DUBLIN, May 9, 2022 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it has completed the divestiture of Sunosi® (solriamfetol) in the United States to Axsome Therapeutics, Inc. (Nasdaq: AXSM).
Under the terms of the agreement, Jazz received an upfront payment of $53 millionand will receive a high single-digit royalty on Axsome’s net sales in the United States Sunosi within current guidance and a single-digit royalty on Axsome’s net sales in the United States Sunosi in future directions. Subject to satisfaction of closing conditions, the non-US transaction is expected to close within 60 days.
“The transfer of Sunosi allows us to focus more on the strategic areas where we see the most opportunities for sustainable growth and improved shareholder value,” said Bruce Cozad, chairman and CEO of Jazz Pharmaceuticals. “Going forward, Jazz will continue to invest in our highest strategic priorities, driving Jazz’s transformation into an innovative global biopharmaceutical leader and enhancing top line and earnings growth through operational excellence. . »
About Sunosi® (solriamfetol)
Sunosi is a dual action dopamine and norepinephrine reuptake inhibitor that improves wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received approval from the United States Food and Drug Administration on March 20, 2019to improve wakefulness in adult patients with EDS associated with narcolepsy or OSAS and was designated a Schedule IV drug by the United States 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 owns the worldwide rights to develop, manufacture and commercialize solriamfetol, excluding certain jurisdictions Asia. SK Biopharmaceuticals Co., Ltd., the compound’s discoverer, retains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in United States.
Important Safety Information for Sunosi
SUNOSI (solriamfetol) is available in 75mg and 150mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol which may be a target for people who abuse prescription drugs or illicit drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, as this could cause death or harm to them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or street drugs.
Before taking SUNOSI, tell your doctor about all your medical conditions, including if you:
- have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
- have had a heart attack or stroke
- have a history of mental health problems (including psychosis and bipolar disorder), or 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 planning to breastfeed. It is not known if SUNOSI passes into your breast milk. Discuss with your doctor the best way to feed your baby if you are taking SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI can cause serious side effects, including:
- Increased blood pressure and heart rate. SUNOSI can cause increases in blood pressure and heart rate which 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 lower 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, trouble sleeping (insomnia), irritability and restlessness. 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:
- decreased appetite
- sleep problems
These are not all possible side effects of SUNOSI. Call your doctor for advice on side effects.
We encourage you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please find complete prescribing information here: https://pp.jazzpharma.com/pi/sunosi.en.USPI.pdf
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company focused on innovating to transform the lives of patients and their families. We are committed to developing life-changing medicines for people with serious diseases – often with limited or no treatment options. We have a diverse portfolio of marketed drugs and new product candidates, from early to late-stage development, in neuroscience and oncology. In these therapeutic areas, we identify new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland, and has employees worldwide, serving patients in nearly 75 countries. For more information, visit www.jazzpharma.com and follow @JazzPharma on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements relating to: the proposed ex-U.S. divestiture of Sunosi to Axsome, the royalties to be received by Jazz in connection with the sale in the United States and the other benefits expected from it; Jazz’s expectation to deliver sustainable growth and increased shareholder value; Jazz’s expectations for improved revenue and net income growth through operational excellence; and other statements that are not historical facts. These forward-looking statements are based on Jazz’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements due to such risks and uncertainties, which include, but are not limited to, risks and uncertainties associated with: Jazz’s and Axsome’s ability to complete the ex- cesion to the United States of Sunosi on the proposed terms or on the planned timetable, or not at all; Jazz’s ability to achieve its long-term projected goals and objectives; and other risks and uncertainties affecting Jazz, including those described from time to time under “Risk Factors” and elsewhere in Jazz’s filings and reports with the Securities and Exchange Commission, including Jazz on Form 10-K for the fiscal year ended December 31, 2021, and Jazz’s future filings and reports. Other risks and uncertainties not currently known to Jazz may also affect Jazz’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if subsequently made available by Jazz on its website or otherwise. Jazz undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date on which the forward-looking statements have been done.
Andrea N. Flynndoctorate
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
Ireland +353 1 634 3211
USA +1 650 496 2717
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
Ireland +353 1 637 2141
USA +1 215 867 4948
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SOURCE Jazz Pharmaceuticals plc