Cenobamate is a novel and small molecule investigational antiepileptic drug being developed to treat partial-onset seizures in adult patients.
Under exclusive licensing agreement, Arvelle will develop and commercialize cenobamate in Europe.
As per terms of the deal, SK Biopharmaceuticals will secure an upfront payment of $100m from Arvelle. SK will also secure up to $430m based on the achievement of certain regulatory and commercial milestones, as well as royalties on net sales generated in Europe.
SK Biopharmaceuticals is also provided with an option to purchase a significant equity stake in Arvelle and hold commercial rights for all non-European territories.
SK Biopharmaceuticals has discovered and developed cenobamate, and the new drug application (FDA) for the investigational treatment was accepted by the US Food and Drug Administration (FDA) in February 2019 for the potential treatment of partial-onset seizures in adults.
SK Biopharmaceuticals president and CEO Dr Jeong Woo Cho said: “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.”
Based on the data of SK’s global clinical trial program, Arvelle is planning to file a marketing authorization application (MAA) for cenobamate for partial-onset seizures in adult patients
Cenobamat is believed to work via two separate mechanisms, including enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
Cenobamate is not yet secured approval from the FDA, European Medicines Agency (EMA) or any other regulatory authorities.
Arvelle Therapeutics president and CEO Mark Altmeyer said: “We launched Arvelle to bring truly innovative CNS products to patients suffering from serious neurological conditions and cenobamate is the perfect first pipeline product.”
Arvelle Therapeutics is a newly created firm that secured financing commitments from a global syndicate of investors, which include NovaQuest, LSP, BRV Capital Management, Andera Partners, and H.I.G. BioHealth Partners.
SK Biopharmaceuticals is engaged in the research and development of advanced treatments for disorders of central nervous system (CNS) and cancer.