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One of two drugs being developed by Biogen and Sage Therapeutics failed a mid-stage study and the companies announced they would not pursue it further.The $1.5 billion collaboration hinges on approved drugs that are already facing challenges.
Last week, the companies announced that SAGE-324 failed to beat a placebo in a mid-stage trial in patients with essential tremor, Cut with an ax As a result, an open-label study was conducted.
Sage and Biogen’s relationship was valued at $1.5 billion in 2020 agreement The company co-developed SAGE-324 with Zurzuvae, a drug for the treatment of depression, which was subsequently approved. Postpartum depressionWith SAGE-324 soon to be phased out, Biogen may be looking to squeeze more profit out of Zurzuvae.
At the same time that the FDA approved Zurzuvae last year to treat postpartum depression, the agency Rejected It has been approved as a second indication for major depressive disorder, which is a much larger market than postpartum depression. Half a million women in the United States suffer from postpartum depression each year. 21 million There are a large number of adults in the United States who suffer from MDD, and this approval could hurt the drug’s revenue potential. Sage lays off 40% The company cut staff and announced a series of executive changes as a result of the refusal.
Biogen also 11% were fired About 1,000 of its employees bought Zurzuvae last year. But Biogen said Zurzuvae’s adoption rate was “EncouragingIn the first three months of 2024, sales will jump to $12 million from $2 million in the fourth quarter of 2023. And PPD’s total sales could reach $500 million, BioPharma Dive reported in April. At the time, the companies Next steps For MDD approval.
It is unclear whether Biogen and Sage are still pursuing an MDD indication. Neither company mentioned MDD prospects in their most recent earnings calls. Mixed resultsThe FDA noted that further testing is needed.
But Sage sees big things in Zurzvaer for PPD. CEO Barry Green said:Potential for a big hit“Zurzuvae” in the PPD field First-line therapy And the standard of care has changed, he said during the company’s first-quarter earnings call.
Biogen hit hard
The setback with Sage isn’t Biogen’s only problem in recent years. The company has struggled with its Alzheimer’s disease programs after announcing in January that it was taking its struggling Alzheimer’s treatment Aduherm off the market. The drug received accelerated approval from the FDA in 2021, but the controversy has grown after criticism that the drug doesn’t work. Three F.D.A. officials Quit your job.
Biogen has since allocated its Alzheimer’s treatment resources to another drug, Rekembi. Approved in 2023Sales of Lukembi, which Biogen developed with Eisai, are expected to hit just $10 million in 2023 but rise to $19 million in the first quarter of 2024. And the approval of Eli Lilly’s Alzheimer’s drug donanemab in early July has helped Biogen Showdown To boost sales and increase patient intake.
Biogen and Eisai Negative opinions Eisai applied to the European Medicines Agency (EMA) for approval of Leqembi in the European Union this month, but said it would ask the EMA for reapproval.
Sage is also growing this spring. Discontinued The Parkinson’s disease drug failed to meet its primary endpoint in a Phase 2 trial.
After its Alzheimer’s failure, Biogen bounced back with revenue from drugs it had acquired. $7.3 billion Last year, it acquired Reata Pharmaceuticals Inc. Skyclaris, which treats Friedreich’s ataxia. $78 million Q1 2024 Revenue.
Biogen told BioPharma Dive in April that it would continue to diversify to build new pipelines.
