South Korean pharmaceutical company SK Biopharmaceuticals has been awarded funding for its lead drug from its drug development program for the treatment of refractory epilepsy. The Korea Drug Development Fund will support clinical development of the drug for the next three years.
South Korean pharmaceutical company SK Biopharmaceuticals announced that the lead drug, YKP3089, from its drug development program for the treatment of refractory epilepsy, has been awarded funding from the Korea Drug Development Fund to support clinical development for the next three years. An agreement between the two parties was signed on February 22.
“The selection of YKP3089 by the Korean Drug Development Fund is an acknowledgement of its potential to become a global blockbuster. If our Phase 2 and Phase 3 clinical trials go smoothly, we will be able to market the drug in 2017.”
The Korea Drug Development Fund was established in September 2011 with assets of $1 billion to develop at least ten new drugs by 2019. A consortium of three health-related Korean ministries, the Ministry of Knowledge Economy, the Ministry of Education, Science and Technology, and the Ministry of Health and Welfare.
YKP3089 is the lead molecule in SK Biopharmaceuticals’ pipeline. The funding support received will be used to support global late Phase 2 clinical trials in refractory epilepsy.
Dr. Jeong Woo Cho, Vice President for SK Biopharmaceuticals’ Drug Development Business, said, “The selection of YKP3089 by the Korean Drug Development Fund is an acknowledgement of its potential to become a global blockbuster. If our Phase 2 and Phase 3 clinical trials go smoothly, we will be able to market the drug in 2017.”
Dr. Cho added, “As the drug has shown marked efficacy in reducing pain in various animal models of neuropathic pain as well in epilepsy, we will be conducting simultaneous Phase 2 trials for this additional indication. The worldwide neuropathic pain market is $2.5 billion in size, and if YKP3089 shows efficacy in various types of this pain, the value of the drug will be tremendous.”
According to the World Health Organization, epilepsy affects approximately 0.5% of the world’s population, or 50 million people worldwide, making it one of the most common neurological diseases. The Epilepsy Foundation estimates that 3 million Americans are affected by epilepsy. Epilepsy is a condition that makes people susceptible to seizures. Seizures vary from a momentary disruption of the senses, to short periods of unconsciousness or staring spells, to convulsions. All seizures are caused by abnormal excitation of the nervous system. Chronic, untreated epilepsy is known to result in cerebral, mental, and bodily damage over time producing social and financial burdens.
Treatment of epilepsy by anticonvulsant drugs can eliminate seizures in one-third of patients and can produce more than 50% reduction in seizures in another one-third of patients. No single anticonvulsant controls all types of epilepsy. Different patients require different drugs, and some may require multiple drugs. There remains a high unmet medical need for new, more effective and better tolerated drugs which treat seizure disorders. (Source: The Epilepsy Foundation). Datamonitor estimates that the worldwide market for antiepileptic drugs is estimated to grow to be $4.9 billion by 2019.
YKP3089 was discovered early on to have a broad spectrum of action in animal models of epilepsy and seizure disorders. It is also active in other models of behavioral disorders and has authorized Investigational New Drug status from the U.S. Food and Drug Administration. A pilot study in the U.S. demonstrated efficacy in human patients who were sensitive to light-induced seizures. A global Phase 2 clinical trial to evaluate the drug’s efficacy in reducing seizure frequency in patients with partial onset seizures not fully-controlled despite receiving other antiepileptic drugs has been initiated.
About SK Biopharmaceuticals
SK Biopharmaceuticals is a newly-independent development-stage pharmaceutical company as of April 2011, after being spun out from SK Holdings, the third-largest conglomerate in South Korea. SK Biopharmaceuticals focuses on discovery and development of new drugs as well as providing custom services for the manufacture and sales of active pharmaceutical ingredients as well as producing intermediates of drugs for major companies, including Pfizer and Roche, in their factories that have been newly approved in Korea for current Good Manufacturing Practices of active pharmaceutical ingredients.
SK Biopharmaceuticals leads all Korean pharmaceutical companies with 13 authorized INDs in the U.S. SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, 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, irritable bowel syndrome, and Parkinson’s disease.