(AOF) – Valneva, a vaccine company, today announced that it will be presenting on its single-shot chikungunya vaccine candidate during the fourth quarter of 2022 at several leading scientific conferences, including at the World Vaccine Congress Europe in Barcelona on October 13, at the 20th International Congress of Tropical Medicine and Malaria (ICTMM2020) in Bangkok on October 27; at the American Society of Tropical Medicine and Hygiene (ASTMH) meeting, to be held October 30-November 3 in Seattle.
She will also be present and will communicate at the European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), which will be held virtually from November 6 to 9, 2022 in Vienna and at the Joint International Tropical Medicine Meeting (JITMM) 2022 in Bangkok from December 7 to 9, 2022.
Presentations will be made by Valneva’s chief scientific officers, including Juan Carlos Jaramillo, MD, Valneva Medical Director, Katrin Dubischar, VP, Chikungunya Vaccine Program Director, and Susanne Eder-Lingelbach, VP Clinical Development.
In August 2022, Valneva began submitting the marketing authorization application dossier to the US health authority, Food and Drug Administration (FDA), for its single-shot chikungunya vaccine candidate in people aged 18 and over.
This submission follows positive final results for the pivotal Phase 3 trial announced in March 20221 and for the clinical batch homogeneity trial announced in May 20222. A clinical study of VLA1553 in adolescents is ongoing in Brazil3, in order to potentially allow for future regulatory submissions after obtaining potential clearance in adults.
The program received “Fast Track” and “Breakthrough Therapy” status from the FDA in 2018 and 2021, respectively. VLA1553 also received “PRIority MEdicine” (PRIME) status from the European Medicines Agency in 2020, and Valneva expects to file a marketing authorization application for VLA1553 in Europe in the first half of 2023.
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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: 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 vaccine distribution rights for third parties;
– Capital held at 13.02% by the Grimaud la Corbière group and 8.19% by BPI France, Frédéric Grimaud chairing the 5-member supervisory board and Thamas Lingelbach the management board;
– Solid balance sheet with €307m in equity against €42m in debt, reinforced by net cash of nearly €350m in April 2022.
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, the only single-shot vaccine against chikungunya, the only inactivated and adjuvanted whole virus COVID-19 vaccine, vaccine candidates 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: the British government (orders of 100 million doses of anti-Covid vaccines and options out of 190 million by 2025, i.e. €1.4 billion in total), with Pfizer to co-develop and sell the one against Lyme disease ($308 million), with the American authorities for Ixiario against Japanese encephalitis ($70 million), with Bavarian Nordic for the marketing and distribution of specialized vaccines, with Batavia Biosciences to develop an inexpensive vaccine against polio, with the Butantan institute against chikingunya for low-income countries.
Challenges
– In 2022, launch of phase 3 trials for the vaccine against Lyme disease and awaiting the approval of the American authority for the sale of the chikingunya vaccine and that of the European Union for Covid 19 (60 million doses);
– Sensitivity to travel of sales of vaccines already on the market (against Japanese encephalitis and cholera);
– Uncertainties about the commercial success of the vaccine against Covid 19 in the United Kingdom, given the strong competition already established;
– 2022 objectives: excluding Covid vaccine, turnover between €430 and €590 million and R&D expenditure between €65 and €75 million.
An inevitable race for new blockbusters
The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite the loss, since 2019, of the patents for its three star products (Avastin, Herceptine, Rituxan) Roche was able to renew its portfolio by bringing new molecules to market. However, the discovery and launch of new drugs are increasingly expensive. AstraZeneca spends about $6 billion a year on R&D in a pharmaceutical industry where the life of a patent only lasts ten to fifteen years. This leads laboratories to withdraw from certain activities. Thus J&J, Pfizer, GSK and, no doubt, Novartis soon prefer to refocus on specialty drugs and abandon any ancillary activity.