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SK’s bio biz put to test as it waits for FDA approval for antiepileptic drug

The US Food and Drug Administration is likely to make a final decision in November on approval for Cenobamate, an investigational antiepileptic drug developed by SK Biopharmaceuticals.

The company is the pharmaceuticals development business under SK Holdings. The firm has been researching for new treatments for diseases related to central nervous system since 1993.

Since 2011, when SK Biopharmaceuticals was spun off to become a separate entity, the company has used roughly 480 billion won ($406 million) for research and development. 

Its first novel drug, solriamfetol is a sleep disorder treatment. SK Biopharm aceuticals out-licensed the compound after phase 1 clinical trials to US-based Jazz Pharmaceuticals in 2011.

Jazz successfully completed phase 3 clinical trials and had the compound approved for commercialization in the US under the name Sunosi in March.

Sales of Sunosi began in the US in July.

This marked the first case for a Korean company to have discovered a novel drug candidate in the area of central nervous system that was approved by FDA for sales in the US.

SK Biopharmaceuticals expects the result of its application for antiepileptic drug cenobamate from FDA on Nov. 21. If it gets approval, commercialization of the drug in the US will be carried out by its US subsidiary SK Life Science.

The US sales are anticipated to start from 2020 and move on to Europe and eventually in Asia, including Korea, China and Japan.

The global market for epilepsy treatment, according to market analysis firm Global Data, amounted to 6.8 trillion won in 2018 and is estimated to grow to nearly 7.8 trillion won by 2021.

The company's Swiss partner Arvelle has acquired the rights for development and commercialization of cenobamate in 32 European countries from SK Biopharmaceuticals and will work on the application for its approval by the European Medicines Agency.

Production of cenobamate will be undertaken by Korea-based SK Biotek, which is 100 percent owned by the consolidated SK Pharmteco in Sacramento, California.

Other than solriamfetol and cenobamate, SK Biopharmaceuticals has six more pipelines in development to treat rare nervous system disease, concentration difficulties, depression and schizophrenia.

For SK Biopharmaceuticals' initial public offering, NH Investment and Securities and Korea Investment and Securities were named the underwriters.

Citi and Morgan Stanley will oversee the overseas trading.

The KIS anticipates market capitalization of Biopharmaceuticals to reach 4-5 trillion won.

By Lim Jeong-yeo (