SK Biopharmaceuticals will launch its antiepileptic drug, XCOPRI, in the second quarter of next year, the company’s top manager said.
|SK Biopharmaceuticals CEO Cho Jeong-woo explains the significance of obtaining U.S. sales approval for XCOPRI, during a news conference at SK Seorin Building in Jongno-gu, central Seoul, on Tuesday.|
“The U.S. Food and Drug Administration’s approval of XCOPRI marks the first such case for a Korean pharmaceutical company that has independently conducted drug development, from finding a candidate substance to obtaining a sales approval without exporting technology,” SK Biopharmaceuticals CEO Cho Jeong-woo said.
It has given birth to a Korean pharmaceutical company that has accumulated experience and know-how on developing innovative new drugs, which has parallel abilities to multinational pharmaceutical companies, Cho added.
The company received FDA’s approval for the drug last Thursday and aims to enter the U.S. market in the second quarter of 2020 after going through a review by the U.S. Drug Enforcement Administration (DEA), which is expected in February.
SK Life Science, the company’s U.S. subsidiary, will be in charge of sales and marketing for the drug.
SK Life Science has completed the hiring of sales directors by dividing the U.S. market into 12 regions and plans to hire an additional 110 sales personnel and start operating its sales department from next January.
“In the U.S., physicians in smaller clinics can prescribe epilepsy treatments, and we plan to market the drug directly to 14,000 doctors prescribing epilepsy medications,” Cho said. “Such a sales platform will allow us to build up our sales network.”
Cho also stressed that the company expects that XCOPRI will be successful in the U.S., as epilepsy is not easy to control with one drug, and most patients use multiple treatments.
Regarding the sales of the drug in other regions, Cho said that the company plans to take charge of sales and marketing in Asian countries, including Korea, China, and Japan, while Arvelle Therapeutics GmbH, will be in charge of marketing in Europe.
SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize XCOPRI in Europe in February.
“We are now focusing on expanding the number of treatable patients based on the significant efficacy identified during the FDA approval process,” Cho said. “Based on the clinical results of XCOPRI, we will develop it as a leading brand for epilepsy treatment.”
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