EANS-News: Canadian authorities grant product approval for Intercell's Vaccine to prevent Japanese Encephalitis
Geschrieben am 30-10-2009 |
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. --------------------------------------------------------------------------------
New Products
Vienna, Austria, October 30, 2009 (euro adhoc) - Intercell AG (VSE: ICLL) today announced that the Health Canada granted product approval for IXIARO®, the company's vaccine to prevent Japanese Encephalitis (JE).
This decision of the Canadian authorities represents another important milestone for the product's global reach. Intercell's vaccine to prevent Japanese Encephalitis has already been successfully approved and launched in the USA, Europe and Australia.
"We are very pleased that IXIARO is now also approved by the Canadian authorities. This reflects another step in growing our IXIARO business by supplying this important product to travelers", states Gerd Zettlmeissl, Chief Executive Officer of Intercell.
Intercell's Japanese Encephalitis vaccine will be available for the Canadian market by the end of the year and will be distributed and marketed to travel clinics by Novartis Pharmaceuticals Canada Inc. and to the military personnel by Intercell.
IXIARO is a purified, inactivated product for active immunization against infection by the Japanese Encephalitis Virus. IXIARO is manufactured at Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.
About Japanese Encephalitis
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 effective protection for the millions of travelers and military personnel who live in or travel to areas where the virus circulates.
About IXIARO
Intercell's novel Japanese Encephalitis vaccine is a purified, inactivated vaccine for active immunization of adults against the Japanese Encephalitis virus. 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 IXIARO found that the vaccine demonstrated immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to the control arm, 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 the control arm. » Further, Intercell's Japanese Encephalitis vaccine had a more favorable local tolerability profile in the head-to-head study with JE-VAX®.
Please refer to the Product / Prescribing information (PI) / Medication Guide approved in your respective countries for complete information including safety about this vaccine.
Ende der Mitteilung euro adhoc --------------------------------------------------------------------------------
ots Originaltext: Intercell AG Im Internet recherchierbar: http://www.presseportal.de
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 Börsen: Wien / official market
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