Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration
16 Septembre 2022 - 10:30PM
Valneva and IDT Biologika Agree on Termination of their COVID-19
Collaboration
Saint-Herblain
(France) and
Dessau-Roßlau
(Germany), September
16,
2022 – Valneva SE (Nasdaq: VALN;
Euronext Paris: VLA), a specialty vaccine company, and IDT
Biologika today announced they have agreed to terminate their
collaboration following the delivery of inactivated COVID-19 bulk
vaccine to Valneva, and considering the current order levels and
existing inventories.
As per the commercial manufacturing services
agreement signed in November 20211, IDT Biologika produced VLA2001
bulk vaccine at its Biosafety Level 3 facilities in Germany, and
Valneva bought the batches that were manufactured so far by IDT. In
light of the reduced European Commission order2, Valneva has
suspended manufacturing of the vaccine and, as compensation, will
pay IDT up to €36.2 million in cash and the equivalent of €4.5
million in kind, in the form of specified equipment purchased by
Valneva.
Valneva has started to deliver doses of VLA2001
to the European Member States who ordered the vaccine and is
retaining inventory for potential additional supply to these Member
States should demand increase. In parallel, the Company is
continuing discussions with various other governments around the
world, with the aim to deploy approximately eight to ten million
doses of remaining inventory into international markets in the next
six to twelve months.
About VLA2001VLA2001 is
produced on Valneva’s established Vero-cell platform, leveraging
the manufacturing technology for Valneva’s licensed Japanese
encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated
whole virus particles of SARS-CoV-2 with high S-protein density, in
combination with two adjuvants, alum and CpG 1018. This adjuvant
combination has consistently induced higher antibody levels in
preclinical experiments than alum-only formulations and shown a
shift of the immune response towards Th1. CpG 1018 adjuvant,
supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a
component of the US FDA- and EMA-approved HEPLISAV-B® vaccine.
VLA2001’s manufacturing process, which has already been upscaled to
final industrial scale, includes chemical inactivation to preserve
the native structure of the S-protein. VLA2001 is expected to
conform with standard cold chain requirements (2 to 8 degrees
Celsius).VLA2001 is the first COVID-19 vaccine to receive a
standard marketing authorization in Europe3 and the only whole
virus, inactivated, adjuvanted COVID-19 vaccine to receive
marketing authorization in Europe for use as primary vaccination in
people from 18 to 50 years of age. The vaccine was also granted
conditional marketing authorization in the United Kingdom4 and
emergency use authorization in the United Arab Emirates5 and
Kingdom of Bahrain6. Valneva currently has agreements to supply
VLA2001 to certain EU Member States7 and the Kingdom of Bahrain8.
In August 2022, the World Health Organization (WHO) issued
recommendations for use of VLA20019.
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 commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against Lyme disease and the chikungunya virus.
About IDT
BiologikaIDT Biologika is an innovative biotech
company with a successful history dating back 100 years. On the
basis of modern technologies and high levels of expertise, we
support customers in the development and manufacture of innovative
virus vaccines, gene and immune therapy products as well as
biologics employed worldwide as protection against diseases. German
sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the
US, the IDT Corporation has a manufacturing site for clinical test
samples in Rockville, Maryland.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineVP, Global Communications and European Investor
RelationsM +33 (0)6 4516
7099investors@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor RelationsM +001
917 815 4520joshua.drumm@valneva.com |
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Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the
manufacturing and commercialization plans for VLA2001. 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 future results. 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 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, the ability to obtain or maintain patent or
other proprietary intellectual property protection, the
cancellation of existing contracts, including but not limited to
the HMG Supply Agreement, and the impact of the COVID-19 pandemic,
the occurrence of any of which could substantially harm Valneva’s
business, financial condition, prospects and results of operations.
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 this press release as of the date hereof 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.
1 Valneva and IDT Biologika Announce Collaboration for
Production of Inactivated COVID-19 Vaccine VLA2001 - Valneva2
Valneva Confirms Amendment of Advance Purchase Agreement with
European Commission for Valneva’s Inactivated COVID-19 Vaccine -
Valneva3 Valneva Receives Marketing Authorization in Europe for
Inactivated Whole-Virus COVID-19 Vaccine VLA20014 Valneva Receives
Conditional Marketing Authorization from UK MHRA for its
Inactivated COVID-19 Vaccine5 Valneva Receives Emergency Use
Authorization from the United Arab Emirates for its Inactivated
COVID-19 Vaccine6 Valneva Receives Emergency Use Authorization from
Bahrain for its Inactivated COVID-19 Vaccine VLA20017 European
Commission Approves Purchase Agreement Amendment for Valneva’s
Inactivated COVID-19 Vaccine8 Valneva Signs Advance Purchase
Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA20019
Valneva Confirms WHO Recommendations for its Inactivated COVID-19
Vaccine
- 2022_09_16_VLA_IDT_Termination_PR_EN_Final
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