Valneva and Pfizer Enter into a Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

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Pfizer Inc. and Valneva, a specialty vaccine business, announced today that they have entered into an Equity Subscription Agreement for Lyme disease vaccine candidate VLA15 and have revised the terms of their Collaboration and License Agreement. Pfizer expects to start the Phase 3 investigation of VLA15 in the third quarter of 2022, as stated initially on April 26, 2022.

Pfizer will invest €90.5 ($95) million in Valneva as part of the Equity Subscription Agreement, representing 8.1 percent of Valneva’s share capital at a price of €9.49 per share, as part of a reserved capital increase to support the strategic Lyme relationship between the two businesses. The average closing price of the company’s shares on Euronext Paris during the ten trading days before the date of the Equity Subscription Agreement was used to calculate the per-share acquisition price. On June 22, 2022, the equity investment will be completed. Valneva intends to use the money from Pfizer’s equity investment to assist its Lyme disease Phase 3 development commitment.

“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,”

Thomas Lingelbach, Chief Executive Officer of Valneva, commented.

Valneva and Pfizer also revised the conditions of their partnership and licensing agreement, which they previously announced on April 30, 2020. Valneva will now cover 40% of the remaining shared development expenditures, up from 30% in the original deal. Pfizer will pay Valneva tiered royalties ranging from 14 percent to 22 percent, compared to 19 percent royalties in the original arrangement. In addition, based on total sales, Valneva will be eligible for up to $100 million in milestone payments. Other developments and early commercialization milestones are unaffected, totaling $168 million, including a $25 million payment to Valneva at the start of the Phase 3 trial by Pfizer.

“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. 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,”

said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer.

Pfizer might submit a Biologics License Application (BLA) to the US Food and Drug Administration as early as 2025 if the planned Phase 3 trial for VLA15 is successfully initiated and completed.

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