Biogen licenses BMS-986168, phase 2 anti-tau antibody from Bristol-Myers Squibb

BMS-986168 is an antibody targeting extracellular tau, the protein that forms the deposits, or tangles, in the brain associated with AD and other neurodegenerative tauopathies such as PSP. PSP is a rare and devastating condition that affects movement, speech, vision, and cognitive function. Biogen plans to rapidly initiate phase 2 studies for BMS-986168 in both AD and PSP.

“Biogen aims to be a leader in Alzheimer’s disease and we are building a pipeline with multiple approaches to address the complex, devastating process of neurodegeneration,” said Michael Ehlers, executive vice president, research & development. “Based on encouraging safety and efficacy data, we believe BMS-986168 is a promising anti-tau candidate that may represent the next wave of medicines for Alzheimer’s disease as well as the first real answer for progressive supranuclear palsy.”

The addition of BMS-986168 to Biogen’s pipeline signifies both a broader commitment to rare neurodegenerative diseases as well as a strengthened focus on AD, a condition that affects millions of patients and families. With an expanded AD pipeline that includes a range of anti-tau and anti-amyloid candidates as well as a BACE inhibitor programme, Biogen is targeting multiple mechanisms implicated in the disease.

Under the agreement, Biogen will receive worldwide rights to BMS-986168. Biogen will be responsible for the full development and global commercialization of BMS-986168 in AD and PSP. Bristol-Myers Squibb will receive an upfront payment of $300 million from Biogen and may receive up to $410 million for additional milestone payments and potential royalties.

Biogen will also assume all remaining obligations to the former stockholders of iPierian, related to Bristol-Myers Squibb’s acquisition of the company in 2014. Biogen may pay up to $550 million in remaining milestones plus royalties including a near term $60 million milestone.

The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the second calendar quarter of 2017.

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person’s inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide. Evidence suggests that pathophysiological changes typically begin years prior to the symptoms that lead to a clinical diagnosis. As the disease progresses, cognitive impairments, behavioral changes and functional disability commonly associated with AD begin to manifest.

Progressive supranuclear palsy (PSP) is a rare neurodegenerative brain disorder that affects movement, control of walking (gait) and balance, speech, swallowing, vision, mood and behavior, and thinking. PSP, like AD, is a tauopathy, which is a class of neurodegenerative disease associated with the pathological aggregation of tau protein in the human brain. Estimates vary, but incidence is estimated to be about three to six in every 100,000 people worldwide. The disease progresses and causes weakness by damaging certain parts of the brain above nerve cell clusters called nuclei. These nuclei particularly control eye movements. One of the classic signs of the disease is an inability to aim and move the eyes properly, which individuals may experience as blurring of vision.

Biogen licenses, bristol-myers squibb