Valneva Announces Major COVID-19 Vaccine Partnership with U.K.
Government
· UK Government has secured
supply of 60 million doses at a cost of €470 million
with options over another 130 million doses between 2022
and 2025
- UK Government invests in Valneva’s manufacturing
facility in Livingston, Scotland, to support scale up, creating
major UK vaccine facility
- Inactivated, adjuvanted, two-dose SARS-COV-2 vaccine
candidate scheduled to enter first clinical studies in December
2020
- Combines Valneva’s proven approach with Dynavax CpG
1018 adjuvant
Saint-Herblain (France), September 14th,
2020 – Valneva SE, a specialty vaccine company focused on
prevention against diseases with major unmet needs, today announced
a vaccine partnership with the UK government for its inactivated
COVID-19 vaccine, VLA2001.
Under the agreement, if vaccine development is
successful, Valneva will provide the UK government with 60 million
doses in the second half of 2021. UK Government then has options
over 40 million doses in 2022 and a further 30 million to 90
million doses, in aggregate, across 2023 to 2025. Revenue from
these options could amount to almost €900 million. Valneva’s
inactivated SARS-CoV-2 vaccine is expected to have a two dose
regimen. UK government is also investing up-front in the scale up
and development of the vaccine, with the investment being recouped
against the vaccine supply under the partnership. The agreement
follows the initial intent to participate in the UK Government’s
COVID-19 vaccine response announced in July.
David Lawrence, Chief Financial Officer
of Valneva, said “Our proven track record and
manufacturing capability in Scotland underpins this partnership.
Through our recent discussions we’ve built a great working
relationship with UK Government. I’d like to acknowledge the
contributions of UK government task force and colleagues as well as
other stakeholders including West Lothian, Scottish and UK
politicians who are supporting the ongoing work. We see a fantastic
spirit across all stakeholders to make this partnership
succeed.”
Thomas Lingelbach, CEO of
Valneva, commented, “We made the early decision to choose
a proven and well-established inactivated vaccine approach which is
further validated by this partnership. We are honoured to have been
chosen by the UK Government and are eager to partner with them to
address this terrible ongoing pandemic. This is another
transformational step for Valneva following the Lyme partnership we
signed earlier this year and our chikungunya vaccine commencing
Phase 3 clinical studies last week. ”
U.K. Business Secretary Alok
Sharma, said, “Having visited Valneva just last month, I
have seen first-hand the incredible work they are doing to develop
and manufacture a Covid-19 vaccine. This new agreement could
help us vaccinate millions of people across the country, as well as
help create a UK vaccine manufacturing facility to speed up access
to a potential Covid-19 candidate and boost the country’s
resilience against future pandemics.”
Valneva’s vaccine candidate, VLA2001, is based
on a proven approach and will leverage the company’s existing
manufacturing platform being used for its US FDA and EMA approved
Japanese Encephalitis (JE) vaccine. VLA2001 is expected to enter
clinical studies at the end of 2020 and, if the clinical
development is successful, a first regulatory approval may be
granted in the second half of 2021.
Valneva had previously announced an agreement in
principle with the UK government for the supply of vaccine doses1
and a binding preliminary agreement to support expansion of its
UK-based manufacturing facilities2.
About the Novel Coronavirus SARS-CoV-2
and COVID-19 DiseaseSARS-CoV-2 is a new coronavirus
identified in late 2019 and belongs to a family of enveloped RNA
viruses that include MERS and SARS, both of which caused serious
human infections of respiratory system. The virus, which causes a
disease named COVID-19, has never before been found in humans.
Since this outbreak was first reported in late-2019, the virus has
infected over 29 million people and has caused over 900,000
reported deaths globally (as of September 13, 2020). It has been
declared a pandemic by the World Health Organization (WHO).
Currently, there is no vaccine available for COVID-19.
About VLA 2001VLA2001 is a
Vero-cell based, highly purified inactivated vaccine candidate
against the SARS-COV-2 virus, leveraging the manufacturing
technology for Valneva’s Japanese Encephalitis Vaccine. The Company
has designed a process that largely uses this platform in regard to
upstream and downstream process steps as plug-and-play with
moderate adjustments. The process includes inactivation with BPL to
preserve the native structure of the S protein. The combination
with CpG 1018 is expected to induce a strong immune response and
has the potential to generate high titers of neutralizing
antibodies.VLA2001 is expected to conform with standard cold chain
requirements (2 degrees to 8 degrees centigrade).
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. 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 various vaccines in
development including unique vaccines against Lyme disease,
chikungunya and COVID-19. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit www.valneva.com and
follow the Company on LinkedIn.
Valneva
Investor and Media ContactsDavid LawrenceChief Financial
Officer+447908627213 Laetitia Bachelot-FontaineDirector
Investor Relations & Corporate CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
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1 Valneva Confirms Participation in UK Government COVID-19
Vaccine Response Program
2 Valneva Reports H1 Results Marked by Major Corporate
Achievements and Strong Cash Position
- 2020_09_14_VLA_COVID-19_Contract_UKGov_PR_EN_FINAL
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