AmKor (AmKor Pharma, Inc.) and Hengdian Group (Hengdian Group Ltd) today announced the signing of licensing agreement for further development and commercialization of Neu2000 in China.
Under the agreement terms, Hengdian Group will pay RMB 5 million Yuan as a research fund for the study of acute myocardial infarction (AMI) and burns immediately after signing and additional RMB 5 million Yuan as an upfront after completion of the phase II clinical trial for stroke, AMI or burns in China. Hengdian Group will provide 12 percent of the net sales as royalty to AmKor upon the commercial sale of the Neu2000 product in China. Moreover, Hengdian Group, as a pharmaceutical company specialized in active pharmaceutical ingredient (API) production for global clinical trials, is responsible for producing API and drug products of Neu2000 for multinational clinical trials through AmKor and Neurotech.
Neu2000 is a moderate, NR2B-selective N-methyl-d-aspartate (NMDA) receptor antagonist and potent antioxidant, which is developed as a dual cytoprotective drug for stroke, spinal cord injury (SCI), AMI and burns by Neurotech Pharmaceuticals Co., Ltd. (Neurotech) in South Korea. These therapeutic mechanisms have been among the most sought after activities in the pharmaceutical development of neuroprotectant and evaluated its efficacy over the past few decades through numerous studies of animal model such as ischemic stroke and SCI.
Neu2000 is an investigational stroke treatment with proven human safety through phase I clinical trial in Quintiles US. In the double-blinded, phase I clinical trial, Neu2000 showed excellent safety profiles up to 6 g per healthy young humans (80 subjects) and up to 4 g per normal elderly humans (15 subjects) without serious adverse events. Neu2000 did not show any Central Nervous System toxicities compared with other NMDA antagonists which have failed due to clinical toxicities. As dosing of only 125 to 1500 mg of Neu2000 per human was enough to exceed the therapeutic plasma concentrations showing maximal efficacy in animal models of stroke, SCI, and AMI, AmKor made a decision to move toward clinical proof-of-concept trial of Neu2000 for the target diseases.
Dr. BJ Gwag, President and CEO of AmKor and Neurotech, said, "We are pleased to establish a partnership with Hengdian Group with sincere trust and belief in the relationship and are going to plan phase II clinical trials of Neu2000 first in South Korea and China."