With a team of Axovant veterans leading the way, CNS startup Arvelle Therapeutics is nearing approval for licensed epilepsy med cenobamate in the EU after snagging an FDA approval in late 2019. Looking to take its first med to market, Arvelle has agreed to hand the reins to Italy’s Angelini Pharma in the first big biopharma buyout of 2021.
Angelini will pay $610 million post-approval with $350 million in sales milestones to acquire Switzerland’s Arvelle, a team helmed by three veterans from the Vivek Ramaswamy outfit that expects an EU nod for cenobamate this year, the companies said Monday.
Arvelle bagged an expanded $208 million Series A funding round back in May on the promise of identifying novel small-molecule candidates for central nervous system disorders as well as marketing cenobamate in Europe as part of a $100 million licensing pact with South Korea’s SK Biopharmaceuticals signed back in February 2019.
The FDA approved cenobamate tablets, marketed as Xcopri stateside, as a treatment for epilepsy in December 2019, and the EMA agreed to pick up Arvelle’s marketing application four months later, in March, for cenobamate as an adjunctive treatment of focal-onset seizures in adults with epilepsy.
Execs from Angelini Holding, the parent company of the pharma brand, called the Arvelle acquisition the “most important investment in the history of our Group” in a statement, touting the “multinational dimension” of the buyout. As part of the deal, SK will sell its 12% Arvelle stake to Angelini and hold on to its licensing royalty rights.
Once the buyout passes regulatory scrutiny and pending cenobamate’s European approval, Angelini plans to open “direct affiliates” to help market the drug in France, the U.K., Switzerland and the Nordic countries by 2022, the companies said.
Arvelle’s leadership team, helmed by CEO Mark Altmeyer, a former chief commercial officer at Ramaswamy’s Axovant, sees big things for cenobamate after SK’s positive outcome from the FDA in late 2019.
The agency based Xcopri’s approval on data from two Phase III studies showing the drug beat out placebo in reducing the frequency of seizures over a 655-patient population. In one study, median percentage changes in seizure frequency were -24.0% for the placebo group compared with -35.5% for the 100-milligram dose group, -55·0% for 200 milligrams, and -55.0% for 400 milligrams, respectively. The second trial showed a statistically significant 56% reduction in median seizure frequency with the 113 patients on 200 milligrams, versus a 22% reduction with placebo.
FDA regulators ended up recommending the 200-milligram dose for standard maintenance but allowed that some may need 400 milligrams daily. Cenobamate also sports a Promising Innovative Medicine tag from the UK’s MHRA for the treatment of drug-resistant focal-onset seizures in adults.