SK Biopharmaceuticals said that Angelini Pharma, its EU partner, has won sales approval for cenobamate, an epilepsy drug, in France.

SK Biopharmaceuticals' EU partner has won approval for Cenobamate in France and has now completed the approval process for the drug in all five major EU countries.
SK Biopharmaceuticals' EU partner has won approval for Cenobamate in France and has now completed the approval process for the drug in all five major EU countries.

The company initially launched cenobamate, under the product name Ontozry, in the EU market after obtaining sales approval from the European Commission in March last year.

Angelini Pharma released Ontozry for the first time in Germany for the EU market in June last year.

Afterward, within a year and a half, the company expanded cenobamate’s market share to the remaining four major European markets, including the U.K., Italy, Spain, and France. The size of the epilepsy market in the five major EU countries is about $1.7 billion, which corresponds to about 73 percent of the total epilepsy market in EU.

Aside from the five major countries, the company is also marketing the treatment in 10 other EU countries.

“With the expansion of sales in Europe through the approval of Ontozry in France, we expect to secure sales royalties and milestone revenue related to sales performance from Angelini Pharma,” an SK Biopharmaceuticals official said.

Meanwhile, Cenobamate exceeded $100 million in exports to the U.S. and Europe from July 1, 2021, to June 30, 2022, and was awarded the “$100 million achievement award” during the 59th Day of Trade ceremony held on Monday.

According to the company, it was the first time a Korean pharmaceutical company won the $100 million achievement award for a single locally-developed new drug.

In the U.S., SK Biopharmaceutical received marketing approval for Cenobamate from the Food and Drug Administration (FDA) in 2019 and launched the product under the name Xcopri.

 

Copyright © KBR Unauthorized reproduction, redistribution prohibited