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Intercell AG

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Start of Phase III clinical trials for Japanese Encephalitis Vaccine now approved by major European authorities - EMEA supports Intercell’s Clinical Development Strategy

  Disclosure announcement transmitted by euro adhoc.
  The issuer is responsible for the content of this announcement.
09.08.2005
Vienna - August 9, 2005 - Intercell AG (VSE - "ICLL") today announced
that the company has received the approval for the start of Phase III
clinical studies for the Japanese Encephalitis Vaccine (IC51) from
major European authorities. The responsible German authority, the
Paul Ehrlich Institute (PEI), has approved the start of respective
Phase III clinical trials in Germany, which will contribute the
largest contingent for these Phase III studies outside the US. The
Phase III clinical trials are now approved in Australia, Austria,
Bulgaria, Germany, Romania, the UK and the US.
Furthermore, Intercell has received Scientific Advice from the
European Medicines Agency (EMEA) regarding the further development of
its cell culture-based Japanese Encephalitis Vaccine, IC51 in Europe.
Based on this advice the company will proceed with its global
development program also with a view to submitting a Marketing
Authorization Application (MAA) in Europe through the centralized
procedure.  Currently only suboptimal vaccines produced on mouse
brain are used in Europe. None of these vaccines have received
regulatory approval in Europe, and thus can be made available to
travelers only through special legal and regulatory procedures.
Having received all necessary regulatory approvals, Intercell is
planning to start its global, multi-center Phase III trials in
September 2005.
About Intercell AG Intercell AG is a fast growing biotechnology
company focusing on the design and development of novel vaccines for
prevention and treatment of diseases with substantial unaddressed
medical need. The Company’s unique position is based on the
combination of antigens and immunizers (adjuvants) derived from its
proprietary technology platforms and its in-house GMP manufacturing
facilities. Intercell’s technology has been endorsed by collaborative
agreements with a number of global pharmaceutical companies,
including Sanofi Pasteur, Merck&Co., Inc., SciGen Ltd. and the
Statens Serum Institut. The Company has a broad development pipeline
with a vaccine for Japanese Encephalitis about to enter Phase III, a
vaccine for Hepatitis C undergoing Phase II trials, and five products
focused on infectious diseases in the pre-clinical phase. Intercell
is listed on the Vienna stock exchange under the symbol "ICLL".
This communication expressly or implicitly contains certain
forward-looking statements concerning Intercell AG and its business.
Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Intercell AG to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Intercell AG is providing this communication as of this date and does
not undertake to update any forward-looking statements contained
herein as a result of new information, future events or otherwise.
end of announcement                               euro adhoc 09.08.2005 07:48:06

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:
Börsen: Wiener Börse AG / official market

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Plus de actualités: Intercell AG