Eisai to Present Eight Lemborexant Posters at SLEEP 2019 Meeting, Including New Pooled Analyses From Phase 3 Studies and New Phase 1 Data

Data to be presented include:

- Long-term safety and pooled analyses from the Phase 3 clinical development program for insomnia, including data on the impact of lemborexant treatment on daily function, disease severity, sleep onset and sleep maintenance

- The respiratory safety profile of lemborexant in healthy adult and elderly subjects, and in those with mild obstructive sleep apnea

- New results from a study of lemborexant's efficacy in a preclinical rodent model of Irregular Sleep-Wake Rhythm Disorder (ISWRD)

News provided by

Eisai Co., Ltd.

May 28, 2019, 10:09 ET

TOKYO, May 28, 2019 /PRNewswire/ -- Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") today announced eight poster presentations on lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder, will be presented at the 33^rd annual meeting of the Associated Professional Sleep Societies (SLEEP 2019), June 8-12, in San Antonio.

Long-term safety data from SUNRISE 2 (Study 303), sleep architecture data from SUNRISE 1 (Study 304) and pooled analyses from these two Phase 3 studies with a combined adult and elderly insomnia disorder population totaling over 1,600 patients will be presented, reporting on the impact of lemborexant treatment on daily function, disease severity, sleep onset and sleep maintenance. Findings from these analyses reveal important insights and will be presented in the following posters:

Poster 102/Abstract 0367: Lemborexant Treatment for Insomnia: Six-month Safety
Poster 105/Abstract 0368: Efficacy and Tolerability of Lemborexant in Female and Male Subjects With Insomnia
Poster 106/Abstract 0369: Effect of Lemborexant on Sleep Architecture in Older Adults With Insomnia Disorder
Poster 107/Abstract 0370: Patient-Reported Sleep Onset and Sleep Maintenance: Pooled Analyses of Lemborexant Phase 3 Studies
Poster 108/Abstract 0371: Lemborexant Treatment for Insomnia in Phase 3: Impact on Disease Severity

"Eisai strives to help people who experience insomnia fall asleep, stay asleep and wake ready the next morning," said Ivan Cheung, Chairman and CEO, Eisai Inc. "Our work to develop lemborexant is one more way in which Eisai is breaking through to provide innovative solutions to patients whose current medical needs are not being met."

Additionally, Eisai will present Phase 1 study results evaluating respiratory function following lemborexant administration, as respiratory safety is a concern in the treatment of insomnia.¹ Presentations on this topic include:

Poster 103/Abstract 0429: Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
Poster 104/Abstract 0430: Respiratory Safety of Lemborexant in Healthy Adult and Elderly Subjects

Lemborexant is also being studied as a potential treatment of ISWRD in patients with Alzheimer's disease. The following poster with data from a preclinical model of ISWRD will also be presented:

Poster 022/Abstract 0056: SAMP8 Mice as a Preclinical Model for Irregular Sleep-Wake Rhythm Disorder and Efficacy of the Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant

All data will be presented during the P-18 poster session on Monday, June 10, 5:15 – 7:15 p.m. CT.

Separate from the poster presentations, Eisai will host a symposium entitled An Interactive Case-Based Dialogue on Insomnia Diagnostic and Therapeutic Decision Making. This symposium will be chaired by Phyllis Zee, MD, PhD, Professor of Neurology, Northwestern University and Director, Sleep Disorders Center at Northwestern Memorial Hospital, and will feature other esteemed faculty:

Sonia Ancoli-Israel, PhD, Emeritus Professor of Psychiatry and Medicine and Professor of Research, University of California San Diego School of Medicine
Daniel Buysse, MD, Professor of Sleep Medicine, Professor of Psychiatry and Clinical and Translational Science, University of Pittsburgh School of Medicine
David Neubauer, MD, Associate Professor, Johns Hopkins School of Medicine, Faculty, Johns Hopkins Sleep Disorders Center

Information about completed and ongoing lemborexant clinical studies is available at clinicaltrials.gov.

Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for December 27, 2019.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

1. About Lemborexant
Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep. Eisai is investigating lemborexant as a potential treatment option for multiple sleep-wake disorders, such as insomnia. Additionally, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.

2. About Sleep Disorders
Population studies show that sleep disorders affect many more people worldwide than previously thought.² Insomnia symptoms affect approximately 30 percent of the adult population worldwide.³ Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.^4,5

Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.^4,6

Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.⁷ Studies suggest an optimal sleep duration between seven and eight hours.⁸

Women are 1.4 times more likely than men to suffer from insomnia.⁹ Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.¹⁰

3. About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites, and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com.

References
¹Ambien Full Prescribing Information. Retrieved from http://products.sanofi.us/ambien/ambien.pdf.
² Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
³ Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10.⁴ Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
⁵Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
⁶ Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.
⁷ Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
⁸ Cappuccio FP, et al. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33(5):585-592.
⁹ Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, tenth revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, second edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69:592– 600.
¹⁰Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.