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

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 ?aminobutyric acid (GABA(A)) ion channel.



            
      Cenobamate Poster Presentations at the AES 2019 Annual Meeting

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                Poster Session #: 1.322                  
            Saturday, December 7                   
            Cenobamate Adverse Events by Time of Onset
                                                                                                          and Dose from Two Randomized Clinical Studies
                                                         
            
              Authors present             in Patients with Uncontrolled Focal Seizures
                                                         12:00 - 2:00 p.m. ET

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                Poster Session #: 1.295                  
            Saturday, December 7                   
            Efficacy of Adjunctive Cenobamate in Patients
                                                                                                       with Uncontrolled Focal Seizures Based on
                                                         
            
              Authors present             Number of Concomitant Antiepileptic Drugs,
                                                         12:00 - 2:00 p.m. ET                            Seizure Frequency, and Epilepsy Duration at
                                                                                                       Baseline

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                Poster Session #: 2.206                  
            Sunday, December 8                     
            Long-Term Efficacy and Safety of Adjunctive
                                                                                                       Cenobamate in Patients with Uncontrolled Focal
                                                         
            
              Authors present             Seizures: Open-Label Extension of a Randomized
                                                         12:00 - 2:00 p.m. ET                            Clinical Study

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                Poster Session #: 3.295                  
            Monday, December 9                     
            Safety of Cenobamate for the Treatment of Focal
                                                                                                       Seizures, Following 1-Week vs 2-Week Titration
                                                         
            
              Authors present             Schedules
                                                         12:00 - 2:00 p.m. ET

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                Poster Session #: 3.297                  
            Monday, December 9                     
            Long-Term Safety of Adjunctive Cenobamate in
                                                                                                       Patients with Uncontrolled Focal Seizures: Open-
                                                         
            
              Authors present             Label Extension of a Randomized Clinical Study
                                                         12:00 - 2:00 p.m. ET

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                Poster Session #: 3.296                  
            Monday, December 9                     
            A Review of the Pharmacokinetic Properties of
                                                                                                       Cenobamate (YKP3089), a Novel Antiepileptic
                                                         
            
              Authors present             Drug for the Treatment of Uncontrolled Focal
                                                         12:00 - 2:00 p.m. ET                            Seizures

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      Cenobamate Scientific Exhibit at the AES 2019 Annual Meeting

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

                                                                                                       
            -- Clinical efficacy and safety

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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.

    1. Epilepsy Foundation. What Is Epilepsy?
       https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy.
       Accessed November 2019.
    2. 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.
    3. National Institute of Neurological Disorders and Stroke. The Epilepsies
       and Seizures: Hope through Research.
       https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Thro
       ugh-Research/Epilepsies-and-Seizures-Hope-Through#3109_9. Accessed
       November 2019.
    4. Epilepsy Foundation. Staying Safe.
       https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe.
       Accessed November 2019.
    5. 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.

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