|title||SK Holdings Announces U.S. FDA's Acceptance of IND for YKP10811 and SKL-N05|
- SK Holdings receives IND acceptance by U.S. FDA for YKP10811, a treatment for irritable bowel syndrome and SKL-N05, a treatment for narcolepsy
- SK Holdings records three approval of IND in 2009
Seoul, January 11, 2010 – SK Holdings, one of the largest multinationals based in South Korea, announced today the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) Application for YKP10811, a treatment for irritable bowel syndrome (IBS) discovered by SK Holdings.
SK Holdings has been conducting preclinical research in IBS area based on the competitive R&D capability in central nervous system (CNS) disorders since it is known that gastrointestinal tract may be associated with CNS.
Byong-Sung Kwak, Ph.D., EVP, Head of Life Science Business Division, SK Holdings said, "YKP10811 shows competitive efficacy in animal models and has demonstrated good safety profiles compared with the current treatments."
Meanwhile, SK Holdings also announced the U.S. FDA has accepted the IND application for SKL-N05, filed as ADX-N05 in the U.S., as a potential treatment for narcolepsy, submitted by Addrenex Pharmaceuticals, Inc. (Addrenex)
SK Holdings and Addrenex entered into a license agreement focused on the development and commercialization of SKL-N05 in May 2009.
SK Holdings records three IND acceptances in 2009 including SKL10406, an antidepressants, YKP10811 and SKL-N05.
About Irritable Bowel Syndrome (IBS)
IBS is one of the most common functional gastrointestinal disorders characterized by chronic pain in lower abdomen and/or discomfort associated with alterations in abdominal bowel habits. This can include constipation with difficult bowel movements or diarrhea due to excess fluid in the colon.
Despite being very common, the pathophysiology of IBS is still far from being understood, and is most probably multifactorial. Significant progress has been made to discover to treat IBS during the past two decades, although unmet medical needs still exist. Pharmacologic therapy has been aimed at treating the dominant symptoms of diarrhea, constipation or abdominal pain and bloating.
The potential size of global market is estimated to be over $10 billion.
Narcolepsy is a type of sleep disorder characterized by overwhelming drowsiness, sudden attacks of sleep and excessive daytime sleepiness even after adequate night time sleep.
The incidence of this disorder is estimated to be 0.02 ~ 0.16% and the market for the treatment of narcolepsy is a well known niche area within CNS-related indications.
R&D at Life Science Business Division of SK Holdings
As part of its strategy to foster life science business as a new growth engine, SK Holdings has been investing in its Life Science Business Division (http://lifescience.sk.com/english), consisting of Drug Development Business and Custom Manufacturing Service (CMS) business.
Since 1993, the company has been developing a number of innovative drug candidates for central nervous system disorders, and has been actively conducting clinical trials.
Operating a research and development center each in Korea (Daejeon), the United States (New Jersey) and China (Shanghai), the company has been introducing more than one investigational new drug (IND) every year based on its world-class capabilities of developing new drugs in the central nervous system area. The company aims to grow into a global R&D-oriented pharmaceutical company in the future.
The company has also been achieving substantial performance in the CMS business since 1996, leveraging its technological expertise accumulated through experience in petrochemical industry. With the cutting-edge 'continuous low-temperature process technology' which differentiates the company from others in processes of reaction, catalyst, and separation, the company is supplying pharmaceutical intermediates to world's top 10 pharmaceutical companies.
The company plans to establish good manufacturing practice (GMP) capabilities and to expand its business areas into active pharmaceutical ingredients in the future.