Dong-A ST licenses epilepsy drug to Australian firm in novel 'relay export' model

South Korea's pharmaceutical industry has achieved what practitioners are calling a "stepping-stone" global licensing model — acquiring the rights to an innovative drug developed by another domestic company, then re-exporting those rights to a strategically important overseas market. The approach combines global intermediary trade with contract manufacturing capabilities to reduce in-house development risk, and is being described as a next-generation commercialization partnership.

Dong-A ST announced Wednesday that it has signed a license-out agreement with Australian pharmaceutical company Arotex covering the rights to develop and sell the epilepsy drug cenobamate — marketed as Xcopri — in Australia and New Zealand.

The deal's significance lies in breaking from the conventional "develop in-house, then export" formula. Dong-A ST acquired the rights to a drug already proven by a major domestic biotech and is now re-exporting those rights overseas through its own global network, setting a new commercial milestone for the industry.

In January 2024, Dong-A ST signed a license-in agreement with the drug's original developer, SK Biopharm, covering 30 countries — including South Korea, countries across East and Southeast Asia, Russia, Australia, New Zealand and Turkey. The company then focused its regulatory capabilities on securing domestic approval, which the Ministry of Food and Drug Safety granted last November. It is currently pursuing national health insurance reimbursement listing.

The Australian deal, struck just two years after the 2024 license-in, marks Dong-A ST's first re-export achievement, securing a distribution hub in the Oceania region. Under the agreement, Dong-A ST transfers to Arotex the exclusive rights to develop and commercially sell cenobamate in Australia and New Zealand.

Arotex, one of the top local prescription drug companies in Australia, will handle all regulatory approvals and marketing in both markets. Dong-A ST plans to generate revenue through a diversified supply structure by manufacturing and supplying the finished product from its domestic production facilities.

Cenobamate is a dual-mechanism drug that selectively inhibits sodium channels involved in excitatory neuronal signaling while enhancing the function of GABAA receptors, which mediate inhibitory signaling. Global Phase 3 trial results in adult patients with focal-onset seizures demonstrated a statistically significant reduction in seizure frequency alongside a strong complete seizure-freedom rate, validating the drug's efficacy in international markets.

"This agreement is the first global business model in which we have taken an innovative drug strategically in-licensed from outside and re-exported it to overseas markets by combining it with our own global network," Dong-A ST President and CEO Jeong Jae-hoon said. "Going forward, we will continue to expand our international footprint and strengthen our fundamental competitiveness in global markets through diverse partnerships that organically connect the strengths of developers and distributors."