Vienna (Austria), February 12, 2013 – Intercell AG (VSE; "ICLL") announced today that the pediatric indication for IXIARO®, a vaccine to protect against Japanese Encephalitis (JE), was granted Marketing Authorisation by the European Medicines Agency (EMA) and the European Commission (EC). The European Commission Decision ratifies the positive opinion from the European Committee for Human Medicinal Products (CHMP) in December 2012. The approval by the European Union provides formal Marketing Authorisation for the pediatric indication of IXIARO® in all 27 member states as well as Norway, Liechtenstein and Iceland.
"We are delighted that our JE vaccine has been granted pediatric licensure in Europe, which will now enable travelers of all ages to obtain protection against this disease with a licensed vaccine. The approval of IXARO® for children is based on additional clinical studies that have once more confirmed the favorable safety and immunogenicity profile of the vaccine.", says Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Intercell submitted applications for pediatric licensure of the JE vaccine to major regulatory agencies in late Q2 2012 based on data from a Phase III clinical study conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia. In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents aged 2 months to less than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases.
Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, Switzerland, United States, Canada, Hong Kong, Singapore, Israel (IXIARO®) and Australia and New Zealand (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.
Intercell's next-generation vaccine to protect travelers against Japanese Encephalitis (JE) has been licensed in more than 30 countries world-wide, and is the Company's first product on the market. Extension of the approved indications to include the pediatric age segment in the EU, allows vaccine to be administered to adults and children aged 2 months and above who travel to, or live in, endemic areas. Intercell and its marketing and distribution partners are committed to introducing the IXIARO® product for administration in all approved age groups as soon as possible. Product which is currently available on the market in Europe can be used in accordance with the approved method of administration in all people aged 3 years and above.
In the U.S. the pediatric label extension is currently under review by the FDA.
The vaccine is manufactured by Intercell AG's wholly-owned subsidiary Intercell Biomedical Ltd. at its cGMP facility in Livingston, Scotland.