euro adhoc: Intercell AG
other
Australia first country to receive positive
recommendation for Intercell's Vaccine to Prevent Japanese Encephalitis
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New Products
12.12.2008
» Australian Drug Evaluation Committee (ADEC) has issued a positive recommendation for Intercell's first product, a new vaccine against Japanese Encephalitis » Marketing approvals in Europe and USA are expected in December 2008 » New vaccine targets travelers to, and population in, endemic areas
Vienna/Austria, December 12, 2008 - Intercell AG (VSE: ICLL) today announced that the Australian Drug Evaluation Committee (ADEC) has issued a positive recommendation for the company´s new vaccine against Japanese Encephalitis. Following the recommendation by ADEC, approval of Intercell´s JE vaccine in Australia is subject to final authorization by the Therapeutic Goods Administration (TGA), the regulatory body responsible for the evaluation of new therapies in Australia. The TGA considers the advice and recommendation provided by ADEC when making its final decision. ADEC recommended the Intercell JE vaccine for active immunization against Japanese Encephalitis (JE) virus for persons 18 years of age and older. JESPECT should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal).
Intercell is successfully advancing parallel regulatory processes in all key markets and marketing approval in the U.S. and Europe is also expected before the end of the year.
Japanese Encephalitis is a deadly disease that kills as many as 30% of symptomatic persons who develop encephalitis. Japanese Encephalitis is becoming a larger risk for travelers. There is increasing travel to rural areas where the disease is more common, and climate change is extending the range of disease-carrying mosquitoes.
"This is a major accomplishment for Intercell. The JE-vaccine addresses a critical unmet need for effective and safe protection against Japanese Encephalitis, not only for travelers, but also for people living in endemic areas," said Gerd Zettlmeissl, Chief Executive Officer of Intercell AG. "We are also still very optimistic about positive decisions in the U.S. and Europe this year."
Intercell's vaccine is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. The vaccine is manufactured in Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 a year, causing 10-15,000 deaths up to 50% of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia, and is the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia. No treatment is currently available; only vaccination effectively prevents the disease. Though other vaccines have been available in the past, use of those products has been limited by reports of neurological reactions.
About Intercell's JE vaccine
Intercell's novel JE vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. With over 3 billion people living in endemic areas, Japanese Encephalitis, a mosquito-borne flaviviral infection, is the leading cause of childhood encephalitis and viral encephalitis in Asia. The vaccine was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).
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. That data was 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 JE vaccine had an excellent local tolerability profile in the head-to-head study with JE-VAX®
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
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