SK biopharmaceuticals criticized for delayed cenobamate release in Korea, leaving patients without effective treatment until 2027
As SK biopharmaceuticals’ epilepsy drug cenobamate (U.S. brand name: Xcopri) has yet to arrive in Korea, the Korean Society of Epilepsy, a group of epilepsy specialist physicians, has criticized the company for “ignoring the suffering of Korean patients for profit.”
Cenobamate is a globally recognized Korean new drug for epilepsy, approved by the U.S. FDA in 2019 and by the European Medicines Agency (EMA) in March 2021.
It is actively prescribed for patients with drug-resistant epilepsy in the U.S., Europe, and Canada.
The use of cenobamate in the treatment of epilepsy is expected to grow in the future. While cenobamate's licensed indication is currently limited to adult patients with partial onset seizure epilepsy, it is likely to be expanded to include pediatric and adult patients with generalized onset seizure epilepsy and pediatric patients with partial onset seizure epilepsy. Clinical studies are underway to expand cenobamate’s indications.
Heo Kyoung, president of the Korean Epilepsy Society (KES), said, “There is no other drug in existence as effective as cenobamate. It is praised as a 'game changer' and a 'breakthrough' in the treatment of epilepsy, and it is so significant that it has been featured in global academic journals."
He lamented that while American patients with epilepsy have had access to a highly effective new Korean drug since 2020, Korean patients have not been able to use this same drug, which was released in the U.S. four years ago.
Worse still, Korean patients with epilepsy will have to wait three more years for cenobamate.
According to Heo, the KES has been advocating for SK Biopharmaceuticals to quickly introduce cenobamate to Korea since 2022.
However, it will be 2027 at the earliest before Korean patients can actually receive the drug in hospitals, he said, lamenting the seven-to-eight-year gap between the time of U.S. patients' access and that of Koreans'.
Heo has been conducting clinical research on cenobamate in Korea since 2022.
He has been having regular meetings with SK biopharmaceuticals and Dong-A ST, which received the domestic sales rights to cenobamate in January of this year, to urge for the rapid introduction of cenobamate in Korea.
However, he has never received a proper answer from SK biopharmaceuticals or Dong-A ST, regarding the introduction of the drug in Korea.
‘No reason why FDA-approved drug cannot enter Korea’
"There is no reason why a new drug that has passed the U.S. FDA and the EMA cannot be approved by the Ministry of Food and Drug Safety in Korea," Heo said.
He raised suspicions that the reason for the delayed introduction of cenobamate may be that the domestic pharmaceutical company excluded Korea from product launching because of the Korean government's low drug price policy, just as multinational pharmaceutical companies often do because of the difficulty in drug pricing.
As Korean drug prices are referenced when setting drug prices in many countries, companies try to avoid introducing new drugs in Korea or delay their release as much as possible to secure better prices.
Heo, who has observed foreign pharmaceutical companies' new drugs for epilepsy not being introduced in Korea for this reason, said it "doesn't make sense" that even a Korean-made epilepsy drug, developed with Korean capital and technology, has not been released in the country.
To change this reality, the KES has been knocking on the doors of major media outlets and filing a complaint with the government.
Since cenobamate is desperately needed for the treatment of Korean patients with drug-resistant epilepsy, on July 5, last year, the KES sent a complaint to the Ministry of Health and Welfare.
Along with the KES, the Korea Bureau for Epilepsy (KBE), a group of medical professionals specializing in epilepsy, as well as patients and family members of epilepsy patients, has called on the government and the National Assembly for a rapid introduction of cenobamate in Korea.
KBE sent a letter to the Ministry of Health and Welfare and the Ministry of Food and Drug Safety on April 28, 2023, to request the approval of SK biopharmaceuticals' epilepsy drug cenobamate in Korea. On July 5, 2023, KBE, together with the KES, sent the same letter to the Ministry of Health and Welfare. The KES has also repeatedly requested lawmakers to help speed up the introduction of cenobamate in Korea.
Kim Deok-soo, secretary general of the KBE, said, "From the perspective of patients with epilepsy, it does not make sense that cenobamate has good treatment effects in foreign countries and has been on the market for several years, but domestic patients cannot use it at all."
"I wonder if SK biopharmaceuticals is dragging time because of the domestic drug pricing system," he said, raising the same suspicion as the KES.
SK biopharmaceuticals: we have trasferred cenobamate rights to Dong-A ST
However, SK biopharmaceuticals strongly denied the allegations.
"We do not have the manpower or organization to launch cenobamate in Korea, including licensing and marketing," said an SK Biopharmaceuticals official.
"We have not considered the domestic drug pricing system or reimbursement, and have been working to quickly launch cenobamate in the Asian market including Korea."
The company emphasized that it has been working to quickly launch cenobamate for patients with epilepsy in Korea and abroad.
As an example, the company cited the "royalty-free transfer" of cenobamate rights to Dong-A ST in January 2024, when it signed a license agreement for 30 countries including Korea, Southeast and Southwest Asia, Russia, Australia, New Zealand, and Turkiye.
The SK biopharmaceuticals official said, "This was a consideration of social value for many global patients waiting for cenobamate rather than revenue."
The official clarified that the domestic launch was not possible because SK biopharmaceuticals did not have any manpower for domestic licensing or marketing, not because it considered domestic drug prices.
Dong-A ST: we're preparing to apply for cenobamate approval in Korea
Dong-A ST, which signed a license-in agreement with SK Biopharmaceuticals in January this year, also emphasized that it is preparing for a quick introduction of cenobamate in Korea.
"We are currently working on preparations for the domestic product license so that we can supply cenobamate to patients with epilepsy early," said an official from Dong-A ST.
"When submitting a license application, there are many things that are needed, such as data on the drug," the Dong-A ST official went on to say.
“We are not importing something that is sold overseas, nor is it a product that Dong-A ST has been producing, so it takes time to prepare for domestic licensing, but it does not mean that we are delaying domestic introduction."
Dong-A ST's target timeline for the domestic introduction of cenobamate is to apply for reimbursement in 2026. After applying for reimbursement, it takes time to negotiate the drug price, and even after reimbursement, it takes time to supply the drug to hospitals.
In the end, as Heo said, domestic patients with epilepsy will only be able to use the new drug cenobamate in 2027 at the earliest.
‘SK Biopharmaceuticals with ownership should step up for Korean patients’
"If SK biopharmaceuticals truly considers the social value of cenobamate, it should be actively involved in the domestic launch of cenobamate," Heo said.
He believes that since SK biopharmaceuticals is only licensing the rights to cenobamate to Dong-A ST, not selling the drug, SK biopharmaceuticals has the final say, and the timeline for Dong-A ST's domestic launch will vary depending on SK biopharmaceuticals’ needs.
"Does it make sense for Korean patients with epilepsy to use a Korean new drug made by a major Korean company seven years later than U.S. epilepsy patients?" said Heo.
He emphasized that if SK biopharmaceuticals is willing to speed up the launch of cenobamate for the sake of Korean patients with drug-resistant epilepsy, it should show its sincerity to the public.