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SK Biopharmaceuticals, Eurofarma Enter into Licensing Agreement for Cenobamate in Latin America

2022.07.14

SK Biopharmaceuticals, Eurofarma Enter into Licensing Agreement for Cenobamate in Latin America

SK Biopharmaceuticals will now be present in four continents -- North America, Europe, Asia, and Latin America

 

Pangyo, Gyeonggi Province, Korea, July 14, 2022 – SK Biopharmaceuticals today announced that it has entered into a licensing agreement for Eurofarma, a Brazilian pharmaceutical company with business in over 20 countries, to develop and commercialize cenobamate in Latin America for the treatment of epilepsy. Cenobamate is approved and available in the United States and Europe for the treatment of partial-onset seizures in adults.

 

Under the terms of the agreement, SK Biopharmaceuticals has granted Eurofarma the exclusive rights to develop and commercialize cenobamate in Latin America. In return, SK Biopharmaceuticals will receive an upfront payment of US$15 million, and will be eligible to receive future milestones of up to US$47 million, in addition to royalties on sales generated in Latin America.

 

The agreement reinforces the company’s commitment and capabilities in developing medicines for central nervous system disorders and providing treatment options for the epilepsy communities in this region and around the world. Cenobamate has been previously launched in the United States and Europe, and SK Biopharmaceuticals forged partnerships for cenobamate in Japan, China, Canada, and Israel. With this agreement, SK Biopharmaceuticals will now be present in four continents: North America, Europe, Asia, and Latin America.

 

“We are extremely pleased to partner with Eurofarma, which has a proven track record in the region and a widespread network to drive development and commercialization of cenobamate in Latin America,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals. “This partnership reaffirms our commitment to provide innovative treatments to people with epilepsy. We will continue to broaden our footprint around the world to support the patient community with cenobamate.”

 

Epilepsy is one of the most common neurological diseases, affecting over 6 million people in Latin America.[1] According to the Pan American Health Organization (PAHO), the regional office of the World Health Organization (WHO) for the Americas, over half of the people living with epilepsy in Latin America and the Caribbean do not receive appropriate treatment.[2] Collaborating with Eurofarma, a Brazilian pharmaceutical company that covers 100% of Latin America and has, for 2022, a projected investment in innovation of more than BRL500 million, SK Biopharmaceuticals aims to bring its innovative product widely to the region.

 

About SK Biopharmaceuticals

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.

 

About Eurofarma

The Eurofarma Group has been operating in the healthcare industry since its establishment in 1972, producing and marketing innovative products and services to improve people’s quality of life. Focused on generating shared value, it operates in the areas of Prescription, Non-Prescription, OTC and Generic Drugs, Hospital and Oncology. Offers more than 700 products, over 2,000 SKUs, and serves 42 medical specialties. Present in over 20 countries, with a manufacturing park in Brazil and plants in six other Latin American countries, it generated net sales of BRL 7.1 billion in 2021, growth of 23% over the previous year, and employs more than 8,100 people.

 

About Cenobamate

Cenobamate is an anti-seizure medication (ASM) 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 for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI® (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone.  The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

 

Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY®. Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively.

 

Media Inquiries

SK Biopharmaceuticals

Hyongki Park, Director of Communications

h.p.comm@sk.com

 

 

Jaehee Kang, Communications Manager

jaeheekang@sk.com

 


[1] Kevin Pacheco-Barrios, et al. Burden of epilepsy in Latin America and The Caribbean: a trend analysis of the Global Burden of Disease Study 1990 – 2019. The Lancet Regional Health – Americas. available at: https://doi.org/10.1016/j.lana.2021.100140  

[2] Pan American Health Organization | Word Health Organization. Available at: https://bit.ly/3nF31qV [Last accessed July 2022]

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

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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