Sunosi is indicated to improve wakefulness in adult patients suffering from excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA)

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Axsome acquires Sunosi rights in the US. (Credit: James Yarema on Unsplash)

Axsome Therapeutics has completed the acquisition of Jazz Pharmaceuticals’ US rights to dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) Sunosi (solriamfetol).

Under the agreement, Axsome has made an upfront payment of $53m to Jazz, which is eligible to receive additional royalty on net sales of Sunosi in the US.

Sunosi is indicated to improve wakefulness in adult patients suffering from excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

The US-based biopharmaceutical company is expected to close the transaction within 60 days, subject to the satisfaction of conditions.

Axsome chief executive officer Herriot Tabuteau said: “We are proud to provide narcolepsy and obstructive sleep apnea patients with excessive daytime sleepiness continued access to Sunosi, and we intend to further research of this important medicine in other clinical settings.

“The Sunosi acquisition marks the transformation of Axsome into a commercial neuroscience company, and reflects our commitment to the millions of people living with serious neurologic and psychiatric conditions.”

Sunosi received the US Food and Drug Administration (FDA) approval in 2019 and the European Medicines Agency (EMA) approval in 2020.

Data from randomised placebo-controlled studies in patients with EDS associated with narcolepsy or OSA has supported the regulatory approvals.

In 2014, Jazz acquired a licensed drug from Aerial Biopharma, obtaining global rights to develop, manufacture, and market the drug, except in certain regions in Asia.

SK Biopharmaceuticals, the original discoverer of the compound retains the rights in 12 Asian markets, including Korea, China and Japan.

Furthermore, Sunosi is a federally controlled substance (C-IV), as its active ingredient can be a target for people who abuse prescription medicines or street drugs.

Jazz Pharmaceuticals chairman and CEO Bruce Cozadd said: “The divestiture of Sunosi enables us to sharpen our focus on the strategic areas where we see the most opportunity for sustainable growth and enhanced shareholder value.

“Looking forward, Jazz will continue to invest in our highest strategic priorities, driving the transformation of Jazz to an innovative, global biopharmaceutical leader, and delivering improved top- and bottom-line growth through operational excellence.”