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SK Biopharmaceuticals, Ono Pharmaceutical Enter Licensing Agreement for Cenobamate in Japan

2020.10.13

SK Biopharmaceuticals, Ono Pharmaceutical Enter Licensing Agreement for Cenobamate in Japan

 

SK Biopharmaceuticals and Ono Pharmaceutical collaborate to develop and commercialize cenobamate

 

SK Biopharmaceuticals to receive an upfront payment of JPY 5 billion from Ono, with future milestones of up to JPY 48.1 billion and royalties on net sales

 

Pangyo, Gyeonggi Province, Korea, Oct. 13, 2020 – SK Biopharmaceuticals and Ono Pharmaceutical announced that they have entered into an exclusive licensing agreement for Ono to develop and commercialize cenobamate in Japan. Cenobamate is a treatment for partial-onset seizures (POS) that received FDA approval in 2019.


As per terms of the deal, SK Biopharmaceuticals will receive an upfront payment of JPY 5 billion (US$ 47 million) from Ono. SK Biopharmaceuticals will also be eligible to receive up to JPY 48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double digit royalties on net sales generated in Japan.

 

SK Biopharmaceuticals will conduct a Phase 3 clinical study  for partial-onset seizures in adults in Northeast Asia (Japan, China, and Korea). In addition, SK Biopharmaceuticals has an option for co-promotion with Ono in the Japanese market.

 

“We are very pleased to form a strategic partnership with Ono that will mutually benefit both sides,” said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals. “This agreement would give SK Biopharmaceuticals an unprecedented opportunity not only to expand our presence in one of Asia’s largest pharmaceuticals markets but also to further create social value by reaching out to patients with epilepsy in Japan.”

 

“We are very delighted to enter into this collaboration with SK Biopharmaceuticals on cenobamate discovered and developed by SK Biopharmaceuticals,” said Gyo Sagara, President, Representative Director of Ono. “We believe that cenobamate will be a new treatment option for patients suffering from epilepsy in Japan.”

 

About SK Biopharmaceuticals Co., Ltd.
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 Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on the oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at www.ono.co.jp/eng.

 

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

 

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Media Contacts:

Asia-Pacific Media Inquiries
SK Biopharmaceuticals Co., Ltd.
Hyongki Park
h.p.comm@sk.com

 

U.S. Media Inquiries
SK Life Science, Inc.
media@sklsi.com

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