On May 9, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it has completed the divestiture of Sunosi (solriamfetol) in the U.S. to Axsome Therapeutics, Inc. (Nasdaq: AXSM) (Press release, Jazz Pharmaceuticals, MAY 9, 2022, View Source [SID1234613973]).

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Under the terms of the agreement, Jazz received an upfront payment of $53 million, and will receive a high single-digit royalty on Axsome’s U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S. net sales of Sunosi in future indications. Subject to the satisfaction of conditions to closing, the ex-U.S. transaction is expected to close within 60 days.

"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," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "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."

About Sunosi (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.

Important Safety Information for Sunosi

SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:

have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
have had a heart attack or a stroke
have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?

SUNOSI may cause serious side effects, including:

Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:

headache
decreased appetite
problems sleeping
nausea
anxiety
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.