SK Biopharmaceuticals has a full value chain ready for its newly approved partial onset seizure epilepsy drug Xcopri, said the company’s CEO Cho Jeong-woo, Tuesday.

Beginning from compound discovery to preclinical trials, clinical trials and product approval in the US, SK Biopharmaceuticals has directly overseen every step of Xcopri’s commercialization. Now it will continue to directly handle local marketing and sales from the second quarter of 2020, said Cho during a press conference in Seoul.

Xcopri (cenobamate) attained commercialization approval from the US Food and Drug Administration on Nov. 21.

In clinical trials, Xcopri showned significant improvement in the frequency of seizures in patients who previously experienced minimal benefits from other multiple AEDs, according to the firm.

Patients who had taken 100 milligrams, 200 milligrams and 400 milligrams of Xcopri respectively showed 36 percent, 55 percent and 55 percent reduction in median seizure frequency, compared with 24 percent in a placebo group. During the maintenance phase, 4 percent, 11 percent and 21 percent of the aforementioned respective dosage groups reported zero seizures, in comparison to 1 percent in the placebo group.

Xcopri’s current indication is for partial onset seizures in adults aged over 17 years. It can be taken in combination with other anti-epileptic drugs or independently.

Partial onset seizures affect 52 percent of all patients with epilepsy in the US, while primary generalized tonic-clonic (PGTC) seizures affect another 43 percent.

SK Biopharmaceuticals is carrying out a clinical phase 3 trial to determine whether Xcopri is effective in treating PGTC seizures. If successful, the drug could gain access to 95 percent of the US market, Cho said.

In 2018, the US market accounted for 54 percent of the global epilepsy market. In 2020, the market is anticipated to be worth $3.3 billion. As drug prices rise, the market will only continue to expand, said Cho.

SK Biopharmaceutical has a number of pipelines for central nervous system disorders, but it is also carrying out active research for novel oncology treatments in the brain tumor area since five years ago.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)