Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe
14.2.2019 11:00:00 EET | Business Wire | Press release
SK Biopharmaceuticals and Arvelle Therapeutics GmbH today announced that they have entered into an exclusive licensing agreement for Arvelle to develop and commercialize cenobamate in Europe. Cenobamate is a novel, small molecule investigational antiepileptic drug for the potential treatment of partial-onset seizures in adult patients. Under the agreement, SK Biopharmaceuticals will receive an upfront payment of $100 million and is eligible to receive up to $430 million upon achievement of certain regulatory and commercial milestones in addition to royalties on net sales generated in Europe. SK Biopharmaceuticals will have an option to obtain a significant equity stake in Arvelle and will also retain commercial rights for all non-European territories. Cenobamate was discovered and developed by SK Biopharmaceuticals from inception through to the acceptance of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA).
“We are very pleased to enter into this licensing agreement with Arvelle, as it provides important validation of the global potential for cenobamate as a new treatment option for adults with partial-onset seizures,” said Dr. Jeong Woo Cho, President and CEO of SK Biopharmaceuticals. “Arvelle’s experienced leadership team and focus on CNS disorders make them the ideal partner to advance the development and commercialization of our compound in Europe.”
Arvelle Therapeutics is a newly created company that received one of the largest initial financing commitments for a European-focused biopharmaceutical company from a global syndicate of investors that include NovaQuest, LSP, BRV Capital Management, Andera Partners, and H.I.G. BioHealth Partners. Mark Altmeyer has been named President and CEO of Arvelle. Altmeyer brings more than 30 years of global biopharmaceutical experience to Arvelle. As President and CEO of Otsuka America Pharmaceutical, Inc., Altmeyer oversaw the growth of Abilify® into a multi-billion-dollar product. Most recently, he served as President and Chief Commercial Officer of Axovant Sciences and previously led the neuroscience business unit at Bristol-Myers Squibb Company. Altmeyer is joined by a talented team of colleagues from Axovant with deep experience in CNS drug development and global commercialization. Arvelle intends to file a Marketing Authorization Application (MAA) for cenobamate for partial-onset seizures in adult patients based on the data generated from SK Biopharmaceuticals’ global clinical trial program.
“We launched Arvelle to bring truly innovative CNS products to patients suffering from serious neurological conditions and cenobamate is the perfect first pipeline product,” said Altmeyer. “Given the data generated in clinical trials and the FDA acceptance of the NDA, we believe cenobamate has the potential to be an important antiepileptic drug treatment option for adult patients suffering from partial-onset seizures. We appreciate the support and validation of our investors and are very enthusiastic about our potential in the European market.”
“We are very excited to invest in the talented team at Arvelle on this new venture,” said Martijn Kleijwegt, Managing Partner of LSP. “SK Biopharmaceuticals has done an excellent job on the discovery and development of cenobamate and we believe that Arvelle is the right company to gain EU approval for cenobamate and ultimately bring it to patients in Europe.”
About Cenobamate
Cenobamate (YKP3089) was discovered by SK Biopharmaceuticals and SK life science and is being investigated for the potential treatment of partial-onset seizures (also known as “focal seizures”) in adult patients. Cenobamate’s mechanism of action is not fully understood, but it is believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
Global trials for adults with partial-onset seizures are ongoing to evaluate cenobamate safety. An additional clinical trial is investigating cenobamate safety and efficacy for another form of epilepsy in adult patients.
The U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application for cenobamate for the potential treatment of partial-onset seizures in adults in February 2019.
Cenobamate is not approved by the FDA, European Medicines Agency (EMA) or any other regulatory authorities. Safety and efficacy have not been established.
About SK Biopharmaceuticals
SK Biopharmaceuticals is focused on research and development of treatments for disorders of central nervous system (CNS) and cancer. SK Biopharmaceuticals is an affiliate of SK Group, the second largest conglomerate in Korea.
Currently, SK Biopharmaceuticals is conducting basic research for the development of innovative new drugs at its research center in Pangyo, Gyeonggi Province, Korea. Further, the company is pursuing global clinical development and direct marketing through its U.S. subsidiary SK Life Science, Inc., in Fair Lawn, New Jersey, USA.
SK Biopharmaceuticals has a pipeline of eight compounds in development for the treatment of CNS disorders including epilepsy, sleep disorder and attention deficit hyperactivity disorder, among others. The first product the company is planning to commercialize, cenobamate (YKP3089), is an investigational compound for the potential treatment of partial-onset seizures in adult patients. The NDA for cenobamate for the potential treatment of partial-onset seizures in adult patients is currently under review by the FDA. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng.
