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Biogen, Sage Therapeutics To Jointly Develop And Commercialize Zuranolone, SAGE-324

Biogen Inc. (BIIB) and Sage Therapeutics, Inc. (SAGE) said Friday they have entered into a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders, and SAGE-324 for essential tremor and other neurological disorders.

Under the terms of the deal, Sage will receive $1.525 billion in cash. This will be comprised of an upfront payment of $875 million and a $650 million equity investment in Sage from the purchase of about 6.2 million newly issued shares of Sage common stock at a price of $104.14 per share.

In addition, Sage will be eligible to receive up to about $1.6 billion in potential milestone payments if zuranolone and SAGE-324 programs achieve certain development and commercial milestones.

Biogen and Sage will share responsibility and costs for development as well as profits and losses for commercialization in the U.S. Outside the U.S., Biogen will be responsible for development and commercialization, excluding Japan, Taiwan and South Korea with respect to zuranolone, and will pay Sage tiered royalties in the high teens to low twenties.

"We are excited about the potential to bring together Biogen's leading capabilities in neuroscience with Sage's deep expertise in psychiatry. Major depressive disorder affects approximately 17 million people in the U.S. alone, and is a common co-morbidity of multiple neurological disorders in Biogen's core therapeutic areas," said Michel Vounatsos, Biogen's Chief Executive Officer.

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 received breakthrough therapy designation from the U.S. Food and Drug Administration or FDA for MDD. If successfully developed and approved, it has the potential to be a novel treatment paradigm in depression.

Biogen noted that if approved, zuranolone would also be highly complementary to several of its own 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).

SAGE-324 is a next-generation positive allosteric modulator of GABAA receptors in Phase 2 development for essential tremor with potential in other neurological conditions such as epilepsy and PD.

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