Biogen and Sage Therapeutics Ink Deal for Treating Depression

On November 27th, Biogen, a global pioneer in developing therapies for neurological and neurodegenerative diseases, announced that it had entered into a partnership with Sage Therapeutics Inc. The deal intends to develop and commercialize zuranolone (SAGE-217), Sage Therapeutics’ positive allosteric modulator of the gamma-aminobutyric acid (GABAA) receptor for major depressive disorder (MDD), postpartum depression (PPD), and other psychiatric disorders. They also intend to advance SAGE-324 for essential tremors and other neurological disorders.

If this deal goes through, Sage Therapeutics is expected to receive $1.5 billion in cash, including an upfront payment of $875 million and a $650 million equity investment along with pre-discussed royalties and profits.

Major Depressive Disorder

In the US, it is estimated that approximately 17 million people suffer from MDD each year. This number has increased by almost three folds due to the COVID-19 pandemic as per published scientific findings. Annually, around 50,000 women are estimated to experience postpartum depression, one of the most common depressive periods that occurs before or after childbirth. Common treatments include hormone therapy, antidepressants, and counseling.

Zuranolone, a potential gamechanger in the field of MDD and PPD, aims to bring to the market an “as-needed” therapy that might lower the intake of antidepressants and provide a better quality of life to the patient. Currently, the oral drug is under Phase 3 development and is a part of the LANDSCAPE and NEST clinical programs, while having already grabbed breakthrough therapy designation from the USFDA for MDD.

Michel Vounatsos, Biogen’s Chief Executive Officer, 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 comorbidity 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”.

An elated Mike Cloonan, Chief Operating Officer at Sage Therapeutics, added, “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”.

Zuranolone

The GABAA system is responsible for regulating the functions of the central nervous system (CNS) and is the major inhibitory signaling pathway of the brain and CNS. Zuranalone intends to target this pathway to achieve success in MDD and PDD.

Interestingly, last year, the company was in hot water as zuranolone failed a key Phase 3 trial (MOUNTAIN) where no improvement was observed when compared to patients in the placebo group. Since then, the company has pivoted and completely changed its development strategy. This led to two key positive studies, MDD-201 (for MDD) and ROBIN (for PDD), which have been completed with zuranolone (dosage: 30 mg).

Sage intends to navigate the US market by not only collaborating with “like-minded” Biogen but also in ways including the development of acute rapid response therapy (RRT) in MDD with new antidepressant therapies and “as-needed” treatment of MDD. This has led the company to advance four pivotal clinical trials, the results of which are expected in 2021. If all goes well, zuranolone would be highly complementary to several of Biogen’s therapeutic areas of focus, such as multiple sclerosis (MS), Alzheimer’s disease (AD), spinal muscular atrophy (SMA), among others. The companies have a strong chance to blitz the market given that depression is a common phenomenon in almost every part of the world, and that competition remains sparse.

By T. Chakraborty, Ph.D.

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References

1. https://investors.biogen.com/news-releases/news-release-details/biogen-and-sage-therapeutics-announce-global-collaboration

Author

Tulip Chakraborty