Valneva Receives Notice of European Commission’s Intent to Terminate COVID-19 Vaccine Purchase Agreement
16 Mai 2022 - 7:15AM
Saint-Herblain
(France),
May 16,
2022 – Valneva
SE, a specialty vaccine company, today announced that it has
received a notice from the European Commission (“EC”) of intent to
terminate the advance purchase agreement (“APA”) for Valneva’s
inactivated whole-virus COVID-19 vaccine candidate VLA2001.
The APA provides the EC with a right to
terminate the APA if VLA2001 had not received a marketing
authorization from the European Medicines Agency (“EMA”) by April
30, 2022. Based on the terms of the APA, Valneva has 30 days from
May 13, 2022 to obtain a marketing authorization or propose an
acceptable remediation plan.
The Company will work with the EC and the
participating EC member states to agree to a remediation plan and
to make VLA2001 available to those member states who still wish to
receive it.
Thomas Lingelbach, Chief Executive
Officer of Valneva, commented, “the EC
decision is regrettable especially as we continue to receive
messages from Europeans who are looking for a more traditional
vaccine solution. We have started a dialogue with member states who
are interested in our inactivated approach. Valneva continues to
believe that its vaccine candidate VLA2001 can make an important
contribution to the fight against COVID-19 and complement existing
vaccines with an inactivated, whole virus approach”.
The Company announced on April 25, 20221 that it
received a further List of Questions (“LoQ”) from the Committee for
Medicinal Products for Human Use (“CHMP”) of the EMA. Valneva
submitted its responses on May 2, 2022 and believes that they
adequately address the remaining questions. If the CHMP accepts
Valneva’s responses, the Company would expect to receive a positive
CHMP opinion at the latest in June 2022.
VLA2001 received a Conditional Marketing
Authorization from the Medicines and Healthcare products Regulatory
Agency in the United Kingdom on April 14, 20222 and Emergency Use
Authorizations from the Ministry of Health & Prevention of the
United Arab Emirates and from the National Health Regulatory
Authority in Bahrain on May 13, 2022 and on February 28, 20223,
respectively.
If the EC ultimately terminates the APA, Valneva
will not be required to return the down payments received since
Valneva has committed the full amount of those down payments and
the APA does not require reimbursement of such payments under these
circumstances.
Based on the outcome of the discussions with the
EC and the relevant member states, Valneva will reconsider its
full-year 2022 financial guidance.
The Company will hold an analyst call and a
webcast at 3:00pm CEST or 9:00am EDT. The webcast details will be
available on the Company’s website.
About VLA2001VLA2001 is
currently the only whole virus, inactivated, adjuvanted vaccine
candidate in clinical trials against COVID-19 in Europe. It is
intended for active immunization of at-risk populations to prevent
carriage and symptomatic infection with COVID-19 during the ongoing
pandemic and potentially later for routine vaccination including
addressing new variants. VLA2001 may also be suited for boosting,
as repeat booster vaccinations have been shown to work well with
whole virus inactivated vaccines. VLA2001 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).
About Valneva SE
Valneva 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 possible
regulatory approval of 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 and the impact of the COVID-19 pandemic. 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 Provides Regulatory Update on its inactivated COVID-19
Vaccine Candidate2 Valneva Receives Conditional Marketing
Authorization from UK MHRA for its Inactivated COVID-19 Vaccine –
Valneva3 Valneva Receives Emergency Use Authorization from Bahrain
for its Inactivated COVID-19 Vaccine VLA2001 – Valneva
- 2022_05_16_EC APA_Notice_PR_EN_Final
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