US pharma giant Pfizer said that it will invest $95 million in Valneva, a French specialty vaccine company, for an 8.1% stake.

The two firms have signed an equity subscription agreement in this connection. Besides, they have amended the terms of their collaboration and license agreement for VLA15, a vaccine candidate for Lyme disease.

Pfizer had earlier revealed plans to launch the VLA15 phase 3 study in Q3 2022.

Valneva will use the investment from the American pharma giant to support its contribution for the phase 3 development.

As per the updated terms of the collaboration and license agreement, the French vaccine developer will now cover 40% of the remaining shared development costs instead of 30% as decided in the initial agreement.

Valneva will receive tiered royalties from Pfizer, in the range of 14% to 22%, compared to royalties beginning at 19% as per the initial agreement.

The royalties will also be complemented by milestone payments of up to $100 million to Valneva, which will be contingent on cumulative sales.

Thomas Lingelbach — CEO 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.”

There will be no change in the other development and early commercialization milestones, of which $168 million will be intact, which includes a payment of $25 million to Valneva after Pfizer’s launch of the VLA15 phase 3 study.

Pfizer expects to submit a biologics license application (BLA) of the VLA15 vaccine candidate as early as 2025 to the US Food and Drug Administration, subject to successful launch and completion of the intended phase 3 study in Lyme disease.

Kathrin U. Jansen — Pfizer Senior Vice President and Head of Vaccine Research and Development said: “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.”

  France, Kathrin U. Jansen, Lyme Disease, Pfizer, Pharma acquisition news, Thomas Lingelbach, Valneva, VLA15