About Arvelle Therapeutics
Arvelle Therapeutics is a biopharmaceutical company with the mission of bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational antiepileptic drug, in the European market. Arvelle is headquartered in Switzerland and received one of the largest initial financing commitments for a European-focused biopharmaceutical company with investments from a global syndicate including NovaQuest Capital Management, LSP, BRV Capital Management, Andera Partners and H.I.G. BioHealth Partners. More information is available at http://arvelletx.com/.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190214005290/en/
Contact information
For Arvelle Therapeutics:
Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Media Release: Jannik Sinner and Allianz Announce Multi-Year Global Partnership29.1.2026 12:04:00 EET | Press release
Tennis star Jannik Sinner and Allianz Group announced a multi-year global partnership today, with the leading insurer and asset manager becoming an official partner of the four-time Grand Slam champion. Boasting approximately 300 million fans worldwide and a billion-strong ATP global fan base, tennis is the second-most popular sport behind football across Allianz key markets. A cornerstone of the collaboration is empowering children and youth through education and sport, providing them with enhanced opportunities for growth, health, and future success. This partnership also expands Allianz's involvement in sports, fostering awareness and emotional connections with people and customers in key Allianz markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260129184263/en/ Allianz Global Brand Ambassador, Jannik Sinner At the heart of the partnership between the world’s most valuable insurance brand and the current No. 2 ATP t
How Aker Security Builds Control Rooms for Real-Time Decision-Making29.1.2026 11:00:00 EET | Press release
In today’s security landscape, the challenge lies in aggregating, visualizing, and using large volumes of data effectively in situations where time, precision, and coordination are critical. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260129578139/en/ GSOC Aker Security oversees security and preparedness for large parts of the Group, covering several thousand employees. Its services include travel security, global event and incident monitoring, crisis management, and security advisory services. "We approached Cyviz because we needed a solution that could bring everything together on a single platform, while at the same time supporting the way we actually work operationally," says Tonje Evensen Bråthen, Head of the Global Security Operations Center (GSOC) at Aker Security. Real-Time Overview in Aker Security’s GSOC The control room is designed for continuous operational use and supports the work carried out in the GSOC. Th
Multi-Color Corporation Initiates Implementation of Restructuring Agreement29.1.2026 08:58:00 EET | Press release
Multi-Color Corporation (“MCC” or the “Company”), a global leader in prime label solutions, today announced that to implement the previously announced restructuring support agreement (the “RSA”), the Company has commenced its prepackaged Chapter 11 filing in the United States Bankruptcy Court for the District of New Jersey (“the Court”). MCC announced on January 27 it had entered into the RSA with holders of approximately 72% in amount of MCC’s secured first lien debt and its equity sponsor, CD&R, on the terms of a comprehensive financial restructuring. The transactions contemplated by the RSA will significantly deleverage MCC’s balance sheet, reducing its net debt load from approximately $5.9 billion to approximately $2.0 billion. The Company’s annualized cash interest will also be reduced from approximately $475 million to $140 million in 2026, a reduction of over $330 million, with long-term debt maturities extended to 2033 following consummation of the restructuring transactions. A
Takeda Reports Third-Quarter FY2025 Results: Updates Full Year Outlook to Reflect VYVANSE ® Generics Impact, OPEX Discipline and FX Tailwind; Progressing Toward Three Transformative Launches Ahead29.1.2026 08:37:00 EET | Press release
Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the third quarter of fiscal year 2025 (nine months ended December 31, 2025). The gap between incremental Growth & Launch Products revenue and VYVANSE erosion is narrowing, and operational efficiencies drove year-on-year reductions in operating expenses, including R&D. The company raised its full-year forecasts based on cost discipline and FX tailwind, while its Revenue Management Guidance has been updated primarily due to the impact of VYVANSE generics. Takeda is positioned for long-term growth and has multiple late-stage programs with multibillion-dollar peak revenue potential. Following the positive readouts from Phase 3 studies in 2025, the company has submitted New Drug Applications (NDAs) for oveporexton and rusfertide and is on track to file an NDA for zasocitinib. Each of these programs, which Takeda expects to launch within the next 18 months, has the potential to redefine standards of care, transform patient liv
Ubitus Partners with Maizuru City, Kyoto to Launch AI Data Center Project, Advancing the Deployment of a Top-Tier AI GPU Center in Japan29.1.2026 08:00:00 EET | Press release
Ubitus K.K. (Headquarters: Shinjuku, Tokyo; Representative Director & CEO: Wesley Kuo), a global leader in cloud streaming and AI solutions, today announced that it will hold a land signing ceremony and press conference with Maizuru City, Kyoto Prefecture, on January 29, 2026. At the event, Ubitus will officially unveil its comprehensive plan to construct an AI Data Center in Maizuru City, marking the company’s transition into the physical construction phase of its initiative to build a top-tier AI GPU center in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128944842/en/ Ubitus will launch its Maizuru City AI Data Center project on January 29, marking the first step toward building a top-tier AI GPU center in Japan. Powered by NVIDIA Blackwell GPUs and NeoCloud, the project strengthens Japan’s AI infrastructure and regional development. This land agreement represents the first major milestone following Ubitus’ sel
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom