The CHMP positive opinion is based on data from a global clinical trial program conducted by SK life science, a subsidiary of SK Biopharmaceuticals
Cenobamate will now be referred to the European Commission for final approval, an important step towards launching as a new treatment option for the European epilepsy community
PANGYO, GYEONGGI PROVINCE, Korea I January 29, 2021 I SK Biopharmaceuticals announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-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-seizure medications (ASMs). The European Commission (EC), which is authorized to approve medicines in the European Union, is expected to issue its decision within approximately 67 days of receipt of the CHMP opinion.
SK Biopharmaceuticals and Arvelle Therapeutics entered into a licensing agreement in 2019 for Arvelle to commercialize SK Biopharmaceuticals’ cenobamate in Europe. Cenobamate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset (focal-onset) seizures in adults, and it is commercially available in the U.S. under the brand name XCOPRI® (cenobamate tablets) CV.
Angelini Pharma, which recently announced a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics, plans to launch cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom), after obtaining final approval from the EC. Cenobamate will be branded as ONTOZRY™ for the European markets.
“The positive CHMP opinion brings us all toward achieving a major milestone that will enable patients in Europe to access cenobamate, which has been 20 years in the making,” said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals and SK life science. “Once approved, SK Biopharmaceuticals will ensure, with its European partners, a launch of this medicine to the epilepsy community.”
“Positive CHMP opinion of cenobamate represents an important milestone for Angelini Pharma and for patients. Cenobamate showed significant efficacy, with more patients achieving a 50 percent or greater reduction in seizure frequency and rates of zero seizures of up to 21 percent compared to placebo,” said Pierluigi Antonelli, CEO of Angelini Pharma. “The acquisition of the company will propel us to address the needs of patients with different central nervous system (CNS) disorders through an innovative portfolio.”
There are an estimated six million people in Europe with epilepsy1 and approximately 40 percent of adult patients with focal-onset seizures continue to experience seizures after treatment with two ASMs.2
The CHMP positive opinion was based on results from a global clinical trial program conducted by SK life science, the U.S. subsidiary of SK Biopharmaceuticals. The clinical trial program includes two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.
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 new cases each year in the country.3 There are an estimated six million people in Europe with epilepsy.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. 4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).4,5 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.3
About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK life science’s website at www.SKLifeScienceInc.com.
Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, 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 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/.
About Arvelle Therapeutics International GmbH
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational anti-seizure medicine, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.8 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at https://arvelletx.com.
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 therapeutic 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 15 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups.
About Cenobamate
Cenobamate was discovered and developed by SK Biopharmaceuticals and SK life science. 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 as an anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults, and is available under the brand name XCOPRI® (cenobamate tablets) CV. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe. In October 2020, SK Biopharmaceuticals sealed an exclusive licensing agreement with Ono Pharmaceutical to develop and commercialize cenobamate in Japan.
Cenobamate has recently gained recognition by healthcare regulatory bodies in the United Kingdom and Germany given its potential use in treatment resistant focal-onset seizures in epilepsy. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has designated cenobamate as a Promising Innovative Medicine (PIM). A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme.
In addition, as of August 2020, the German Federal Institute for Drugs and Medical Devices (BfArM) has included cenobamate for the treatment of drug-resistant focal-onset seizures in adults in its list of confirmed drugs for compassionate use (CPU) programmes for one year within the country.
INDICATION:
XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age.
Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.
Please see full Prescribing Information.
References
- Epilepsy Alliance Europe. Background information. https://www.epilepsyallianceeurope.org/about/background/ Last accessed 03.12.2020.
- 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.
- Epilepsy Foundation. What Is Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy. Accessed November 12, 2020.
- Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 12, 2020.
- Epilepsy Foundation. Challenges with Epilepsy. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed November 12, 2020.
