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

Geschrieben am 15-12-2008


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New Products

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®


end of announcement euro adhoc
--------------------------------------------------------------------------------


ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Intercell AG

Lucia Malfent

Head of Corporate Communications

Tel. +43 1 20620-1303

lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wiener Börse AG / official market


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