Singapore, Nov 24, 2009: AmKor and China-based Hengdian Group have 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 ($732, 385) as a research fund for the study of acute myocardial infarction (AMI) and burns immediately after signing and additional 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 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 is said to have shown 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.
Dr BJ Gwag, President 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."
The R&D of Neu2000 was supported partly by "National Research Laboratory grant," "G7 grant" and "Functional Proteomics Project of the 21st Century Frontier Research Program" from the Ministry of Science and Technology in Korea. It was also supported by grants from "Brain Research Center" in Ajou University School of Medicine and from "Driving Force Project for the Next Generation" by Gyeonggi Provincial Government in Korea.
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