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SK Biopharmaceuticals nears commercial launch of novel CNS drug

Collected: 2017.03.29

Distributed: 2017.03.30

Source: Go Direct

SK Biopharmaceuticals, the prescription drug arm of South Korea’s SK Corporation, is one step closer to commercial launch of SKL-N05, a narcolepsy medicine, as the company announced on Monday that it has successfully completed drug efficacy tests in a phase III study, which will serve as a base for an FDA approval in the U.S.

The global phase III study met primary endpoints, showing that a single dose of SKL-N05 significantly reduced the level of sleepiness in patients with sleep apnea, said the company.

SK Biopharmaceuticals already signed a license deal with U.S.-based Jazz Pharmaceuticals to co-develop the drug in 2011. The two are planning to complete the remaining procedures for the study and file for marketing approval with the FDA as early as late this year with a goal of commercial launch next year.

Narcolepsy is a rare and highly unmet neurological disorder whose symptoms include periods of excessive daytime sleepiness and it affects one or two persons per 1,000.

SK Biopharmaceuticals is entitled to receive milestone and royalty payments on sales from Jazz after regulatory approval by the FDA and marketing.

SK Biopharmaceuticals also aims to complete a phase III study of YKP3089, a new epilepsy drug, within this year. Other investigational drugs in the pipeline include those to treat CNS illnesses such as ADHD, Parkinson’s disease and bipolar disorder.

By Chung Wook and Shin Chan-ok

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