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Biogen scuttles a Tysabri program after the drug fails stroke test, thinning the pipeline

Biogen’s hopes of expanding its franchise for Tysabri (natalizumab) by breaking into ischemic stroke just flopped, leaving the big biotech with one less program in an already thin pipeline.

Investigators for Biogen $BIIB say that the drug failed the primary and secondary endpoints in a Phase IIb trial, offering convincing data that the drug would not work for this indication. The hard data will be held back for a scientific conference.

Michael Ehlers, Biogen

Biogen’s plans for the ischemic stroke field are now limited to a Phase III ready BIIB093, which tackles SUR1-TRPM4 channels, hitting a pathway involved in brain swelling, or cerebral edema. The drug — picked up for $120 million last May — is being studied for large hemispheric infarction, a severe form of ischemic stroke.

Eliminating the program will only heighten pressure on Biogen to do something dramatic on the deal front. The neurosciences company has done a few deals under new CEO Michel Vounatsos, but not of a size to satisfy analysts fretting over a pipeline dominated by risky Alzheimer’s drugs. Jefferies’ Michael Yee emphasized that point this morning.

While today’s announcement of the failure of the Phase IIB Tysabri stroke trial is disappointing, we remain long-term positive and believe the Phase III Alzheimer’s trial can work but the company needs more balanced programs in between as it is levered too much towards Alzheimer’s.

Biogen R&D chief Michael Ehlers noted:

“While we are disappointed with the ACTION 2 study results, we have furthered our knowledge of the disease and will continue to pursue innovative approaches in this area, including BIIB093 (intravenous glibenclamide) for prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke.”


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