Intercell AG

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

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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.

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ots Originaltext: Intercell AG
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Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303

Branche: Biotechnology
ISIN:      AT0000612601
B√∂rsen:  Wiener B√∂rse AG / official market

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