Arvelle Therapeutics and SK Biopharmaceuticals’ $530 Million Licensing Agreement

Goodwin advised Arvelle Therapeutics GmbH on the transaction

SK Biopharmaceuticals and Arvelle Therapeutics GmbH 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).

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.

Goodwin advised Arvelle Therapeutics GmbH with a team including Karen Spindler (Picture), Mitchell Bloom, Robert Puopolo, Richard Matheny, Todd Hahn and Nancy Urizar.

Involved fees earner: Mitchell Bloom – Goodwin Procter; Todd Hahn – Goodwin Procter; Richard Matheny – Goodwin Procter; Robert Puopolo – Goodwin Procter; Karen Spindler – Goodwin Procter; Nancy Urizar – Goodwin Procter;

Law Firms: Goodwin Procter;

Clients: Arvelle Therapeutics GmbH;

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Author: Ambrogio Visconti