SK Biopharm's 'Cenobamate' Nears European Launch

SK Biopharm 'Cenobamate' (Provided by SK Biopharm)

[Asia Economy Reporter Chunhee Lee] The European launch of SK Biopharm's new drug 'Cenobamate' is imminent.

SK Biopharm announced on the 1st that Cenobamate received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 29th of last month (local time).

Cenobamate is an epilepsy treatment drug developed by SK Biopharm itself and approved by the U.S. Food and Drug Administration (FDA) in November 2019. In Europe, it is scheduled to be launched under the product name 'OntozryTM' through its partner Angelini Pharma. Considering that the final approval by the European Union (EU) Commission is usually granted within about 67 days from the CHMP recommendation date, marketing authorization is expected to be obtained within the second quarter.

Europe is the world's second-largest epilepsy treatment market, with an estimated 6 million patients according to the World Health Organization (WHO). If Cenobamate obtains European approval, SK Biopharm will receive milestone payments of up to $430 million (4.805 billion KRW) from Angelini Pharma. Royalties based on sales will be received separately once sales begin in earnest. With the number of countries under the technology export contract increasing to 41 as of last December, the scale of revenue is expected to grow further.

Jungwoo Cho, CEO of SK Biopharm, said, "The CHMP's recommendation for marketing approval will be an important milestone in providing Cenobamate to epilepsy patients in Europe," adding, "We will work closely with our partner to successfully launch this innovative new drug." Pierluigi Antonelli, CEO of Angelini Pharma, said, "The CHMP recommendation for Cenobamate's marketing approval is a monumental event for Angelini Pharma as well," and added, "We will become a European leader that meets the needs of central nervous system (CNS) patients through an innovative portfolio."

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