VIENNA, Austria, Jan. 23 /PRNewswire-FirstCall/ -- Intercell AG (VSE: ICLL) today announced that the Australian Therapeutic Goods Administration (TGA) granted product approval for the company's vaccine to prevent Japanese Encephalitis. This final decision step for the new vaccine follows the positive recommendation provided by Australian Drug Evaluation Committee (ADEC) in December 2008.
This decision of the Australian authorities represents the first regulatory approval for the vaccine in any country. Intercell has been successfully advancing parallel regulatory processes in all key markets for travelers and military personnel with an imminent product approval in the U.S. Following the CHMP positive opinion of the European Medicines Agency (EMEA) obtained in December 2008, the approval by the European Union providing formal market authorization for all 27 member states as well as for Norway and Iceland will follow within the next weeks according to the defined EMEA process.
"We are very pleased that all approval processes for our novel Japanese Encephalitis vaccine have proceeded in line with our planned timelines. We are now moving forward to bring this important product to both travelers and military personnel in early 2009," states Thomas Lingelbach, Chief Operating Officer of Intercell.
Japanese Encephalitis is a deadly disease that kills as many as 30% of those who manifest the disease. Japanese Encephalitis is only becoming a larger risk for travelers. There is increasing travel to rural areas where the disease is more common, and climate change is extending the range of disease-carrying mosquitoes.
Intercell's vaccine will be the only registered JE-vaccine available in
the Australian market and will be distributed and marketed by CSL Biotherapies
Pty Ltd., which has the exclusive right for marketing and distribution of the
novel cell culture-based vaccine in Australia,
|SOURCE Intercell AG|
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