EANS-Adhoc: Valneva SE / ACIP Unanimously Votes to Extend the Recommendations for Use of IXIARO® Vaccine

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21.06.2013

Lyon (France), June 21, 2013 - Valneva SE today announced that the
U.S. Centers for Disease Control and Prevention (CDC) Advisory
Committee on Immunization Practices (ACIP) approved by unanimous vote
on June 19, 2013 to extend the current JE vaccination recommendations
for use of IXIARO® to include travelling individuals aged 2 months
and above.

The ACIP's last recommendations for vaccination against JE were
issued in June 2009 and published by CDC in Morbidity and Mortality
Weekly Report (MMWR) in March 2010. At that time, IXIARO® was only
approved by the U.S. Food and Drug Administration (FDA) for use in
person 17 years of age and older.

The ACIP's new recommendations follow the marketing approval for
IXIARO® in individuals aged 2 months and above from the FDA which
Valneva received on May 17, 2013. IXIARO® is developed by Valneva SE
and the rights to market and distribute the vaccine to the private
sector in the United States are held by Novartis Vaccines.

"Valneva is pleased that the ACIP has extended the JE vaccination
recommendations for IXIARO® to include infants, children and
adolescents. Following FDA's recent approval for pediatric use of
IXIARO®, this marks a successful conclusion of a major step in
supporting vaccination of traveling children against a potentially
devastating disease. We hope that ACIP and CDC will extend the JE
vaccination recommendations for use of IXIARO® even further and we
trust, in accordance with the new May 2013 JE guidance issued by the
Assistant Secretary of Defense for Health Affairs, that the U.S.
military will follow these new ACIP recommendations for immunizing
military dependents residing in endemic countries of Asia", Thomas
Lingelbach, President and Chief Executive Officer and Franck Grimaud,
President and Chief Business Officer of Valneva stated.

The ACIP vote followed a presentation by Valneva of clinical trial
data showing that IXIARO®, administered at a dose of 0.25 mL in
children aged ?2 months to <3 years and 0.5 mL in children aged 3
years and older, induced a seroprotection rate exceeding 99% and had
a safety profile that was comparable to that of routinely used
pediatric vaccines against other diseases (7-valent pneumococcal
conjugate vaccine and inactivated Hepatitis A virus vaccine).

The ACIP consists of 15 experts in fields associated with
immunization who have been selected by the Secretary of the U.S.
Department of Health and Human Services to provide advice and
guidance on the control of vaccine-preventable diseases. ACIP
develops written recommendations for the routine administration of
vaccines to children and adults in the civilian population. The ACIP
is the only entity in the federal government that makes such
recommendations.

Contacts:

Valneva
Laetitia Bachelot-Fontaine
Communications@valneva.com
T +33 228 07 37 10

NewCap
Axelle Vuillermet / Pierre Laurent
Valneva@newcap.fr
T +33 (0)1 44 71 94 93

About Valneva SE Valneva is a new European biotech company focused on
vaccine development and antibody discovery. It was created in 2013
through the merger between Intercell AG and Vivalis SA. Valneva's
mission is to excel in both antibody discovery, and vaccine
development and commercialization, either through in-house programs
or in collaboration with industrial partners using innovative
technologies developed by the company. Valneva generates diversified
revenue from both its marketed product, a vaccine for the prevention
of Japanese encephalitis (IXIARO®),commercial partnerships around a
portfolio of product candidates (in-house and partnered), and
licensed technology platforms (EB66®cell line, VIVA|ScreenTM and
IC31®)developed by Valneva that are becoming widely adopted by the
biopharmaceutical industry. www.valneva.com

About Japanese Encephalitis Japanese Encephalitis (JE) is a deadly
infectious disease found mainly in Asia. 67,900 cases of JE are
estimated to occur in Asia each year, although the actual number of
cases is likely much higher due to underreporting in rural areas and
other factors. JE is fatal in approximately 30 percent of those who
show symptoms, and leaves half of survivors with permanent brain
damage. The disease is endemic in Southeast Asia, a region with more
than 3 billion inhabitants. Only within 1 month in the year 2005,
Japanese Encephalitis killed more than 1,200 children during an
epidemic outbreak in Uttar Pradesh, India, and Nepal.

