Valneva and IDT Biologika agree to end their COVID-19 collaboration

Saint-Herblain (France) and Dessau-Roßlau (Germany), September 16, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a company specializing in vaccines, and IDT Biologika announced today that they have agreed to end their collaboration following the delivery to Valneva of an inactivated vaccine in bulk against COVID-19, and given current order levels and existing inventories.

In accordance with the commercial manufacturing services agreement signed in November 2021[1], IDT Biologika has produced the VLA2001 bulk vaccine at its biosafety level 3 facility in Germany, and Valneva has purchased the batches manufactured so far by IDT. In light of the European Commission’s reduced order[2]Valneva has suspended the manufacture of the vaccine and, in compensation, will pay IDT up to 36.2 million euros in cash and the equivalent of 4.5 million euros in kind, in the form of specified equipment purchased by Valneva.

Valneva has begun delivering doses of VLA2001 to European Member States that have ordered the vaccine and is maintaining inventory for possible additional supply to these Member States should demand increase. In parallel, the Company is continuing its discussions with various other governments around the world, with the aim of deploying approximately eight to ten million doses of remaining stocks in international markets over the next six to twelve months.

About VLA2001
VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging Valneva’s licensed Japanese encephalitis vaccine manufacturing technology, IXIARO®. VLA2001 consists of inactivated SARS-CoV-2 whole virus particles with high protein S density, in combination with two adjuvants, alum and CpG 1018. This combination of adjuvants consistently induced higher antibody levels in preclinical experiments than alum-only formulations and showed a shift in immune response towards Th1. CpG adjuvant 1018, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of HEPLISAV-B approved by the US FDA and EMA.® vaccine. The manufacturing process for VLA2001, which has already been scaled up to final industrial scale, includes chemical inactivation to preserve the native protein S structure. VLA2001 is expected to meet standard cold chain requirements (2 to 8 degrees Celsius).

VLA2001 is the first COVID-19 vaccine to receive standard marketing authorization in Europe[3] and the only whole-virus, inactivated, adjuvanted COVID-19 vaccine to receive marketing authorization in Europe for use as a primary vaccination course in people aged 18-50. The vaccine has also been granted conditional marketing authorization in the UK[4] and emergency use authorization in the United Arab Emirates[5] and Kingdom of Bahrain[6]. Valneva currently has agreements to supply VLA2001 to certain EU Member States[7] and the Kingdom of Bahrain[8]. In August 2022, the World Health Organization (WHO) issued recommendations for the use of VLA2001[9].

About Valneva SE
Valneva is a specialty vaccines company focused on the development and commercialization of prophylactic vaccines against infectious diseases with significant unmet medical needs. The Company takes a highly specialized and targeted approach to vaccine development, then applies its extensive knowledge of vaccine science to develop prophylactic vaccines against these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a wide range of candidate vaccines in and through the clinic, including candidates against Lyme disease and chikungunya virus.

About IDT Biologika
IDT Biologika is an innovative biotechnology company with a successful history dating back 100 years. Based on modern technologies and a high level of expertise, we support our customers in the development and manufacture of innovative viral vaccines, gene and immune therapy products as well as biological products used worldwide as protection against diseases. The German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the United States, IDT Corporation has a clinical test specimen manufacturing site in Rockville, Maryland.

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
Vice President, Global Communications and European Investor Relations
M +33 (0)6 4516 7099
[email protected]

Joshua Drumm, Ph.D.
Vice President, Global Investor Relations
M +001 917 815 4520
[email protected]

Forward-looking statements
This press release contains certain forward-looking statements regarding Valneva’s business, including with respect to manufacturing and commercialization plans for VLA2001. Furthermore, even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, such results or developments of Valneva may not be indicative of future results. In some instances, you can identify forward-looking statements by words such as “could”, “should”, “may”, “expect”, “anticipate”, “believe”, “intend”, “estimates”, “aims”, “targets” or similar words. These forward-looking statements are based on Valneva’s current expectations 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 realised. significantly different. any future results, performance or achievement expressed or implied by such forward-looking statements. In particular, Valneva’s expectations could be affected by, among other things, uncertainties related to the development and manufacturing of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, fluctuations currencies, the impact of the global market and credit crisis in Europe, 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 which could materially adversely affect 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 in this presentation will actually materialize. 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 and IDT Biologika announce collaboration for the production of the inactivated COVID-19 vaccine VLA2001 – Valneva

[2] Valneva Confirms Amendment to Advance Purchase Agreement with European Commission for Valneva’s Inactivated COVID-19 Vaccine – Valneva

[3] Valneva Receives Marketing Authorization in Europe for VLA2001 Inactivated Whole Virus COVID-19 Vaccine

[4] Valneva receives conditional marketing authorization from the UK MHRA for its inactivated COVID-19 vaccine

[5] Valneva Receives UAE Emergency Use Authorization for Inactivated COVID-19 Vaccine

[6] Valneva receives emergency use authorization from Bahrain for its inactivated COVID-19 vaccine VLA2001

[7] The European Commission approves the amendment to the contract for the purchase of Valneva’s inactivated COVID-19 vaccine

[8] Valneva signs advance purchase agreement with Bahrain for VLA2001 inactivated COVID-19 vaccine

[9] Valneva confirms WHO recommendations for its inactivated COVID-19 vaccine

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