Vienna (Austria), April 2, 2009 – Intercell AG (VSE: ICLL) today 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
“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
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.
Intercells 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
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.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito borne infection that strikes 30,000 to 50,000 individuals a
year, causing 10,000 to 15,000 deaths (both probably an underestimate due to underreporting
and other factors). Up to 50 percent of survivors have persistent neurological sequelae.
Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia
and the most important viral encephalitis in Asia. The disease is most common in several
developing countries in Asia, including India and China. As there is no specific treatment for
JE, health care experts recommend vaccination as the only highly effective protection for the
millions of travelers and military personnel who live in or travel to areas where the virus
Intercell's novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active
immunization against the Japanese Encephalitis virus. The total development time of this
vaccine took more than 10 years. The vaccine was developed under a Collaborative Research
and Development Agreement with the Walter Reed Army Institute of Research, a biomedical
research laboratory for the U.S. Department of Defense.
Intercell's Phase III trials for the vaccine found that the vaccine demonstrated excellent
immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to
placebo, combined with an excellent local tolerability profile. These data were published in The
Lancet in December 2007:
» The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX®.
» Intercell's vaccine demonstrated an overall clinical safety profile similar to placebo.
» Further, Intercell's Japanese Encephalitis vaccine had a more favorable local tolerability
profile in the head to head study with JE-VAX®.
About Intercell AG
Intercell AG is an innovative biotechnology company that designs and develops novel
vaccines for the prevention and treatment of infectious diseases with substantial unmet
medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the company's first
product on the market.
The Company's technology platforms include an antigen-discovery system, adjuvants and a
novel patch based delivery system. Based on these technologies, Intercell has strategic
partnerships with a number of global pharmaceutical companies, including Novartis, Merck &
Co., Inc., Wyeth, Sanofi Pasteur, Kyowa Hakko Kirin and the Statens Serum Institut.