(AOF) – The European Medicines Agency (EMA) has started the gradual review of the registration dossier for VLA2001, the whole virus, inactivated and adjuvanted Valneva vaccine candidate against Covid-19. At the same time, the laboratory continues to submit its dossier to the United Kingdom (to the MHRA), including verification of the integrity of phase 3 clinical data (required before finalizing the submission). Potential regulatory approvals are expected in the first quarter of 2022.
Valneva also provides an update on VLA2001 in the context of the emergence of the Omicron variant. The company believes that VLA2001 may play a role in protection against the new variant Omicron.
Unlike other vaccines which only target the SARS-CoV-2 virus Spike protein, VLA2001 is developed using the entire envelope of the virus.
Preservation of the entire viral envelope is expected to elicit an expanded immune response which, in conjunction with the adjuvant CpG 1018, may improve the immunological profile of the vaccine by stimulating T cell responses against other proteins in the vaccine. SARS-CoV-2.
Valneva will assess the ability of VLA2001 to generate neutralizing antibodies against the Omicron variant.
Valneva also confirms that its technology platform can be adapted to new variants when needed.
The company has started to work and carry out tests on the variants in the laboratories of its French and Austrian sites; this includes the production of viral cells for three previous variants of concern, including the Delta variant.
Valneva has produced a complete industrial pilot batch on the basis of the Alpha variant, thus validating the adaptability of its production process to variant-based vaccines.
Valneva has started the production of doses of VLA2001 for the European Commission and has stocks ready to be labeled and distributed upon obtaining regulatory approval.
Valneva expects to have the capacity to produce more than one hundred million doses of vaccine per year by combining internal and external production (CMO).
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= / Key points / =
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Revenue of € 110m € bn drawn from Europe for 56%, ahead of America (27%), then Asia-Oceania (9%) and Africa-Middle East (8%) ;
– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments through a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;
– Capital 15.07% owned by the Grimaud la Corbière group, 8.78% by the British MVM Life Science and 8.20% by BPI France, Frédéric Grimaud chairing the 5-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 in cash at the end of June, and then by listing on the Nasdaq and the 1ers payments from Pfizer (€ 140 million) and the British government.
= / Issues / =
– Medium-term strategy for further development of the Ixiaro and Dukoral vaccines to finance its R&D, expansion of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships to enhance the group’s assets;
– Innovation strategy inherent in the business model, supported by € 85 million in 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 on 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 vaccine against polio,
– with the Butantan institute for a vaccine against chikingunya for low-income countries.
= / Challenges / =
– Sensitivity to the results of studies of vaccines against Lyme disease (phase 2) in particular (marketing request 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 the Covid 19;
– 2021 objectives: excluding Covid vaccine, turnover between € 80 and 105 million and R&D expenses between € 65 and 75 million.
Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7 billion euros): 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 expenses reimbursed by Medicare will be 2.4%, which should generate at least 0.5% growth in laboratory turnover,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the actual benefit is sufficient.