SK Life Science plots 2020 launch for now-approved seizure drug Xcopri
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 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.
Source : fiercepharma