April 13, 2017
By Mark Terry, BioSpace.com Breaking News Staff
In two separate deals, Bristol-Myers Squibb with Biogen and Roche , the company brought in upfront payments totaling $470 million, with up to $1.1 billion possible in milestones plus royalties.
Bristol-Myers licensed BMS-986168 to Biogen for an upfront payment of $300 million and up to $550 million in milestones, plus royalties and a near-term $60 million milestone. BMS-986168 is an antibody that targets extracellular tau, which are the proteins that form tangles in the brain associated with Alzheimer’s disease and other neurodegenerative disorders such as progressive supranuclear palsy (PSP).
Biogen plans to quickly launch a Phase II trial of the compound in both Alzheimer’s 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, Biogen’s executive vice president, research & development, in a statement. “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.”
In addition, Biogen is taking on all remaining obligations to former stockholders of iPierian, which BMY acquired in 2014.
Early in Alzheimer’s, the brain is affected by beta-amyloid plaques. Later in the disease, tau proteins are present. Biogen is currently conducting clinical trials of aducanumab, an antibody against beta-amyloid. On December 9, 2016, the company announced promising early results from its Phase Ib trial of the drug. If aducanumb and the new compound targeting tau are affective, they could make for a promising combination therapy for Alzheimer’s.
PSP is a rare neurodegenerative brain disease that affects movement, walking and balance, speech, swallowing, vision, mood, behavior and thinking. It is a tauopathy—in other words, it is related to problems with tau proteins in the brain.
Bristol-Myers’ deal with Roche is for BMS-986089, an anti-myostatin adnectin for Duchenne muscular dystrophy (DMD). Roche is paying $170 million upfront with $205 million in potential milestones.
“Licensing these assets to Biogen and Roche will enable Bristol-Myers Squibb to prioritize the other promising opportunities for asset development that have advanced across our diversified portfolio,” said Mike Burgess, Bristol-Myers Squibb’s head of Cardiovascular, Fibrosis and Immunoscience Development, in a statement. “We recognize the significant unmet medical needs for patients with PSP and with DMD, and are pleased to put the future development of these compounds into the hands of Biogen and Roche, who both have strong capabilities, focus and leadership in neurodegenerative and rare diseases.”
DMD is a muscle wasting disease that usually causes death in early adulthood. It mostly affects boys, about 1 in every 3,500 to 5,000 male children. The only drug on the market to directly treat it is Sarepta Therapeutics ’s Exondys 51 (eteplirsen), which was approved by the U.S. Food and Drug Administration in September 2016 with a conditional and controversial approval that requires the company to conduct a two-year, randomized controlled trial to verify its benefits.
Of BMY, John Carroll, writing for Endpoints News, says, “Bristol-Myers, meanwhile, has been shaking up its R&D group in recent months, after the fiasco with the checkpoint Opdivo as it slipped behind Merck ’s Keytruda on non-small cell lung cancer. Bristol-Myers brought in a new R&D chief, Thomas Lynch, and has been selectively looking for ways to economize as it looks to make a comeback in a field that it helped to pioneer.”
