Biogen Inc. announced that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM. Effective as of January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM rather than sharing global profits and losses. The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion. Effective immediately, Biogen’s existing final decision-making rights on ADUHELM have converted to sole decision making and commercialization rights worldwide. Overall, economic arrangements for both companies in 2022 are expected to remain materially unchanged with Eisai’s share of expenses capped at an agreed amount for the costs related to development, commercialization, and manufacturing of ADUHELM for the period from January 1, 2022 to December 31, 2022. Once the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM’s economics beyond these royalties.
The companies will continue to jointly develop and commercialize the investigational therapy lecanemab. Eisai continues to serve as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. Both companies share economics equally with Eisai booking all sales for lecanemab and Biogen reflecting its 50% share of profits and losses.
The supply agreement related to lecanemab has been extended from five to 10 years. Biogen will manufacture the lecanemab drug substance in its Solothurn, Switzerland facility with the goal of providing reliable commercial supply worldwide.
“This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of ADUHELM,” said Michel Vounatsos, Chief Executive Officer at Biogen. “In addition, we are pleased to be expanding our agreement with Eisai through a new long-term manufacturing contract.”
“The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. 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.” said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both ADUHELM and lecanemab. Eisai will increase its focus on lecanemab and remains committed to bringing a new treatment option expeditiously to patients in need worldwide.”
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
