Biogen (NSDQ:BIIB) has entered into a licensing agreement with Sage Therapeutics (NSDQ:SAGE) to commercialize zuranolone (SAGE-217) and SAGE-324.
It will pay $1.5 billion in addition to potential milestone payments.
Zuranolone is an investigational neuroactive steroid that could treat major depressive disorder, postpartum depression, insomnia and other psychiatric disorders.
SAGE-324 could potentially treat essential tremor and other neurological disorders.
Biogen had been banking on Alzheimer’s drug Aducanumab’s blockbuster potential until an FDA advisory committee voiced skepticism about its potential.
The two companies are likely to focus initially on commercializing zuranolone, which is the subject of several Phase 3 trials. “SAGE-324, on the other hand, is still in Phase IIa development,” said Philippa Salter, a neurology analyst at GlobalData.
Zuranolone had shown promising results in Phase 2 studies for patients with major depressive disorder, postpartum depression and bipolar depression. The drug faced a setback, however, when its Phase 3 MOUNTAIN study of the medicine failed to meet its primary endpoint.
But the drug still has potential, Salter said. Sage recently announced that the drug improved symptoms of depression in the majority of patients within 14 days.
If further studies bear out this result, the drug could fill a significant unmet need for major depressive disorder, Salter said. Current drugs on the market generally take “a few weeks of treatment” to work, she added. “Zuranolone’s approval as a rapid-acting, short course treatment would be a welcome and much needed addition to the MDD treatment paradigm,” Salter.
Sage’s stock dipped on Dec. 1, however, after two analysts weighed in on the deal with Biogen. Raymond James analyst Dane Leone downgraded Sage’s stock while Citi analyst Neena Bitritto-Garg reduced her price target for the company.
GlobalData anticipates that zuranolone will launch in the U.S. in 2022.
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