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Intercell Submits Marketing Authorization Application (MAA) to EMEA for Licensure of Japanese Encephalitis Vaccine

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
Company Information
06.12.2007
» Intercell submitted MAA for its lead product, a vaccine against 
Japanese   encephalitis » Product is intended to be licensed through 
centralized regulatory procedure   in Europe » Company expects 
positive CHMP opinion in 2008
Vienna (Austria), December 6, 2007 - Intercell AG (VSE: ICLL) 
announced the regulatory submission of the MAA (Marketing 
Authorization Application) today for its lead product, a vaccine 
against Japanese encephalitis (JE). After successful Phase III 
clinical trials performed in Europe, the United States and Australia,
the new JE vaccine is intended to be licensed through the centralised
regulatory procedure by the EMEA (European Medicines Agency).
"It is a major achievement that we have been able to manage 
Intercell´s first MAA submission according to our stated business 
plans. Furthermore, we are on track for filing a license application 
for our JE vaccine in the United States later this month.  We are 
encouraged and committed to further delivering on the next steps 
towards product licensure and commercialization in the U.S., Europe, 
and elsewhere", stated Thomas Lingelbach, Intercell´s Chief Operating
Officer.
Subject to EMEA´s validation of the submission, a review by the 
rapporteurs (Germany) and co-rapporteurs (Norway) will be initiated 
and the Company is expecting a positive opinion by the Committee for 
Medicinal Products for Human Use (CHMP) in 2008.
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 previously affected. In successfully
concluded pivotal Phase III non-inferiority trials, Intercell´s IC51 
vaccine has demonstrated a favorable safety and immunogenicity 
profile:
» The immunogenicity of IC51 was comparable to that of the U.S. 
licensed   product, JE-VAX® » IC51 demonstrated an overall clinical 
safety profile similar to placebo » Furthermore, IC51 showed an 
excellent local tolerability profile in this   head-to-head study 
with JE-VAX®
Intercell´s novel investigational JE vaccine, manufactured at the 
Company´s proprietary GMP (Good Manufacturing Practice) manufacturing
facility in Scotland, 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.
About Intercell Biomedical Ltd.
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 throughout the last years, 
the Company has further increased its capacities and has established 
a state-of the art, GMP commercial manufacturing facility to support 
the future supplies of its Japanese encephalitis vaccine. Besides the
manufacturing facility, which is fully dedicated to these studies and
still has the potential for further expansion , the Livingston site 
also has separate development and clinical manufacturing capacities. 
With more than 70 employees, the organization operates under a 
Manufacturing License from the MHRA (Medicines and Healthcare 
products Regulatory Agency) for Investigational Medicinal Products 
(IMP, Investigational Medicinal Products)) and is in the process of 
becoming for commercial manufacturing.
end of announcement                               euro adhoc 06.12.2007 17:20:00

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
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