Expanding into North America and Europe
Bapam aims for Q4 profit turnaround
driven by growth momentum
SK Biopharm's epilepsy drug 'Cenobamate' (local product name Xcopri) has received marketing approval in Canada following the United States.
On the 14th, SK Biopharm announced on the 15th that Health Canada granted a Notice of Compliance for Cenobamate, approving its marketing authorization application in Canada. The local commercialization will be handled by the Canadian pharmaceutical company Paladin Labs.
Cenobamate is a new drug developed entirely independently by SK Biopharm, from the discovery of the new drug candidate to clinical development and New Drug Application (NDA) submission, becoming the first in Korea to do so. It was approved by the U.S. Food and Drug Administration (FDA) in 2019 for partial-onset seizures (POS) in adults with epilepsy. Four years after FDA approval, it has now been approved in Canada, accelerating plans to target the North American market, which accounts for more than half of the global epilepsy market.
Cenobamate's sales in the U.S. reached 53.9 billion KRW in the first quarter, growing about 70% compared to the same period last year, continuing its sales growth trend. The total prescriptions (TRx) in the U.S. also increased by about 10% from the previous quarter to approximately 55,000 in the first quarter. As of March, the number of prescriptions was 19,910, which is 2.1 times the average prescription count at 35 months for existing competing drugs.
Riding on Cenobamate's growth, SK Biopharm aims to achieve its first quarterly profit in the fourth quarter of this year. To this end, it plans to improve the incentive system for sales representatives in the U.S. and expand its aggressive marketing efforts by targeting not only epilepsy specialists but also general neurologists.
Expansion is also continuing in terms of region, age, and indications. Cenobamate was approved for sale in Europe in March 2021 under the product name 'Ontozry' and is increasing the number of countries where it is sold within Europe. It has been launched in a total of 18 countries, including the five major European countries: Germany, the United Kingdom, Italy, Spain, and France. In Asia, phase 3 clinical trials for adults with partial-onset seizures are being conducted simultaneously in Korea, China, and Japan for product launch.
Additionally, phase 3 clinical trials for primary generalized tonic-clonic (PGTC) epilepsy patients in pediatric and adolescent populations are underway in nine countries, including Korea, the U.S., Germany, Hungary, Poland, and Spain. In Korea, the Ministry of Food and Drug Safety approved the clinical trial plan (IND) in March for adolescents aged 12 to under 18 years.
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