Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe.

Arvelle Therapeutics is a biopharmaceutical company with the mission of bringing innovative solutions to patients suffering from CNS disorders. 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.

BASEL, Switzerland- Arvelle Therapeutics GmbH  and SK Biopharmaceuticals 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.

Source: Businesswire