SK Life Science plots 2020 launch for now-approved seizure drug Xcopri

FDA Building 2
SK Life Science picked up its first FDA approval for seizure med Xcopri. (FDA)

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. 

Free Amazon Webinar

Performing end to end real-world evidence generation in the cloud with traceability and transparency- a Sanofi journey

In this webinar you will hear about Sanofi’s journey and experience in building an industrialized big data & analytics platform in the cloud that handles billions of rows of RWD data with complete data traceability, security, and supports both traditional and advanced analytics for day to day evidence generation (RWE).

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. 

RELATED: Axovant sends off its small molecule team with an epilepsy drug and $100M in funding commitments 

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. 

Suggested Articles

Nearly four decades after it was approved, the FDA has ordered that heartburn drug Zantac and its generics be removed from the market.

In a non-randomized study in China, Avigan cleared virus after a median 4 days, significantly shorter than the 11 days observed for AbbVie's Kaletra.

Pfizer's 1.1-million-square-foot sterile injectables plant in Visakhapatnam has been criticized by the FDA for poor quality testing.