South Korean biotech ADEL has entered into an exclusive worldwide license agreement with Sanofi for ADEL-Y01, an investigational antibody therapy for Alzheimer’s disease. The deal is valued at up to $1.04 billion.

ADEL will receive an $80 million upfront payment and is eligible for additional milestone payments tied to development and commercial targets. The company will also receive tiered royalties on net sales up to double-digit percentages.

According to the Alzheimer’s Association, almost two-thirds of Americans living with Alzheimer’s are women—of the 7.2 million people age 65 and older with Alzheimer’s in the United States, 4.4 million are women. Women in their 60s are about twice as likely to develop Alzheimer’s during the rest of their lives as they are to develop breast cancer.

ADEL-Y01 is a humanized monoclonal antibody that targets tau protein acetylated at Lysine-280. Unlike therapies targeting total tau, ADEL-Y01 selectively inhibits the aggregation and propagation of toxic tau species while preserving the function of normal tau. The asset is currently in a global Phase 1 clinical trial under an IND approved by the U.S. FDA.

“This strategic partnership with Sanofi, a global leader in healthcare, underscores ADEL’s technological strength and highlights the therapeutic promise of ADEL-Y01,” said Seung-Yong Yoon, CEO of ADEL. “By combining our scientific expertise with the proven development and commercialization capabilities of Sanofi, we hope to accelerate the delivery of this disease-modifying therapy to people living with Alzheimer’s around the world.”

Erik Wallstroem, Global Head of Multiple Sclerosis, Neurology and Gene Therapy Development at Sanofi, said: “ADEL’s innovative approach to targeting tau acetylation offers a promising and differentiated mechanism for addressing the underlying causes of Alzheimer’s disease.”

ADEL has been co-developing the asset with Oscotec Inc. since 2020. The company was founded in 2016 by Professor Seung-Yong Yoon of Asan Medical Center, University of Ulsan College of Medicine.

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