Angelini Pharma and SK Biopharmaceuticals announce treatment of more than 100,000 patients globally with Innovative Anti-Seizure Medication Cenobamate
- Milestone coincides with expansion of cenobamate access to more than 100 markets worldwide
Rome (Italy) and Gyeonggi (Korea), 11 March 2024 – Angelini Pharma, part of the privately owned Angelini Industries, and SK Biopharmaceuticals Co., Ltd., a global biotech focused on developing treatments for central nervous system (CNS) disorders and oncology, today announced that more than 100,000 patients1 have been treated globally with cenobamate, an innovative anti-seizure medication (ASM) developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science.
Cenobamate is licensed by Angelini Pharma in Europe, where it is approved for the treatment of focal-onset seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.
From 2021, with approvals granted by the European Commission (EC) and subsequently by Swissmedic and the UK Medicines and Healthcare products Regulatory Agency (MHRA), cenobamate was launched in Europe, Switzerland and the UK under the brand name ONTOZRY®. Angelini Pharma has now successfully brought this treatment to patients in countries including Switzerland, the UK, Ireland, Germany, Italy, Spain, France, Benelux, Poland, Norway, Finland, Czech Republic, Greece, Hungary and Slovakia, Iceland and Liechtenstein.
“Since receiving marketing authorization for cenobamate in March of 2021, Angelini Pharma has continued to work to bring this important treatment option to more adults living with inadequately controlled epilepsy despite a history of treatment with at least two anti-epileptic medicinal products across Europe,” said Jacopo Andreose, Chief Executive Officer at Angelini Pharma. “We remain committed to helping people living with central nervous system disorders, including those affecting Brain Health, by raising awareness about the high unmet need, helping improve access to important treatment options and replicating our learnings across our broader product portfolio and pipeline.”
“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, Inc. “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 and South America, and the Middle East and North Africa region (MENA), will potentially provide access to patients in more than 100 markets worldwide.”
About Epilepsy
Epilepsy is one of the most widespread neurological diseases in the world, affecting approximately 50 million people of all ages.2 In Europe, approximately six million people are estimated to be living with this disease.3 Epilepsy can have multiple potential causes, including genetics and other factors, though approximately half of cases worldwide do not have a known cause.2
The complications associated with epilepsy are severe, with a risk of premature mortality up to two times higher than the general population.2 The recurrent seizures associated with this condition also have wide-ranging effects on a person’s broader physical and mental health, education and employment opportunities and other quality of life factors such as social relationships.2
Treatments are available to help reduce seizures and improve quality of life, and approximately 70% of people living with epilepsy are thought to be responsive to these treatments.2
About Cenobamate
The product is an anti-seizure medication (ASM) approved in Europe as adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients living with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.
The product is a novel small molecule that provides a unique, dual, complementary mechanism of action aimed at treatment of seizures. The unique dual mechanism of action suggests that it has the potential to both prevent seizure initiation and limit seizure spread.4,5
Cenobamate was discovered and developed by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science.
Long-term data on the product is being studied in open-label extensions of the double-blind placebo-controlled trials, as well as the open-label safety studies in adults with uncontrolled focal-onset seizures. Additionally, the product is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).6–10
About Angelini Pharma and Angelini Industries
Angelini Pharma is an international pharmaceutical company, part of the Italian privately-owned multi-business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com.
Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over 2 billion euros, generated in the health, industrial technology, and consumer goods sectors. A targeted investment strategy for growth; constant commitment to research and development; deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates. To learn more visit www.angeliniindustries.com.
ONTOZRY® is a registered trademark of SK Biopharmaceuticals Co., Ltd.
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.
References
- Ferrari, L., Rosenfeld, W.E. and Kamin, M. (2024), A global update on cenobamate based on real-world experience in over 100 000 patients. Epilepsia. https://doi.org/10.1111/epi.17935.
- WHO. “Epilepsy Key Facts.” N.p., 9 Feb. 2023. Web. 24 Aug. 2023.
- Zarocostas J. BMJ 2010; 341 :c4756 doi:10.1136/bmj.c4756
- Guignet et al. Epilepsia 2020;61:2329–39
- Löscher et al. Epilepsia 2021;62:596–614
- French et al. Epilepsia 2021;62:2142–50
- Klein et al. Neurology 2022, 99 (10) e989–e998
- Chung et al. Neurology 2020;94:e2311–e22
- Krauss et al. Lancet Neurol 2020;19:38–48
- Sperling et al. Epilepsia 2020;61:1099–108