Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics
Jazz to receive
Transaction designed to ensure uninterrupted patient access to Sunosi
Jazz remains committed to neuroscience with growing franchises in sleep disorders and epilepsy
The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi's consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition.
Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine.
"This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader," said
"We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization™ platform with three complimentary assets," said
Sunosi is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA. More information about Sunosi, including Full Prescribing Information and Medication Guide, is available https://pp.jazzpharma.com/pi/sunosi.en.USPI.pdf.
The respective obligations of Jazz and Axsome to consummate the transactions contemplated by the definitive agreement are subject to the satisfaction or waiver of a number of customary conditions, including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR Act).
The transaction is structured to be completed in sequential closings for the
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
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:
- decreased appetite
- problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please find full prescribing information here: https://pp.jazzpharma.com/pi/sunosi.en.USPI.pdf
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to: the proposed divestiture of Sunosi to Axsome, the anticipated upfront payment and expected use thereof and royalties to be received by Jazz in connection therewith and the other anticipated benefits thereof; Jazz's expectation of delivering sustainable growth and enhanced shareholder value; Jazz's expectations with respect to Axsome's ability to maximize the value of Sunosi through future growth, including with respect to Axsome's ability to drive Sunosi as a one of the lead products in their portfolio and the expectation of uninterrupted access to Sunosi throughout the transition of Sunosi to Axsome; Jazz continuing to invest in its ongoing launches, advance its pipeline, pursue opportunistic corporate development, and focus on achieving anticipated margin expansion; Jazz's commitment to develop new, innovative therapies in neuroscience and oncology for patients and delivering on its recently announced Vision 2025; 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 such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: Jazz's and Axsome's ability to complete the proposed divestiture of Sunosi on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to the expiration or securing early termination of the applicable waiting period under the HSR Act; maintaining or increasing sales of and revenue from Jazz's oxybate products, Zepzelca and other key marketed products; effectively launching and commercializing Jazz's other products and product candidates; obtaining and maintaining adequate coverage and reimbursement for Jazz's products; the time-consuming and uncertain regulatory approval process, including the risk that Jazz's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients such as those being experienced, and expected to continue to be experienced, by Jazz as a result of the effects of the COVID-19 pandemic; the ultimate duration and severity of the COVID-19 pandemic and resulting global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Jazz's business operations and financial results; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing Jazz's intellectual property rights and Jazz's commercial success being dependent upon Jazz obtaining, maintaining and defending intellectual property protection for its products and product candidates; delays or problems in the supply or manufacture of Jazz's products and product candidates; complying with applicable
Vice President, Head, Investor Relations
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