SUWON, SOUTH KOREA--(Marketwire - November 23, 2009) -
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."
AmKor, a Neurotech's subsidiary, is a clinical-stage company focused on the
development of drugs to treat the body's response to injury. Its principle
efforts are currently directed at advancing Neu2000 through phase II
clinical trials in stroke, SCI, AMI and burns.
Neurotech is a biopharmaceutical venture company which discovers and
develops new drugs for the treatment of neurological and inflammatory
diseases.
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.
Hengdian Group is at the present one of the largest Chinese conglomerates,
ranked 3rd in the "Top 10 National Private Enterprises," with a total
yearly turnover exceeding 16.7 billion RMB (over 2 billion USD). The
headquarters is based in Hengdian, Zhejiang Province and the group has 3
public companies -- electronics, pharmaceutical and chemical industry, film
and entertainment -- more than 60 sub-companies and about 200 manufacturing
factories with over 40,000 employees.