Sage Therapeutics strikes $3.1bn licensing deal with biogen for depression and neurological disorder treatments

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has entered into a high-stakes global collaboration and licensing agreement with Biogen, valued at up to $3.1 billion, aimed at advancing two promising drug candidates for (MDD), postpartum depression (PPD), and neurological conditions. The deal will see the two US-based pharmaceutical giants co-develop and commercialize Sage’s zuranolone (SAGE-217) and SAGE-324, with a focus on transforming the treatment landscape for these challenging conditions.

Zuranolone: A New Hope for Depression

Zuranolone is currently in Phase 3 clinical trials, targeting MDD, PPD, and other psychiatric disorders. This once-daily, two-week oral therapy works as a positive allosteric modulator of the GABAA receptor, a crucial component in managing mood regulation. It has already been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA), underscoring its potential as a transformative treatment.

Zuranolone’s clinical journey has seen mixed results. Pivotal studies, including the MDD-201 and ROBIN studies, showed positive results with a 30 mg dose. However, the MOUNTAIN Study, a critical Phase 3 trial, failed to meet its primary endpoint. Despite this, Sage Therapeutics highlighted encouraging data from a six-month follow-up of the MOUNTAIN Study and an interim analysis from the SHORELINE Study, both of which suggest that zuranolone could still offer significant therapeutic benefits.

Biogen’s CEO, , emphasized the strategic fit of zuranolone with Biogen’s core therapeutic areas, which include multiple sclerosis (MS), Alzheimer’s disease (AD), and Parkinson’s disease (PD). He noted that depression, affecting millions in the U.S. alone, often coexists with these neurological conditions, creating a substantial unmet need in the field.

SAGE-324: A Potential Breakthrough in Neurology

SAGE-324, another drug in the collaboration, targets essential tremor, a debilitating condition that currently lacks sufficient treatment options. Like zuranolone, it functions as a positive allosteric modulator of the GABAA receptor and is currently in Phase 2 development for essential tremor. However, its potential extends beyond this, with possible applications in epilepsy, Parkinson’s disease, and other .

Sage Therapeutics’ Chief Operating Officer, Mike Cloonan, stressed the importance of this partnership in advancing treatments for essential tremor and other under-addressed neurological conditions. He described the collaboration as an opportunity to leverage both companies’ strengths to deliver breakthroughs in psychiatry and neuroscience.

A $3.1 Billion Opportunity

The financial details of the deal are substantial. Biogen will pay Sage Therapeutics an upfront cash payment of $875 million, along with a $650 million equity investment, purchasing nearly 6.2 million newly issued shares of Sage. Additionally, Sage stands to earn up to $1.6 billion in milestone payments as both zuranolone and SAGE-324 meet development and commercial milestones.

This deal also establishes a shared responsibility for the development and commercialization of the drugs in the U.S., with profits and losses split between the two companies. Outside the U.S., Biogen will handle the development and commercialization efforts, with the exception of Japan, Taiwan, and South Korea for zuranolone. Biogen will also pay Sage tiered royalties in the high teens to low twenties for sales outside the U.S.

Looking Ahead

The deal is expected to close by the end of January 2021, subject to antitrust reviews and customary closing conditions. If successful, this collaboration will significantly enhance Sage Therapeutics’ ability to expand its pipeline and advance its multi-franchise approach, creating a substantial impact in the treatment of depression and neurological disorders.

Sage Therapeutics’ partnership with Biogen marks a pivotal moment in the treatment of depression and neurological disorders. With both companies combining their expertise, this $3.1 billion deal has the potential to bring much-needed innovations to areas of medicine that have long struggled with a lack of effective treatments. As the development of zuranolone and SAGE-324 progresses, their success could reshape the future of psychiatry and neurology, offering new hope to millions of patients worldwide.


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