Excerpt
- Pfizer will invest €90.5 million in Valneva
- Planned Phase 3 study confirmed to initiate in Q3 2022
Article Summary
Valneva announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15.
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 average closing price of the Company’s Shares on Euronext Paris for the ten trading days prior to the commencement of the Equity Subscription Agreement was used to calculate the acquisition price per share. On June 22, 2022, the equity investment is scheduled to close. The profits from Pfizer’s equity investment will be used by Valneva to fund its Phase 3 development contribution to the Lyme disease programme.
Additionally, the terms of the collaboration and licence agreement that Valneva and Pfizer announced on April 30, 20201 were updated. In contrast to the earlier agreement of 30% Valneva will now pay 40% of the remaining shared development costs. As compared to the initial agreement’s 19 percent starting point, Pfizer will now pay Valneva tiered royalties that range from 14 to 22 percent. In addition to the royalties, Valneva will also get milestone payments of up to $100 million based on total sales. There are still $168 million left in further development and early commercialization milestone payments, including a $25 million payment to Valneva upon Pfizer’s start of the Phase 3 study.
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 VLA15.
