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Pfizer to buy 8.1% stake in Valneva in support of joint Lyme disease programme

VLA15 is the only Lyme disease vaccine candidate currently in clinical development

Pfizer

Pfizer will invest €90.5m in Valneva to represent 8.1% of the company’s share capital in a deal that will further support the strategic Lyme partnership between the two companies.

Valneva is planning to use the proceeds from Pfizer’s equity investment to support its phase 3 development contribution to its Lyme disease vaccine candidate VLA15, the terms of which were revised by the two companies.

Valneva will fund 40% of the remaining shared development costs, compared to 30% in the initial agreement. Pfizer will pay Valneva tiered royalties of up to 22% which will be complemented by up to $100m in milestones payable to Valneva based on cumulative sales.

Lyme disease is a systemic infection transmitted to people by infected Ixodes ticks carrying Borrelia Burgdorferi bacteria. It is estimated to affect around 476,000 people in the US and 130,000 people in Europe each year.

Early symptoms of Lyme disease, such as a gradually expanding erythematous rash called erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia, are often overlooked or misinterpreted.

If left untreated, the disease can cause more serious complications including arthritis, carditis or affect the nervous system. Cases are rising as it continues to spread, underscoring the medical need for vaccination against the disease.

VLA15 is the only Lyme disease vaccine candidate currently in clinical development and has demonstrated a strong immunogenicity and safety profile in pre-clinical and clinical studies so far. The vaccine uses a mechanism that targets the outer surface protein A of Borrelia burgdorferi.

The programme was granted Fast Track designation by the US Food and Drug Administration (FDA) in July 2017, with Pfizer and Valneva expecting to initiate their phase 3 trial this year, subject to regulatory approval.

Commenting on the agreement, Thomas Lingelbach, chief executive officer of Valneva, said: "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.”

The anticipation for the phase 3 trial comes after Pfizer and Valnever announced positive phase 2 paediatric results in April.

Article by
Emily Kimber

22nd June 2022

From: Sales, Healthcare

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