Ixiaro regulatory update

Intercell said the European Commission approved a regulatory application for Ixiaro Japanese Encephalitis (JE) vaccine to include pediatric patients. An application for the pediatric indication is under review in the U.S., where it has Orphan Drug designation. The product is already marketed for adults as Ixiaro in Canada, Europe, Hong Kong, Israel, Singapore and the U.S., and as Jespect in Australia and New Zealand. Biological E. has rights to develop and market the vaccine in India, Pakistan, Nepal and Bhutan under a 2005 deal. In December, Intercell said it would merge with Vivalis S.A. (Euronext:VLS, Nantes, France). The merger is expected to close in May (see BioCentury, Dec. 24, 2012). ...