SK Biopharmaceuticals said Thursday that it has signed an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate, an epilepsy treatment candidate, in Europe.
Cenobamate is a novel, small molecule investigational antiepileptic drug for the potential treatment of partial-onset seizures in adult patients. The drug is the first epilepsy drug independently developed by a Korean company, beginning from candidate discovery to the FDA application, without making technology export.
The agreement comes after the FDA started inspecting the company’s new drug application on Feb. 7.
Under the accord, SK Biopharma 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. The company has also won an option to obtain a significant equity stake in Arvelle and will also retain commercial rights for all non-European territories.
Arvelle said it plans to prioritize the development of cenobamate with world-class experts and funds and will submit a new drug application to the European Medicines Agency based on global clinical data provided by SK Biopharma.
If Arvelle receives EMA approval, the company can market the drug in 32 European countries, including Britain, Germany, France, and Switzerland.
"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," SK Biopharma CEO and President Cho Jeong-woo said. "Arvelle's experienced leadership team and focus on central nervous system (CNS) disorders make them the ideal partner to advance the development and commercialization of our compound in Europe."
Arvelle President and CEO Mark Altmeyer also 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.”
Given the data generated in clinical trials and the FDA acceptance of the NDA, we believe cenobamate has the potential to be an essential antiepileptic drug treatment option for adult patients suffering from partial-onset seizures, he added.
According to Global Data, a market research firm, the market for epilepsy drugs stands at $6.2 billion in 2018 and will increase to $7 billion in 2021.