|title||SK Holdings Announces U.S. FDA's Approval of IND for SKL10406|
- SK Holdings receives IND approval by U.S. FDA for SKL10406, an antidepressant
- Proved to be more effective with remarkably less side effects
- The ninth approval of IND in SK Holdings' history
Seoul, November 3, 2009 – 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 Application for SKL10406, an antidepressant discovered by SK Holdings.
This is the ninth approval of IND in SK Holdings' history, after SK Holdings received the first approval in 1996.
SK Holdings has been conducting preclinical studies to evaluate the efficacy and safety since SKL10406 was selected as a project supported by the Ministry for Health, Welfare and Family Affairs.
Byong-Sung Kwak, Ph.D., EVP, Head of Life Science Business Division, SK Holdings said, "SKL10406 shows competitive efficacy in animal models and does not have side effects such as weight gain and sexual dysfunction. It is expected to have great market potential because it shows a wide spectrum of therapeutic effects such as depression, pain and anxiety."
Being one of the most common disorders in central nervous system, depression is a psychiatric disorder that results from abnormality of neurotransmitters in brain and various stress.
It is known that the drugs currently used cannot fulfill a lot of unmet needs such as high level of efficacy, early onset of therapeutic effects and less side effects such as weight gain and sexual dysfunction.
The global market sized of antidepressants is estimated to be worth $11 billion.
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.