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SK Biopharmaceuticals Initiates Clinical Development Program for Cenobamate in Asia

2020.09.10
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SK Biopharmaceuticals Initiates Clinical Development Program for Cenobamate in Asia

 Phase 3 clinical trial to support registrational filings in China and Japan

Company on track to expand presence in Asia, reflecting its commitment to reach more people with epilepsy worldwide

 

Pangyo, Gyeonggi Province, Korea, September 10, 2020 – SK Biopharmaceuticals, Co., Ltd., a global innovative pharmaceutical company, announced plans to initiate a Phase 3 clinical trial for cenobamate in Asia, in line with the company’s planned expansion beyond the U.S., where the drug is approved as a treatment for partial-onset seizures in adults.

 

The trial will be initiated in Korea following the Korean Ministry of Food and Drug Safety’s (MFDS) acceptance of the company’s Investigational New Drug (IND) application for the trial on September 9, 2020. More than 500 patients from China, Japan and Korea are expected to be enrolled in the Phase 3 clinical trial.

 

In China on September 9, 2020, the company received approval to initiate the Phase 3 trial as well as a separate Phase 1 clinical trial from China’s National Medical Products Administration (NMPA), after submitting its Clinical Trial Application (CTA) in June 2020.

 

SK Biopharmaceuticals also plans to submit a Clinical Trial Notification (CTN) for the Phase 3 trial to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), under the wing of the Ministry of Health, Labour and Welfare, in October 2020.

 

“The initiation of the Phase 3 clinical trial in Asia is a major milestone for cenobamate in our continuous effort to address unmet needs in epilepsy and central nervous system disorders worldwide,” said Jungshin Park, vice president of SK Biopharmaceuticals’ drug development business. “SK Biopharmaceuticals has been planning to enter Asian markets after launching our anti-seizure medication in the U.S. and forming a partnership for commercialization in Europe. We are pleased to move forward as intended to expand our global footprint.”

 

The Phase 3 trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of cenobamate as an adjunctive therapy in subjects with partial-onset seizures, with an optional open-label extension.

 

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.

 

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.

 

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/.

 

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

 

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Media Contacts:

SK Biopharmaceuticals
H. Park, senior communications manager

skbp_comm@sk.com

 

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SK Biopharmaceuticals Co., Ltd. Privacy Policy

SK Biopharmaceuticals Co., Ltd. (“Company”) is dedicated to complying with privacy regulations in pursuant of applicable laws and committed to protecting your privacy and personal information by setting a privacy policy in compliance with applicable laws. The Company may, in its discretion, amend this Privacy Policy according to changes in applicable laws and management.

1. Collection, Purpose, and Use of Personal Information

The Company collects only the minimum amount of personal information required to provide our services, and the collected personal information will only be used for the purposes stated in this policy. Your personal information is not used for any other purposes or disclosed to an outside source without prior authorization.

  • Purpose of collection : To review customer inquiries, contact customers to verify inquiry, reply, notify results.
  • Collected information : Required : email, name
  • Collected information : Optional : phone number, interests, nationality, company name, profession.
  • Method of collection : Collection through inquiries made through the website’s contact us section

2. Disclosure of Personal Information to Third Party

The Company uses the provided personal information only for the purposes stated in Article 1, and does not use your personal information or disclose such information to a third party without prior authorization. However, exceptions are provided if Company receives disclosure requests in accordance with procedures designated by the law. The following are examples of such exceptions.

  • Request that follows the procedure and method designated by provisions of the law
  • Request from investigative agencies that follow the procedure and method designated by the law for the purpose of investigation

3. Retention and Storage Period of Personal Information

The Company immediately destroys personal information a year after achieving the purpose of collection. However, if storage is necessary in accordance with applicable laws, the Company may store personal information for a period of time required by such law.

4. Destruction Procedure and Method of Personal Information

1. Destruction Procedure

  • In the event the Company no longer needs to maintain the personal information such as when the retention period has expired or the Company has achieved the information’s purpose, the Company shall immediately destroy such personal information.
  • In the event the Company is required by other laws to continually store the personal information despite the authorized retention period having expired or the purpose being achieved, the Company shall move such personal information to a separate database (DB) or change its storage location to store until the purpose of its continued retention has been achieved, upon which the Company shall immediately destroy the personal information.

2. Destruction Method

  • Personal information that is printed on paper shall be destroyed by being shredded or incinerated.
  • Personal information that is stored in electronic formats will be destroyed through technical methods in which records cannot be reproduced.

5. Rights and Duties of Information Provider and Exercising Methods

1. You may at any time make the following requests to exercise your privacy rights.

  • Request to access personal information
  • Request to revise information in case of error
  • Request to withdraw agreement/delete information
  • Request to cease operation

2. To exercise the rights stated in Article 5-1, you may state the request through a written statement, email, or fax, and the Company shall promptly execute the request upon receipt.

3. If the Company receives a request from the information provider to revise or delete personal information for any reason including error, the Company shall not use or provide personal information until the revision or deletion is completed.

4. You may exercise the rights stated in Article 5-1 through a delegated figure (“Agent”). However, in order for Agent to exercise the rights of information provider, Agent must submit a letter of attorney completed by the information provider.

5. The Company does not collect personal information from minors in principle. However, in the event that the collection of personal information from a minor is inevitable through 1:1 inquiry, the Company shall seek agreement from a legal representative and immediately destroy the information once the information’s purpose has been achieved or the authorized retention period has expired.

6. Measures to Secure Safety of Personal Information

The Company has established and is operating the following technical and managerial security measures to ensure that the collected personal information is not lost, stolen, leaked, falsified, or damaged.

1. Managerial Security Measures

  • The Company has established and is operating internal security plans in regards to privacy.

2. Technical Security Measures

  • Control of access to personal information and limited rights to access: The Company has installed security programs to prevent hackers or computer viruses from leaking and damaging personal information and is conducting regular updates and maintenance.
  • The Company has appointed the minimum number of representatives that have access to personal information and conducts regular internal training sessions. The training of such representatives is held on a strictly confidential basis and the Company prescribes clear responsibilities in accidents regarding personal information to all current and former employees.

7. Contacts of Personal Information Manager and Representative

To protect the personal information provided to us and handle complaints and inquiries from information providers regarding their personal information, the Company has designated the following department and representative in charge of protecting personal information.

  • Personal Information Representative and Department : Wan-ho Nam, SK Biopharmaceuticals Business Strategy Team, Business Management Manager
  • Phone : +82-31-8093-0114
  • Email : skbp@sk.com

8. Amendment and Notice of Privacy Policy

1. This Privacy Policy takes effect starting July 1, 2018.

2. In the event of any future addition, deletion, revision, and such amendments to the privacy policy following changes in applicable laws or security technology, the Company will notify the purpose and contents of the amendment on the Company’s website at least a week prior to enacting the amended privacy policy.

Date of notice and enactment: July 1, 2018