Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe
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
Wizz Air Tops Major Airline Emissions Rankings2.7.2025 12:00:00 EEST | Press release
Wizz Air is the world's most emissions-efficient airline in new rankings released today by Cirium, the aviation analytics firm. The Cirium Flight Emissions Review ranks the top 20 airlines globally, through a consistent benchmark for flight emissions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702342529/en/ The top 20 Major airlines globally, ranked by lowest CO2/ASK Wizz Air, the Hungary-based ultra-low-cost airline emits an industry low of 53.9 grams of CO₂ per Available Seat Kilometer (ASK)*, followed by Frontier Airlines (54.4 grams) and Pegasus (57.1 grams) according to the report. The rankings provide the aviation industry with verified comparable data on an equal playing field as the sector advances toward Net Zero by 2050 commitments. The rankings performance use Cirium's EmeraldSky platform, which achieved ISAE 3000 Reasonable Assurance from PricewaterhouseCoopers (PwC) and official accreditation from the Roc
L&T Technology Services Chosen by TRATON GROUP as Strategic Engineering Partner in Global R&D Transformation2.7.2025 11:59:00 EEST | Press release
L&T Technology Services (BSE: 540115, NSE: LTTS), today announced that it has been chosen by the TRATON GROUP, one of the world’s leading manufacturers of commercial vehicles, as a strategic engineering partner. This collaboration in LTTS’ Mobility segment will support TRATON’s roadmap to build a unified, future-ready product-development platform that delivers scale, speed, and sustainable mobility solutions worldwide. TRATON is reshaping its global R&D ecosystem to unlock cross-brand synergies while expanding the share of battery-electric vehicles in line with its 2029 profitability and sustainability targets. LTTS’ selection will see the company provide engineering support, from mechanical and software engineering to digital systems integration - across key development hubs in Sweden, Germany, the United States, Poland, and India. The collaboration positions LTTS to deepen existing workstreams and pursue new programs across TRATON’s brands, spanning software-defined vehicle architect
Nexo Becomes First-Ever Digital Wealth Platform of the DP World Tour, Launches Nexo Championship2.7.2025 11:30:00 EEST | Press release
Nexo, the premier digital assets wealth platform, has signed a three-year landmark partnership with the DP World Tour, becoming an Official Marketing Partner and the Tour’s Official Digital Wealth Platform through 2027. This agreement marks the first-ever multi-year partnership between a digital assets company and a major global golf tour — a historic convergence of crypto and golf — reflecting both organizations’ shared commitment to performance, innovation, and a global outlook. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702770847/en/ Nexo becomes the first-ever Official Digital Wealth Platform of the DP World Tour. Nexo has also become the Title Partner of the newly renamed Nexo Championship — previously the Scottish Championship — taking place from August 7–10, 2025. The tournament is set at the Trump International Golf Links in Aberdeenshire, which has earned a reputation as one of the finest modern links courses
Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta2.7.2025 11:00:00 EEST | Press release
Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction. These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications.1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI.3 The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrie
Germany’s Largest Public Insurer Versicherungskammer Selects Clearwater Analytics for Scalable Investment Operations2.7.2025 10:00:00 EEST | Press release
Clearwater Analytics (NYSE: CWAN), the most comprehensive technology platform for investment management, today announced that Versicherungskammer Group has selected Clearwater Analytics’ platform to power their middle, back office and risk functions. This decision is based on a comprehensive operating model review that began in 2024, followed by a structured selection process to identify a strategic partner. The rigorous assessment underscored the need for change, as market developments and demographic shifts demanded more agility, transparency, and efficiency. By adopting Clearwater’s modern, cloud-based platform, Versicherungskammer will gain real-time, advanced data analytics to strengthen investment decision-making and drive improved performance. This will allow Versicherungskammer to focus on its core competencies in capital investment in the future. “Partnering with Clearwater marks an important shift in our investment operations strategy and is central to our goal of future-proo
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