SK Biopharmaceuticals’ ‘Cenobamate’ expands its global reach, including the US and Europe

SK Biopharmaceuticals’ self-developed epilepsy drug ‘Xcofree’. Source = SK Biopharmaceuticals

[이코노믹리뷰=곽예지 기자] SK Biopharmaceuticals (326030)’s epilepsy treatment ‘Cenobamate’ (US product name: Excopri) is actively expanding its global reach. In addition to expanding its market share in the US, it is expected to enter new markets such as Europe.

Excofree’s sales in the United States continue to grow. Cenobamate’s sales in the U.S. last year were 78.2 billion won, a six-fold increase compared to the same period last year. In particular, in the fourth quarter of last year, it recorded 27.9 billion won, four times compared to the same period last year. Last year, the number of prescriptions in the U.S. exceeded 90,000, and the number of prescriptions is also increasing rapidly. Cenobamate received approval from the Food and Drug Administration (FDA) in November 2019, and began sales in the United States in May of the following year through SK Life Sciences, a local corporation.

SK Biopharmaceuticals is actively pursuing a paradigm shift in disease recognition and treatment based on the complete seizure disappearance rate, which is the strength of Xcofree. In addition, it plans to expand online and cable TV advertisements and strengthen face-to-face sales and marketing to secure new patients.

In the United States, face-to-face sales are important, and it is known that there is a high correlation between prescription trends and sales activity. As the mandatory wearing of masks has been abolished in many parts of the United States recently, face-to-face business activities are expected to resume, which is expected to lead to the expansion of Xcofree prescriptions.

Excofree received European marketing approval in March of last year, and obtained marketing approval from the UK Drug Administration in April. In June of last year, it was first released in Germany in Europe under the product name ‘On2zrie’. As a result, sales are expected to start in earnest this year. It has signed a commercialization contract in 41 European countries with Abel Therapeutics, a partner of Switzerland. It will be released in major European countries such as France, Italy, Switzerland and Spain in the future.

Cenobamate’s global market expansion continues. SK Biopharmaceuticals plans to export its technology to South America, the Middle East, and North Africa. Hong Kong has already submitted an Application for Product Authorization (NDA). Canada plans to submit it within the year, aiming for approval in 2024. Last year, it signed a partnership with Endo Group to enter the Canadian market. SK Biopharmaceuticals plans to expand its sales channels to the entire North American market, including Canada.

It is speeding up phase 3 clinical trials in Korea, China and Japan for release in Asia. It aims to release it in 2025, and Japan plans to launch it through Ono Pharmaceutical Industries.

In particular, the patent for UCB’s blockbuster epilepsy treatment ‘Vimpat’ expired this month. Vimpat is an epilepsy treatment with the largest market share in the global market. Market dominance is also expected to be strengthened by the expiration of patents for competing drugs.

SK Biopharmaceuticals pipeline.  Source = SK Biopharmaceuticals, Hana Financial Investment
SK Biopharmaceuticals pipeline. Source = SK Biopharmaceuticals, Hana Financial Investment

SK Biopharmaceuticals is also focusing on the development of next-generation innovative new drugs. Carisbamate, a treatment for Lennox-Gasto syndrome, has entered phase 3 clinical trials. It is also strengthening its competitiveness in the field of anticancer drugs. The targeted anticancer drug ‘SKL27969’ is about to undergo phase 1 clinical trials, and the next-generation epilepsy drug ‘SKL24741’ and schizophrenia drug ‘SKL20540’ are about to undergo phase 2 clinical trials.

An SK Biopharmaceutical official said, “This year, we are aiming to achieve more than 160 billion won in sales of cenobamate and 1st place in epilepsy drug recognition. We plan to strengthen our competitiveness in the market.”

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