(AOF) – Valneva, a company specializing in vaccines, announces today that the American health authority, Food and Drug Administration (FDA), has completed the review of the admissibility of the application for marketing authorization. for its single-shot chikungunya vaccine candidate and considered that the dossier was sufficiently complete for a substantive review of the data submitted. The file has been granted priority review status.
The FDA has determined a target date for completing the review of the authorization request, set at the end of August 2023. The press release specifies, however, that the acceptance of the dossier for priority review does not mean that a marketing authorization contract will be awarded, nor does it constitute an assessment of the adequacy of the data submitted.
AOF – LEARN MORE
Key points
– 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 through a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and vaccine distribution rights for third parties;
– Capital held at 9.9% by the Grimaud la Corbière group, 8.24% by BPI France, 7.6% by Deep Track Capital and 6.9% by Pfizer, Frédéric Grimaud chairing the supervisory board of 5 members and Thamas Lingelbach the executive board;
– Solid balance sheet with €307m in equity, reinforced by available cash of close to €400m in October 2022, 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:
– Pfizer to co-develop and sell the one against Lyme disease ($308 million),
– Bavarian Nordic for the marketing and distribution of specialized vaccines,
– Batavia Biosciences to develop an inexpensive polio vaccine,
– the Butantan institute against chikungunya for low-income countries.
Challenges
– After the end of the production of the anti-covid VLA2001 vaccine caused by the fall in public orders, hence the recovery of the financial situation via a call to the market in September 2022 and the tensions on the production of IXIARO, two challenges major: VLA1553 against chikungunya and VLA15 against Lyme disease;
– VLA1553: after the application for authorization in the United States filed in December, application in the European Union expected for the 1st quarter;
– VLA15: end of phase 3 clinical trials of the vaccine against Lyme disease in the 2nd quarter of 2023;
– 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 at the end of September and a reduction to €99m in the net loss, 2022 objectives of turnover between €340m and €360m and R&D expenditure between €95m and €115m.
Find out more about the “pharmacy” sector
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.
