Pharmaceutical Business review

Axsome Therapeutics signs agreement for Sunosi acquisition

Sunosi is indicated to improve wakefulness in excessive daytime sleepiness. Credit: Sammy-Sander from Pixabay.

Under the terms of the deal, Axsome will gain global development, manufacturing commercial, and intellectual property rights to Sunosi, a dual-acting dopamine and norepinephrine reuptake inhibitor, except for certain Asian markets.

Sunosi has been designed for improving wakefulness in excessive daytime sleepiness (EDS) caused due to narcolepsy or obstructive sleep apnea (OSA) in adult patients.

It has already secured approval from the European Medicines Agency (EMA) in 2020 and the US Food and Drug Administration (FDA) in 2019.

Sunosi is claimed to be the first and only DNRI approved for the treatment of EDS in adult patients.

Axsome expects that the deal will accelerate its transformation into a global commercial entity before the potential near-term launch of AXS-07 in migraine and AXS-05 in major depressive disorder (MDD).

Axsome CEO Herriot Tabuteau said: “This acquisition immediately transforms Axsome into a global commercial entity, upon closing, and accelerates our growth as a premier biopharmaceutical company focused on delivering potentially life-changing medicines to people living with serious CNS conditions.

“The addition of Sunosi augments and accelerates our commercial preparedness ahead of the potential near-term launches of our two existing lead assets, AXS-05 and AXS-07, and allows us to fully leverage our first-in-class Digital Centric Commercialization platform with three complementary assets.”

The company stated that the deal is planned to be completed in sequential closings for the US and ex-US territories.

The transaction, subject to satisfaction or waiver of the closing conditions, is expected to be concluded the second quarter of this year in the US.

In the ex-US territories, the acquisition is anticipated to be completed within 60 days after the US transaction.