Biogen and Sage Therapeutics are jointly collaborating to develop and commercialise zuranolone (SAGE-217) for depression and other neurological disorders and SAGE-217 for movement disorders.
Specifically, the potential breakthrough treatment will be investigated for use in major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders. SAGE-217, meanwhile, will be investigated for essential tremor and other.
“With the recent and pending data outputs for zuranolone and SAGE-324, the timing is right for a collaboration between two like-minded companies committed to patients and driven by a passion for neuroscience and brain health,” said Mike Cloonan, Chief Operating Officer at Sage Therapeutics.
“Through this collaboration, Sage and Biogen have the potential to build something greater together than either could have done alone.
“We will leverage each other’s existing expertise while continuing to build new capabilities in our efforts to create paradigm shifts in the treatment of depression, PPD and essential tremor – disorders that have gone too long with few treatment innovations.
“Additionally, the cash from the collaboration is expected to enable Sage to accelerate and expand value potential for its pipeline and will enhance Sage’s strategic, financial and operational flexibility as well as strengthening our multi-franchise approach.”
Zuranolone, a potential first-in-class, two-week, once-daily oral therapy in development for the treatment of MDD and PPD, is currently in Phase 3 development as part of the LANDSCAPE and NEST clinical programs.
Zuranolone has breakthrough therapy designation from the FDA for MDD and, if successfully developed and approved, has the potential to be a novel treatment paradigm in depression.
The vision for zuranolone in MDD and PPD is based on its potential, being evaluated in the LANDSCAPE and NEST development programs, to work rapidly and to continue providing sustained benefit beyond the period of dosing.
Together, these two features, if supported by positive clinical efficacy and safety data, could provide an alternative option to how depression is treated today based on a target profile of an “as-needed” short course of treatment for a depressive episode, with rapid and sustained efficacy and favourable tolerability.
The development of an “as-needed” treatment for depression may help ease the difficulties associated with chronic use of antidepressants and may enhance quality of life and patient adherence.
If approved, zuranolone would also be highly complementary to several of Biogen’s therapeutic areas of focus, including multiple sclerosis (MS), Alzheimer’s disease (AD), spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). Depression is a common co-morbidity in patients with these neurological disorders and their caregivers.
Upon closing of the transaction, Biogen and Sage will collaborate to further define the development and commercialization strategy for zuranolone.
Beyond PPD and MDD, zuranolone may also have potential in other psychiatric disorders including bipolar disorder and generalized anxiety disorder.
The strategic collaboration is global in scope and under the terms of the agreement, Sage will receive $1.525 billion in cash to be comprised of an upfront payment of $875 million and a $650 million equity investment in Sage from the purchase of approximately 6.2 million newly issued shares of Sage common stock at a price of $104.14 per share, representing a premium of 40 percent over the 30-day volume-weighted average share price of $74.39 per share as of November 25, 2020.