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SK Biopharmaceuticals’ epilepsy drug to start clinical trial in Japan

Collected: 2018.01.17

Distributed: 2018.01.18

Source: Go Direct

SK Biopharmaceuticals, the prescription drug unit of South Korean conglomerate SK Group, is on track to start a clinical trial in Japan for its epilepsy drug YKP3089, which is in its final stages of the phase III study in the United States.

According to the bio industry on Wednesday, the company received approval from Korea’s Ministry of Food and Drug Safety for the phase I study of YKP3089, also known as cenobamate, in Japan.

Cenobamate is a new anti-epileptic drug candidate developed by SK Biopharmaceuticals. It is in global phase III safety review in the U.S., having been cleared in efficacy tests. The drug maker aims to file for a new drug application to the U.S. Food and Drug Administration by the end of this year.

Datamonitor Healthcare, a pharmaceutical data provider, forecasts the epilepsy drug market to grow from $4.9 billion in 2014 to $6.1 billion this year.

SK Biopharmaceuticals projects cenobamate to earn over 1 trillion won ($937.4 million) annually and generate an operating profit rate of 50 percent in the U.S. alone, based on the market performance of UCB’s Vimpat, the world’s No. 1 anti-epileptic drug.

By Kim Myung-hwan and Kim Hyo-jin

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