Date: 2013-06-12
Type of information: Milestone
Compound: CicloMulsion® and NeuroSTAT®
Company: NeuroVive Pharmaceutical (Sweden) Sihuan Pharmaceutical (China)
Therapeutic area: Cardiovascular diseases
Type agreement: development
commercialisation
Action mechanism: CicloMulsion® and NeuroSTAT® 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. CicloMulsion® is currently in a 1000 patient Phase III clinical trial evaluating its ability to reduce reperfusion injuries in patients with myocardial infarction. NeuroSTAT® is expected to enter a Phase IIa clinical trial in patients with severe traumatic brain injury before the end of 2012.
Disease: heart reperfusion injury after stenting, heart reperfusion injury after traumatic brain injury
Details: * On November 20, 2012, NeuroVive, a leading mitochondrial medicine company, has announced a collaboration agreement with Sihuan Pharmaceutical Holdings Group Ltd. for the development and commercialisation in China of NeuroVive\'s most clinically advanced products CicloMulsion® and NeuroSTAT®. CicloMulsion® and NeuroSTAT® are in clinical development by NeuroVive for the treatment of heart reperfusion injury after stenting and traumatic brain injury respectively. 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.
Sihuan Pharmaceutical is one of the largest domestic pharmaceutical companies in China and the market leader in the fast-growing Chinese cardio-cerebral vascular (CCV) drugs market. 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.
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 commercialisation of NeuroSTAT® in China for traumatic brain injury will be finalised during the course of 2013.
Financial terms: Sihuan Pharmaceutical shall make upfront and milestone payments totalling RMB35 million (€4.3 million) and RMB12 (€1.5 million) 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.
Latest news: * On June 12, 2013, NeuroVive has announced that its subsidiary NeuroVive Pharmaceutical Asia Ltd. has received the first milestone payment from Sihuan Pharmaceutical, the company´s collaboration partner for the development and distribution of the products CicloMulsion® and NeuroSTAT® in the Chinese market. The work also continues on completing an application to the Chinese healthcare regulation agency (CFDA) for a clinical trial on CicloMulsion® in China. No financial details regarding the payment are being disclosed due to contractual confidentiality. This first milestone payment will be used primarily for NeuroVive´s Asian business.
