[Edaily Reporter Minji Son ] Donga ST(170900)(Dong-A ST) recently signed a license-out (technology export) agreement with Australian pharmaceutical company Arotex for its domestically developed new epilepsy drug cenobamate (product name: Xcopri Tablets) in Australia and New Zealand. Meanwhile, as South Australian health authorities have already granted limited approval for the drug’s use, observers are viewing this as a positive sign for the company’s entry into the local market.

Despite Not Yet Having TGA Approval… South Australia Recognizes Cenobamate

According to South Australian health authorities on the 25th, cenobamate was listed on the “Completed High Cost Medicine Reviews” list last year following an evaluation by the South Australian Medicines Evaluation Panel (SAMEP). SAMEP conducts separate evaluations of high-cost medicines—those with a treatment cost of 10,000 Australian dollars or more per patient or those that have a significant impact on public healthcare finances—and classifies them on the review list as △ officially listed, △ conditionally approved, or △ not recommended for use.

Although cenobamate has not yet received marketing authorization from the Australian Therapeutic Goods Administration (TGA), it was listed with the notation that limited use is permitted for specific patient groups. This reflects its approval by the U.S. Food and Drug Administration (FDA) in 2019 and the European Medicines Agency (EMA) in 2021. Currently, cenobamate is used in the United States and Europe as an adjunctive therapy for the treatment of focal-onset seizures in adult patients with epilepsy.

The SAEMP has made cenobamate available to adult patients with drug-resistant focal-onset seizures who have not responded to treatment with at least six different medications listed on the Australian Pharmaceutical Benefits Scheme (PBS) or who have experienced serious side effects. Of course, neurologists must follow specific procedures to prescribe cenobamate to patients.

First, approval must be obtained under the Special Access Scheme (SAS), which permits the use of unapproved medications, followed by an Individual Patient Use (IPU) authorization, which signifies that the drug may be used on an exceptional basis for a specific patient. Prescribing physicians must also submit the initial 26-week (approximately 6-month) treatment results and annual follow-up reports to SAEMP.

The South Australian health authorities have set the dosage of cenobamate as follows: △12.5 mg for weeks 1–2, △25 mg for weeks 3–4, △50 mg for weeks 5–6, △100 mg for weeks 7–8, △150 mg for weeks 9–10, and △200 mg or higher starting from weeks 11–12. No specific time limit has been set for treatment duration. This means long-term administration is possible as long as the therapeutic effect is maintained. However, treatment should be discontinued if the frequency of partial seizures has not decreased by at least 50% by the time of the next scheduled medical visit.

Approval in Australia and New Zealand Gains Momentum… Positive News for Donga ST and SK BIOPHARMACEUTICALS

The pharmaceutical and biotech industries view the limited approval of cenobamate—an unapproved drug in some regions of Australia—as evidence that the drug’s clinical utility and local medical demand have been partially validated. In particular, analysts suggest that the ability to accumulate actual prescribing experience even before TGA marketing authorization could have a positive impact on the future commercialization process.

This development is also expected to be a positive factor for the technology export agreement recently signed by Donga ST. Since cenobamate has already been partially validated locally and Donga ST has secured a partner specializing in commercialization, the company is expected to accelerate its market entry.

This month, Donga ST signed an agreement with Arotex for the development and sales rights to cenobamate in Australia and New Zealand. Arotex will be responsible for local regulatory approval and commercialization, while Donga ST will manufacture and supply the finished product.

A source in the pharmaceutical and biotech industry stated, “Although its use is currently limited, as prescribing experience accumulates in local clinical settings, this real-world usage data could serve as a reference during future marketing authorization and reimbursement negotiations,” adding, “Building awareness among healthcare professionals and patients will also be advantageous for market entry following formal approval.”

This is also viewed as a significant achievement for Donga ST. This is because achieving early, tangible results in overseas technology exports based on licensed products allows the company to demonstrate its global business capabilities more rapidly. Previously, Donga ST signed a license-in agreement with SK BIOPHARMACEUTICALS, the original developer of cenobamate, covering a total of 30 countries—including South Korea, East and Southeast Asia, Russia, Australia, New Zealand, and Türkiye—in 2024.

SK BIOPHARMACEUTICALS is also expected to benefit, as it can secure new markets without the need for a separate sales organization or additional investment in personnel. With Senobamate already considered to have entered blockbuster status in the U.S. market, if the approval process proceeds smoothly in Australia and New Zealand as well, further market expansion and a corresponding increase in revenue—such as royalties—are also worth anticipating.