(AOF) – Valneva announced the release of new data from a small exploratory study on the heterologous booster use of its inactivated COVID-19 vaccine, VLA2001. In this study, “a booster dose with VLA2001 generated only a marginal increase in neutralizing antibody response,” the biotech company said.
“Although these latest boost results do not match the encouraging results of previously observed homologous and heterologous boosts, we are pleased to once again confirm the favorable safety and tolerability profile of VLA2001,” commented Juan Carlos Jaramillo, medical director of Valneva, mentioned in a press release.
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– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Turnover of €348m €bn drawn from Europe for 56%, ahead of the Americas (27%), then Asia-Oceania (9%) and Africa-Middle East (8%);
– Business model: Diversified vaccine portfolio for the general public, financing of clinical developments by specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties ;
– Capital held at 11.68% by the Grimaud la Corbière group, 8.15% by BPI France, 8.14% by Pfizer at the end of September, Frédéric Grimaud chairs the 5-member supervisory board and Thamas Lingelbach the management board ;
– Solid balance sheet with 307 million euros of equity against 42 million euros of debt at the end of April, strengthened by available liquidity which gives financial visibility until the end of 2024.
– Medium-term strategy based on research and development funding through the sale of Ixiaro and Dukoral vaccines, the extension of the production network (3 sites, in Scotland, Sweden and Austria) and partnerships that enhance the group’s assets;
– Innovation strategy inherent in the business model, rich in a portfolio of 398 patents and supported by 173 million euros of research and development costs, 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 vaccine against the whole COVID-19 virus,
– candidate vaccines against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy: energy efficiency, minimization of waste, optimal use of water and 5% reduction, vs 2016, of CO2 emissions by 2025;
– Good visibility of the activity thanks to the vaccine agreements with:
– with Pfizer to co-develop and sell Lyme disease drug ($308 million),
– with Bavarian Nordic for the marketing and distribution of specialized vaccines,
– with Batavia Biosciences to develop an inexpensive polio vaccine,
– with the Butantan institute against chikungunya for low-income countries.
– Three big uncertainties in autumn 2022:
– the end of the production of the anti-covid vaccine VLA2001 caused by the decline in public orders, then the recovery of the financial situation by calling the market,
– the sale of VLA2001 shares on international markets,
– the expected decision of the US Department of Defense on a new order for IXIARO in 2023;
– Evolution of the investment after the capital increase of September, equal to 103 million euros (Deep Track with 6.97% of the shares, BPI France 7.6%)
– US Health Authority response to chikungunya vaccine marketing;
– End of Phase 3 clinical trials of Lyme disease vaccine in Q2 2023;
– Launch in early 2023 of the marketing, in partnership with VBI Vaccines, of PreHevbri, the only vaccine authorized in Europe against hepatitis B;
– After the doubling of revenues in the first semester, 2022 targets of turnover between €340 and €360 million and R&D expenditure between €65 and €75 million.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has risen from 41% to 31% in global R&D. China’s share rose from 1% to 8%. As for the United States, which has supplanted Europe, in 2001 they devoted only 2 billion euros more per year to R&D than Europe, while now this gap has reached 25 billion! Some experts accuse the European authorities of failing to implement effective policies. Pharmaceutical research funding should therefore have been better targeted through the ‘Horizon 2020’ programme. France only comes in eighteenth place in European funding despite the quality of its research. The United States, on the other hand, concentrates funding on Boston and some centers of excellence.