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
ADM Club Digitises the Renaissance Court Model Through a Bespoke Technology Stack for Independent Luxury and High Affinity Audiences1.9.2026 09:08:00 EEST | Press release
Alessia Demetz, Founder & CEO of Alesya de Monaco LTD, headquartered in London and the Principality of Monaco, created ADM Club – a business model built on a vertical digital architecture and designed for global scalability – operating at the intersection of luxury craftsmanship and an international network of high-net-worth connoisseurs. This powerful, disruptive vision — bringing hyper-curated craft direct to the customer — translates into digital form the role once played by patrons within Renaissance courts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260821319838/en/ Credits: Photo courtesy of ADM Club. Photography by Martin Morrell. Designed from the outset to enable the model to scale, this architecture supports both the development of the ADM Club network and deployment with international partners, opening the way to collaborations with operators and organisations that reach high-spending audiences. ADM Club is no
Flashnet Partners with Netmore in Strategic Global Partnership for Smart Street Lighting1.9.2026 09:00:00 EEST | Press release
Netmore Group, the leading network operator and platform provider for Massive IoT, today announced that Flashnet, a Lucy Group company and global leader in intelligent street lighting solutions, has joined Netmore's Pulse Partner Program. The partnership marks another important milestone in Netmore's growing ecosystem, combining best-in-class connectivity with proven smart infrastructure solutions to accelerate the digital transformation of cities and utilities around the world. Driven by rapid urbanisation, government sustainability mandates, and the accelerating rollout of smart city programs worldwide, smart street lighting is increasingly recognized as the entry point for smart city transformation and one of the fastest-growing segments of the global IoT infrastructure market. As municipalities and utilities continue to modernize critical infrastructure, this partnership provides a scalable and reliable framework for implementing intelligent street lighting systems that reduce ener
Fujirebio Expands Access in Canada to Blood-based Neurology Testing with Health Canada Class II Medical Device Licenses for the Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma Assays1.9.2026 08:00:00 EEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market. "The approval of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for clinical use in Canada marks another important step in our mission to expand access to reliable and clinically meaningful blood-based biomarkers for clinicians and patients worldwide," said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “As a pioneer in neurological diagnostics, Fujirebio remains committed to advancing patient care through innovative, fully automated testing solutions." These approvals further strengthen Fujirebio’s comprehensive neurological diagnostics portfolio by broadening access to high-quality biomarker solutions designed to inform clinical decision-making across the
Helical Fusion Named a Final Candidate for Japan’s METI Fusion Power Demonstration Program1.9.2026 05:00:00 EEST | Press release
Helical Fusion Co., Ltd., a fusion energy company developing a Helical Stellarator toward commercially viable fusion power, has been named a final candidate for Japan’s Ministry of Economy, Trade and Industry (METI) program supporting the demonstration of fusion power generation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260831991676/en/ Image of Helix HARUKA, Helical Fusion’s Integrated Demo Device(left), and Helix KANATA, Helical Fusion’s Fusion Pilot Plant(right) The program is designed to accelerate fusion power demonstration in the 2030s under Japan’s national energy and fusion strategies. It supports private-sector technology development across multiple fusion approaches, including tokamak, stellarator and laser fusion, with approximately JPY 60 billion in total government support anticipated over the three years through 2028. The amount to be awarded to Helical Fusion will be announced following the formal grant
Strategic Combination of ITC Infotech and Happiest Minds Technologies to Create a Scaled, Future-Ready, AI-First Global Technology Services Enterprise with US$ 1 Billion Revenue by FY28 [1]1.9.2026 00:35:00 EEST | Press release
ITC Infotech (ITCI), a wholly owned subsidiary of ITC Limited and a leading global technology services player, today announced the proposed strategic combination with Happiest Minds Technologies Limited (Happiest Minds) to create a scaled, future-ready, AI-first global technology services enterprise. The ITCI Board approved a proposal to acquire 22.1% equity stake from the promoter of Happiest Minds in two tranches under a Share Purchase Agreement. The transaction would be funded through a Rights Issue by ITC Infotech. ITCI Board has also approved a proposed Scheme of Amalgamation of Happiest Minds with ITCI which will be effected after the share acquisition. Pursuant to the scheme, the shares of ITCI will be listed on the stock exchanges. The proposed transaction has also been endorsed by the Board of Directors of ITC Limited. This strategic combination will synergistically blend ITCI’s AI-led capabilities across Cloud, Data Analytics, PLM, SAP, enterprise transformation, industry-spe
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