Intercell Announces FDA Approval of IXIARO, a Novel Vaccine to Prevent Japanese Encephalitis
Intercell AG announced that the U.S. food and Drug Administration (FDA) approved IXIARO®, a new vaccine for the prevention of Japanese encephalitis (JE). The initial target for use of Intercell's vaccine will be adult travelers and military personnel who visit or are deployed to affected countries, including India, China, and other parts of Asia.
"This approval is a major achievement for Intercell, and it marks a significant milestone in this company’s history. The approval of IXIARO by the FDA – part of a regulatory process that included parallel filings in Europe and Australia – puts us in a select group of biotechnology companies with both an FDA-approved product and an outstanding pipeline of promising vaccine candidates," said Intercell's Chief Executive Officer, Gerd Zettlmeissl. "With this decision, Americans – both civilians and military personnel – will have an efficacious and safe way to protect themselves from the devastating and deadly effects of Japanese Encephalitis."
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 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.
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