Pfizer and Valneva have updated the terms of their existing collaboration and license agreement for the development of Valneva’s Lyme disease vaccine candidate, VLA15
Pfizer is set to invest $95m (€90.5m) in exchange for an 8.1% stake in French vaccines company Valneva, at a price of €9.49 per share, through a reserved capital increase.
The two companies have updated the terms of their existing collaboration and license agreement for the development of Valneva’s Lyme disease vaccine candidate, VLA15.
Under the updated terms, Valneva is now responsible for funding 40% of the remaining shared development costs compared to 30% according to the initial agreement.
Pfizer will pay tiered royalties between 14% and 22% to Valneva, along with up to $100m in milestone payments based on cumulative sales.
Valneva intends to use the proceeds from equity investment to support its Phase 3 development contribution to the Lyme disease programme.
Valneva chief executive officer Thomas Lingelbach 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.”
In April this year, Pfizer announced its plans to initiate a Phase 3 study of VLA15 in the third quarter of this year.
After successful initiation and completion of the Phase 3 study of VLA15, the US drugmaker is anticipated to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in 2025.
VLA15 is an investigational multivalent protein subunit vaccine, which is the only Lyme disease vaccine candidate currently in clinical development, according to Pfizer.
The vaccine leverages an established mechanism of action that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.
Lyme disease is a systemic infection caused by Borreliaburgdorferi bacteria and is transmitted to humans by infected Ixodes (blacklegged) ticks.
Pfizer senior vice president and vaccine research and development head Kathrin U Jansen 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.”