Pfizer has agreed to invest €90.5 million to buy an 8.1% percent stake in French vaccines company, as the companies announced developments in their partnership to tackle Lyme disease.
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Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.
As part of the Equity Subscription Agreement, Pfizer will invest €90.5 ($95) million in Valneva, representing 8.1% of Valneva’s share capital at a price of €9.49 per share, through a reserved capital increase to further support the strategic Lyme partnership between the two companies.
The per share purchase price was determined based on the average closing price of the Company’s Shares on Euronext Paris during the 10 trading days preceding the date of the Equity Subscription Agreement. The equity investment is due to close on June 22, 2022.
Valneva is planning to use the proceeds from Pfizer’s equity investment to support its Phase 3 development contribution to the Lyme disease program.
In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 20201.
Valneva will now fund 40% of the remaining shared development costs compared to 30% in the initial agreement.
Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement. In addition, the royalties will be complemented by up to $100 million in milestones payable to Valneva based on cumulative sales.
Other development and early commercialization milestones are unchanged, of which $168 million remain, including a $25 million payment to Valneva upon Pfizer’s initiation of the Phase 3 study.
Pending successful initiation and completion of the planned Phase 3 study for VLA15, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration as early as 2025.
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.
OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans.
The vaccine covers the six most common OspA serotypes expressed by Borrelia burgdorferisensu lato species that are prevalent in North America and Europe.
VLA15 has demonstrated a strong immunogenicity and safety profile in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 20172.
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA151. ■