Valneva and Emergent BioSolutions Join Forces
to Develop a Vaccine against the Zika Virus
- Valneva grants Emergent an exclusive worldwide license for its
Zika vaccine technology (ZIKV)
- Valneva and Emergent will co-develop the vaccine until the
release of Phase I data with operational responsibility for
Valneva
- Emergent has an option to continue product development upon the
release of Phase I data, in exchange for an initial €5 million
milestone payment, potential additional milestones of up to €44
million related to product development, approval,
commercialization, and product sales, and royalties on annual net
sales
- Agreement includes a technology transfer to Emergent's Bayview
manufacturing facility for Phase II/III production and future
commercial supplies
- Parties seek to commence Phase I in the US in late 2017 or
early 2018 and anticipate first Phase I data within six months
after trial initiation
Lyon (France), July 26, 2017 - Valneva SE (VLA),
a fully integrated, commercial stage biotech company focused on
developing innovative, life-saving vaccines, announces today that
it has granted Emergent BioSolutions Inc. (NYSE:EBS) exclusive
worldwide rights to its Zika vaccine technology ZIKV. Valneva and
Emergent will co-develop ZIKV-VLA1601, a highly purified
inactivated vaccine candidate against the Zika virus, which was
successfully developed by Valneva using the established inactivated
manufacturing platform of its licensed Japanese Encephalitis
vaccine IXIARO®/ JESPECT®.
Emergent and Valneva seek to initiate a Phase I
clinical trial in the U.S. in late 2017 or early 2018 and
anticipate Phase I data within six months after trial
initiation.
Franck Grimaud, President & Chief
Business Officer (CBO) of Valneva, commented "We are extremely
proud that Emergent recognizes the value of our vaccine platform
technology, our Zika product candidate and our competencies in the
field. We look forward to working jointly towards being among the
first companies in the world to generate a Zika vaccine."
Under the terms of the agreement, Emergent
receives an exclusive worldwide license for Valneva's Zika vaccine
technology. The parties will share all costs until the availability
of Phase I data in the US. Valneva will be responsible for the
program's execution until completion of the Phase I trial through a
joined governance structure.
Upon availability of Phase I data, Emergent has
an opt-in right at predefined terms and conditions, including an
opt-in milestone payment of €5 million, in addition to a €1 million
upfront payment paid on signing, potential additional milestone
payments of up to €44 million related to product development,
approval, commercialization, and product sales, and future
royalties on annual net sales.
The agreement also includes a technology
transfer to Emergent's Bayview manufacturing facility in Baltimore,
Maryland in the US for Phase II/III and any future commercial
manufacturing. Valneva retains a right of first negotiation for
potential product commercialization in Europe.
About Valneva's Zika vaccine candidate (ZIKV)
- VLA1601
VLA1601 is a highly Purified Inactivated Vaccine
("PIV") candidate against the Zika virus, developed using the same
manufacturing platform as Valneva's IXIARO® (JESPECT®) Japanese
Encephalitis ("JE") vaccine. Health authorities and Key
Opinion Leaders have expressed a preference for the PIV approach
over other vaccine technologies (such as live-attenuated
approaches) since the initial target population for a Zika vaccine
is expected to be women of child-bearing age, including those who
may be pregnant. There is a theoretical risk that live-attenuated
or replication competent viral vaccines given to pregnant women may
be capable of crossing the placenta and infecting the fetus. For
this reason, live vaccines are not recommended during pregnancy. In
pre-clinical development, VLA1601 demonstrated excellent purity and
had an overall biological, chemical and physical profile comparable
to the commercially produced JE vaccine, which means that a similar
safety and immunogenicity profile could be expected. Valneva has an
established manufacturing process in its dedicated clinical JE
vaccine facility.
About IXIARO®/JESPECT®
Valneva's Japanese encephalitis vaccine is
indicated for active immunization for the prevention of Japanese
encephalitis in persons who travel to or live in endemic areas.
IXIARO® is the only vaccine against Japanese encephalitis being
marketed to the US military as well as travelers from North America
or Europe visiting endemic countries.
IXIARO® is approved for use in individuals aged
2 months and older in the US, EU, Norway, Liechtenstein and
Iceland. In Canada, Hong Kong, Singapore, Israel and Switzerland,
IXIARO® is indicated for use in persons 18 years of age and above.
In Australia and New Zealand, the Japanese encephalitis vaccine is
marketed under the trade name JESPECT® and is indicated for use in
persons 18 years of age and above. In Europe, a rapid immunization
schedule (two doses in one week) is approved for IXIARO® in adults
between 18 and 65 years of age.
About Valneva SE
Valneva is a fully integrated, commercial stage
biotech company focused on developing innovative life-saving
vaccines.
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 and IC31®
adjuvant).
Valneva shares are tradable on Euronext-Paris,
the Vienna stock exchange and Deutsche Börse's electronic platform
Xetra®. The Company has operations in France, Austria, Great
Britain, Sweden, Canada and the US with over 400 employees. More
information is available at www.valneva.com.
Valneva Investor and Media Contacts:
Laetitia
Bachelot-Fontaine
Nina Waibel
Head of Investor Relations
Corporate Communications Specialist
& Corporate
Communications
T +43-1-206
20-1149
T
+02-28-07-14-19
M +43-676-84 55 67 19
M +33 (0)6 4516
7099
communications@valneva.com
investors@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 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 in this press
release will in fact be realized. Valneva is providing the
information in these materials as of the date of this press
release, and disclaims any intention or obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events, or otherwise.
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