Valneva Provides Update on IXIARO® Supply Contract with U.S. Department of Defense
18 Août 2022 - 7:00AM
Saint Herblain
(France), August
18,
2022 – Valneva SE (Nasdaq: VALN;
Euronext Paris: VLA) a specialty vaccine company, today announced
that the U.S. Department of Defense (DoD) has decided not to
exercise the second option year of the contract1 to supply
Valneva’s Japanese encephalitis (JE) vaccine IXIARO®.
Due to the past and ongoing impact of the
COVID-19 pandemic on its operations, the DoD considers its existing
IXIARO® supply levels sufficient to meet current needs. The DoD has
communicated an interest in negotiating a new supply contract in
2023, once inventory returns to standard levels. The Company
expects no impact on its 2022 financial guidance as a result of
this decision and will continue deliveries of IXIARO® pursuant to
the terms of the first option year, which the DoD exercised with
amended terms2, through the fourth quarter of 2022. The DoD has
relied on IXIARO® since 2010 to help protect personnel who are
deployed to JE endemic areas, for whom JE vaccination is
recommended.
The total minimum value of the existing supply
contract was approximately $118 million, assuming the exercise of
the second option year, which had a minimum value of approximately
$36 million for 250,000 doses.
Thomas
Lingelbach,
President and Chief
Executive Officer of
Valneva, commented: “We thank the DoD for
their partnership and look forward to further contract negotiations
in the future. In parallel, we continue to see significant recovery
in the private travel market for IXIARO®, which more than tripled
in the first half of this year compared to the first half of
2021.”
About IXIARO®/JESPECT®
Valneva’s Japanese encephalitis vaccine is
indicated for active immunization for the prevention of the disease
for people who travel to, or live in, endemic areas. It has
received marketing approval in the U.S., Europe, Canada, Hong Kong,
Singapore, and Israel under the trade name IXIARO® and in Australia
and New Zealand where it is marketed as JESPECT®. It is the only
vaccine available to the U.S. military for Japanese Encephalitis.
IXIARO® is approved for use in individuals two months of age and
older in the U.S. and EU member states, Canada, Norway,
Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic
of Korea and Israel. In all other licensed territories,
IXIARO®/JESPECT® is indicated for use in persons aged 18 years or
more.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious
disease found mainly in Asia. About 70,000 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.
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, India and China, a region
with a population of more than three billion. In 2005, JE killed
more than 1,200 children in only one month during an epidemic
outbreak in Uttar Pradesh, India, and Nepal.
About Valneva SEValneva is a
specialty vaccine company focused on the development and
commercialization of prophylactic vaccines for infectious diseases
with significant unmet medical need. The Company takes a highly
specialized and targeted approach to vaccine development and then
applies its deep understanding of vaccine science to develop
prophylactic vaccines addressing these diseases. Valneva has
leveraged its expertise and capabilities both to successfully
commercialize two vaccines and to rapidly advance a broad range of
vaccine candidates into and through the clinic, including
candidates against Lyme disease, the chikungunya virus and
COVID-19.
Media
& Investor ContactsLaëtitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to prospects for
future contracts. 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 sustained 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. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
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 Valneva Announces New IXIARO® Supply Contract with the US
Government worth up to $166 million2 Valneva: U.S. DoD Exercises
First Year Option on IXIARO® Supply Contract
- 2022_08_18_VLA_DoD_Option_PR_EN final
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