Pfizer invests $95m in Valneva
The equity investment is due to close on June 22, 2022, representing a price of €9.49 a share.
Valneva will use the proceeds from Pfizer’s equity investment to support its Phase 3 development contribution to the duo’s Lyme disease vaccine program. The Phase 3 trial is due to start in Q3, 2022; with Pfizer potentially submitting a Biologics License Application to the US Food and Drug Administration in 2025.
VLA15 is the only Lyme disease vaccine candidate in clinical development. The multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi, the tick-born bacteria that causes Lyme disease. The companies reported positive Phase 2 data for the vaccine in February.
A changing climate has increased the threat of Lyme disease, with the ticks that carry the disease being found in a growing number of areas. With no vaccine available, VLA15 gained Fast Track designation from the US Food and Drug Administration (FDA) in July 2017.
Thomas Lingelbach, Chief Executive Officer of Valneva, said: “Pfizer’s investment in Valneva highlights the quality of the work that we’ve done together over the past two years and is a strong recognition of Valneva’s vaccine expertise. This subscription agreement will contribute to our investment in the Phase 3 study while limiting the impact on our cash position. Lyme disease is spreading and represents a high unmet medical need which impacts the lives of millions of people in the Northern Hemisphere. We are looking forward to further investigating our VLA15 candidate in Phase 3, which will take us a step closer to potentially help protect both adults and children from this devastating disease.”
“Lyme disease continues to place a heavy burden on countries in North America and Europe, with an estimated 600,000 cases each year across both regions,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “As the geographic footprint of Lyme disease widens, the medical need for vaccination becomes even more imperative. We are excited to continue partnering with Valneva on the development of VLA15 and look forward to working together to progress the program with the goal of bringing forward a vaccine that could help prevent this debilitating disease.”
The two companies have updated the terms of their collaboration and license agreement for the vaccine, originally signed in April 2020. 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 $100m in milestones payable to Valneva based on cumulative sales. Other development and early commercialization milestones are unchanged, of which $168m remain, including a $25m payment to Valneva upon Pfizer’s initiation of the Phase 3 study.