Valneva SE

EANS-News: Valneva SE
Biological E's Japanese Encephalitis vaccine prequalified by the World Health Organization

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Joint Ventures/Cooperation/Collaboration

Hyderabad, India / Lyon, France (euro adhoc) - Hyderabad, India / Lyon, France
July 22 2013 - Indian Biopharmaceutical company Biological E (BioE) and European
biotech company Valneva SE (Valneva) today announced that the World Health
Organization (WHO) has awarded prequalification for global use in adults of
BioE's Japanese Encephalitis vaccine. This is the first prequalification of a
Japanese Encephalitis vaccine, and is a key step in ensuring the vaccine can be
distributed to developing countries. BioE also expects the pediatric indication
to be prequalified by the end of the year. 

Ms Mahima Datla, Managing Director, Biological E Limited said, "We are happy
that our JE vaccine is the first ever WHO prequalified JE vaccine. It is an
extremely important achievement for the vaccines community as our vaccine's
prequalification is well in time to support GAVI's plans of introducing the JE
vaccine in several developing countries." 

Thomas Lingelbach, Valneva's President and Chief Executive Officer and Franck
Grimaud, Valneva's President and Chief Business Officer, also commented, "We
share the excitement for this great achievement and are pleased that our
technology used for IXIARO® will now help introducing an excellent vaccine in
countries of substantial needs." (IXIARO® is an FDA and EMA approved vaccine). 

Biological E and Valneva (ex Intercell) established a partnership in 2005 for
the development and commercialization of a Japanese encephalitis vaccine for
endemic regions, based on Valneva's JEV technology. The vaccine, which was
successfully developed under this partnership, is being marketed in India under
the trade-name JEEV® and commercialization in other JE-endemic countries is
planned.

Biological E has emerged as a fast growing company. It was in the news recently
for entering into a five year Pentavalent supply arrangement with GAVI, for
forming a Joint Venture with GlaxoSmithKline (GSK)  to create a six-in-one
paediatric vaccine combining GSK's IPV and BioE's pentavalent vaccine and for
licensing Novartis's Phase II Typhoid Conjugate vaccine. 


Media contacts

Divya Bijlwan
Associate Vice President
Strategic Operations and Planning   
Biological E Limited
T +91-40-30214092
Email: divya.bijlwan@biologicale.co.in


Valneva SE
Laetitia Bachelot- Fontaine
Investor Relations and Communication Manager
T +33 2 28 07 37 10
M + 33 6 45 16 70 99
E Communications@valneva.com 


About Japanese Encephalitis
Japanese encephalitis is a disease caused by a flavivirus that affects the
membranes around the brain. Approximately 1 in 200 infections results in severe
disease characterized by rapid onset of high fever, headache, neck stiffness,
disorientation, coma, seizures, spastic paralysis and death. The case fatality
rate can be as high as 60% among those with disease symptoms; 30% of those who
survive suffer from lasting damage to the central nervous system. The severity
of JE infections has been recognized by the medical community and the global
health authorities have emphasized the need for routine vaccination, campaigns
and travelers vaccine for endemic countries.  The disease is endemic to many
regions in Asia and South East Asia including in India, Bangladesh, Bhutan,
Myanmar, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Sri
Lanka, Thailand and Vietnam. 


About Biological E Limited
Biological E Limited is a leading Indian life sciences company established in
1953. It is a globally focused biopharmaceutical company and develops,
manufactures and markets innovative vaccines and biologics that respond to
health care needs worldwide. The company exports various vaccines to several
countries. The company's product development efforts are driven by an
internationally experienced management team and the company has several
strategic partnerships with leading biotechnology and pharmaceutical companies
and research institutes around the world. 
www.biologicale.com

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 antibody discovery technology, and the IC31® adjuvant) developed
by Valneva that are becoming widely adopted by the biopharmaceutical industry
worldwide. Headquarted in Lyon, France, the company employs approximately 350
people in France, Austria, Scotland, the United States, and Japan. The
internationally experienced management team has a proven track-record across
research, development, manufacturing, and commercialization
www.valneva.com

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the
business of Biological E and 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 Biological E and Valneva are consistent with the forward-looking
statements contained in this press release, those results or developments of
Biological E and 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 Biological E and
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 Biological E and
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. Biological E and Valneva are 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, or 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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company:     Valneva SE
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phone:       +33 4 78 76 61 01
mail:     communications@valneva.com
WWW:      www.valneva.com
sector:      Biotechnology
ISIN:        FR0004056851
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language:   English
 

 


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