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news.Intercell has reported the submission of application to register the company's investigational Japanese encephalitis or JE vaccine in Australia to the Therapeutic Goods Administration or TGA. The submission process was executed by Intercell's partner CSL Biotherapies.
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This TGA submission has been based on the market authorization application with the European Medicines Agency and the biological license application with the FDA, submitted in December 2007. The production of the vaccine for the Australian market will be performed at Intercell’s state-of-the-art vaccine manufacturing facility in Livingston, Scotland.
Gerd Zettlmeissl, CEO of Intercell, said: “The submission of licensure applications with three major governmental authorities is a key milestone for Intercell. With this we are fully on track for the future global commercialization of our vaccine against Japanese encephalitis.”