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Biogen signs $3.1bn deal with Sage for potential depression therapies

Zuranolone already has a breakthrough therapy designation from the US FDA

Biogen has bet up to $3.1bn on a series of potential depression and movement disorder therapies currently being developed by Sage Therapeutics.

The collaboration and licence agreement will see Biogen and Sage jointly develop and commercialise zuranolone, an investigational treatment for major depressive disorder (MDD), postpartum depression and other psychiatric disorders.

The two companies are also set to co-develop SAGE-324, another experimental drug designed to treat essential tremor and other neurological disorders.

Under the terms of the agreement, Biogen will pay Sage $1.525bn in cash, comprised of an upfront payment of $875m and a $650m equity investment in the company.

Dependent on whether or not zuranolone and SAGE-324 hit certain development and commercial milestones, Sage will also be eligible to receive up to approximately $1.6bn in potential milestone payments.

“We are excited about the potential to bring together Biogen’s leading capabilities in neuroscience with Sage’s deep expertise in psychiatry,” said Michel Vounatsos, chief executive officer, Biogen.

“Major depressive disorder affects approximately 17 million people in the US alone, and is a common co-morbidity of multiple neurological disorders in Biogen’s core therapeutic areas,” he added.

In the US, Biogen and Sage will share responsibility and costs for development, as well as profits and losses for commercialisation.

Outside the US, Biogen will hold responsibility for development and commercialisation with respect to zuranolone, excluding Japan, Taiwan and South Korea.

Zuranolone is currently being studied in phase 3 development and has already picked up a breakthrough therapy designation from the US Food and Drug Administration (FDA) for MDD.

Last year, Sage announced that zuranolone did not meet the primary endpoint in its first phase 3 study, failing to hit a statistically significant reduction in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at day 15 compared to placebo.

However, Sage has maintained that follow-up data from this study, as well as top-line interim results from another phase 3 trial, are ‘encouraging’.

“Biogen and Sage believe that zuranolone is clinically active in MDD based on the data compiled to date and look forward to planned data readouts in 2021,” the companies said in a statement.

The deal bolsters Biogen’s pipeline as it awaits a key FDA decision on its potential Alzheimer’s disease treatment aducanumab.

Earlier this month, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted no on a number of counts regarding the efficacy and evidence supporting the use of aducanumab in Alzheimer’s disease (AD).

Although the FDA is not required to follow guidance from expert panel decisions, it usually does so.

The agency is set to announce its final decision on whether to approve aducanumab’s Biologics Licence Application (BLA) by 7 March 2021.

Article by
Lucy Parsons

30th November 2020

From: Sales



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