(AOF) – Valneva and Pfizer have entered into a stock subscription agreement and updated the terms of their collaboration and license agreement for the Lyme disease vaccine candidate, VLA15. As announced on April 26, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.
Under the share subscription agreement, Pfizer will invest 90.5 million euros ($95 million), or 8.1% of Valneva’s share capital at a price of 9.49 euros per share, through the through a reserved capital increase intended for the strategic partnership concluded between the two companies on Lyme disease.
Pfizer’s investment in the capital of Valneva is expected to be effective on June 22, 2022. Valneva plans to use the proceeds of this investment to fund part of its contribution to Phase 3 of the Lyme program.
Valneva and Pfizer have also updated the terms of their collaboration and licensing agreement that they announced on April 30, 2020.
Valneva will now fund 40% of Phase 3 costs, up from 30% in the original agreement. Pfizer will pay Valneva escalating royalties ranging from 14% to 22%, up from royalties starting at 19% in the original agreement.
In addition, the royalties will be supplemented by milestone payments of up to $100 million, payable to Valneva based on cumulative sales.
The other payments related to the development stages and the start of commercialization remain retained, ie 168 million dollars, including a payment of 25 million dollars to Valneva during the initiation of Phase 3 by Pfizer.
Clinical trials (Phases I, II, III)
Phase I: small-scale testing of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: assessment of tolerance and efficacy on several hundred patients to identify side effects. Phase III: evaluation of the overall benefit/risk ratio with several thousand patients.
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