Valneva and IDT Biologika Agree on Termination of their

Saint-Herblain (France) and Dessau–Roßlau (Germany), September 16, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine firm, and IDT Biologika right this moment introduced they’ve agreed to terminate their collaboration following the supply of inactivated COVID-19 bulk vaccine to Valneva, and contemplating the present order ranges and present inventories.

As per the business manufacturing providers settlement signed in November 2021¹, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 services in Germany, and Valneva purchased the batches that had been manufactured to date by IDT. In gentle of the decreased European Commission order², Valneva has suspended manufacturing of the vaccine and, as compensation, can pay IDT as much as €36.2 million in money and the equal of €4.5 million in variety, within the type of specified tools bought by Valneva.

Valneva has began to ship doses of VLA2001 to the European Member States who ordered the vaccine and is retaining stock for potential extra provide to those Member States ought to demand enhance. In parallel, the Company is constant discussions with numerous different governments around the globe, with the intention to deploy roughly eight to 10 million doses of remaining stock into worldwide markets within the subsequent six to 12 months.

About VLA2001
VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing expertise for Valneva’s licensed Japanese encephalitis vaccine, IXIARO^®. VLA2001 consists of inactivated complete virus particles of SARS-CoV-2 with excessive S-protein density, together with two adjuvants, alum and CpG 1018. This adjuvant mixture has persistently induced larger antibody ranges in preclinical experiments than alum-only formulations and proven a shift of the immune response in direction of Th1. CpG 1018 adjuvant, equipped by Dynavax Technologies Corporation (Nasdaq: DVAX), is a element of the US FDA- and EMA-approved HEPLISAV-B^® vaccine. VLA2001’s manufacturing course of, which has already been upscaled to remaining industrial scale, contains chemical inactivation to protect the native construction of the S-protein. VLA2001 is predicted to evolve with customary chilly chain necessities (2 to eight levels Celsius).
VLA2001 is the primary COVID-19 vaccine to obtain a normal advertising and marketing authorization in Europe³ and the one complete virus, inactivated, adjuvanted COVID-19 vaccine to obtain advertising and marketing authorization in Europe to be used as major vaccination in individuals from 18 to 50 years of age. The vaccine was additionally granted conditional advertising and marketing authorization within the United Kingdom⁴ and emergency use authorization within the United Arab Emirates⁵ and Kingdom of Bahrain⁶. Valneva at present has agreements to provide VLA2001 to sure EU Member States⁷ and the Kingdom of Bahrain⁸. In August 2022, the World Health Organization (WHO) issued suggestions to be used of VLA2001⁹.

About Valneva SE
Valneva is a specialty vaccine firm targeted on the event and commercialization of prophylactic vaccines for infectious ailments with important unmet medical want. The Company takes a extremely specialised and focused method to vaccine improvement and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these ailments. Valneva has leveraged its experience and capabilities each to commercialize three vaccines and to quickly advance a broad vary of vaccine candidates into and by means of the clinic, together with candidates towards Lyme illness and the chikungunya virus.

About IDT Biologika
IDT Biologika is an revolutionary biotech firm with a profitable historical past courting again 100 years. On the premise of trendy applied sciences and excessive ranges of experience, we help clients within the improvement and manufacture of revolutionary virus vaccines, gene and immune remedy merchandise in addition to biologics employed worldwide as safety towards ailments. German websites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a producing web site for medical take a look at samples in Rockville, Maryland.

Forward-Looking Statements
This press launch accommodates sure forward-looking statements referring to the business of Valneva, together with with respect to the manufacturing and commercialization plans for VLA2001. In addition, even when the precise outcomes or improvement of Valneva are in line with the forward-looking statements contained on this press launch, these outcomes or developments of Valneva will not be indicative of future outcomes. In some circumstances, you may determine forward-looking statements by phrases reminiscent of “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or comparable phrases. These forward-looking statements are based mostly on the present expectations of Valneva as of the date of this press launch and are topic to a quantity of recognized and unknown dangers and uncertainties and different components that will trigger precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievement expressed or implied by these forward-looking statements. In specific, the expectations of Valneva might be affected by, amongst different issues, uncertainties concerned within the improvement and manufacture of vaccines, surprising medical trial outcomes, surprising regulatory actions or delays, competitors on the whole, foreign money fluctuations, the affect of the worldwide and European credit score disaster, the flexibility to acquire or keep patent or different proprietary mental property safety, the cancellation of present contracts, together with however not restricted to the HMG Supply Agreement, and the affect of the COVID-19 pandemic, the incidence of any of which might considerably hurt Valneva’s business, monetary situation, prospects and outcomes of operations. In gentle of these dangers and uncertainties, there may be no assurance that the forward-looking statements made throughout this presentation will the truth is be realized. Valneva is offering the knowledge on this press launch as of the date hereof and disclaims any intention or obligation to publicly replace or revise any forward-looking statements, whether or not because of this of new data, future occasions, or in any other case.

1 Valneva and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001 – Valneva
2 Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva’s Inactivated COVID-19 Vaccine – Valneva
3 Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001
4 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine
5 Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine
6 Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001
7 European Commission Approves Purchase Agreement Amendment for Valneva’s Inactivated COVID-19 Vaccine
8 Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001
9 Valneva Confirms WHO Recommendations for its Inactivated COVID-19 Vaccine

• 2022_09_16_VLA_IDT_Termination_PR_EN_Final