19 February 2019 - - Swiss biopharmaceutical company SK Biopharmaceuticals and Arvelle Therapeutics GmbH has entered into an exclusive licensing agreement for Arvelle to develop and commercialize cenobamate in Europe, the company said.

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 USD 100m and is eligible to receive up to USD 430m 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 by the US Food and Drug Administration.

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 commercialisation.

Arvelle intends to file a Marketing Authorization Application for cenobamate for partial-onset seizures in adult patients based on the data generated from SK Biopharmaceuticals' global clinical trial program.

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 US Food and Drug Administration 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 or any other regulatory authorities. Safety and efficacy have not been established.

SK Biopharmaceuticals is focused on research and development of treatments for disorders of central nervous system 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 US 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.

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.