Angelini Pharma acquires Arvelle Therapeutics to create a leading European innovator in Central Nervous System (CNS) and Mental Health Disorder treatments

Angelini Pharma, an international pharmaceutical company which is a part of the private Italian Angelini Group – and Arvelle Therapeutics, a Swiss-based biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, announced that they have concluded a definitive merger agreement under which Angelini Pharma will acquire Arvelle Therapeutics in an all cash transaction for a total aggregate valuation of up to $960 million. Following regulatory approval, $610M will be paid. Subsequently, and subject to cenobamate reaching certain revenue targets, a further $350M will be paid.

Following Angelini Pharma’s acquisition of Arvelle Therapeutics, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom). 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, whilst also creating significant value for shareholders. 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 [1]. 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” – commented Thea Paola Angelini and Sergio Marullo of Condojanni, respectively executive vice president and CEO of Angelini Holding – “and it is the confirmation of the shareholder’s commitment to pharma, which remains our biggest business. 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.”

“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” says Pierluigi Antonelli, CEO Angelini Pharma. “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 & CEO of 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.”

SK Biopharmaceuticals, a global innovative pharmaceutical company listed on the Korea Stock Exchange, announced that it has agreed to sell its 12 percent stake in Arvelle Therapeutics to Angelini Pharma. SK Biopharmaceuticals will remain eligible to receive all payments inherited by the license agreement signed between Arvelle Therapeutics and SK Biopharmaceuticals in February 2019. In addition, revenue share payments due to certain of the Arvelle shareholders will be assumed by Angelini Pharma.

“We are delighted to start a new working relationship with Angelini Pharma that will enable all of us to move a step forward in launching cenobamate in Europe as we have promised to the epilepsy community” said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals. “This marks the beginning not only of a new relationship with Angelini, but also the year of our European entry. SK Biopharmaceuticals will continue its efforts with our partners to provide a new treatment option to patients worldwide.”

For Arvelle, Centerview Partners UK LLP is acting as sole financial advisor and Sidley Austin LLP is acting as legal counsel and NautaDutilh N.V. is also providing legal counsel. For Angelini Pharma, White & Case (Europe) LLP is acting as legal counsel, with the support of KPMG for the due diligence Tax & Accounting.