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
ABB Robotics and PSYONIC Use Human-Generated Data to Advance Robotic Dexterity16.6.2026 07:01:00 EEST | Press release
ABB Robotics is collaborating with California bionics company, PSYONIC, to advance robotic gripping and dexterity using a new approach that utilizes real-world manipulation data from human prosthetic use. By combining the PSYONIC Ability Hand with an ABB GoFa™ cobot, the collaboration will explore how touch and motion data generated by human prosthetic use can be used to train robots to perform delicate, variable tasks that have traditionally been difficult to automate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612749544/en/ “Human dexterity and the instinctive understanding of how to handle different objects is one of the most difficult things to replicate in industrial-grade robotics, but it’s a fundamental need for truly autonomous and versatile robots,” said Marc Segura, President, ABB Robotics. “As we develop the next generation physical AI, robots will learn and understand the world as we do. This collaboration
Signaloid Announces Availability of Amazon AWS Machine Image (AMI) for Accelerating Compute Workloads Ranging from Finance to Reinforcement Learning16.6.2026 07:00:00 EEST | Press release
British computing technology company Signaloid today announced the release of the Signaloid Compute Engine Amazon Machine Image (AMI) via AWS Marketplace. The release enables organizations to deploy Signaloid’s distribution-extended compute hardware (UxHw®) technology within their Amazon Virtual Private Clouds (VPCs). The AMI provides access to UxHw, which delivers orders-of-magnitude performance improvements on x86_64 and ARM (AArch64) AWS Elastic Compute Cloud (EC2) instances. Without requiring software rewrites, UxHw enables existing applications to compute directly on probability distributions, automating algorithms such as Monte Carlo methods in finance and physics, importance sampling in reinforcement learning, and particle filters in physical AI and robotics. The technology works through binary translation and optimization at the LLVM intermediate representation (LLVM IR) level, with optional hardware acceleration via FPGAs and Signaloid’s C0-ASIC that was recently taped-out in
Murata Collaborates with Synopsys to Provide Simulation Models Through Ansys Electromagnetic and Thermal Analysis Tools16.6.2026 05:00:00 EEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces a new collaboration with Synopsys, Inc., enabling users of Synopsys' simulation tools to navigate directly to Murata's website to access and download the latest high-performance simulation models from Murata. The collaboration covers Synopsys' 3D electromagnetic field analysis tool Ansys HFSS™ and thermal analysis tool Ansys Icepak®, and marks a significant step toward streamlining the simulation workflow for electronic circuit designers. Murata is also the first company to offer passive component simulation models via Ansys Icepak*. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615241645/en/ [Murata Manufacturing Co., Ltd.] New collaboration with Synopsys As demand for high-speed, high-capacity communications continues to grow, electronic circuit design has become increasingly complex. Engineers must now account for a range of physical phenomena
Trimontium Launches with $1.5 billion in AUM, Redefining Flexible Capital Solutions16.6.2026 02:01:00 EEST | Press release
Trimontium (the “Firm”), an institutionally backed alternative asset manager specialising in flexible capital solutions, today announced its launch with $1.5 billion in assets under management. The Firm’s investment approach is rooted in credit and special-situations expertise, with the flexibility to originate and execute tailored financing solutions across the full capital structure for a wide range of corporate needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615892895/en/ Trimontium Founder and CIO, Vlado Spasov Founded by former Blackstone executive Vlado Spasov, Trimontium is one of the largest first-time alternative asset managers based in Europe focused on flexible capital solutions to launch, according to available market data. The Firm is backed by leading institutional partners in the United States, Canada, Asia, and Australia, who collectively manage over $15 trillion in assets. Trimontium has sourced all
Newmont Announces Key Executive Appointments for the Next Phase of Delivery16.6.2026 00:20:00 EEST | Press release
Newmont Corporation (NYSE: NEM, ASX: NEM, PNGX: NEM) (“Newmont”) today announced leadership appointments that further shape its go-forward Executive Leadership Team under President and Chief Executive Officer Natascha Viljoen and reflect the depth of leadership talent within the company. Effective July 1, 2026, Brian Tabolt has been appointed Chief Financial Officer, Mark Rodgers has been appointed Chief Operating Officer, and David Thornton has been appointed Chief Technical Officer. In addition, David Fry has been promoted to Executive Vice President, Project Development, reflecting the importance of disciplined project development and execution as Newmont advances its highest-return growth opportunities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615487768/en/ Mark Rodgers - COO “These appointments bring together respected leaders with deep industry experience and a strong understanding of our operational, financia
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