Status: 20.06.2022 2:05 p.m
The US pharmaceutical company Pfizer is investing in Valneva. The biotech group wants to use the proceeds to produce a Lyme disease vaccine. There had recently been setbacks in the development of the corona vaccine.
The US pharmaceutical group Pfizer is acquiring a good eight percent stake in the French-Austrian biotech company Valneva for EUR 90.5 million via a capital increase. Both sides announced this. Pfizer pays EUR 9.49 per share. Valneva intends to use the proceeds from the equity investment to finance its Lyme disease vaccine, which is scheduled to enter the third and final phase of clinical development in the third quarter of this year.
Possible application for approval in 2025
Valneva and Pfizer partnered for the vaccine in spring 2020. Valneva will now fund 40 percent of the remaining joint development costs, up from 30 percent in the original agreement. The company is also said to receive tiered royalties ranging from 14 percent to 22 percent from Pfizer, while royalties in the original agreement started at 19 percent.
In addition, Valneva is now looking forward to success-based milestone payments of up to $100 million. Pfizer will lead late-stage development and will have sole control over commercialization.
Valneva says it is the only Lyme disease vaccine candidate currently in clinical development. If development is successful, Pfizer hopes to apply to the FDA for approval of the vaccine in 2025.
Inactivated vaccine against Corona
The stock market reacted strongly to the news. At times, the papers rose by more than 21 percent and currently cost around 9.60 euros. However, Valneva shares had also collapsed significantly a few days ago. At the beginning of June they were still trading well above the 11 euro mark at times and in mid-April they were even just under 19 euros. At the peak of the pandemic, when the race for the big vaccine deal was even more open, investors paid almost 30 euros per Valneva share in November 2021.
At the time, Valneva was seen as a great hope for increasing the number of people willing to be vaccinated. Because unlike the new mRNA vaccines from the manufacturers BioNTech or Moderna, the Valneva vaccine, a so-called dead vaccine, is based on killed viruses, i.e. on a long-established approach to vaccine production.
approval process is ongoing
However, Valneva recently had to question the future of the inactivated vaccine after the European Commission announced that it might terminate the pre-purchase agreement for the vaccine due to delays in the approval process.
The approval process at the European Medicines Agency (EMA) is currently ongoing. The authority had accepted the submission of the application for approval in mid-May. According to Valneva, a final vote is expected in the week of June 21. Valneva also continues to work with authorities outside the European Union to obtain potential future approvals and additional purchase agreements.