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
1NCE adds Data Benchmarking, AI Capabilities and ISO certification9.9.2026 11:00:00 EEST | Press release
1NCE announced a new upgrade of 1NCE Insights and the launch of 1NCE AI. Both expand 1NCE's foundational platform services, giving customers greater intelligence and control over connected device data. The new 1NCE Insights upgrade gives customers access to aggregated benchmark data from 30,000+ deployments. They can compare network usage patterns, battery performance, hardware choices and traffic optimization against real-world peers, enabling faster product development. 1NCE AI provides access to leading AI models through a unified API gateway, eliminating vendor fragmentation. The service is Germany-hosted and fully GDPR-compliant, with 1NCE's Token service enabling customers to manage and optimize AI token costs across all models. Data security is foundational. Customer-collected data belongs to the customer. 1NCE Insights uses only anonymized, aggregated network data. 1NCE's infrastructure is ISO/IEC 27001:2022 certified by TÜV Rheinland, valid through 2029. "Our platform gives cu
FinXP Partners with Thredd to Strengthen Multi-Region Card Issuing Capabilities9.9.2026 10:00:00 EEST | Press release
FinXP, a European payment infrastructure provider, has partnered with Thredd, the AI-first issuer processing platform, to strengthen FinXP’s card issuing capabilities and support the next phase of its embedded finance offering. The partnership with Thredd will enable FinXP to enhance its debit card programmes with a modern issuer-processing stack, supporting tokenisation, provisioning, risk and fraud prevention, card controls, and automated back-office operations. FinXP will retain control of its own ledger and programme strategy, while Thredd will provide the programme infrastructure needed to support secure, scalable and flexible card issuing across multiple regions. FinXP has been issuing cards for five years and already supports businesses with accounts, payments, collections, payouts, card issuing and embedded finance solutions. The partnership with Thredd marks a further step in FinXP’s strategy to provide scalable, multi-region payment infrastructure to fintechs, platforms and b
HSCALE Secures Landmark Strategic Deal With Major US Cloud Provider for Hyperscale Data Centre Campus in Spain9.9.2026 10:00:00 EEST | Press release
HSCALE, the pan-European hyperscale data centre platform, announced today a major strategic deal with a significant global cloud provider to deliver large-scale, high-performance digital infrastructure in a strategic metropolitan area within the Iberian Peninsula. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909242953/en/ HSCALE's CCO Paul Berry-Selwood The agreement is a defining milestone for HSCALE and anchors the development of a next-generation campus designed for the demanding requirements of hyperscale cloud and artificial intelligence workloads. In a deal worth more than US$1billion, the development is currently one of the largest data centres currently under construction in Spain. This deal provides a framework for both parties to progress further infrastructure opportunities across EMEA. Located in one of Europe's largest and most strategically important metropolitan markets, the project will add critical capa
Fighting Fire with Fire: Mobileum and Apate Shut Down Scam Operations From the Inside Out9.9.2026 10:00:00 EEST | Press release
Mobileum Inc. (“Mobileum”), a leading global provider of analytics and network solutions, and Apate.ai (“Apate”) have announced a partnership that equips communications service providers (CSPs) with advanced AI-powered fraud prevention capabilities designed to detect, disrupt, and investigate scam call operations. According to the Global Anti-Scam Alliance, scammers stole an estimated $442 billion in 2025, with phone calls, text messages and emails being the top three communication channels used by scammers. Through the integration of Mobileum’s Active Intelligence Platform with Apate's conversational AI agents, CSPs can now move beyond traditional call blocking and take a more proactive role in disrupting scam activity. Rather than simply preventing suspicious calls, messages and other communications from reaching customers, the solution engages fraudsters directly, collecting valuable intelligence that helps identify tactics, uncover networks, expose the artifacts they use (bank acco
KONGSBERG Selects Echodyne MESA Radar for Counter-UAS Weapon Systems9.9.2026 09:00:00 EEST | Press release
Echodyne, the radar platform company, today announced that KONGSBERG has selected Echodyne's MESA® radar platform for a range of air and surface applications. Among the first use cases, KONGSBERG has integrated MESA radar into the PROTECTOR RS4 and PROTECTOR RS6 remote weapon stations (RWS), adding the precision radar data needed to turn the world's most widely deployed RWS family into a highly effective counter-unmanned aircraft system (C-UAS) effector. The selection pairs KONGSBERG's proven weapon-station architecture and Collaborative Fire Control capabilities with Echodyne's compact, solid-state radar. The result is a scalable approach for adding high-fidelity detection, tracking and targeting data to static, crewed and uncrewed platforms without the size, weight and power demands traditionally associated with high-performance electronically scanned array radar. "KONGSBERG has set the standard for remote weapon systems through decades of field experience, disciplined engineering an
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