Valneva SE

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
indexes:     ATX Prime
stockmarkets: regulated dealing: Euronext Paris, regulated dealing/prime
             standard: Wien 
language:   English
 



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