Dong-A ST first to pay the raised new drug approval fee?

Applied for a prior consultation for its new epilepsy drug cenobamate…is required to submit an application in 3 months

Developed by SK Biopharm, the two companies signed a licensing agreement last year

With the new drug approval fee raised to KRW 410 million on Jan.

 

1 this year, the industry is eyeing whether Dong-A ST will become the first to apply for marketing authorization and pay the raised new drug approval fee.

 

According to industry sources on the 7th, Dong-A ST applied for a prior consultation before applying for marketing authorization for its new drug cenobamate for epilepsy at the end of last year.

 

Cenobamate is known under the brand name ‘Xcopri’ in the U.S.

 

The prior consultation is a procedure introduced when the fee was increased as an ‘innovative measure for new drug approval,’ and is only available once for new drugs that are scheduled to apply for marketing authorization within 3 months.

 

SK Biopharm and Dong-A ST signed an agreement in January for cenobamate

Cenobamate is a new drug independently developed by SK Biopharm, which was approved by the U.S.

 

Food and Drug Administration (FDA) in November 2019 and launched in the U.S.

 

in May 2020.

 

In Europe, the drug was granted marketing authorization through the company’s partner Angelini Pharma in March 2021 and has been launched sequentially since then, showing strong growth in the global market.

 

Since licensing out cenobamate to the European market for the first time in 2019, the cumulative upfront payment for the drug is currently about KRW 600 billion, and the total amount of technology exports, including milestone payments, is reportedly 1.6 trillion.

 

In the U.S.

 

market, SK Biopharm has a direct sales system.

 

Domestic marketing authorization, production, and sales are handled by Dong-A ST.

 

In January last year, SK Biopharm signed a licensing agreement with Dong-A ST for its cenobamate.

 

Under the agreement, Dong-A ST will receive cenobamate’s finished drug manufacturing technology from SK Biopharm and will be in charge of marketing authorization, production, and sales of the drug in 30 countries including Korea, Southeast Asia, Southwest Asia, Russia, Australia, New Zealand, and Turkey.

 

Dong-A ST plans to launch the product in 2026 after completing preparations for cenobmate’s approval and reimbursement.

 

With the increase in new drug approval fees this year, the company will receive benefits such as a dedicated review team and prioritized GMP surveys, so the company expects to be able to launch the product in 2026 as planned.

 

Meanwhile, SK Biopharm is currently conducting Phase III clinical trials in Asia, including Korea, for adult partial-onset epilepsy.

 

The trial is expected to be finalized around 2025.

 

According to SK Biopharm, there are about 190,000 patients with epilepsy in Korea.

 

Its relevant market is estimated to be worth KRW 130 billion.