Angelini Pharma, an international pharmaceutical company which is a part of the private Italian Angelini Group, and Arvelle Therapeutics, a Swiss-based biopharma focused on central nervous system (CNS) disorders, have concluded a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics for up to $960 million. Following regulatory approval, $610 million will be paid. Subsequently, and subject to cenobamate reaching certain revenue targets, a further $350 million will be paid.
 
Following Angelini Pharma’s acquisition of Arvelle Therapeutics, Angelini Pharma will have the exclusive license to commercialize cenobamate in the EU and other countries in the European Economic Area (Switzerland and the UK). Angelini plans to launch cenobamate after receiving approval from the European Medicines Agency (EMA), which is expected in 2021.
 
Since its founding in 2019, Arvelle’s management team has focused on bringing cenobamate to people with epilepsy in Europe. They have worked in close collaboration with the European regulators to advance the marketing authorization application (MAA), and they have successfully prepared for launch by building an organization throughout Europe and ensuring launch readiness across key areas of the business.
 
Cenobamate is a Promising Innovative Medicine by the UK’s MHRA for the treatment of drug-resistant focal-onset seizures in adults. Cenobamate is a small molecule with a unique dual complementary mechanism of action. It acts positively modulating the γ-aminobutyric acid (GABAA) ion channel and inhibiting voltage-gated sodium currents. Key study findings documented cenobamate’s clinical efficacy by showing a significant greater reduction in median seizure frequency and more patients achieving a 50% or greater reduction in seizure frequency compared to the placebo group. Cenobamate is approved by the Food and Drug Administration (FDA) in the United States as an anti-seizure medication (ASM) for the treatment of partial-onset (focal-onset) seizures in adults, and is available under the brand name XCOPRI (cenobamate tablets) CV.
 
“It’s the most important investment in the history of our Group and it is the confirmation of the shareholder’s commitment to pharma, which remains our biggest business,” said Sergio Marullo di Condojanni, chief executive officer, Angelini Holding. “This acquisition represents a milestone in our growth path as it definitively drives us towards the multinational dimension, to which all the companies of Angelini Group are now looking at. We are proud that, for the second time in a year, we have managed to win a significant and coveted asset, which strengthens and positions us among the most important players in the market.”
 
Pierluigi Antonelli, chief executive officer, Angelini Pharma, said, “At Angelini Pharma, we are thrilled to sign this promising agreement and are enthusiastic about the commitment and work that our colleagues at Arvelle have put into the business during the last years. We share the same patient-centric culture and agility attitude. This transaction will propel us into a leading European player, well positioned to address the needs of patients with different Central Nervous System (CNS) disorders through an innovative portfolio, distinctive medical capabilities and extensive commercial presence, also via the opening of direct affiliates in France, UK, Nordics and Switzerland by 2022.”
 
“I am very proud of the team we have built at Arvelle and the progress we have made over the last two years in helping bring cenobamate to people suffering with epilepsy in Europe” said Mark Altmeyer, president and chief executive officer, Arvelle Therapeutics. “We think there is an excellent strategic fit with Angelini Pharma and believe the acquisition of Arvelle, and the launch of cenobamate can help accelerate their goal of becoming a leading CNS industry player.”