(AOF) – Valneva and Pfizer have signed a subscription agreement and renewed the terms of cooperation and licensing agreement for Lyme disease vaccine candidate, VLA15. As announced on April 26, Pfizer plans to begin phase 3 of the VLA15 study in the third quarter of 2022.
Under the share subscription agreement, Pfizer is investing € 90.5 million ($ 95 million), or 8.1% of Valneva’s share capital, at a price of € 9.49 per share, by increasing its reserve capital to strengthen the strategic partnership. between them. Lyme disease companies.
Pfizer’s investment in the capital Valneva is expected to take effect on June 22, 2022. Valneva plans to use the proceeds from this investment to finance part of its contribution to Phase 3 of the Lyme program.
Valneva and Pfizer also updated the terms of cooperation and the licensing agreement they announced on April 30, 2020.
Valneva will now finance 40% of the costs of Phase 3, compared to 30% in the initial agreement. Pfizer will pay Valneva a rising royalty of 14% to 22%, up from 19% in the original deal.
In addition, royalties will be supplemented by basic payments of up to $ 100 million to be paid to Valneva on the basis of aggregate sales.
Other payments related to the development and start-up phases remain unchanged at $ 168 million, including a $ 25 million payment to Valneva after the start of Pfizer’s Phase 3.
Clinical trials (phases I, II, III)
Phase I: small testing of the molecule in humans to assess its safety, tolerability, metabolic and pharmacological properties. Phase II: Assessment of tolerability and efficacy in several hundred patients to identify side effects. Phase III: assessment of the overall benefit / risk balance in several thousand patients.
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– specialist in the development of preventive vaccines against infectious diseases with limited therapeutic capabilities;
– Turnover of 348 million euros received from Europe by 56%, ahead of America (27%), then Asia-Oceania (9%) and Africa-Middle East (8%);
– Business model: portfolio of diversified vaccines for the general public, funding of clinical development with specialized infrastructure, 2 commercial vaccines (Ixiaro and Ducoral against Japanese encephalitis and cholera) and the right to distribute vaccines to third parties;
– 13.02% of the capital belongs to the Grimaud la Corbière group and 8.19% to BPI France, Frederic Grimm heads the 5-member supervisory board and Thomas Lingelbach heads the board;
– A solid balance of € 307 million of equity against € 42 million of debt, backed by net cash of almost € 350 million in April 2022.
– Medium-term strategy based on R&D funding through the sale of Ixiaro and Dukoral vaccines, expansion of the production network (3 sites, in Scotland, Sweden and Austria) and partnerships to promote the group’s assets;
– Innovative strategy inherent in the business model, rich portfolio of 398 patents and supported by 173 million euros in R&D, with 3 main assets and 3 preclinical programs: the only vaccine in clinical development against Lyme, the only one-time vaccine against chikungunya, the only inactive juvant vaccine against COVID-19 virus, candidates for vaccine against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy: energy efficiency, waste minimization, optimal water use and reduction of CO2 emissions by 5% compared to 2016 until 2025;
– Good visibility through vaccine agreements with: the UK government (ordering 100 million doses of Covid vaccines and options from 190 million by 2025, ie € 1.4 billion in total), jointly develop and sell Lyme vaccine with Pfizer ( $ 308 million), with US authorities for Ixiario against Japanese encephalitis ($ 70 million), with Bavarian Nordic for marketing and distribution of specialized vaccines, with Batavia Biosciences for the development of low-cost polio vaccines, with the Butianquin Institute for Rhutan income.
– Phase 3 trials of the Lyme disease vaccine will begin in 2022 and US authorities are expected to approve the sale of the Chickinga and European Union vaccine from Covid 19 (60 million doses);
– Sensitivity to travel sales of vaccines already on the market (against Japanese encephalitis and cholera);
– Uncertainty about the commercial success of the Covid 19 vaccine in the United Kingdom, given the already strong competition;
– Targets for 2022: excluding the Covid vaccine, turnover from 430 to 590 million euros and research and development costs from 65 to 75 million euros.
Oncology supports laboratory work
According to GlobalData, in 2021 the profit of oncology amounted to 163 billion dollars (out of a total of 613 billion US dollars), which is 11.9% more. Its average annual growth over the past twenty years has reached 15.4%. This segment, which is becoming increasingly competitive, is dominated by several heavyweights, such as MSD (Merck & Co. Inc), Roche, BMS
immunooncology, a specialty that has run this market for ten years, supports research. GlobalData estimates that this segment could reach 180 billion in 2026. Major players seek to strengthen in this niche. Pfizer recently acquired Canadian biotechnology Trillium Therapeutics for $ 2.3 billion. After this operation, the American group received two promising molecules for the treatment of blood cancer.