Valneva will use the proceeds to support the Phase 3 development of its candidate vaccine VLA15. As announced on Apr. 26, Pfizer plans to initiate the Phase 3 study in the third quarter of this year.
The two firms have also updated the terms of their collaboration and license agreement, which they entered in April 2020. Valneva will now fund 40% of the remaining shared development costs, compared with 30% in the initial agreement. Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, versus royalties starting from 19% previously. The royalties will be complemented by up to $100 million in milestones based on cumulative sales. Other milestone payments remain unchanged.
Thomas Lingelbach, Valneva’s CEO, described Pfizer’s investment as a “strong recognition” of its vaccine expertise. He commented: “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.”
VLA15 is the only Lyme disease vaccine candidate currently in clinical development, according to the companies. Lyme disease is a systemic infection caused by Borreliaburgdorferi bacteria transmitted to humans by infected deer or ticks. Early symptoms are often overlooked but if left untreated, the disease can cause more serious complications affecting the joints, heart or nervous system.
Pending successful initiation and completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application to the US Food and Drug Administration as early as 2025.
Author: Elaine Burridge, Freelance Journalist
