SK Biopharmaceuticals, which targets the U.S. market with its epilepsy treatment, Cenobamate (XCopri in the U.S.), is stepping up the development of follow-up products.
The Ministry of Food and Drug Safety approved the phase 3 clinical trial of SK Biopharmaceuticals’ Carisbamate (YKP509) last Thursday. SK Life Science, the U.S. branch of SK Biopharmaceuticals, conducts the global clinical trial of Carisbamate, according to the company.
Carisbamate is a candidate substance developed by SK Biopharmaceuticals to treat the rare disease Lennox-Gastaut Syndrome (LGS). Before SK Biopharmaceuticals was spun off from SK Corp. in 1999, the company transferred related technology to Johnson & Johnson but retrieved the rights later. Now, SK Biopharmaceuticals is continuing its development.
SK Biopharmaceuticals plans to confirm the effectiveness and safety of the additional therapy in LGS-related seizures by administering Carisbamate suspension in children and adults in a phase 3 clinical trial. Kyungpook National University Chilgok Hospital, Samsung Medical Center, and Seoul National University Hospital will carry out the trial.
Besides, SK Biopharmaceuticals submitted its phase 3 IND (investigative new drug) clinical trial application to the U.S. Food and Drug Administration in January. It is now recruiting patients in eight hospitals in the U.S. and Colombia. The company seeks to recruit 252 patients to complete the trial by January 2025.
Commenting on the regulatory approval of the phase 3 clinical trial, SK Biopharmaceuticals said it would make Carisbamate the next-generation flagship product following Cenobamate.
“Our flagship product has been Cenobamate. However, we expect Carisbamate to be our next mainstay item or ‘next step,’” a company official said.
According to a public notice posted by SK Biopharmaceuticals, the company recorded 88.8 billion won ($67.3 million), an operating loss of 9.2 billion won, and a net loss of 15 billion won in the third quarter on a consolidated basis. Its turnover increased by 270.91 percent from a year ago and 66.25 percent from the preceding quarter, but the company remained in the red.
“The continuous growth of our products in the U.S. and advances to Latin America and Europe pushed our sales,” the company said. “Our operating loss also narrowed by 40.7 billion won thanks to increased sales of both products and services.”
Cenobamate has shown steady growth since it entered the U.S. market and stepped up its advances to the European market, the company added, expecting its global sales to exceed the yearly target of 185 billion won in 2022.
According to SK Biopharmaceuticals, Cenobamate’s cumulative sales in the first nine months totaled 119.4 billion won.
To enhance the brand recognition of Cenobamate, SK Biopharmaceuticals plans to operate a booth in the American Epilepsy Society (AES) in the fourth quarter and participate in various academic meetings and events to conduct PR and marketing activities for epilepsy specialists.