SK life science to Present Latest Cenobamate Data at the American Epilepsy Society 2019 Annual Meeting

Poster presentations to feature clinical and pharmacokinetic information, including new data on long-term use of cenobamate in adult patients with partial-onset seizures

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SK Life Science, Inc.

Dec 06, 2019, 09:00 ET

PARAMUS, N.J., Dec. 6, 2019 /PRNewswire/ -- SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, will present the latest data on its antiepileptic drug (AED) cenobamate at the American Epilepsy Society (AES) 2019 Annual Meeting in Baltimore, Maryland (December 6 — 10, 2019).

At the meeting, the company will present a total of six posters on the safety, efficacy and pharmacokinetics of cenobamate, including two posters detailing results from two long-term, multicenter, open-label extension studies of cenobamate in adults with partial-onset seizures. The company will also present additional information on cenobamate's mechanism of action, clinical pharmacology and clinical efficacy and safety at a special scientific exhibit and posters session.

"We are excited to present these data at AES and to provide more information on long-term use of cenobamate in adult patients with partial-onset seizures," said Marc Kamin, MD, chief medical officer at SK life science. "With the recent FDA approval of cenobamate, SK life science is looking forward to making this treatment available to patients in the second quarter of 2020, pending scheduling review by the U.S. Drug Enforcement Administration."

Cenobamate was discovered by SK Biopharmaceuticals and SK life science and was approved by the U.S. Food and Drug Administration (FDA) on November 21, 2019, for the treatment of partial-onset seizures in adults. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ‑aminobutyric acid (GABA_A) ion channel.

Cenobamate Poster Presentations at the AES 2019 Annual Meeting

Poster Session #: 1.322	Saturday, December 7 Authors present 12:00 — 2:00 p.m. ET	Cenobamate Adverse Events by Time of Onset and Dose from Two Randomized Clinical Studies in Patients with Uncontrolled Focal Seizures
Poster Session #: 1.295	Saturday, December 7 Authors present 12:00 — 2:00 p.m. ET	Efficacy of Adjunctive Cenobamate in Patients with Uncontrolled Focal Seizures Based on Number of Concomitant Antiepileptic Drugs, Seizure Frequency, and Epilepsy Duration at Baseline
Poster Session #: 2.206	Sunday, December 8 Authors present 12:00 — 2:00 p.m. ET	Long-Term Efficacy and Safety of Adjunctive Cenobamate in Patients with Uncontrolled Focal Seizures: Open-Label Extension of a Randomized Clinical Study
Poster Session #: 3.295	Monday, December 9 Authors present 12:00 — 2:00 p.m. ET	Safety of Cenobamate for the Treatment of Focal Seizures, Following 1-Week vs 2-Week Titration Schedules
Poster Session #: 3.297	Monday, December 9 Authors present 12:00 — 2:00 p.m. ET	Long-Term Safety of Adjunctive Cenobamate in Patients with Uncontrolled Focal Seizures: Open- Label Extension of a Randomized Clinical Study
Poster Session #: 3.296	Monday, December 9 Authors present 12:00 — 2:00 p.m. ET	A Review of the Pharmacokinetic Properties of Cenobamate (YKP3089), a Novel Antiepileptic Drug for the Treatment of Uncontrolled Focal Seizures

Cenobamate Scientific Exhibit at the AES 2019 Annual Meeting

Special Scientific Exhibit and Posters	Sunday, December 8 2:00 — 5:00 p.m. ET Room 321 — 323, Level 300	Will feature poster presentations on cenobamate, including information on: • Mechanism of action • Clinical pharmacology • Clinical efficacy and safety

About Epilepsy
Epilepsy is a common neurological disorder characterized by seizures.¹ There are approximately 3 million adults in the U.S. living with epilepsy and approximately 60% have partial-onset seizures, which begin in just one part of the brain.^2,3 People with epilepsy are at risk for accidents and other health complications including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).^3,4 Despite the availability of many antiepileptic therapies, approximately 40% of adults with partial-onset seizures have inadequate control of their seizures, even after treatment with two antiepileptic drugs (AEDs).⁵

About SK Biopharmaceuticals, Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). Additionally, SK Biopharmaceuticals is focused on early research and development in oncology. Both are part of SK Group, one of the largest conglomerates in Korea.

SK Holdings continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information please visit http://hc.sk.co.kr/en/.

Currently, SK Biopharmaceuticals is conducting basic research for the development of innovative new therapies at its research center in Pangyo, Gyeonggi Province, Korea. SK life science, based in Paramus, New Jersey, is pursuing clinical development and the U.S. commercialization of cenobamate. Additionally, in early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe.

SK Biopharmaceuticals and SK life science have a pipeline of eight compounds in development for the treatment of CNS disorders including epilepsy, Lennox-Gastaut syndrome and attention-deficit/hyperactivity disorder, among others. For more information, visit SK Biopharmaceuticals' website at www.skbp.com/eng and SK life science's website at www.SKLifeScienceInc.com.

Epilepsy Foundation. What Is Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy. Accessed November 2019.
Centers for Disease Control and Prevention. Active Epilepsy and Seizure Control in Adults — United States, 2013 and 2015. https://www.cdc.gov/mmwr/volumes/67/wr/mm6715a1.htm?s_cid=mm6715a1. Accessed November 2019.
National Institute of Neurological Disorders and Stroke. The Epilepsies and Seizures: Hope through Research. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Epilepsies-and-Seizures-Hope-Through#3109_9. Accessed November 2019.
Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 2019.
Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established And New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. https://www.ncbi.nlm.nih.gov/pubmed/29279892. Published online December 26, 2017.