Pangyo - SK Biopharmaceuticals, a global innovative pharmaceutical company, announced that it has agreed to sell its 12% stake in Arvelle Therapeutics to Angelini Pharma, an international pharmaceutical company of the Italian privately held Angelini Group, as part of Angelini Pharma's $960 million acquisition of 100% of the stock of Arvelle Therapeutics.

Following the takeover of Arvelle Therapeutics, Angelini Pharma will have the rights to commercialize cenobamate in 41 countries in Europe. Angelini Pharma will also assume all obligations, including $430 million in milestone payments to SK Biopharmaceuticals, under a licensing agreement sealed between SK Biopharmaceuticals and Arvelle in 2019. This agreement came with an upfront payment of $100 million to SK Biopharmaceuticals, as well as royalties on net sales generated in Europe.

SK Biopharmaceuticals will also receive an upfront payment of about $32 million, with an additional $23 million in regulatory and sales milestone payments, totaling up to approximately $55 million through the 12% share sale. Prior to entering into the share sale, SK Biopharmaceuticals exercised its warrant through which it had obtained a 12% stake in Arvelle.

Cenobamate is a treatment for focal-onset seizures discovered and developed by SK Biopharmaceuticals and its U.S. subsidiary, SK life science that received U.S. FDA approval in 2019, and is awaiting approval from the European Medicines Agency.

SK Biopharmaceuticals will strengthen its global business portfolio through organic and inorganic growth, while closely collaborate with Angelini Pharma, which has centennial experience in developing medicines through its strong global R&D and marketing platforms, to help prepare for the upcoming European commercial launch of cenobamate.

'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 promised to the epilepsy community,' said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals. 'This marks the beginning not only of our new relationship 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.'

'At Angelini Pharma, we are thrilled to sign this promising agreement. This transaction, which has been made possible thanks to the commitment and the full support of the new generation of Angelini shareholders, will propel us into a leading European player, well positioned to address the needs of patients with different Central Nervous System disorders through innovative portfolio, distinctive medical capabilities and extensive commercial presence, also via the opening of direct affiliates in France, UK, Nordics and Switzerland by 2022,' says Pierluigi Antonelli, CEO of Angelini Pharma. 'We are enthusiastic as well for the work that our colleagues at Arvelle Therapeutics have put in place during last years as we share the same patient-centric culture and agility attitude.'

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.

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.

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 EUR1,7 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.

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 conditions 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.

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 antiepileptic drug, 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.

About Cenobamate

Cenobamate was discovered and developed by SK Biopharmaceuticals and SK life science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the -aminobutyric acid (GABAA) ion channel.

Cenobamate is approved in the United States as an anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults, and is available under the brand name XCOPRI (cenobamate tablets) CV. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe. In October 2020, SK Biopharmaceuticals sealed an exclusive licensing agreement with Ono Pharmaceutical to develop and commercialize cenobamate in Japan.

Contact:

Alessandra Favilli

Email: alessandra.favilli@angeliniholding.com

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