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Intercell Finalizes Submission of US Biological License Application (BLA) To FDA For Licensure of Japanese Encephalitis Vaccine » Intercell delivers next important step towards product licensure in the United ...

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
20.12.2007
Vienna (Austria), December 20, 2007 - Intercell AG (VSE: ICLL) 
announced today that after having submitted the Market Authorization 
Application in Europe earlier this month it has now also completed 
the submission process of its Biological License Application (BLA) 
with the US Food and Drug Administration (FDA) for the use of its 
vaccine to prevent Japanese encephalitis (JE).
Because JE is a significant and serious public health threat in Asia,
the initial target for use of Intercell´s vaccine will be adult 
civilian travellers and military personnel who visit or a deployed to
affected countries, including India, China, and Southeast / Southwest
Asia.
"It is a major achievement that, following our successful clinical 
development, we have also been able to conclude all key 
industrialization steps in time for regulatory submissions in the 
United States and Europe. We are confident to be able to deliver on 
the next steps towards respective product approvals", states Thomas 
Lingelbach, Intercell´s Chief Operating Officer.
Earlier this month, Intercell also announced the submission for MAA 
(Marketing Authorization Application) regulatory filing with the EMEA
(European Medicines Agency). The company has successfully completed 
the clinical phase-III pivotal efficacy and safety trials for its 
lead product and, subject to the validation of the most recent 
submissions, expects licensures in the US and the EU in 2008. Filing 
in Australia is planned for early in 2008.
"The completion of the submissions with both the FDA and the EMEA is 
a key regulatory milestone for Intercell. To be able to 
simultaneously manage the company´s first BLA and MAA reflects our 
commitment to company goals, our business strategy, and to delivering
on the next steps towards commercialization in Europe and the US 
together with our partner Novartis," explains Intercell´s Chief 
Executive Officer, Gerd Zettlmeissl.
About Intercell´s investigational JE vaccine
Intercell´s novel investigational 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.
In successfully concluded pivotal non-inferiority Phase III trials, 
Intercell´s Japanese Encephalitis vaccine demonstrated a favorable 
safety and immunogenicity profile:
» The immunogenicity was comparable to that of the U.S. licensed 
product, JE-   VAX®
» It demonstrated an overall clinical safety profile similar to 
placebo
» Further, Intercell´s JE vaccine showed an excellent local 
tolerability   profile in this head-to-head study with JE-VAX®
Intercell´s novel JE vaccine, manufactured in the company´s 
proprietary manufacturing facility, is prepared using tissue culture 
rather than live organisms and does not contain any stabilizers such 
as gelatin or preservatives in its formulation.
On June 13, 2006, Novartis and Intercell announced that the companies
had reached an agreement for Novartis to acquire marketing and 
distribution rights for Intercell´s Japanese Encephalitis Virus 
Vaccine in the United States, Europe and certain other markets in 
Asia and Latin America.
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

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Plus de actualités: Intercell AG