Jazz Pharmaceuticals Receives EU Marketing Authorisation for Sunosi® (solriamfetol) for Excessive Daytime Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea

DUBLIN, Jan. 20, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission approved Sunosi^® (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).¹ Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA.

"We are excited that with this approval we can offer Sunosi, a daytime medicine that can provide sustained wakefulness throughout the day, to patients living with excessive daytime sleepiness as a result of OSA or narcolepsy in Europe, where historically, treatment options have been very limited," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

Once-daily Sunosi is approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA.¹ At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose.

"Most people feel tired sometimes, but those with excessive daytime sleepiness may experience an irresistible need to sleep during the day and an increased likelihood of falling asleep at unexpected times, which can interfere with work, school and other activities," said Professor Jean-Louis Pépin, M.D., Ph.D., director of INSERM unit 1042 and head of the sleep and physiology department at the University Hospital in Grenoble, France. "In the EU, approximately 16 million people* may be affected by OSA to some extent, and some of them continue to experience excessive daytime sleepiness despite adequate treatment with CPAP for upper airway obstruction. Solriamfetol has the potential to be an important treatment option for patients living with excessive daytime sleepiness as a result of OSA or narcolepsy."

The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.

"Today's approval is an important milestone both for patients and for Jazz as we expand our neuroscience business to Europe to address unmet needs for people living with chronic, and often debilitating, sleep disorders," said Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals. "Jazz is committed to making Sunosi available to patients in the EU and will now pursue rolling launches across the European Union on a country-by-country basis as pricing and reimbursement and scheduling decisions are made."

The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.^2-5 The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%). The most serious and frequently occurring adverse reactions were increased blood pressure and palpitations. The majority of most frequently reported adverse events occurred within the first two weeks of treatment and resolved for most patients within 2 weeks. Solriamfetol was evaluated in more than 900 adults with EDS associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after six months of use.

In the TONES 2 and TONES 3 12-week clinical studies in narcolepsy and OSA patients, respectively, approximately 68-74% of people taking solriamfetol at the 75 mg dose and 78-90% of people taking solriamfetol at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.

Solriamfetol is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained in these patients and treatment should be initiated by a healthcare professional experienced in the treatment of narcolepsy or OSA.

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using solriamfetol, please refer to the Summary of Product Characteristics for further information.

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).^2-7 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.^8,9 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.

About Obstructive Sleep Apnea and Excessive Daytime Sleepiness
Obstructive sleep apnea (OSA), commonly referred to as sleep apnea, is a highly prevalent disease affecting approximately 16 million people in the EU* to some extent.¹⁰ Excessive daytime sleepiness (EDS), a major symptom of OSA, is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.^11,12 Positive airway pressure therapy, with its most common form being continuous positive airway pressure (CPAP), has been shown to be an effective therapy for sleep apnea that frequently results in improvement in EDS in many patients;^13,14 however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable.^15,16,17 EDS may persist in people with OSA despite using CPAP.^18,19

About Narcolepsy
Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness (EDS), and the inability to regulate sleep-wake cycles normally.²⁰ Narcolepsy is a rare disease with an estimated prevalence of 0.02% in European populations.²¹ Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis, and it is estimated that more than 50% of patients with narcolepsy have not been diagnosed.^22,23,24 There are five primary symptoms of narcolepsy, including EDS, cataplexy, sleep-related hallucinations, sleep paralysis and sleep disruption.¹¹ While all patients with narcolepsy experience EDS, they may not experience all five symptoms.¹¹

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine, with an R&D expansion into neuroscience, and a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development, and is focused on transforming biopharmaceutical discoveries into novel medicines. Jazz Pharmaceuticals markets Sunosi^® (solriamfetol), Xyrem^® (sodium oxybate) oral solution, Defitelio^® (defibrotide sodium), Erwinaze^® (asparaginase Erwinia chrysanthemi) and Vyxeos^® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Sunosi, Defitelio^® (defibrotide), Erwinase^® and Vyxeos^® liposomal 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit https://www.jazzpharmaceuticals.com/medicines. For more information, please visit www.jazzpharmaceuticals.com and follow us on Twitter at @JazzPharma.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' commitment to making Sunosi available to patients in the European Union (EU); Jazz Pharmaceuticals' expectation of pursuing rolling launches of Sunosi across the EU on a country-by-country basis as pricing and reimbursement and scheduling decisions are made; and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' 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 effectively commercializing Sunosi in the EU and other risks and uncertainties including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' 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 they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals 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 as of which the forward-looking statements were made.

* This figure represents OSA prevalence in the EU5, including France, Germany, Italy, Spain and the United Kingdom.

References

1. European Medicines Agency Summary of Product Characteristics (SmPC). Sunosi.
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4. Strollo PJ et al. Solriamfetol for the Treatment of Excessive Sleepiness in OSA. Chest 2019; 155(2):364-374.
5. Malhotra et al. A Long-Term Safety and Maintenance of Efficacy Study of Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea. Poster 331 presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies June 2–6, 2018.
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9. U.S. Department of Justice. Drug Enforcement Administration. Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV. Available at: https://www.deadiversion.usdoj.gov/fed_regs/rules/2019/fr0617_3.htm Last accessed July 2019.
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20. Johns Hopkins Medicine. Conditions and Diseases. Narcolepsy. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/narcolepsy Last accessed November 2019
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