Pfizer will invest $95 million to buy a stake in Valneva, in addition to strengthening its ongoing Lyme disease partnership with the French specialty vaccines company.
As part of the Equity Subscription Agreement, Pfizer will buy an 8.1% percent stake in Valneva. According to Valneva, the company is planning to use the proceeds from Pfizer’s 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 first announced in April 2020 for the Lyme disease vaccine candidate VLA15. 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.
The VLA15 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. The program was granted Fast Track designation by the U.S. FDA in July 2017.
Pfizer plans to initiate the phase 3 study of VLA15 in the third quarter of 2022. Pending successful initiation and completion of the trial, Pfizer could potentially submit a BLA to the FDA as early as 2025.