Valneva Receives Notice of Termination of COVID-19 Vaccine Supply Agreement by UK Government
13 September 2021 - 07:00AM
Saint-Herblain
(France),
September 13,
2021 – Valneva SE, a specialty vaccine company,
today announced that it has received a termination notice from the
UK Government (“HMG”) in relation to the Supply Agreement for its
COVID-19 vaccine candidate, VLA2001. The contract provides HMG with
the right to terminate. HMG has alleged that the Company is in
breach of its obligations under the Supply Agreement, but the
Company strenuously denies this.
Valneva is continuing its VLA2001 development
plan. Testing for the Company’s pivotal Phase 3 trial, Cov-Compare,
is ongoing at Public Health England (“PHE”). Valneva recently
announced that its Phase 3 results are expected to be available
early in the fourth quarter and that these results will form part
of its rolling submission for conditional approval of VLA2001 with
the UK’s Medicines and Healthcare products Regulatory Agency
(“MHRA”). Subject to these data and MHRA approval, Valneva believes
that initial approval for VLA2001 could be granted in late
2021.
Valneva has worked tirelessly, and to its best
efforts, on the collaboration with HMG including investing
significant resources and effort to respond to HMG’s requests for
variant-derived vaccines. Valneva continues to be committed to the
development of VLA2001 and will increase its efforts with other
potential customers to ensure that its inactivated vaccine can be
used in the fight against the pandemic.
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 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, beginning
with the identification of deadly and debilitating infectious
diseases that lack a prophylactic vaccine solution and for which
there are limited therapeutic treatment options. It then applies
its deep understanding of vaccine science, including its expertise
across multiple vaccine modalities, as well as its established
vaccine development capabilities, to develop prophylactic vaccines
to address these diseases. The Company 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,
COVID-19 and the chikungunya virus.
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 the progress,
timing, design, data read-outs, anticipated results and completion
of clinical trials 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.
- 2021_09_13_VLA_HMG_PR_EN_Final