SK Biopharmaceuticals Announces U.S. FDA's Authorization of IND for SKL15508

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SK Biopharmaceuticals Announces U.S. FDA's Authorization of IND for SKL15508

SEOUL, Korea--(April 17, 2013)--The Korea-based international pharmaceutical company, SK Biopharmaceuticals, announced today the U.S. Food and Drug Administration (FDA) has authorized the Investigational New Drug (IND) application for SKL15508 to treat cognitive impairment associated with schizophrenia (CIAS).

SK Biopharmaceuticals has developed this novel drug since 2007, taking the approach that while the existing drugs treat schizophrenia by reducing positive and, in some cases, negative symptoms of the disease, they have little effect on the cognitive impairment that so frequently disrupts the lives of its sufferers.

SKL15508 potently relieves the signs of cognitive impairment in animal models with a very large safety margin. In addition, when administered with currently available drugs, SKL15508 demonstrates synergistic effects that are expected to improve overall symptoms in patients while minimizing side effects.

SK Biopharmaceuticals will initiate global clinical trials of SKL15508 this year. Expansion into other cognitive impairment disorders, such as Alzheimer's disease, is under consideration by the company.

Dr. Christopher Gallen, CEO and President of SK Biopharmaceuticals, said, "This is the fourteenth IND approval for SK Biopharmaceuticals. We will continue to discover and develop novel drugs in central, peripheral, and enteric nervous systems to create a better future for patients suffering from these serious disorders. The world needs better treatments for nervous system diseases, and we are working hard to create and develop them."

About CIAS

Schizophrenia is a chronic mental disorder characterized by a breakdown of thought processes and by a deficit of typical emotional responses.

Over 50 million patients are suffering from schizophrenia, and the number of patients is increasing in developed societies.

The global market size of antipsychotics is estimated to be worth about $50 billion and $70 billion in 2012 and 2021, respectively.

About SK Biopharmaceuticals

SK Biopharmaceuticals is a global pharmaceutical company that was spun out in April 2011 from SK Holdings, the third-largest conglomerate in South Korea. SK Biopharmaceuticals focuses on the discovery and development of new drugs for the treatment of central nervous system disorders. SK Biopharmaceuticals also provides custom services for the manufacture and sales of active pharmaceutical ingredients as well as produces intermediates of drugs for global pharmaceutical companies at its facility in Daejeon, South Korea. The plant has been approved by the Korean FDA for the production of active pharmaceutical ingredients under current Good Manufacturing Practices.

SK Biopharmaceuticals leads all Korean pharmaceutical companies with 14 authorized INDs in the U.S. SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, corporate offices in Seoul, South Korea, commercial and partnering offices in Shanghai, China, and its business development and clinical research center in New Jersey for the clinical development of its assets in the areas of epilepsy, neuropathic pain, depression, schizophrenia, chronic constipation, Parkinson's disease, and Alzheimer's disease.

For more information, visit www.skbp.com

Contacts

SK Life Science
Business Development
Duncan Taylor, 201-421-3842
dtaylor@sklsi.com