(AOF) – Valneva today announced that clinical data from the pivotal Phase 3 trial for its single-shot chikungunya vaccine candidate, VLA1553, has been published in “The Lancet”, “one of the leading medical journals most recognized in the world. According to the vaccine company, the article reports that VLA1553 “showed a very high sero-response rate of 98.9% 28 days after a single injection of the vaccine”, and demonstrated a good safety profile and was well tolerated in both young and older adults.
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Key points
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Turnover of €361 million from vaccines, in particular for travellers, for 32% and for the rest mainly from contracts for the supply of vaccines against COVID-19;
– 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 distribution rights for third parties;
– Capital held at 9.9% by the Grimaud la Corbière group, 8.92% by BPI France, 7.6% by Deep Track Capital and 6.9% by Pfizer, Frédéric Grimaud chairing the supervisory board of 7 members and Thamas Lingelbach the management board;
– Solid balance sheet reinforced by the call to the market in September 2022, with available cash close to €289m, providing financial visibility until the end of 2024.
Challenges
– Medium-term strategy based on financing R&D through sales of the Ixiaro and Dukoral vaccines, extension of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships promoting the group’s assets;
– Innovation strategy inherent in the business model, rich in a portfolio of 398 patents and supported by €173 million in R&D 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,
– candidate vaccines against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy: energy efficiency, minimization of waste, optimal use of water and reduction of 5%, vs 2016, of CO2 emissions by 2025;
– Good visibility of the activity thanks to the agreements on vaccines with: with Pfizer to co-develop and sell the one against Lyme disease ($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;
– Continued growth of Ixiaro and Dukoral vaccines
Challenges
– After the end of the production of the anti-covid vaccine, two major challenges: VLA1553 against chikungunya and VLA15 against Lyme disease:
– VLA1553: waiting for marketing authorization by the United States Health Authority for August, application to the European Union expected for the 1st quarter;
– VLA15: end of phase 3 clinical trials of the vaccine in the 2nd quarter;
– Launch of the marketing, in partnership with VBI Vaccines, of PreHevbri, the only vaccine authorized in Europe against hepatitis B;
– After an 11% increase in revenues and a net loss of €143.3 million, 2023 objectives:
– revenues of €220 to €260 million including €140 million from product sales, including marginal sales of anti-COVID-19 vaccines in the Kingdom of Bahrain, and €110 million from other operating income,
– R&D expenditure of approximately €80 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 fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.