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Intercell Receives Manufacturer´s Licence for Future Commercial Manufacturing of its Vaccine Against Japanese Encephalitis

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
16.01.2008
» Successfully passed inspection by the Medicines and Healthcare
  products Regulatory Agency (MHRA)
» Intercell receives Manufacturer´s Licence for its site in
  Livingston, Scotland
» Major milestone in bringing vaccine against Japanese Encephalitis
  to the American (US) and European markets
Vienna (Austria), January 16, 2008 - Intercell AG (VSE: ICLL) 
announced today that its fully owned manufacturing site in 
Livingston, Scotland (Intercell Biomedical Ltd.), has been granted 
the Manufacturer´s Licence for the commercial manufacturing of its  
vaccine against Japanese Encephalitis. The issuance of the license is
following a GMP (Good Manufacturing Practice) inspection performed by
the Medicines and Healthcare products Regulatory Agency (MHRA).
The Manufacturer´s Licence is required to support the Marketing 
Authorization Application (MAA) process in Europe which is being 
coordinated by the European Medicines Agency (EMEA) and represents 
the basis for future product release and export to the US.
"The issuance of the Commercial Manufacturer´s Licence is a key 
achievement on Intercell´s path to bringing our new investigational 
Japanese Encephalitis vaccine onto the market and should allow us to 
produce a sufficient launch stock for product approvals in the 
respective locations," states Gerd Zettlmeissl, Intercell´s Chief 
Executive Officer.
"Receiving the Manufacturer´s Licence validates our ongoing 
commitment to focus on quality compliance and execution for our 
future commercial supplies," says Thomas Lingelbach, Intercell´s 
Chief Operating Officer.
Intercell expects the pre-approval inspection by the US FDA (Food and
Drug Administration) in support of the US licensure process within 
the forthcoming months.
About Intercell´s investigational JE vaccine (IC51)
Intercell´s novel investigational JE vaccine (IC51) 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 JE virus remains virulent in this region and has 
recently spread to countries not previous affected.
In successfully concluded pivotal Phase III trials, Intercell´s IC51 
vaccine has demonstrated a favorable safety and immunogenicity 
profile:
» The immunogenicity of IC51 was at least as good as the U.S. 
licensed   product, JE-VAX®
» IC51 demonstrated an overall clinical safety profile similar to 
placebo
» Further, IC51 showed an excellent local tolerability profile in 
this   head-to-head study with JE-VAX®
Intercell´s novel JE vaccine is produced using tissue culture rather 
than live organisms and does not contain any stabilizers such as 
gelatin or preservatives in its formulation. Novartis will market and
distribute Intercell´s Japanese Encephalitis virus vaccine in the 
United States, Europe and certain other markets in Asia and Latin 
America. CSL is Intercell´s marketing and distribution partner in 
Australia.
About Intercell Biomedical Ltd. (Livingston, Scotland)
In 2004, Intercell acquired a manufacturing plant in Livingston, 
Scotland, which has enabled the Company to gain in-house GMP 
manufacturing capabilities for its Japanese encephalitis vaccine and 
to manufacture the investigational product used in the Phase III 
clinical trials. With major investments in the last years, the 
Company has further increased capacities and established a state-of 
the art, GMP commercial manufacturing facility to support the future 
supplies of its Japanese encephalitis vaccine. Besides the fully 
dedicated and further expandable manufacturing facility, the 
Livingston site has also separate development and clinical 
manufacturing capacities.
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Corporate Communications
Campus Vienna Biocenter 2, A-1030 Vienna
P: +43-1-20620-303
Mail to: LMalfent@intercell.com

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

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