- U.S. FDA approves Intercell's first marketed product, a new vaccine against Japanese Encephalitis for travelers and military personnel
- Commercial product launch in the U.S. planned for Q2 2009
VIENNA, March 30 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Food and Drug Administration (FDA) approved IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE). The initial target for use of Intercell's vaccine - the only such product currently manufactured for the U.S. market - 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."
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 number of cases are likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent 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 travelers and military personnel who live in or travel to areas where the virus circulates.
Intercell's vaccine is a purified, i
|SOURCE Intercell AG|
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