NeuroVive, a mitochondrial medicine company based in Sweden, has signed a collaboration agreement with Sihuan Pharmaceutical Holdings Group, based in China, for the development and commercialization of NeuroVive's most clinically advanced products CicloMulsion and NeuroSTAT in China.
Sihuan will be 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 totaling $5.6 million and $1.9 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.
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.
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.
"This is a breakthrough for our business development as it is the first time Sihuan Pharmaceutical is collaborating with a renowned international pharmaceutical company,” said Che Fengsheng, chairman and CEO, Sihuan Pharmaceutical. “The collaboration will bring together Sihuan Pharmaceutical's competitive advantages in product development, marketing promotion and distribution network and NeuroVive's advanced drug development technology. This will enrich our product portfolio, raise the level of our product resources and widen our revenue stream. We believe that CicloMulsion and NeuroSTAT will become new drivers of our sales, sustain our growth in the long run, and consolidate Sihuan Pharmaceutical's leadership in the CCV drug market. "
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.
