SK Biopharmaceuticals Announces 100,000 Patients Globally Have Been Treated with Cenobamate Through Sales of XCOPRI® and ONTOZRY® in the U.S., Europe, Israel, and Canada

Milestone Coincides with SK Biopharmaceuticals’ Global Plan Expanding Cenobamate Access to More Than 100 Markets Worldwide

SEOUL, South Korea and ROME, March 12, 2024 /PRNewswire/ — SK Biopharmaceuticals Co., Ltd., a global biotech focused on developing treatments for central nervous system (CNS) disorders and oncology, and the first and only Korean company to independently develop and commercialize a new drug in the U.S., today announced more than 100,000 patients have been treated globally with cenobamate, an anti-seizure medication (ASM) developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, Inc.

Cenobamate was first launched in the U.S. by SK Life Science, Inc. in 2020 after the Food and Drug Administration (FDA) approved the treatment for adults with partial-onset seizures. In the U.S., cenobamate is marketed under the brand name XCOPRI^® (cenobamate tablets) CV. In 2021, with the approvals granted by the European Commission (EC), and subsequently by Swissmedic and MHRA, cenobamate was launched in Europe, Switzerland, and the UK, under the brand name ONTOZRY® by SK Biopharmaceuticals’ licensing partner Angelini Pharma SpA, part of the privately owned Angelini Industries, for the adjunctive treatment of focal-onset seizures in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-seizure medications. 

Since 2023, Dexcel Pharma, an international specialty pharmaceutical company, has been marketing cenobamate in Israel. Also in 2023, Paladin Labs Inc. launched cenobamate in Canada. Both Dexcel and Paladin commercialized cenobamate under the XCOPRI brand name. Cenobamate is also being developed for commercialization in Southeast Asia and Australia (Dong-A ST), Latin America (Eurofarma), the Middle East and North Africa (Hikma MENA FZE), the Greater China Area (Ignis Therapeutics), and Japan (Ono Pharmaceutical Co., Ltd.).

“We are proud of our ongoing collaboration with SK Biopharmaceuticals and today’s news reiterates the positive impact of our partnership in meeting the needs of people living with epilepsy in Europe,” said Jacopo Andreose, CEO of Angelini Pharma. “We are excited to continue transforming the landscape of epilepsy care with innovative treatment options and to advocate for epilepsy as a priority for healthcare systems across Europe.”

“We are proud to see the impact that cenobamate is having on those patients living with epilepsy, a condition that is estimated to affect more than 50 million people globally,” said Donghoon Lee, President and CEO of SK Biopharmaceuticals and SK Life Science. “This cenobamate milestone coincides with the completion earlier this year of SK Biopharmaceuticals’ strategic Global Partnering plan. The plan, resulting in cenobamate licensing agreements in Asia, Europe, North America, South America, and the Middle East and North Africa region (MENA) will potentially provide access to patients in more than 100 markets worldwide.”

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Note: This information is an estimate derived from the use of information under license from the following IQVIA information service: NPA, NSP, XPD for the period May 2020-December 2023. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.

About Epilepsy

Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 news cases each year in the country.^[1,2] Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one’s safety, relationships, work, driving, and much more.^[3,4] 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, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.^[5]

About Cenobamate

Cenobamate is an anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science, Inc. 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 (GABAA) ion channel. 

Cenobamate is approved in the United States for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI^® (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone. The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

Cenobamate is also approved in Canada where Paladin Labs Inc., an operating company of Endo International plc, launched cenobamate in January of 2024. Dexcel Pharma, an international specialty pharmaceutical company, is launching the treatment in Israel in April 2024. Both Dexcel and Paladin are marketing cenobamate under the brand name XCOPRI.  

Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY^®.

Additionally, cenobamate is in clinical development in the Greater China region, Asia, Australia, Latin America, and the Middle East and North Africa via development and commercialization agreements with Ono Pharmaceutical, Ignis Therapeutics, Dong-A ST, Eurofarma, and Hikma MENA FZE.

About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.

SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, Inc. are pharmaceutical companies focused on the research, development, and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin their expansion into oncology. SK Biopharmaceuticals and SK Life Science, Inc. have a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, through SK Life Science Labs, its R&D subsidiary in the U.S., SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals’ website at www.SKBP.com/eng, SK Life Science’s website at www.SKLifeScienceInc.com, and SK Life Science Labs’ website at www.SKLSLabs.com.

SK Biopharmaceuticals, SK Life Science, and SK Life Science Labs are part of SK Group, one of the largest conglomerates in Korea. SK Inc., the parent company of SK Biopharmaceuticals, 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 Inc. 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.

About Angelini Pharma

Angelini Pharma is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of Mental Health (including Pain), Rare Diseases and Consumer Healthcare. Over the past 50 years, in the field of mental health, Angelini Pharma has gained international recognition for its substantial efforts to improve the management of patients with mental health disorders thanks to important, internally developed, molecules (such as trazodone) and its commitment to fighting mental health stigma. Angelini Pharma operates directly in 25 countries employing almost 3.000 people and commercializes its products in more than 50 countries through strategic alliances with leading international pharmaceutical groups. For additional info visit www.angelinipharma.com.

XCOPRI^® and ONTOZRY^® are registered trademarks of SK Biopharmaceuticals Co., Ltd.

References 

1. Epilepsy Foundation. Who Can Get Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Accessed February 2024.
2. Epilepsy Foundation. Facts & Statistics About Epilepsy. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics. Accessed February 2024.
3. Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed February 2024.
4. Epilepsy Foundation. Complications and Risks. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed February 2024.
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.

Source : SK Biopharmaceuticals Announces 100,000 Patients Globally Have Been Treated with Cenobamate Through Sales of XCOPRI® and ONTOZRY® in the U.S., Europe, Israel, and Canada

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