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Valneva: its inactivated vaccine candidate shows neutralization of the Omicron variant – 01/20/2022 at 09:25


(Photo credits: Valneva Group – )

(AOF) – Valneva announced the results of a preliminary laboratory study which demonstrated that antibodies from the serum of people vaccinated with three doses of Valneva’s inactivated vaccine candidate against Covid-19, VLA2001, neutralized the Omicron variant. Serum from 30 participants in the Phase 1/2 trial, VLA2001-201, was used in a virus-like assay to assess neutralization of the historic SARS-CoV-2 virus as well as that of the Delta and Omicron.

All 30 samples (100%) showed neutralizing antibodies against the historical virus and the Delta variant, and 26 samples (87%) against the Omicron variant. The average reduction in neutralization compared to historical virus was 2.7 times for Delta and 16.7 times for Omicron.

Valneva continues to submit data to the European Medicines Agency (EMA), the UK health agency MHRA, and the Bahraini health agency NHRA as part of the phased review process of the registration dossier aimed at obtaining a initial marketing authorization for VLA2001. The company still expects to have finalized these submissions in time to receive potential regulatory approvals in the first quarter of 2022.

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=/ Key points /=

– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;

– Turnover of €110m €bn drawn from Europe for 56%, ahead of the Americas (27%), then Asia-Oceania (9%) and Africa-Middle East (8%) ;

– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments by a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;

– Capital held at 15.07% by the Grimaud la Corbière group, 8.78% by the British MVM Life Science and 8.20% by BPI France, Frédéric Grimaud chairing the five-member supervisory board and Thamas Lingelbach chairing the management board ;

– Solid balance sheet with €449m in equity against €196m in debt, reinforced by net cash of €330m at the end of June, and then by the Nasdaq listing and the 1 er s payments from Pfizer (€140 million) and the British government.

=/ Issues /=

– Medium-term strategy to pursue the development of the Ixiaro and Dukoral vaccines to finance its R&D, to extend the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships promoting the group’s assets;

– Innovation strategy inherent to the business model, supported by 85 M€ of R&D investments, with 3 main assets and 3 preclinical programs:

– the only vaccine in clinical development against Lyme disease,

– the only single injection vaccine against chikungunya,

– the only inactivated and adjuvanted whole virus COVID-19 vaccine currently in clinical trial in Europe,

– candidate vaccines against human metapneumovirus, parvovirus and norovirus;

– Environmental strategy for the regular reduction of environmental impacts;

– Good visibility of the activity thanks to agreements with:

– the British government (orders for 100 million doses of anti-Covid vaccines by 2022 and options for 190 million by 2025, i.e. €1.4 billion in total),

– with Pfizer to co-develop and market a vaccine against Lyme disease for $308 million,

– with the American authorities for the Ixiario vaccine against Japanese encephalitis ($70 million),

– with Bavarian Nordic for the marketing and distribution of specialized vaccines,

– with Batavia Biosciences for the development of an inexpensive polio vaccine,

– with the Butantan Institute for a chikingunya vaccine for low-income countries.

=/ Challenges /=

– Sensitivity to the results of studies of vaccines against Lyme disease (phase 2) in particular (marketing application for 2024) and against chikingunya and Covid 19 (phase 3);

– Outcome of discussions with the European Commission on the supply of 60 million doses of anti-Covid vaccine and marketing of this vaccine by the end of the year;

– Impact of the pandemic: stable turnover at €47.5 million and widening of the net loss to €86.4 million due to R&D expenditure on Covid 19;

– 2021 objectives: excluding Covid vaccine, turnover between €80 and €105 million and R&D expenditure between €65 and €75 million.

Boost for French pharmacy

At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for university hospital research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,

Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.



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