Cenobamate Receives Positive CHMP Opinion for Adjunctive Treatment of Focal-Onset (Partial-Onset) Seizures

PANGYO, GYEONGGI PROVINCE, Korea, Jan. 29, 2021 /PRNewswire/ -- 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 (GABA_A) 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.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI^® (cenobamate tablets) CV

DO NOT TAKE XCOPRI IF YOU:

• Are allergic to cenobamate or any of the other ingredients in XCOPRI.
• Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS:

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION:

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org.  

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.  

DRUG ABUSE:

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

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.

XCOPRI^® is a registered U.S. trademark of SK Biopharmaceuticals Co., Ltd.

Media Contacts:
Arvelle Therapeutics:
Juan Vergez
Head of Marketing and Corporate Communications
Email: [email protected]

Angelini Pharma
Daniela Poggio, Head of Communications
Email: [email protected]

SK Biopharmaceuticals
Hyongki Park
Head of Communications
Email: [email protected]; [email protected] 

Trio Health
Nina Bass +44 (0) 208 8080 3005
[email protected] 

Chloe Nichols +44 (0) 208 8080 3004
[email protected]

Nick James +44 (0) 208 8080 3006
[email protected]

References

1. Epilepsy Alliance Europe. Background information.  https://www.epilepsyallianceeurope.org/about/background/ Last accessed 03.12.2020.
2. 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.
3. Epilepsy Foundation. What Is Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/what-epilepsy. Accessed November 12, 2020.
4. Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed November 12, 2020.
5. Epilepsy Foundation. Challenges with Epilepsy. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed November 12, 2020.

SOURCE SK Biopharmaceuticals

Related Links

https://www.skbp.com