- The Food and Drug Administration on Thursday approved a new treatment for partial-onset seizures in adults, providing another therapeutic option for patients with epilepsy.
- Cenobamate will be sold as Xcopri by SK Life Science, the U.S. subsidiary of the massive Korean conglomerate SK Group. The company plans to hire a salesforce to support the drug's launch, which is expected by the second quarter of next year. Xcopri is SK Life Science's first commercial product.
- The delayed launch is due to a required review by the Drug Enforcement Administration, which typically completes within three months of FDA approval, the company said in a Nov. 21 statement.
The FDA approval wraps a decade of quiet growth from SK Life Science, which has been developing its presence in the pharmaceutical industry.
The U.S. subsidiary first got involved in drug discovery in the 1990s. At that time, it mainly licensed compounds to other drugmakers after advancing them to Phase 1 testing.
Around 2010, SK decided to further develop its own candidates, focusing particularly on Xcopri in epilepsy.
In the past few years, the company has grown from about 45 U.S.-based employees to around 120, the company's chief commercial officer Sebby Borriello, said in an interview last month.
Borriello joined in 2016 as SK's first commercial-focused employee, a group that has since expanded to more than 30. Hiring will continue as the company builds a salesforce, he said.
The executive has spent the past few years mapping commercial plans for Xcopri, including talking with payers about the clinical results on seizure reductions.
One of SK Life Science's trials, for instance, showed a 56% reduction from baseline in median seizure frequency compared to a 22% reduction among a placebo group over 12 weeks.
While the company has yet to release the list price of Xcopri, Borriello hinted the cost would allow the drug to compete with other branded anti-epileptic drugs.
"We will not put ourselves in a disadvantaged position when it comes to pricing compared to the other branded agents on the market," Borriello said in an interview.
While he declined to give further details, a licensing deal signed earlier this year may hint at the drug's commercial prospects.
In February, Arvelle Therapeutics paid $100 million upfront and outlined $430 million in potential milestone payments to acquire European commercialization rights for Xcopri.
Neuroscience has proved a challenging field, with multiple industry leaders exiting the R&D space. But the nervous system has remained SK's therapeutic focus, with a pipeline of experimental treatments in attention-deficit and hyperactivity disorder, bipolar disorder and rare forms of childhood-onset epilepsy.
Like others who remain in the space, SK Life Science is targeting diseases with clear regulatory pathways, chief medical officer Marc Kamin said in an October interview with BioPharma Dive.
"There are some areas in nervous system development, for instance, Alzheimer's, depression, schizophrenia, where the studies are extremely difficult, extremely challenging," Kamin said. "Before we get into some of those areas, you have to give it pause."