Valneva Announces Signing of a New EB66®
Commercial License with Bavarian Nordic
- Valneva's EB66® cell-line licensed to Bavarian
Nordic for MVA-BN® based product candidates
- Valneva to support process development
Lyon (France), April 18, 2017 - Valneva
SE ("Valneva" or "the Company"), a fully integrated, commercial
stage biotech company focused on developing innovative lifesaving
vaccines, today announced that it has entered into a commercial
agreement with Danish biotech company Bavarian Nordic (OMX:
BAVA, OTC:BVNRY), for the production of poxvirus-based vaccines
using Valneva's EB66® cell-line technology.
The agreement grants Bavarian Nordic the rights
to develop and commercialize multiple poxvirus-based vaccines on
the EB66® cell-line.
Bavarian Nordic's vaccine candidates are
currently produced on chicken embryonic fibroblast (CEF) and the
company will explore the potential of switching to Valneva's EB66®
technology.
Valneva will support Bavarian Nordic in
establishing and optimizing the manufacturing process on EB66® for
future large scale industrialization under a dedicated service
agreement.
Thomas Lingelbach, CEO, and Franck Grimaud,
Deputy CEO of Valneva, commented, "This new partnership is of
significant strategic importance for Valneva as it could be the
first time that a late stage clinical vaccine development program
is transferred to our EB66®cell line and could therefore set a
precedent. We look forward to Bavarian Nordic's clinical results
and are pleased to support them on their development route."
In a recent scientific article published by
Elsevier, one of the world's major providers of scientific
information, the EB66® cell line demonstrated to be a valuable cell
substrate for Modified Vaccinia Ankara ("MVA")-based vaccine
production showing that EB66® cells are highly permissive to
recombinant MVA viruses and that it is possible to manufacture and
purify a recombinant MVA virus at the clinical production scale
(100 L) in a three-week timeframe[1].
Financial terms of the agreements were not
disclosed but do include upfront payments, milestones and future
royalties on sales.
About the EB66® Cell Line
Valneva's EB66® cell line is a highly efficient
platform for vaccine production. It is derived from duck embryonic
stem cells and today represents a compelling alternative to the use
of chicken eggs for large scale manufacturing of human and
veterinary vaccines. EB66® is one of the most extensively studied
and characterized cell line available for use in human vaccine
development. More than 20 different families of viruses have been
shown to efficiently propagate in EB66® cells. To date, Valneva has
more than 35 license agreements with some of the world's largest
pharmaceutical companies for the use of its EB66® cell line
technology in both human and animal health vaccines. The first
human vaccine produced using the EB66® technology received
marketing approval in 2014 and the first veterinary vaccine in
2012.
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
The Company seeks financial returns through
focused R&D investments in promising product candidates and
growing financial contributions from commercial products, striving
towards financial self-sustainability.
Valneva's portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has proprietary vaccines in
development including candidates against Clostridium difficile and
Lyme disease. A variety of partnerships with leading pharmaceutical
companies complement the Company's value proposition and include
vaccines being developed using Valneva's innovative and validated
technology platforms (EB66® vaccine production cell line, IC31®
adjuvant).
Valneva is listed on Euronext-Paris and the
Vienna stock exchange and has operations in France, Austria, Great
Britain, Sweden, Canada and the US with over 400 employees. More
information is available at www.valneva.com.
Contact Valneva
SE Laetitia Bachelot-Fontaine Head of Investor Relations &
Corporate Communications T +02-28-07-14-19 M +33 (0)6 4516 7099
investors@valneva.com |
Nina Waibel
Corporate Communications Specialist T +43-1-206 20-1149
communications@valneva.com |
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 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, or otherwise.
[1] Arnaud et al. "The EB66® cell line as a valuable cell
substrate for MVA-based vaccines production", Elsevier, Vaccine
Volume 34, Issue 48, 21 November 2016, Pages 5878-5885,
http://www.sciencedirect.com/science/article/pii/S0264410X16309781
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/8e9c99a8-fc4f-4c0f-a470-012efa29e3c5