SOURCE: SK Biopharmaceuticals
Post Views: 51
The CHMP positive opinion is based on data from a global clinical trial program conducted by SK life science, a subsidiary of SK Biopharmaceuticals
Cenobamate will now be referred to the European Commission for final approval, an important step towards launching as a new treatment option for the European epilepsy community
PANGYO, GYEONGGI PROVINCE, Korea I January 29, 2021 I SK Biopharmaceuticals announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-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-seizure medications (ASMs). The European Commission (EC), which is authorized to approve medicines in the European Union, is expected to issue its decision within approximately 67 days of receipt of the CHMP opinion.
SK Biopharmaceuticals and Arvelle Therapeutics entered into a licensing agreement in 2019 for Arvelle to commercialize SK Biopharmaceuticals’ cenobamate in Europe. Cenobamate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset (focal-onset) seizures in adults, and it is commercially available in the U.S. under the brand name XCOPRI® (cenobamate tablets) CV.
Angelini Pharma, which recently announced a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics, plans to launch cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom), after obtaining final approval from the EC. Cenobamate will be branded as ONTOZRY™ for the European markets.
“The positive CHMP opinion brings us all toward achieving a major milestone that will enable patients in Europe to access cenobamate, which has been 20 years in the making,” said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals and SK life science. “Once approved, SK Biopharmaceuticals will ensure, with its European partners, a launch of this medicine to the epilepsy community.”
“Positive CHMP opinion of cenobamate represents an important milestone for Angelini Pharma and for patients. Cenobamate showed significant efficacy, with more patients achieving a 50 percent or greater reduction in seizure frequency and rates of zero seizures of up to 21 percent compared to placebo,” said Pierluigi Antonelli, CEO of Angelini Pharma. “The acquisition of the company will propel us to address the needs of patients with different central nervous system (CNS) disorders through an innovative portfolio.”
There are an estimated six million people in Europe with epilepsy1 and approximately 40 percent of adult patients with focal-onset seizures continue to experience seizures after treatment with two ASMs.2
The CHMP positive opinion was based on results from a global clinical trial program conducted by SK life science, the U.S. subsidiary of SK Biopharmaceuticals. The clinical trial program includes two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.
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 new cases each year in the country.3 There are an estimated six million people in Europe with epilepsy.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. 4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).4,5 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.3
About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK life science’s website at www.SKLifeScienceInc.com.
Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, 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 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/.
About Arvelle Therapeutics International GmbH
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational anti-seizure medicine, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.8 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at https://arvelletx.com.
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 therapeutic 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 15 countries employing almost 3,000 people and commercializes its products in more than 70 countries through strategic alliances with leading international pharmaceutical groups.
About Cenobamate
Cenobamate was discovered and developed by SK Biopharmaceuticals and SK life science. 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 as an anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults, and is available under the brand name XCOPRI® (cenobamate tablets) CV. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe. In October 2020, SK Biopharmaceuticals sealed an exclusive licensing agreement with Ono Pharmaceutical to develop and commercialize cenobamate in Japan.
Cenobamate has recently gained recognition by healthcare regulatory bodies in the United Kingdom and Germany given its potential use in treatment resistant focal-onset seizures in epilepsy. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has designated cenobamate as a Promising Innovative Medicine (PIM). A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme.
In addition, as of August 2020, the German Federal Institute for Drugs and Medical Devices (BfArM) has included cenobamate for the treatment of drug-resistant focal-onset seizures in adults in its list of confirmed drugs for compassionate use (CPU) programmes for one year within the country.
INDICATION:
XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age.
Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.
Please see full Prescribing Information.
References
- Epilepsy Alliance Europe. Background information. https://www.epilepsyallianceeurope.org/about/background/ Last accessed 03.12.2020.
- 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.
- Epilepsy Foundation. What Is Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy. Accessed November 12, 2020.
- Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 12, 2020.
- Epilepsy Foundation. Challenges with Epilepsy. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed November 12, 2020.
SOURCE: SK Biopharmaceuticals
Post Views: 51
