Under the terms of the agreement, following the final review of the quantities required by each of the Member States of the European Union, Valneva plans to deliver 24.3 million doses in the second and third quarters of 2022, subject to regulatory approval from the European Medicines Agency (EMA). (Photo credit: Valneva Group)

(AOF) – Valneva, a company specializing in vaccines, has announced that it has signed an advance purchase agreement with the European Commission for the supply of up to 60 million doses of VLA2001, its inactivated vaccine candidate against COVID-19 , for a period of two years. This agreement follows the announcement of November 10 regarding the approval of the agreement by the European Commission.

Under the terms of the agreement, following the final review of the quantities required by each of the Member States of the European Union, Valneva plans to deliver 24.3 million doses in the second and third quarters of 2022, subject to regulatory approval from the European Medicines Agency (EMA). The European Commission has the option of increasing this initial firm order to a total of 60 million doses, with delivery of additional doses in 2023.

AOF – LEARN MORE

= / 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;

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– 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 1iss payments from Pfizer (€ 140 million) and the British government.

= / Issues / =

– Medium-term strategy for the further development of the Ixiaro and Dukoral vaccines to finance its R&D, extension 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),

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– 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 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 spending on the Covid 19;

– 2021 targets: excluding the 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.

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