[SEOUL, Kore=Whowired] May 10, 2012--SK Biopharmaceuticals, a South Korean pharmaceutical company, announced today that it has entered into a licensing agreement with Hanmi Pharmacutical Co., Ltd. for SK Biopharmaceuticals’ diazepam nasal spray (DZNS) technology. In signing the deal, Hanmi acquired regional marketing rights for Korea and China. SK Biopharmaceuticals will receive an upfront payment, development and sales milestones, and royalties on sales in return.
The product is expected to be launched in the Korean market in 2013 and in the Chinese market in 2015. Hanmi has forecast cumulative revenue of $200 million over the first 10 years of sales.
Dr. Christopher Gallen, CEO of SK Biopharmaceuticals, said, “SK Biopharmaceuticals possesses outstanding capabilities to develop new drugs and new drug delivery system products needed by patients. Our alliance with Hanmi will deliver an important new medicine to our patients in Korea and China. This agreement capitalizes on Hanmi’s excellence in sales and marketing in these countries to benefit both companies.”
SK Biopharmaceuticals’ DZNS technology is the first of its kind for the treatment of Acute Repetitive Seizures. The commercialized form of DZNS is expected to show a faster onset of action and improved safety compared to oral administration. In addition, the nasal spray is considered to be much more convenient for patients and their caregivers than the rectal gel formulation currently approved for this indication.
Acute Repetitive Seizures occur in 25% of epilepsy patients. In many cases, these patients merely wait for the seizure to naturally subside, or else they must be transported to an Emergency Room when the seizures become life-threatening.
SK Biopharmaceuticals’ DZNS can provide rapid control of seizure activity regardless of the location where seizures occur. This is expected to significantly improve the quality of life of both patients and their caregivers
The US and European marketing rights to SK Biopharmaceuticals’ DZNS technology were licensed by Neuronex, Inc., a privately-held company, in 2010. Recently, Neuronex entered into a merger agreement with Acorda Therapeutics, Inc.
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 in addition to intermediates of drugs for other major pharmaceutical companies.
SK Biopharmaceuticals, through its affiliate SK Life Science, leads all Korean pharmaceutical companies with 13 authorized INDs in the U.S. Among compounds in current clinical development are YKP3089 in Phase 2b trials for the treatment of epilepsy and neuropathic pain, SKL11197 in a Phase 2a trial for the treatment of neuropathic pain, and YKP10811 in a Phase 2a trial for chronic constipation. In February, YKP3089 was selected for funding by the Korea Drug Development Fund. SK Biopharmaceuticals intends to file INDs later this year for two additional compounds, one for the treatment of Alzheimer’s disease and one for neuropathic pain; both of these compounds are first-in-class candidates acting via new mechanisms of action.
In parallel with its internal development, SK Biopharmaceuticals has adopted a strategy of collaboration with partners to accelerate drug discovery and development. Its current partners include Neuronex with diazepam nasal spray for the treatment of acute repetitive seizures, Aerial BioPharma with SKL-N05 for the treatment of narcolepsy, Medicilon with SKL-PSY for bipolar disorder, and the Mayo Clinic to identify molecules that interact with the TDP-43 protein in amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease).
The Drug Development Business division of SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, and SK Life Science, its business development and clinical research center in Fair Lawn, New Jersey, for the clinical development of its assets in the areas of epilepsy, neuropathic pain, depression, irritable bowel syndrome, and Parkinson’s disease.
The Custom Manufacturing Service (SK CMS) is a second business division of SK Biopharmaceuticals; it generated $40 million last year in the production of Active Pharmaceutical Ingredients for other pharmaceutical company customers. These customers have recognized the quality of the products and the operational efficiency provided by the Korean FDA-approved manufacturing facility in Daejeon, Korea. This facility is fully automated and is used to conduct technologies proprietary to SK Biopharmaceuticals, such as continuous flow synthesis, low temperature reactions, and catalytic conversions, that differentiate the company from other chemical suppliers.
For more information, visit www.skbp.com
SK Life Science, Inc.
Duncan Taylor, 201-421-3842
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