Axsome Therapeutics has agreed to acquire Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), from Jazz Pharmaceuticals.

Sunosi is indicated to improve wakefulness in adults having excessive daytime sleepiness (EDS) because of narcolepsy or obstructive sleep apnea (OSA). The DNRI was approved in 2019 by the US Food and Drug Administration (FDA) and the following year by the European Medicines Agency (EMA).

Herriot Tabuteau — CEO of Axsome Therapeutics said: “Sunosi has demonstrated clinically meaningful efficacy, possesses a unique mechanism of action, and has generated positive patient and physician feedback. We are excited by its significant growth potential and excellent strategic fit with the Axsome portfolio.

“Furthermore, 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.”

As per the terms of the deal, Axsome Therapeutics will get the worldwide commercial, development, manufacturing, and intellectual property rights to Sunosi with the exception of some Asian markets.

Jazz Pharmaceuticals will be paid upfront an amount of $53 million from Axsome Therapeutics along with a high single-digit royalty on the latter’s US net sales of Sunosi in the current indication, as well as a mid single-digit royalty on the US net sales of the drug in future indications.

Axsome Therapeutics will also be assuming the commitments of Jazz Pharmaceuticals to SK Biopharmaceuticals and Aerial Biopharma.

SK Biopharmaceuticals, which is the originator of Sunosi, will retain its rights in 12 Asian markets, including China, Japan, and South Korea.

In 2014, Jazz Pharmaceuticals acquired worldwide rights to Sunosi excluding the 12 Asian markets from Aerial Biopharma.

The assumed commitments to SK Biopharmaceuticals and Aerial Biopharma include tiered royalties in single digits based on Axsome Therapeutics’ sales of Sunosi and revenue milestones up to $165 million and development milestones of $1 million.

Bruce Cozadd — CEO of Jazz Pharmaceuticals said: “In assessing the overall treatment landscape, we determined Axsome would be well positioned to maximize the value of Sunosi, both to patients and to Jazz. Axsome is well placed to leverage its complementary commercial business to ensure Sunosi can effectively reach those who can benefit from this important medicine.

“Further, we believe Axsome’s track record of clinical development provides a promising foundation for the exploration of Sunosi in additional indications.”

The deal is subject to closing conditions with the US transaction to close in Q2 2022, while the ex-US transaction will close within 60 days after the closing in the US.

  Aerial Biopharma, Axsome Therapeutics, Bruce Cozadd, Herriot Tabuteau, Jazz Pharmaceuticals, Pharma acquisition news, SK Biopharmaceuticals, Sleep Apnea, solriamfetol, Sunosi, US Food and Drug Administration, USA