NeuroVive has announced a collaboration agreement with Sihuan Pharmaceutical Holdings Group Ltd. for the development and commercialization in China of NeuroVive's products CicloMulsion and NeuroSTAT.
Sihuan Pharmaceutical is one of the largest domestic pharmaceutical companies in China and has a cardio-cerebral vascular drug franchise. The agreement was entered into by Sihuan Pharmaceutical through its wholly-owned subsidiary Sun Moral International (HK) Ltd. and by NeuroVive through its subsidiary NeuroVive Pharmaceutical Asia Ltd.
CicloMulsion and NeuroSTAT are in clinical development by NeuroVive for the treatment of heart reperfusion injury after stenting and traumatic brain injury respectively. These are indications of huge medical need for which there are currently no approved pharmaceutical treatment options.
Both products act to prevent the death of mitochondria in damaged cells and the cascade of intracellular biochemical events that lead to secondary tissue damage following a traumatic injury. By protecting a cell's mitochondria, NeuroVive's products ensure that energy production is preserved and a damaged cell's normal regenerative mechanisms can act to repair and maintain the cell. CicloMulsion and NeuroSTAT contain cyclosporine which, by inhibiting cyclophilin D, prevents the disruption of the membrane of the mitochondria.
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 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 commercialization of NeuroSTAT in China for traumatic brain injury will be finalized during the course of 2013.
Release Date: November 20, 2012