Sage Therapeutics has secured a global collaboration and licensing deal worth up to $3.1 billion with Biogen for two of its drug candidates intended for the treatment of depression and movement disorders.

Under the terms of the deal, the two US pharma companies will jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD), and other psychiatric disorders. The other drug candidate involved in the deal is SAGE-324, which is targeted to be developed for the treatment of essential tremor and other neurological disorders.

Details of Zuranolone | Zuranolone clinical trials

Zuranolone is a two-week, once-daily oral therapy is presently in phase 3 development as part of the LANDSCAPE and NEST clinical programs.

It is a next-generation positive allosteric modulator of the gamma-aminobutyric acid (GABAA) receptor, which was granted breakthrough therapy from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder.

So far, a couple of positive pivotal studies have been wrapped up with zuranolone 30 mg, one in major depressive disorder (MDD-201) and the other in postpartum depression (ROBIN Study).

In addition to these, the phase 3 MOUNTAIN Study of zuranolone in major depressive disorder failed to meet its primary endpoint.

According to Sage Therapeutics, the promising data from the recently announced six-month follow-up period of the MOUNTAIN Study and the topline interim SHORELINE Study analysis, indicate the potential for zuranolone.

Zuranolone, if approved, is expected to be highly complementary to several of Biogen’s therapeutic areas of focus which include multiple sclerosis (MS), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and Parkinson’s disease (PD).

Michel Vounatsos – Biogen CEO said: “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.

“There is a tremendous unmet medical need in depression, and we are optimistic about the potential for zuranolone to help transform the treatment of depression and address the stigma often associated with chronic use of antidepressants.”

Details of SAGE-324 | SAGE-324 clinical trials

SAGE-324 is also a next-generation positive allosteric modulator of GABAA receptors, which currently is in phase 2 development for the treatment of essential tremor. The drug candidate is also said to have potential in epilepsy, Parkinson’s disease, and other neurological conditions.

Mike Cloonan – Chief Operating Officer at Sage Therapeutics said: “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.

“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.”

As per the terms of the deal, Sage Therapeutics will be paid $1.52 billion in cash, which includes $875 million in upfront payment and an equity investment of $650 million from Biogen for nearly 6.2 million newly issued shares of the former.

Based on zuranolone and SAGE-324 programs meeting certain development and commercial milestones, Sage Therapeutics will stand to earn up to nearly $1.6 billion in the form of potential milestone payments.

Both the companies will share responsibility and costs for development and also profits and losses for commercialization in the US for the two drugs.

Outside the US, Biogen will have the responsibility for development and commercialization with the exclusion of Japan, Taiwan, and South Korea for zuranolone, and will pay tiered royalties in the high teens to low twenties to Sage Therapeutics.

The deal is likely to close by the end of January 2021. It will be subject to completion of review under antitrust laws and the meeting of other customary closing conditions.

  Biogen, major depressive disorder, Michel Vounatsos, Mike Cloonan, neurological disorders, postpartum depression, Sage Therapeutics, USA