SK Biopharm Epilepsy New Drug 'Cenobamate' Approved in Europe Following the US

Published 31 Mar.2021 08:08(KST)

Updated 31 Mar.2021 08:29(KST)

SK Biopharm's 'Cenobamate' US marketed product 'Xcopri' (Provided by SK Biopharm)

[Asia Economy Reporter Lee Chun-hee] SK Biopharm's epilepsy treatment drug 'Cenobamate' has received sales approval in Europe following the United States.

SK Biopharm announced on the 31st that Cenobamate received marketing authorization from the European Union (EU) Commission on the 30th (local time). This came just over two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended approval in February.

Prior to this, Cenobamate began direct sales in the United States under the product name 'Xcopri' in May last year. Cenobamate is the first new drug independently developed by a Korean pharmaceutical company to enter both the US and European markets. In Europe, commercialization is carried out through partner Angelini Pharma.

With this approval, SK Biopharm will receive milestone payments totaling $110 million (124.9 billion KRW) from Angelini Pharma in stages. Additionally, following the acquisition of the existing partner company, Avel Therapeutics, by Angelini Pharma in January, SK Biopharm will receive an additional milestone payment of $13.22 million (15 billion KRW) for transferring all its shares in Avel to Angelini Pharma.

Furthermore, as additional milestone payments will be made based on future European sales performance, it is expected that revenue could reach up to $585 million (664 billion KRW). Since royalties from sales are separate, the total profit scale is anticipated to be even larger.

Cenobamate will be launched in 41 European countries from the third quarter under the European product name ‘Ontozry (ONTOZRY)’. Angelini Pharma plans to sequentially release the product in major countries including Germany, France, Italy, Spain, and the United Kingdom, as well as in European Free Trade Association countries such as Iceland, Norway, and Liechtenstein.

Jung-woo Cho, CEO of SK Biopharm, said, “Our efforts to provide groundbreaking treatment to epilepsy patients in Europe are bearing fruit,” and added, “We will continue to develop new treatment options for central nervous system patients and fulfill our role as a global comprehensive pharmaceutical company.” Pierluigi Antonelli, CEO of Angelini Pharma, also stated, “This will bring new hope to epilepsy patients suffering from unexpected seizure symptoms,” and said, “We will build an innovative product portfolio to meet the needs of central nervous system patients.”