SK Life Science has set out to transform itself into a commercial biopharma company, and with its seizure med Xcopri now armed with an FDA approval, the drugmaker is gearing up for its first-ever launch.
Formerly known as cenobamate, the drug scored its FDA green light Thursday to treat partial-onset seizures in adults. SK plans to launch the med itself—without a marketing partner—next year, executives told FiercePharma.
To prep for that debut, SK has built up its commercial organization, including a marketing team, market access experts, and a salesforce. SK plans to launch with 100 to 125 sales reps, chief commercial officer Sebby Borriello said.
The FDA approved the oral med based on two phase 2 studies that showed the drug reduced seizure frequency compared with placebo. In the maintenance phase of the studies, nearly 20% of patients experienced no seizures, or what chief medical officer Marc Kamin called “seizure freedom.”
Many doctors “welcome this product and already have patients ready to go,” Borriello said. SK plans to launch in the second quarter next year after the DEA scheduling.
While some companies are targeting orphan indications with patient populations in the thousands or tens of thousands, Borriello said SK Life Science made a strategic decision to target diseases that affect hundreds of thousands of patients with unmet needs.
If all goes well, the company will become the first Korean drugmaker to independently discover, develop and launch a product in the U.S., he added. The company has spent more than a decade working on Xcopri.
SK has licensed European rights for Xcopri to Arvelle Therapeutics. That company is a spinoff from Axovant that secured $100 million in initial financing back in February.