Ixiaro regulatory update

Intercell disclosed in its 3Q12 earnings that it submitted regulatory applications to FDA and EMA for Ixiaro Japanese Encephalitis (JE) vaccine to include pediatric patients. Intercell also said FDA granted Ixiaro Orphan Drug status in the U.S. for the pediatric indication and that the vaccine was approved for adults in New Zealand. The product is approved 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. ...