euro adhoc: Intercell AG / other / Intercell receives CHMP positive opinion for the approval of IXIARO® in Europe - A vaccine against Japanese Encephalitis
Geschrieben am 15-12-2008 |   
 
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  New Products
  15.12.2008
  » IXIARO® receives positive opinion from European Committee for Human Medicinal Products (CHMP) » First licensed vaccine against Japanese  Encephalitis for travelers and   military personnel to enter markets  in Europe » Commercial product launch in the U.S., Europe and  Australia expected in   early 2009
  Vienna, Austria, December 15, 2008 - Intercell AG (VSE: ICLL) today  announced that the CHMP of the European Medicines Agency (EMEA) has  come to a positive opinion on the Marketing Authorisation for  IXIARO®, a vaccine against Japanese Encephalitis (JE).
  JE is a deadly infectious disease found mainly in Asia. 30-50,000  cases of JE are reported in Asia each year. JE is fatal in  approximately 30% of those persons who manifest JE and leaves  one-half of survivors with permanent brain damage. As there is no  specific treatment for JE, health care experts recommend vaccination  as the only protection for the millions of travelers and military  personnel who live in or travel to areas where the virus circulates.  Consequently the initial target for use of Intercell´s vaccine will  be adult civilian travelers and military personnel who visit or are  deployed to affected countries, including India, China, Southeast and Southwest Asia.
  "The CHMP positive opinion is great news for the global health care  system as with IXIARO®, European travelers will have access to an  efficacious and safe vaccine to protect from the devastating effects  of Japanese Encephalitis," said Intercell's Chief Executive Officer,  Gerd Zettlmeissl. IXIARO® will be the first vaccine ever licensed in  Europe to protect against JE. "It is great news for Intercell as  well, as our first product ever IXIARO® will from now on provide the  company with significant product sales," adds Zettlmeissl.
  Intercell's vaccine is a purified, inactivated product for active  immunization against viral infections of Japanese Encephalitis.  IXIARO® is manufactured in 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 Intercell's Japanese Encephalitis vaccine, trade named IXIARO®,  in the United States, Europe and certain other markets in Asia and  Latin America.
  Up to approval the vaccine was tested in a series of clinical trials  with around 5000 individuals. The total development time of this  vaccine from research to approval took more than 10 years, required a total investment of more than EUR 100 m.
  A single Marketing Authorization covering all 27 member states of the European Union as well as Norway and Island will follow as a next  step and will allow for the planned market launch in early 2009. This will then also trigger a EUR 10 m milestone payment by Novartis.  State control testing by the "Official Medicines Control  Laboratories" (Paul Ehrlich Institut, Germany and National Institute  for Biological Standards and Control UK) for vaccine lots intended to be supplied into the European markets, will be initiated shortly.
  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 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 --------------------------------------------------------------------------------
 
  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:  Wiener Börse AG / official market 
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