As the won-dollar exchange rate surges, SK Biopharm is quietly smiling. SK Biopharm sells the epilepsy treatment cenobamate in the United States under the product name "Xcopri." The company can benefit from higher cenobamate results as the exchange rate rises.
Epilepsy is a disease in which nerve cells in a specific part of the brain become abnormally excited and repeatedly cause seizures. Cenobamate is assessed to reduce seizures more than existing treatments.
After receiving approval from the U.S. Food and Drug Administration (FDA) in 2019, SK Biopharm's U.S. subsidiary SK Life Science has sold it directly since the following year. SK Life Science distributes through a third-party logistics provider with which it has a contract, then to pharmaceutical wholesalers, hospitals and pharmacies.
Cenobamate's third-quarter U.S. sales are 172.2 billion won. It accounts for 90% of SK Biopharm's total sales of 191.7 billion won. The company said that "sales come almost entirely from exports."
Cenobamate had been sold only overseas, including in the United States, and was not prescribed domestically, so some patients received prescriptions abroad. Recently, after receiving approval as the 41st new drug from the Ministery of Food and Drug Safety, it became possible to introduce it domestically.
Although SK Biopharm developed cenobamate, Dong-A ST will sell it after receiving a production technology transfer. After Dong-A ST applies for reimbursement pricing and pushes for listing, prescriptions for domestic epilepsy patients are expected to be possible around 2027.
If Dong-A ST applies for reimbursement listing with the Health Insurance Review & Assessment Service (HIRA) within the year, the Ministry of Health and Welfare will issue an order to begin drug price negotiations. Once price talks conclude, the Health Insurance Policy Deliberation Committee of the ministry will review and resolve the matter for final confirmation. This process usually takes about one year.
SK Biopharm is pushing to bring in treatments for central nervous system (CNS) disorders, like cenobamate, from outside. The company noted that it "can leverage the direct sales network built in the United States."
The company faces the task of finding the next growth driver. SK Biopharm recently created a new radiopharmaceuticals (RPT) division for this reason. Radiopharmaceuticals load radioactive isotopes onto substances that bind only to specific cancer tumors to diagnose or treat cancer. When administered to a patient, they emit radiation to cancer cells to destroy cancer tissue.
SK Biopharm's radiopharmaceuticals division is equipped with all functions, including raw material sourcing, pipeline (new drug candidate group) discovery, preclinical execution and business development. The company has already in-licensed radiopharmaceutical candidates twice. Last year it brought in SKL35501 and is preparing to submit a clinical trial plan, and recently it additionally brought in WT-7695 from the technology transfer organization at the University of Wisconsin in the United States. The industry is watching to see whether SK Biopharm can nurture a second flagship drug following cenobamate.