On 27 November, Biogen announced a licensing agreement with Sage Therapeutics to jointly develop and commercialise zuranolone (SAGE-217) and SAGE-324. Zuranolone is in development for major depressive disorder (MDD), postpartum depression (PPD), and other psychiatric disorders, while SAGE-324 is in development for essential tremor and other neurological disorders.

Biogen already has a strong neurology portfolio so this licensing deal will allow it to expand in this therapy area, while complementing the disease areas it is already involved in, including multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, amyotrophic lateral sclerosis, and Parkinson’s disease. Sage Therapeutics has only brought one previous product to the market, Zulresso (brexanolone), which was approved for PPD in the US in 2019, so it will be able to leverage Biogen’s expertise in bringing products to the neurology market, to develop and commercialise its pipeline products. It is expected that the companies will focus initially on zuranolone, which has several ongoing Phase III trials, whereas SAGE-324 is still in Phase IIa development. GlobalData expects zuranolone to launch in the US in 2022, with other markets to follow, with global revenue of $1.3B expected in 2026.

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A key unmet need in the MDD market is for drugs with a rapid onset of action. Currently available products, including the first-line therapy options, selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), show antidepressant effects only after a few weeks of treatment, and in many cases, the dosing needs to be optimised or products need to be combined in order for a maximum therapeutic benefit to be achieved. Zuranolone has a novel mechanism of action (MOA), as a gamma-aminobutyric acid (GABAA) receptor positive allosteric modulator, and is being developed as a rapid-acting, short-course treatment for MDD, which, if approved, would be a welcome and much-needed addition to the MDD treatment paradigm.

Despite its novel MOA, it is unlikely that zuranolone will become first-line therapy for MDD immediately. The current first-line therapy options, SSRIs and SNRIs, have been on the market for many years and are well entrenched in the treatment paradigm for MDD. Furthermore, the majority of SSRIs and SNRIs have cheap generic versions available, meaning it is likely they remain the preferred first-choice option over a more expensive newer drug.

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