Intercell AG (VSE: ICLL) announced that its new vaccine to prevent Japanese Encephalitis, IXIARO, has been approved by the European Commission.
The approval by the European Union, the first for a vaccine to prevent the disease, provides formal market authorization in all 27 member states as well as Norway and Iceland.
“The European approval of IXIARO marks a crucial milestone in Intercell’s evolution as one of the leading independent vaccine development companies with a vaccine marketed,” said Intercell’s Chief Executive Officer Gerd Zettlmeissl. “For the first time, both civilians and members of the military across Europe will have access to a safe and effective vaccine against this devastating and endemic disease found throughout Asia, which kills as many as one in three of the people it strikes.”
This decision follows the positive opinion from European Committee for Human Medicinal Products (CHMP) in December 2008. Novartis AG holds marketing and distribution rights for IXIARO, in the United States, Europe, Japan, Korea and certain other markets in Asia and Latin America.
A final assessment by the European COMP (Committee for Orphan Medicinal Products) focused on updated information indicating that the expected potential European vaccine market for IXIARO is significantly higher than initially evaluated, and, therefore, the vaccine will not have an orphan drug designation.
Intercell’s product is a purified, inactivated vaccine for active immunization against infections with Japanese Encephalitis virus. The new vaccine is manufactured in Intercell’s proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.
In addition to the European approval, Intercell’s vaccine was also approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia, and the U.S. Food and Drug Administration for the U.S. market.
Source: Intercell, Austria