Axovant Launches Arvelle Therapeutics to Commercialize Epilepsy Drug
Axovant Sciences, one of Vivek Ramaswamy’s biotech companies under the Roivant Sciences umbrella, is forming a company called Arvelle Therapeutics. Arvelle is a strategic transition of Axovant’s legacy small molecule team.
In May 2018, Axovant reorganized with the goal of simplifying its structure, cutting costs and streamlining business processes. At that time it cut its internal headcount by about 43 percent and “increased the use of the Roivant platform to supplement internal capabilities.”
Arvelle is launching by licensing European rights to cenobamate from SK Bio-Pharmaceuticals. This is a novel investigational anti-epileptic drug for the treatment of partial-onset seizures. Axovant takes a 5 percent preferred equity stake in Arvelle after the initial planned capital raise of more than $100 million from a global syndicate of investors.
In November 2018, SK Biopharmaceuticals filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), which was accepted in February 2019. It has a target action date of November 21, 2019. Arvelle expects to file a Marketing Authorization Application (MAA) based on data that came out of SK Biopharmaceutical’s development program.
Axovant’s current chief commercial officer, Mark Altmeyer, is stepping down at Axovant to take on the president and chief executive officer of Arvelle. Greg Weinhoff will stay as chief financial officer of Axovant and transition to chief financial business officer at Arvelle in late 2019.
With that transition of its small molecule team to Arvelle, Axovant’s headcount will drop by about 25 percent.
“Throughout the past year, my goal at Axovant was to build a strong pipeline and leadership team with a singular focus on gene therapies,” stated Pavan Cheruvu, chief executive officer of Axovant. “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.”
Two of Axovant’s programs are nelotanserin, a highly selective inverse agonist of the 5HT2A receptor, and RVT-104, an early-stage asset. Nelotanserin is being evaluated in patients with Dementia with Lewy bodies (DLB) or Parkinson’s Disease Dementia (PDD) who are experiencing REM sleep behavior disorder (RBD). RVT-104 is a proposed combination of a higher than presently approved dose of cholinesterase inhibitor rivastigmine and a peripherally active muscarinic receptor antagonist. It is being studied as a possible treatment for Alzheimer’s disease and dementia with Lewy bodies.
The other four programs are for GM1 gangliosidosis, Tay-Sachs and Sandhoff diseases, oculopharyngeal muscular dystrophy, and amyotrophic lateral sclerosis. The GM1 gangliosidosis, Tay-Sachs and Sandhoff gene therapy programs were licensed from the University of Massachusetts Medical School.
“With the addition of new investigational gene therapies for the treatment of GM1 gangliosidosis, Tay-Sachs, and Sandhoff diseases, we are excited about having built a deep pipeline of potentially transformative gene therapies addressing serious conditions,” stated Cheruvu at the company’s third-quarter financial update on Feb. 7.