Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Federal Government

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| Source: VALNEVA

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· UK Government has secured supply of 60 million doses at an expense of EUR470 million with options over another 130 million dosages between 2022 and 2025

  • UK Federal government buys Valneva’s production facility in Livingston, Scotland, to support scale up, developing major UK vaccine facility
  • Suspended, adjuvanted, two-dose SARS-COV-2 vaccine candidate scheduled to get in first medical studies in December 2020
    • Combines Valneva’s proven method with Dynavax CpG 1018 adjuvant

Saint-Herblain (France), September 14 th, 2020— Valneva SE, a specialty vaccine company concentrated on avoidance versus diseases with significant unmet requirements, today revealed a vaccine partnership with the UK federal government for its suspended COVID-19 vaccine, VLA2001

Under the contract, if vaccine development achieves success, Valneva will provide the UK government with 60 million doses in the second half of2021 UK Federal government then has choices over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to2025 Income from these options could amount to practically EUR900 million. Valneva’s suspended SARS-CoV-2 vaccine is anticipated to have a two dosage routine. UK government is likewise investing up-front in the scale up and advancement of the vaccine, with the financial investment being recovered versus the vaccine supply under the collaboration. The contract follows the preliminary intent to take part in the UK Federal government’s COVID-19 vaccine reaction revealed in July.

David Lawrence, Chief Financial Officer of Valneva, said “Our proven performance history and manufacturing capability in Scotland underpins this partnership. Through our recent conversations we have actually developed a fantastic working relationship with UK Federal government. I want to acknowledge the contributions of UK federal government job force and associates in addition to other stakeholders including West Lothian, Scottish and UK political leaders who are supporting the ongoing work. We see a fantastic spirit throughout all stakeholders to make this partnership be successful.”

Thomas Lingelbach, CEO of Valneva, commented, “We made the early choice to select a tested and reputable inactivated vaccine method which is additional 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 awful continuous pandemic. This is another transformational step for Valneva following the Lyme partnership we signed previously this year and our chikungunya vaccine beginning Stage 3 scientific research studies recently. “

U.K. Company Secretary Alok Sharma, said, “Having visited Valneva simply last month, I have seen first-hand the incredible work they are doing to develop and manufacture a Covid-19 vaccine. This new agreement might assist us immunize millions of people throughout the nation, in addition to assistance develop a UK vaccine manufacturing facility to speed up access to a potential Covid-19 candidate and boost the nation’s durability versus future pandemics.”

Valneva’s vaccine candidate, VLA2001, is based upon a tested method and will leverage the company’s existing production platform being used for its United States FDA and EMA authorized Japanese Sleeping sickness (JE) vaccine. VLA2001 is anticipated to enter clinical studies at the end of 2020 and, if the scientific development succeeds, a very first regulatory approval may be approved in the second half of2021

Valneva had actually previously revealed an arrangement in concept with the UK government for the supply of vaccine doses 1 and a binding initial arrangement to support growth of its UK-based manufacturing centers 2

About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

SARS-CoV-2 is a brand-new coronavirus identified in late 2019 and belongs to a household of enveloped RNA infections that consist of MERS and SARS, both of which triggered severe human infections of breathing system. The virus, which triggers a disease called COVID-19, has actually never before been found in humans. Given that this break out was initially reported in late-2019, the infection has actually infected over 29 million individuals and has actually caused over 900,00 0 reported deaths worldwide (since September 13, 2020). It has actually been stated a pandemic by the World Health Organization (WHO) Presently, there is no vaccine offered for COVID-19

About VLA 2001

VLA2001 is a Vero-cell based, highly purified inactivated vaccine prospect against the SARS-COV-2 infection, leveraging the manufacturing technology for Valneva’s Japanese Encephalitis Vaccine. The Company has actually designed a procedure that mainly uses this platform in regard to upstream and downstream process actions as plug-and-play with moderate modifications. The procedure consists of inactivation with BPL to maintain the native structure of the S protein. The mix with CpG 1018 is expected to cause a strong immune action and has the prospective to generate high titers of neutralizing antibodies.

VLA2001 is anticipated to conform with basic cold chain requirements (2 degrees to 8 degrees centigrade).

About Valneva SE

Valneva is a specialty vaccine company focused on prevention against illness with significant unmet requirements. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO ®/ JESPECT ®suggested for the avoidance of Japanese encephalitis and DUKORAL ® suggested for the prevention of cholera and, in some countries, prevention of diarrhea brought on by ETEC. The Business has various vaccines in development consisting of special vaccines versus Lyme illness, chikungunya and COVID-19 Valneva has operations in Austria, Sweden, the UK, France, Canada and the United States with over 500 staff members. For additional information, check out www.valneva.com and follow the Business on LinkedIn

Valneva Investor and Media Contacts

David Lawrence

Chief Financial Officer

447908627213

Laetitia Bachelot-Fontaine

Director Financier Relations & Corporate Communications

M 33(0 )6 4516 7099

investors@valneva.com

Valneva Forward-Looking Statements

This press release contains particular forward-looking statements connecting to the business of Valneva, including with respect to the progress, timing and conclusion of research, development and clinical trials for item candidates, the capability to produce, market, commercialize and achieve market acceptance for product candidates, the ability to safeguard intellectual property and run business without infringing on the copyright rights of others, price quotes for future performance and approximates regarding anticipated operating losses, future incomes, capital requirements and requirements for extra financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this news release, those results or developments of Valneva may not be a sign of their in the future. Sometimes, you can recognize positive declarations by words such as “could,” “should,” “may,” “anticipates,” “anticipates,” “believes,” “intends,” “quotes,” “objectives,” “targets,” or comparable words. These positive statements are based mainly on the present expectations of Valneva as of the date of this news release and undergo a variety of recognized and unidentified risks and uncertainties and other factors that may trigger actual outcomes, performance or achievements to be materially various from any future outcomes, efficiency or achievement revealed or suggested by these positive declarations. In particular, the expectations of Valneva might be affected by, to name a few things, uncertainties associated with the development and manufacture of vaccines, unanticipated medical trial outcomes, unforeseen regulatory actions or hold-ups, competitors in basic, currency variations, the impact of the global and European credit crisis, and the capability to obtain or maintain patent or other proprietary intellectual property defense. In light of these risks and unpredictabilities, there can be no assurance that the forward-looking declarations made throughout this discussion will in truth be understood. Valneva is providing the info in these products since this press release, and disclaim any objective or responsibility to openly update or revise any positive declarations, whether as an outcome of brand-new information, future events, or otherwise.


1 Valneva Validates Participation in UK Government COVID-19 Vaccine Response Program

2 Valneva Reports H1 Results Significant by Significant Corporate Achievements and Strong Cash Position


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