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

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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
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