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.”
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/.
For Arvelle Therapeutics:
Mike Beyer, Sam Brown Inc.
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
Interactive Brokers Group to Host Second Quarter Earnings Conference Call7.7.2020 16:00:00 EEST | Press release
Interactive Brokers Group, Inc. (Nasdaq: IBKR) plans to announce its second quarter financial results on Tuesday, July 21, 2020, in a release that will be issued at approximately 4:00 pm (ET). The press release will also be available on the company's website, www.interactivebrokers.com/ir. A conference call to discuss the company's results will be held at 4:30 pm (ET) on that day, July 21. Members of the public who would like to listen to the conference call should dial 877-324-1965 (U.S. domestic) or 631-291-4512 (international). The number should be dialed approximately ten minutes prior to the start of the conference call. The conference call will also be accessible as an audio webcast through the Investor Relations section of the Interactive Brokers website, www.interactivebrokers.com/ir. About Interactive Brokers Group, Inc.: Interactive Brokers Group affiliates provide automated trade execution and custody of securities, commodities and foreign exchange around the clock on over 1
Virtual Esri User Conference to Explore How GIS Interconnects the World7.7.2020 15:41:00 EEST | Press release
Esri, the global leader in location intelligence, today announced that the 40th annual Esri User Conference will be the largest virtual gathering of GIS professionals. Normally held in San Diego, California, the conference will be presented in a completely virtual format and take place July 13–16, 2020. The Esri User Conference brings together technology innovators, executives, educators, scientists, and GIS users seeking to solve challenges in their organizations and throughout the world, using the most powerful mapping and analytics platform on the planet. This year's conference theme, GIS—Interconnecting Our World, explores how geospatial technology can integrate everything and engage everyone to overcome unprecedented global challenges. Esri founder and president Jack Dangermond will open the conference—which this year will see the Plenary Session span across three days—with his observations on how GIS, the world's nervous system, has never been more interconnected than it is today
Shippeo Extends Paperless Transportation and Advanced Pallet Scanning Capabilities to Its Real-Time Visibility Platform7.7.2020 15:18:00 EEST | Press release
Shippeo, the European leader in real-time transportation visibility solutions, has announced a new mobile application, offering a range of new capabilities. Shippeo’s mobile application allows truck drivers to manage electronic Bill of Lading via smartphone quickly and easily, unlocking the benefits of paperless administration. These include instant synchronisation with TMS for faster billing while also reducing administrative cost. In addition, electronic forms avoid paper handling, reducing hygiene concerns amid the Covid-19 pandemic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200707005487/en/ Shippeo mobile application (Photo: Shippeo) The new Shippeo mobile application features include: Paperless proof of delivery for last mile The mobile app integrates the generation of electronic Bills of Lading (or eCMRs) capturing electronic signatures and enabling paperless proof of delivery and fasting invoicing. Delivery perso
Cybin Corp. and IntelGenx Corp. Enter Into Feasibility Agreement for Fast-Acting, Orally-Dissolving Psilocybin Film7.7.2020 15:00:00 EEST | Press release
Cybin Corp. (“Cybin” or the “Company”), Canada's premier mushroom life sciences company focused on advancing psychedelic and nutraceutical-based products derived from fungi, is pleased to announce that it has entered into a feasibility agreement with IntelGenx Corp. (OTCQB:IGXT; TSX-V:IGX) (“IntelGenx”) for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin, subject to receipt of all necessary regulatory approvals. “We at Cybin are proud to be working with IntelGenx to develop a fast-acting psilocybin film,” said Cybin’s Chief Medical Officer, Dr. Jukka Karjalainen. “Compared to oral psilocybin capsules, which are subject to variable intestinal absorption and high first-pass metabolism in the liver, the systemic bioavailability of orally-dissolving psilocybin film is expected to be quite high. In addition, the dose of psilocybin administered by an orally-dissolving film is expected to be a fraction of what is required in oral capsules. Take
Xerox Adaptive CMYK+ Kit for Xerox Versant Expands Color Palette to More Than a Million7.7.2020 15:00:00 EEST | Press release
Xerox announced the Xerox Adaptive CMYK+ Kit for Xerox Versant®, the print market’s first adaptive technology kit that adds seven specialty colors to an existing production press, enabling instant digital print enhancements. The kit transforms a four-color Xerox Versant® 180 Press into an 11-color Beyond CMYK press capable of creating a million color hues and shades by adding gold, silver, white, clear and fluorescent colors of yellow, magenta and cyan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200707005242/en/ The print market’s first adaptive technology kit that adds seven specialty colors to an existing production press. (Photo: Business Wire) Digital enhancement of print is projected to be a $25 billion market¹, but access to that opportunity usually requires a capital investment in a new press with the ability to print Beyond CMYK. The Xerox Adaptive CMYK+ Kit for Versant gives print providers the ability to simply
Numab Therapeutics and Boehringer Ingelheim Enter into Collaboration to Develop Multi-specific Antibody Therapeutics for Cancer and Retinal Diseases7.7.2020 15:00:00 EEST | Press release
Boehringer Ingelheim and Numab Therapeutics (Numab) today announced that they have entered into a research collaboration and worldwide licensing agreement. It will start with two projects aiming at novel therapies for difficult-to-treat lung and gastrointestinal (GI) cancers and patients with geographic atrophy (GA), a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration (AMD) for which there is no current treatment. The collaboration brings together Boehringer Ingelheim’s leading expertise in the research and development of life changing breakthrough therapies with Numab’s multi-specific antibody platform. Lung and GI cancers and retinal diseases are key focus areas of Boehringer Ingelheim’s research and development program. In oncology the company has built a broad and diverse pipeline, combining cancer immunology and cancer cell directed approaches. The novel T-cell engager to be developed with Numab adds to Boehringer Ingelheim’s g
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