SK biopharm seeks U.S. approval for sleep drug

SK Biopharmaceuticals and Ireland-based Jazz Pharmaceuticals jointly developed a sleep aid and applied for new drug approval to the U.S. Food and Drug Administration to win marketing rights in America, the Korean company said Friday.

Nasdaq-listed Jazz is known mostly for Xyrem, a drug used to treat sleep disorders. Once the U.S. FDA approves of new drug, Solriamfetol, also known as SKL-N05, sales will begin from as early as 2019 in America.

Solriamfetol is an investigational medicine for the treatment of excessive sleepiness associated with narcolepsy and obstructive sleep apnea. Narcolepsy is characterized by the inability to regulate normal sleep-wake cycles, and obstructive sleep apnea is related to impairments in cognitive function, safety, productivity and overall quality of life, according to Jazz.

While the compound was originally discovered by SK Biopharm, it licensed out its technology to Jazz in 2011 after the Phase 1 clinical trial. Since then, the two have jointly developed the drug and, earlier this year, they completed the Phase 3 clinical trial before submitting the application to the United States.

Now Jazz has worldwide development, manufacturing and commercialization rights for soliramfetol, excluding certain jurisdictions in Asia where SK Biopharm still owns rights. SK Biopharm has commercialization rights for the drug in 12 Asian countries, including Korea, Japan, China, Taiwan and Singapore. The Korean company will still earn royalty fees for the technology it licensed out once sales begin in the United States.

Jazz hopes to foster solriamfetol as its next-generation flagship drug for patients suffering from sleeping disorders. While the Ireland-based company still reaps in over 1 trillion won ($930 million) in revenue through Xyrem, its patent is due to expire in 2020, which means Jazz will have to compete with biosimilar products by then.

“The new compound proved to excel in treating excessive sleepiness, compared to Xyrem, in subjective assessment by 880 patients that participated in the Phase 3 clinical trial,” SK said in a statement.

SK Biopharm plans to keep focusing on developing drugs that treat diseases related to central nervous system.

Another drug it has been working on, independently, is Cenobamate, which treats epilepsy. The drug has been recognized for its effectiveness and is currently on a Phase 3 clinical test to confirm the drug’s safety. The company hopes to file a new drug application to the U.S. FDA for the drug as early as next year. According to SK, the new epilepsy drug could generate an annual 1 trillion won in revenue in the United States alone, once marketing is approved there.

“We hope to become a global drug maker with over 10 trillion won market value by 2020,” said Cho Jeong-woo, CEO of SK Biopharm, “by developing and releasing effective medicine for diseases associated with central nervous system.”

According to the company, the market for central nervous system treatment is one of biggest markets in the drug industry, alongside a cure for cancer. The market has been growing constantly from $81 billion in 2014 and is expected to hit $92 billion by 2021, the Korean drug maker said.

BY KIM JEE-HEE [kim.jeehee@joongang.co.kr]