About IXIARO®/JESPECT® Valneva's Japanese Encephalitis vaccine is a
purified, inactivated vaccine for active immunization against the
Japanese Encephalitis virus. The total development time of this
vaccine was more than 10 years. The vaccine was developed under a
Collaborative Research and Development Agreement with the Walter Reed
Army Institute of Research, a biomedical research laboratory of the
U.S. Department of Defense. Valneva's Phase III trials for the
approval of the vaccine in adults found that the vaccine demonstrated
excellent immunogenicity against Japanese Encephalitis and an overall
clinical safety profile similar to the control arm, combined with an
excellent local tolerability profile. These data were published in
The Lancet in December 2007:

? The immunogenicity was comparable to that of the, then still
marketed, U.S. licensed product, JE?VAX®. ? Valneva's vaccine
demonstrated an overall clinical safety profile similar to the
control arm.

Further, Valneva's Japanese Encephalitis vaccine had a more favorable
local tolerability profile in the head?to?head study with JE?VAX®.

In pediatric studies, the JE vaccine showed to be highly immunogenic
in children aged 2 months to <18 years with a safety profile
comparable to pediatric vaccines licensed for other diseases.

Novartis distributes the vaccine to North America and Europe as well
as Hong Kong and Singapore (IXIARO®), whereas bioCSL distributes the
vaccine in Australia and New Zealand (JESPECT®).Please refer to the
Product / Prescribing information (PI) / Medication Guide approved in
your respective countries for complete information including safety
about this vaccine and details for reporting adverse events or
inadvertent use in pregnant women/nursing mothers.

Important Safety Information IXIARO is a vaccine indicated for the
prevention of disease caused by Japanese encephalitis virus (JEV).
IXIARO is approved for use in individuals 2 months of age and older
in the US and EU member states, Norway, Liechtenstein and Iceland. In
all other licensed territories, IXIARO®/JESPECT® is indicated for use
in persons 18 years of age and above. You should not receive this
vaccine if you have had an allergic reaction to IXIARO®/JESPECT® or
any other Japanese Encephalitis Virus vaccine. This vaccine contains
protamine sulfate, which may cause allergic reactions in some people.
Tell your doctor if you have had an allergic reaction to protamine
sulfate or any other JE vaccine before you receive this vaccine.
After you are vaccinated, tell your doctor if you have any of the
following problems because these may be signs of an allergic
reaction: difficulty breathing, hoarseness or wheezing, hives,
dizziness, weakness, or fast heartbeat. IXIARO®/JESPECT® may not
fully protect everyone who gets the vaccine. IXIARO®/JESPECT® does
not protect against encephalitis caused by other viruses/pathogens.
IXIARO®/JESPECT® does not protect against other diseases transmitted
by mosquitoes. This vaccine is given in 2 doses. Dose 2 is scheduled
28 days after Dose 1. Make sure you receive both doses. It is very
important that you receive the 2nd dose of the vaccine at least 7
days before potential exposure to the virus. If you had been
previously vaccinated with IXIARO®/JESPECT®, consult with your doctor
if you need a booster dose. Make sure your doctor knows if you have a
weakened immune system or are using medicines that may weaken the
immune system. Tell your doctor if you are pregnant. The most common
side effects in adolescents >12 years of age and adults are headache,
muscle pain and injection site reactions (e.g., pain, swelling,
tenderness, redness). Nausea, skin rash, fatigue, flu-like illness,
fever, irritability and loss of appetite may also occur. The most
common side effects in children below the age of 12 years are fever,
irritability, diarrhea, vomiting, loss of appetite, injection site
pain and injection site redness.

Forward-Looking Statements This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing and completion of
research, development and clinical trials for product candidates, the
ability to manufacture, market, commercialize and achieve market
acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing on
the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. In addition, even if the actual results or development of
Valneva are consistent with the forward-looking statements contained
in this press release, those results or developments of Valneva may
not be indicative of their achievement in the future. In some cases,
you can identify forward-looking statements by words such as "could,"
"should," "may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and are
subject to a number of known and unknown risks and uncertainties and
other factors that may cause actual results, performance or
achievements to be materially different from any future results,
performance or achievement expressed or implied by these
forward-looking statements. In particular, the expectations of
Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. In light of these risks and uncertainties, there can be
no assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release, and disclaim
any intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events nor otherwise.

Further inquiry note:
Valneva SE
Laetitia Bachelot-Fontaine
Communications@valneva.com
T +33 228 07 37 10

end of announcement euro adhoc
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issuer: Valneva SE
Gerland Plaza Techsud, 70, rue Saint Jean de Dieu
F-69007 Lyon
phone: +33 4 78 76 61 01
mail: communications@valneva.com
WWW: www.valneva.com
sector: Biotechnology
ISIN: FR0004056851
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