Arvelle has licensed European rights to cenobamate, a novel investigational anti-epileptic drug for the potential treatment of focal (partial-onset) seizures, from SK Biopharmaceuticals. Axovant will receive a 5% preferred equity stake in Arvelle following the completion of the planned initial capital raise of over $100 million from a global syndicate of biotechnology investors.

SK Biopharmaceuticals filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in November 2018 and this filing was accepted by the agency in February 2019, with a PDUFA date of November 21, 2019. Arvelle plans to file a Marketing Authorization Application (MAA) based on the data generated from SK Biopharmaceutical’s global clinical trial program.

Axovant’s chief commercial officer Mark Altmeyer will step down from his current role at Axovant to become president and chief executive officer of Arvelle. Greg Weinhoff will remain at Axovant as chief financial officer and transition to the role of chief financial and business officer at Arvelle later in 2019.

 

In addition to receiving reimbursement for direct costs associated with the creation of Arvelle, Axovant will reduce its headcount by approximately 25% with the transition to Arvelle of employees with expertise in small molecule development and commercialization and the wind-down of other small molecule activities.

“Throughout the past year, my goal at Axovant was to build a strong pipeline and leadership team with a singular focus on gene therapies. We learned about cenobamate last year as we were defining the company’s new strategic direction, and we formed a unique relationship with SK Biopharmaceuticals through that process. The transition of  Axovant’s small molecule team to Arvelle completes our transformation into a company focused exclusively on the development of innovative gene therapies, while offering us an opportunity to reduce costs and realize long-term value from our legacy small molecule platform,” said Pavan Cheruvu, M.D., chief executive officer of Axovant. “We wish Mark well in his new role, and are excited about the potential for cenobamate to offer a new treatment option to millions of patients suffering from epilepsy.”