Apr 12 2010
Medinox, Inc. in Carlsbad, California and Orient Europharma in Taiwan announce today that they have entered into a partnering agreement to develop and market NOX-100, a new anti-hypotensive drug. Under the terms of the agreement, Orient Europharma holds the exclusive distribution rights of NOX-100 in Taiwan, China, Korea, Australia, New Zealand and Southeast Asia. Medinox retains the marketing rights in the United States, Japan and Europe.
NOX-100 is an investigative new drug developed by Medinox to treat conditions associated with excessive production of nitric oxide, such as in hemodialysis, cardiopulmonary bypass surgery and septic shock. NOX-100, a small-molecule nitric oxide scavenger, binds nitric oxide and inactivates its properties.
Intradialytic hypotension (IH) is a significant complication of routine hemodialysis in end-stage renal disease patients. Complications of IH include headache, muscle cramps, and increase in mortalities. At present, there is no FDA-approved therapy available for treating and/or preventing IH.
Medinox completed a Phase 1 safety study of NOX-100 in hemodialysis patients in the US. A Phase 2 trial of NOX-100 in hemodialysis will be conducted in Taiwan. This multicenter study will determine if NOX-100 lowers the incidence of IH, decreases the frequency of nurse intervention, and reduces the number of patient complaints and discomfort. Over 380,000 end-stage renal failure patients in the US require dialysis. In Taiwan, more than 60,000 patients are currently in dialysis.