SK’s Narcolepsy Therapy Ready For U.S. Phase III Trial
This article was originally published in PharmAsia News
Executive Summary
South Korean conglomerate SK Group is making some progress in new drug development, with its affiliate SK Biopharmaceuticals poised to begin Phase III clinical trials in the U.S. with a treatment for narcolepsy.
SEOUL - SK Biopharmaceuticals Co. Ltd.’s partner Jazz Pharmaceuticals PLC will proceed with the Phase III study in hospitals in North America and Europe for the treatment of excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, said SK Group.
Jazz has worldwide development, manufacturing and commercial rights to SKL-N05 (also known as JZP-110 and ADX-N05), other than in certain markets in Asia where SK Biopharmaceuticals retains rights.
The South Korean firm holds sales rights in 12 Asian countries including South Korea, Japan and China. SK Biopharmaceuticals will also receive milestone payments based on development, regulatory and sales as well as royalties based on future sales as part of the deal.
Jazz is expected to complete the Phase III study by the end of 2017 and to launch the drug in 2018 after receiving regulatory approval from the U.S. FDA.
According to SK Group, about 15% of Western people are said to be experiencing excessive daytime sleepiness for more than three days a week due to narcolepsy and sleep apnea. The sleep disorder drug market is valued at about $3 billion and is growing more than 6% each year.
In the prior trials, the drug displayed a different mechanism of action than Teva Pharmaceutical Industries Ltd.’s Provigil (modafinil) and other standard stimulants, such as amphetamines, typically used for narcolepsy; while its exact mechanism is unknown, it is believed to interact with dopamine and adrenergic receptors.
The South Korean firm has advanced into new drug development business in 1993 with a goal to enter the global markets. It has been focusing on development of new drugs to treat central nervous system related diseases.
New Drug Push
SK Biopharmaceuticals has gained approvals from the U.S. FDA to proceed with clinical trials for 15 investigational new drugs, which is the largest number by any South Korean pharma firm, the group said.
It has been engaging in development of therapies for epilepsy, anxiety, depression, schizophrenia, irritable bowel syndrome and Parkinson's disease, as well as metabolic diseases.
YKP3089, a new drug for epilepsy, is in the final stage of a Phase II clinical study. After completing the trial, which is being independently conducted by SK Biopharmaceuticals, in June, the company aims to proceed with a Phase III program in October and to launch the drug in the global markets including the U.S. in 2018.
Considering the sales of UCB Group’s Vimpat (lacosamide), which is currently the leading product in the epilepsy market, the company expects its drug to realize annual revenues of about KRW1 trillion ($900.7 million).
The company is seeking to license out YKP10811, a treatment for chronic constipation and irritable bowel syndrome, which is currently in the final stage of Phase II clinical studies in the U.S. and South Korea, to an overseas pharma firm. It expects to reach a licensing agreement in the first quarter of next year.