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
Venture Global Commences Commercial Operations of Phase One of Plaquemines LNG1.11.2026 17:40:00 EET | Press release
On October 31, 2026, Venture Global (NYSE: VG) commenced commercial operations of the first phase of its second LNG export project – Plaquemines LNG – and the sale of low-cost, U.S. LNG to the first phase’s long-term customers. The commercial operations date (COD) for Phase 1 of Plaquemines LNG was reached in just over 53 months from the final investment decision on the project, making it among the fastest greenfield LNG projects ever completed. “Achieving commercial operations at the first phase of our second LNG project in 53 months is a testament to our team's relentless dedication and hard work,” said Venture Global CEO Mike Sabel. “We are thrilled to hit another major milestone that enables us to continue delivering reliable, affordable American LNG to the global market. We deeply appreciate the collaboration of our regulators and supply chain partners, whose shared commitment helped us deliver this project safely and on schedule.” The first post-COD cargo from Plaquemines Phase 1
From the Chishui to the Han: "Moutai Night" Debuts in Seoul to Bridge Cultural Connections1.11.2026 14:44:00 EET | Press release
On October 25, the 2026 “Moutai Night” was held in Seoul, South Korea, under the theme “Born by the Chishui River, Fragrance Along the Han River.” Over a hundred guests from China and South Korea gathered around the Han River, sharing the distinctive appeal of Chinese baijiu, and fostering cultural exchange between the two countries through fine liquor and culture. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261101047521/en/ The event featured an exhibition on Moutai’s brewing techniques and brand history. Hands-on experiences with Miao batik and silverwork showcased Guizhou culture, while creative cocktails brought Chinese spirits into dialogue with Korean tastes. A city-themed video, dance performances and a violin performance rounded out the program, as guests exchanged views on liquor culture in a warm atmosphere. As a flagship cultural initiative designed for global audiences, “Moutai Night” made its Seoul debut, fol
Vedanta Aluminium’s Q2FY27: Profit doubles to INR 6,187 Cr, EBITDA rises 83% YoY31.10.2026 15:12:00 EET | Press release
Vedanta Aluminium Metal Limited (BSE: 544780 & NSE: VAML), India’s largest aluminium producer, announced its unaudited financial results for the quarter and half year ended 30 September 2026, delivering solid financial and operational performance. Revenue increased to INR 22,066 crore, up 41% YoY, supported by higher volumes and improved marketing mix. EBITDA stood at INR 10,192 crore, up 83% YoY, with an EBITDA margin of ~46%. Profit after tax stood at INR 6,187 crore, more than doubling YoY with an increase of 105%. VAML strengthened its balance sheet during the quarter, reducing net debt by INR 3,090 crore QoQ, with Net Debt/EBITDA improving to 0.7x from 0.9x in Q1FY27. The company’s credit profile was validated with India Ratings upgrading its credit rating to AA+ (Stable), alongside rating reaffirmations from ICRA and CRISIL. Operationally, VAML achieved its highest-ever quarterly aluminium production of 649 KT, up 3% QoQ and 5% YoY. Value-added production reached a record 432 KT,
United States Signs Participation Contract for Expo 2030 Riyadh, Strengthening Momentum For Global Participation31.10.2026 10:38:00 EET | Press release
The United States of America has signed its Participation Contract for Expo 2030 Riyadh, marking a significant milestone in the World Expo’s preparations and further strengthening the momentum for international participation in the global event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261031669001/en/ The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia. The signing marks an important step in the United States’ journey towards Expo 2030 Riyadh, paving the way for the development of its pavilion, programming and visitor experience. It also reinforces the growing international commitment to Expo 2030 Riyadh, as countries move from confirming their participation to actively sha
ADNEC Group Kickstarts November with Two of the World’s Largest Events in the Energy and Tourism Sectors31.10.2026 05:53:00 EET | Press release
ADNEC Group, a Modon company, begins November by hosting two of the world’s most significant international events in the same week. ADIPEC 2026, the world’s largest energy event, takes place at ADNEC Centre Abu Dhabi from 2 to 5 November. Meanwhile, World Travel Market (WTM) London, one of the global travel industry’s leading gatherings, takes place at the Group’s Excel London venue from 3 to 5 November. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030918463/en/ ADNEC Centre Abu Dhabi (Photo: AETOSWire) The two events, held simultaneously at the Group’s largest venues in the UAE and the UK, reflect ADNEC Group’s capability to deliver large-scale international events across multiple markets. ADIPEC has grown alongside the venue since it was first held at the ADNEC Centre Abu Dhabi in 2006. This year’s edition is set to be the largest in the event’s history, occupying the venue’s entire 153,000 square metres of exhibition
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