The release of a press release on a Friday evening is rarely synonymous with good news. The announcement made at the end of last week by Valneva is indeed not… The biotech fears that the supply agreement concluded with the European Commission on its candidate inactivated whole virus vaccine against Covid-19, VLA2001, is threatened lack of sufficient volumes, which could compromise this program.
In the early morning, the action plunged more than 20%, to 8.14 euros, after being reserved for the decline.
” Some Member States have confirmed their interest in including an inactivated and adjuvanted whole virus vaccine solution in their portfoliosaid Valneva on Friday. However, the preliminary and non-final volume indications received from the Commission would not be sufficient to ensure the sustainability of the Covid-19 vaccine program “. This would also hamper the future development of the program beyond the current product profile.
Last May, Valneva had received from the European Commission a notice of intent to terminate an agreement which includes the delivery of 24.3 million doses in 2022 with the possibility of increasing this order to reach 35.7 million additional doses delivered in 2023. It has “ the possibility of terminating the contract since VLA2001 did not receive marketing authorization from the EMA before April 30, 2022. According to the terms of the contract, Valneva had a period of 30 days from May 13 (date of receipt of the notification) to obtain an MA or to propose a plan that would remedy the situation in an acceptable manner “Recalls this Monday the analyst firm Oddo BHF.
Pay attention to the 2022 objectives
The regulatory process with the European Medicines Agency (EMA) is continuing as planned, Valneva said. But the next few weeks will be crucial, continues the research office, with the return of the CHMP (Committee for Medicinal Products for Human Use), expected the week of June 21 as well as the potential approval of VLA2001 by the EC quickly behind: “ We believe that in a pandemic context, the results of the studies conducted so far are sufficient to obtain a conditional Marketing Authorization from the EMA (a conditional Marketing Authorization has already been granted by the MHRA to [Royaume-Uni] and the NHRA in Bahrain) (…) VLA2001 generates an immune response directed at the S, M and N proteins of the virus so, according to the company, could have better coverage. Job security is also very good: only 1% of patients reported a side effect. »
For Oddo BHF, “ if the company is unable to agree on sufficient volumes or if the vaccine does not obtain its MA, the 2022 sales targets should be revised significantly downwards (the sales attached to the contract with the European Commission represent 220 million euros in 2022 in our model, i.e. 65% of sales) “.