Intercell AG (VSE: ICLL) today announced that the U.S. Food and Drug Administration (FDA) approved IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE).
The initial target for use of Intercell's vaccine - the only such product currently manufactured for the U.S. market - will be adult travelers and military personnel who visit or are deployed to affected countries, including India, China, and other parts of Asia.
"This approval is a major achievement for Intercell, and it marks a significant milestone in this company's history. The approval of IXIARO by the FDA - part of a regulatory process that included parallel filings in Europe and Australia - puts us in a select group of biotechnology companies with both an FDA-approved product and an outstanding pipeline of promising vaccine candidates," said Intercell's Chief Executive Officer, Gerd Zettlmeissl. "With this decision, Americans - both civilians and military personnel - will have an efficacious and safe way to protect themselves from the devastating and deadly effects of Japanese Encephalitis."
JE is a deadly infectious disease found mainly in Asia. Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual number of cases are likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms and leaves half of survivors with permanent brain damage. As there is no specific treatment for JE, vaccination is the only highly effective protection for the millions of travelers and military personnel who live in or travel to areas where the virus circulates.
Intercell's vaccine is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. IXIARO is manufactured at Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms. Novartis AG holds marketing and distribution rights for IXIARO in the United States, Europe, Japan, South Korea and certain other markets in Asia and Latin America. Intercell will directly distribute and market IXIARO to the U.S. military.
Prior to approval, the vaccine was tested in a series of large-scale clinical trials with around 5,000 individuals. The total development time of this vaccine from research to approval took more than 10 years. The vaccine was developed under a Collaborative Research and Development Agreement with the Walter Reed Army Institute of Research in the U.S. The vaccine was also approved by the Australian Therapeutic Goods Administration (TGA) in January 2009 and is expected to be approved shortly by the European Union following a positive CHMP-opinion.
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 circulates.
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:
Â -- The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX(R). -- 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(R). 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, two proprietary 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.
The Company's development pipeline includes Phase II vaccine programs for Pseudomonas (in-house development) and S. aureus, which is being developed with Merck & Co. Inc. The Company's novel Travelers' Diarrhea vaccine patch will enter Phase III testing in 2009. Intercell is also in clinical trials of a vaccine enhancement patch with injected pandemic influenza vaccines (one shot plus patch). In addition, four other products focused on infectious diseases are in pre-clinical development.