In its efforts to build a multi-franchise portfolio, Biogen added seven new clinical programs in 2019 and expects 11 mid- to late-stage data by the end of 2021, including several near-term opportunities in Alzheimer’s disease, ALS, stroke, lupus, ophthalmology, and biosimilars.

For $75 million upfront and up to $635 million in potential additional payments, Biogen expanded its pipeline of disease-modifying therapies for Alzheimer’s and Parkinson’s diseases, acquiring from Pfizer, PF-05251749, a CNS-penetrant small molecule inhibitor of casein kinase 1 for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. Biogen plans to develop the Phase I asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder in Parkinson’s disease (PD). 

Complementing its expanding efforts in gene therapy across neurological diseases, a broad collaboration with Sangamo Therapeutics for gene regulation therapies in neurology, will initially focus on development of ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, and a neuromuscular target, with exclusive rights for nine additional neurological targets. Biogen paid $350 million upfront, including a license fee and an equity investment. Sangamo is eligible to as much as $2.37 billion in potential milestones and royalties.

Also, in a transaction valued at approximately $800 million, the acquisition of Nightstar Therapeutics added gene therapies focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. NST’s lead assets, NSR-REP1 for the treatment of choroideremia (CHM), a rare, degenerative, X-linked inherited retinal disorder which leads to blindness, and NSR-RPGR, for X-linked retinitis pigmentosa (XLRP), also a rare inherited retinal disease for which there are no approved treatments.

Further, in a significant new transaction with Samsung Bioepis, Biogen acquired commercialization rights to biosimilars of Lucentis (SB11) and Eylea (SB15) in the U.S. and other major markets. Biogen is paying $100 million upfront for the rights and another $210 million in development, regulatory and sales targets. Lucentis was the first VEGF inhibitor approved for wet AMD and grew into a blockbuster with sales of around $3.9 billion last year, with Roche reporting $1.8 billion and Novartis, $2.1 billion. While Regeneron’s rival VEGF Eylea, reported $7.9 billion in sales, up 17% in 2019. Lucentis and Eylea are widely used to treat ophthalmologic conditions and together make up the largest share in the wet AMD market.

Biogen also gained exclusive rights to Samsung’s anti-TNF portfolio under the deal, including BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI (adalimumab), in China.

Of its advancing assets, VUMERITY, a new oral treatment option for relapsing forms of MS, won FDA approval to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. 

Also, Biogen and Eisai plan to pursue regulatory approval for aducanumab in early Alzheimer’s disease. The Phase III EMERGE Study met its primary endpoint showing a significant reduction in clinical decline on measures of cognition and function. If approved, aducanumab would become the first therapy to reduce the clinical decline of AD and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

However, the companies discontinued Phase III studies of the investigational oral BACE inhibitor elenbecestat in early AD based on an unfavorable risk-benefit ratio. As part of this decision, the long-term extension of the Phase II trial of elenbecestat will also be discontinued. The program of the anti-amyloid beta (Aβ) protofibril monoclonal antibody BAN2401, and the Phase III Clarity AD trial of BAN2401 will continue.

In other disappointing news, a Phase II study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP) did not demonstrate efficacy on key clinical endpoints, and as a result, Biogen discontinued development of gosuranemab for PSP and other primary tauopathies. Biogen will continue its ongoing Phase II study of gosuranemab in mild cognitive impairment due to AD or mild AD.

COVID-19 News
Biogen and Vir Biotechnology entered an antibody development and manufacturing agreement to develop Vir’s monoclonal antibodies against coronavirus. Biogen will provide cell line development, process development and clinical manufacturing for Vir’s monoclonal antibodies. Vir has discovered antibodies that bind to the novel coronavirus, and is testing whether they can treat or prevent the infection.

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