euro adhoc: Intercell AG / other / Intercell receives CHMP positive opinion for the approval of IXIARO® in Europe - A vaccine against Japanese Encephalitis (E)

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15.12.2008

» IXIARO® receives positive opinion from European Committee for Human
Medicinal Products (CHMP)
» First licensed vaccine against Japanese Encephalitis for travelers and
military personnel to enter markets in Europe
» Commercial product launch in the U.S., Europe and Australia expected in
early 2009

Vienna, Austria, December 15, 2008 - Intercell AG (VSE: ICLL) today announced
that the CHMP of the European Medicines Agency (EMEA) has come to a positive
opinion on the Marketing Authorisation for IXIARO®, a vaccine against Japanese
Encephalitis (JE).

JE is a deadly infectious disease found mainly in Asia. 30-50,000 cases of JE
are reported in Asia each year. JE is fatal in approximately 30% of those
persons who manifest JE and leaves one-half of survivors with permanent brain
damage. As there is no specific treatment for JE, health care experts recommend
vaccination as the only protection for the millions of travelers and military
personnel who live in or travel to areas where the virus circulates.
Consequently the initial target for use of Intercell´s vaccine will be adult
civilian travelers and military personnel who visit or are deployed to affected
countries, including India, China, Southeast and Southwest Asia.

"The CHMP positive opinion is great news for the global health care system as
with IXIARO®, European travelers will have access to an efficacious and safe
vaccine to protect from the devastating effects of Japanese Encephalitis," said
Intercell's Chief Executive Officer, Gerd Zettlmeissl. IXIARO® will be the first
vaccine ever licensed in Europe to protect against JE. "It is great news for
Intercell as well, as our first product ever IXIARO® will from now on provide
the company with significant product sales," adds Zettlmeissl.

Intercell's vaccine is a purified, inactivated product for active immunization
against viral infections of Japanese Encephalitis. IXIARO® is manufactured in
Intercell´s proprietary manufacturing facility in Scotland and is prepared using
tissue culture rather than live organisms. Novartis AG holds marketing and
distribution rights for Intercell's Japanese Encephalitis vaccine, trade named
IXIARO®, in the United States, Europe and certain other markets in Asia and
Latin America.

Up to approval the vaccine was tested in a series of clinical trials with around
5000 individuals. The total development time of this vaccine from research to
approval took more than 10 years, required a total investment of more than EUR
100 m.

A single Marketing Authorization covering all 27 member states of the European
Union as well as Norway and Island will follow as a next step and will allow for
the planned market launch in early 2009. This will then also trigger a EUR 10 m
milestone payment by Novartis. State control testing by the "Official Medicines
Control Laboratories" (Paul Ehrlich Institut, Germany and National Institute for
Biological Standards and Control UK) for vaccine lots intended to be supplied
into the European markets, will be initiated shortly.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to
50,000 a year, causing 10-15,000 deaths. Up to 50% of survivors have persistent
neurological sequelae. Japanese Encephalitis is the leading cause of viral
neurological disease and disability in Asia and the most important viral
encephalitis in Asia. The disease is most common in several developing countries
in Asia. No treatment is currently available; only vaccination effectively
prevents the disease. Though other vaccines have been available in the past, use
of those products has been limited by reports of neurological reactions.

About Intercell's JE vaccine

Intercell's novel 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. The vaccine was developed for over 10 years under a Collaborative
Research and Development Agreement (CRADA) with the Walter Reed Army Institute
of Research (WRAIR).

Intercell's Phase III trials for the vaccine found that the vaccine demonstrated
excellent immunogenicity against Japanese Encephalitis and an overall clinical
safety profile similar to placebo combined with an excellent local tolerability
profile. That data was published in The Lancet in December 2007:

» The immunogenicity was comparable to that of the U.S. licensed product,
JE-VAX®
» Intercell's vaccine demonstrated an overall clinical safety profile similar
to placebo
» Further, Intercell's JE vaccine had an excellent local tolerability profile
in the head-to-head study with JE-VAX®

Further inquiry note:
Intercell AG
Lucia Malfent
Head of Corporate Communications
Tel. +43 1 20620-1303
[email protected]

end of announcement euro adhoc
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emitter: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: [email protected]
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime, ATX
stockmarkets: official market: Wiener Börse AG
language: English

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