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Orphan Drug status for Intercell’s Japanese Encephalitis Vaccine granted by the European Commission

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
30.01.2006
Intercell AG (VSE, "ICLL") announced today that the company’s
Japanese Encephalitis vaccine, currently in advanced Phase III
trials, has been granted orphan drug status by the European
Commission.
The European Commission has followed a recommendation of a designated
working party at EMEA (European Medicines Agency), which has reviewed
the program from Intercell.
The EMEA's orphan medicinal product designations are based on various
criteria that include the seriousness and incidence of the condition
and the availability of other effective therapies.
The orphan drug designation leads to several important advantages
within the development and especially the marketing of Intercell’s
lead product:
» With the licensure of Intercell’s Japanese Encephalitis vaccine,
the company will receive 10-year sole exclusive market rights for its
product within the EU25 countries including Norway and Iceland.
» The orphan drug designation for Intercell’s Japanese Encephalitis
vaccine also includes fee reduction and waivers during the pre- and
post-approval phases of the product and special participation in EU
funded projects and protocol assistance for additional trials, as for
instance pediatric trials.
"We are convinced that our modern cell culture based vaccine will
increase the market potential for vaccination of travelers against
the Japanese Encephalitis Virus. The orphan drug status allows us to
generate a maximum commercial benefit for our product in the EU",
states Gerd Zettlmeissl, CEO of Intercell.
end of announcement                               euro adhoc 30.01.2006 06:55:14

Further inquiry note:

Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303
kwieser@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market

Plus de actualités: Intercell AG
Plus de actualités: Intercell AG