With three launches to come this year, something has to give over at Biogen—and what's giving will be three programs in stroke, gene therapy and ophthalmology.
Biogen announced a pipeline reprioritization Tuesday in its first-quarter earnings release. On the chopping block is BIIB093, a phase 3 asset for large hemispheric infarction. The therapy is also in phase two development for brain contusion.
BIIB093 was licensed from Remedy Pharmaceuticals in 2017, but, today, the partnership is ending. Biogen has sent a letter of termination, and Remedy will have 30 days to exercise its rights to assume development of the programs. Meanwhile, both studies will continue.
The asset is being cut due to "operational challenges and strategic considerations," said Priya Singhal, M.D., head of Development and interim head of Research and Global Safety and Regulatory Sciences, during a Tuesday earnings call.
"We're looking at every program in great depth, several times over," Singhal said. "I would say the common denominator across all the decisions that you're hearing from us today, is we believe that we should be spending time elsewhere."
Biogen said the BIIB093 cut will result in a modest reduction to full-year 2023 R&D expenses with more “meaningful savings” to come in later years. The company paid out $120 million upfront for BIIB093 in May 2017, with additional milestones and royalties possible down the line.
Another therapy impacted will be BIIB131, a small molecule that was in phase 2b development for acute ischemic stroke. Biogen is pausing the initiation of that trial and will assess whether to initiate it at all. A previous phase 2a study had determined that BIIB131 was generally well tolerated and resulted in improved outcomes of functional independence.
Finally, development of Ionis-partnered antisense oligonucleotide BIIB132 in spinocerebellar ataxia type 3 will be discontinued. A phase 1 kicked off almost exactly a year ago.
Biogen previously announced a refocusing of its gene therapy program, including the end of a partnership with Sangamo. The two companies were working on 12 neurological disease gene targets through a deal signed in 2020 that included $125 million upfront and up to $2.37 billion in milestones.
With the launch of depression treatment zuranolone, tofersen and star Alzheimer's disease treatment Leqembi coming this year—products that CEO Christopher Viehbacher said “represent Biogen at its best”—the company has plenty to focus on. Also at the top of the list is the next Alzheimer's therapy in Biogen's stable, the tau-targeting agent BIIB080.
The FDA’s decision on the amyotrophic lateral sclerosis treatment tofersen, in development with Ionis, is due today.