SK Biopharm's new epilepsy drug licensed in Europe

secured a technology fee of ₩140 billion

Cenobamate, European Commission final approval, released as ONTOZRY in the third quarter

Licensed by Angelini Pharma, $110 million milestone

Received $13.22 million from the sale of Arvelle shares

#SK Biopharmaceuticals announced on the 31st that Cenobamate, a new epilepsy drug, has obtained sales permission from the EC on the 30th (local time).

 

It has been about two months since it received a recommendation for marketing approval from CHMP under the European Medicines Agency (EMA) last month.

 

Through this sales permit, SK Biopharm has secured a total of 1232.2 million dollars (about 140 billion won) worth of technology fees from partners.

 

In addition to the $110 million milestone for European permits received from Angelini Pharma, which is responsible for local sales in Europe, the company will receive an additional $13.22 million milestone for each phase from the sale of its first contract partner, Arvelle Therapeutics.

 

SK Biopharmaceuticals signed a Cenobamate technology transfer contract with Arvelle Therapeutics in February 2019.As Arvelle Therapeutics was acquired by Angelini Pharma earlier this year, it transferred 12% of its existing Arvelle stake to Angelini Pharma.

 

At that time, it secured $31.76 million, a portion of the sale proceeds.

 

SK Biopharmaceuticals expects earnings to improve as sales of'Cenobamate' begin in Europe within this year.

 

Angelini Pharma, a European partner, announced that Cenobamate will be released in 41 countries in Europe from the third quarter of this year under the product name'ONTOZRY'.

 

Starting with major countries such as Germany, France, Italy, Spain, and the UK, it is planned to be released sequentially to Iceland, Norway, and Liechtenstein, which are the signatories of the European Free Trade Agreement.

 

Since May last year, SK Biopharm has started selling three Cenobamate under the product name Xcopri through SK Life Science, a US subsidiary.

 

Unlike the US, the European market has a structure to receive royalties from sales by implementing a commercialization strategy through partners.

 

When the commercialization of'ONTOZRY' begins in earnest, SK Biopharm can secure up to $585 million as a milestone linked to sales performance.

 

Since royalties from sales are separately received, the scale of revenue can be expanded according to the sales volume.

 

The company is confident in its marketability as there has been high interest in'ONTOZRY' in Europe before the approval.

 

At the time of the contract in 2019, SK Biopharm recorded the highest record in exports of central nervous system (CNS) drug technology to Europe.

 

In August of last year, it was selected as a promising innovative treatment by MHRA in the UK, and in December of the same year, as the clinical results were announced at the annual conference of the European Academy of Neurology, it was evaluated as the best-in-class drug in the same category.

 

As the partner company changed from Arvelle to Angelini Pharma, its sales and marketing capabilities have also strengthened.

 

Angelini Pharma is one of the top three pharmaceutical companies in Italy and has a product line specialized in the CNS field, such as pain, depression, and schizophrenia.

 

“Our efforts to provide breakthrough treatments to patients with epilepsy in Europe are paying off,” said SK Biopharm's President Jo Jung-woo.

 

"We will continue to develop new treatment options for patients with the central nervous system and fulfill our role as a global comprehensive pharmaceutical company," he said.

 

Pierluigi Antonelli, president of Angelini Pharma, said, "We expect ONTOZRY to be a new hope for epilepsy patients suffering from unexpected seizure symptoms.

 

We will build an innovative product portfolio to meet the needs of CNS patients."