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March 15, 2022

Biogen and Eisai revise agreements on Alzheimer’s disease therapies

The lecanemab collaboration was revised with the product supply agreement being extended from five to ten years.

Biogen and Eisai have revised their current partnership agreements on Alzheimer’s disease (AD) therapies, aducanumab and lecanemab.

The aducanumab partnership will be converted into an international royalty arrangement that will become effective from 1 January next year.

Under the revised agreement, Eisai will get tiered royalty payments based on net product sales rather than sharing worldwide profits and losses. 

Co-developed by the companies, aducanumab is an anti-amyloid beta (Aβ) antibody to treat AD patients. It is marketed as Aduhelm (aducanumab-avwa) in the US. 

On annual product sales exceeding $1bn, the royalty payments will be in the range of 2% to 8%. 

Furthermore, the current final decision-making rights of Biogen on Aduhelm have been changed to sole decision-making and commercialisation rights globally, which is effective immediately.

Eisai will not take part in Aduhelm’s economics beyond these royalty payments once the tiered royalty model becomes effective next year.

The collaboration on another investigational Aβ protofibril antibody, lecanemab for early AD will continue without changes globally.

The supply agreement linked to lecanemab for commercial production by Biogen has been increased to ten years from five years.

Biogen and Eisai will progress to carry out the co-development and co-commercialisation of lecanemab. 

Eisai is in charge of the development and regulatory submissions linked to lecanemab globally while the companies are jointly commercialising and promoting it.

In addition, Eisai holds the final decision-making rights. 

Both parties equally share the economics while Eisai handles complete sales of the product and Biogen is eligible for half of the profit and loss shares. 

The lecanemab drug substance will be produced by Biogen in its facility in Solothurn, Switzerland, to offer a steady commercial supply of the therapy globally. 

Eisai CEO Haruo Naito said: “The collaboration between both companies has resulted in the approval of Aduhelm in the US as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy.

“We believe this new arrangement will be more effective and enable more focused execution with the goal of maximising the value of both Aduhelm and lecanemab.”

In September last year, the companies initiated a rolling submission of a biologics license application (BLA) to the US Food and Drug Administration (FDA) for lecanemab for early AD treatment.

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