or are deployed to affected countries, including India, China, and other parts of Asia.

Intercell’s vaccine is a purified, inactivated 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 US, Europe, Japan, South Korea, and certain other markets in Asia and Latin America. Intercell will directly distribute and market Ixiaro to the US military.

JE is a deadly infectious disease found mainly in Asia. Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual numbers of cases are likely much higher because of underreporting in rural areas. JE is fatal in approximately 30% of those who show symptoms and leaves half of survivors with permanent brain damage. As there is no specific treatment for JE, vaccination is the only highly effective protection for the millions of travellers and military personnel who live in or travel to areas where the virus circulates.