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

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

• Angelini Pharma and Arvelle Therapeutics have today agreed on a definitive merger agreement valuing Arvelle Therapeutics at up to $960 million

• Angelini Pharma will become a leading player amongst companies focused on Central Nervous System (CNS) and mental health disorder treatments

• Opening direct affiliates in France, UK, Nordics and Switzerland by 2022

Rome, January 4, 2021 - 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, today 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.

About Angelini Holding

Angelini Holding is the parent company of an international group operating in the pharmaceutical and consumer goods sectors. Founded in Italy in 1919, today Angelini group operates in 17 countries with a staff of 5,600 and a turnover of €1,7 billion. In addition to the Pharmaceutical sector, Angelini group operates in Personal and Home

Care business area through Fater, a joint venture with Procter & Gamble, in the Machinery field, again in joint venture with P&G, with the group operating in automation and robotics for the consumer goods industry Fameccanica, in Perfumery and Skincare and Suncare with Angelini Beauty and in the Wine sector through Bertani Domains. Angelini Holding has recently entered the Baby food market as well through MadreNatura, a joint venture with Hero Group, which offers 100% organic baby food products. More information is available at www.angeliniholding.com

About Angelini Pharma

Angelini Pharma is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutics areas of Mental Health (including Pain), Rare Diseases and Consumer Healthcare. Over the past 50 years, in the field of mental health, Angelini Pharma has gained international recognition for its substantial efforts to improve the management of patients with mental health disorders thanks to important, internally developed, molecules (such as trazodone) and its commitment to fighting mental health stigma. Angelini Pharma operates directly in 15 countries employing almost 3.000 people and commercializes its products in more than 50 countries through strategic alliances with leading international pharmaceutical groups. For additional info visit www.angelinipharma.com

About Arvelle Therapeutics

Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational anti-seizure medicine, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.8 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at http://arvelletx.com.

About SK Biopharmaceuticals Co., Ltd.

SK Biopharmaceuticals and its U.S. subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK life science’s website at www.SKLifeScienceInc.com.

Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/.

About Cenobamate

Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures). Cenobamate has been approved in the U.S. where it is commercially available under the trademark XCOPRI®.[1] In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe. Cenobamate is believed to deliver its dual, complementary mechanism of action through a combination of two mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors at a non-benzodiazepine binding site[2], and decreasing excitatory currents by both inhibiting the persistent sodium current and enhancing the inactivated state of voltage-gated sodium channels.[3]

As a once-a-day tablet, cenobamate has been studied in over 2,500 subjects, including more than 1,900 patients across the two phase 2 and one phase 3 trial. Seizure freedom rates seen in the double-blind placebo controlled pivotal studies[4],[5] of adult patients with drug-resistant focal onset seizures who were administered cenobamate as an adjunctive therapy have exceeded existing supportive care.[6],[7]

Long-term data of cenobamate is being studied in the open-label extensions of the double-blind placebo-control trials as well as the open-label safety study in adults with uncontrolled focal-onset seizures.[8] Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).[9]

[1] Cenobamate prescribing information. FDA. Last accessed 20 July, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf

[2]. Sharma R, et al. Eur J Pharmacol 2020; 879:173-117.

[3]. Nakamura M, et al. Eur J Pharmacol 2019; 855:175-182.

[4]. Chung S, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology, 2020;94:1-e12.

[5]. Krauss GL et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicenter, double-blind, randomized, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Apr;19(4):288-289.

[6]. French JA. Cenobamate for focal seizures – a game changer? Nat Rev Neurol. 2020 Mar;16(3):133-134.

[7]. Vossler DG. A Remarkably High Efficacy of Cenobamate in Adults With Focal-Onset Seizures: Epilepsy Curr. 2020 Feb 24;20(2):85-87.

[8]. Sperling MR, et al. Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study. Epilepsia Feb 2020;61:1099–1108.

[9]. Randomized, Double- Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures NCT03678753.