Under the terms of the agreement Sihuan is responsible for clinical development, regulatory and market approval, market access and promotion as well as marketing, distribution and sales in China of CicloMulsion® and NeuroSTAT®.
NeuroVive will supply CicloMulsion® and NeuroSTAT® to Sihuan for clinical trials and, upon launch, will initially supply commercial volumes of the drugs for distribution and sale by Sihuan in China.
Sihuan Pharmaceutical shall make upfront and milestone payments totalling RMB35 million and RMB12 million to NeuroVive in respect of CicloMulsion® and NeuroSTAT® respectively. In addition, the Company shall pay a royalty representing 10% of the net revenue from the two products for a period of 10 years from the time they are launched.
Sihuan intends to conduct a Phase II/III clinical trial in China with CicloMulsion® for the treatment of reperfusion injury following myocardial infarction based on the protocol being used in the Phase III CIRCUS study currently on-going in Europe. NeuroVive will supply Sihuan with CicloMulsion® and placebo for use in the trial which is expected to start in 2013, subject to regulatory approvals.The successful conclusion of the Phase II/III trial together with additional data provided by NeuroVive, including that from the current Phase III CIRCUS study, will be used to gain regulatory approval of CicloMulsion® in China for the treatment of reperfusion injury following myocardial infarction. A similar plan for the clinical development and commercialisation of NeuroSTAT® in China for traumatic brain injury will be finalised during the course of 2013. About NeuroVive Pharmaceutical AB NeuroVive Pharmaceutical AB ( http://www.neurovive.com) the leading mitochondrial medicine company is developing a portfolio of products to treat acute cardiovascular and neurological conditions through mitochondrial protection. NeuroVive's products are based on the cyclophilin D inhibitor cyclosporine, and work by preventing the death of mitochondria in distressed cells and the subsequent cascade of intracellular biochemical events that lead to secondary tissue damage following an acute cardiac or traumatic brain injury.