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.
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.
Sihuan is a leading Chinese pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China. It has a proven track record in R&D, manufacturing, sales and marketing of cardio-cerebral vascular drugs. Its nationwide distribution network covers over 10,000 hospitals through over 3,000 distributors making it the ideal partner to bring NeuroVive's drugs to market in China.
Mikael Brönnegård, CEO of NeuroVive Pharmaceutical said: "Our agreement with Sihuan is a transformational event for NeuroVive and provides strong validation of the huge potential of mitochondrial medicine and specifically the work we have done to develop the cyclophilin inhibitors CicloMulsion® and NeuroSTAT®. Sihuan is one of the leading pharmaceutical companies in China and through this agreement will add significant resources, product development and marketing expertise that will greatly accelerate the development and commercialisation of our products in China. I look forward to a long and productive partnership with Sihuan that I am confident will lead to the launch of NeuroVive's products for the treatment of acute cardiovascular and neurological conditions in the Chinese market estimated to be worth more than 2 billion RMB annually at peak sales."
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said: "This is a breakthrough for our business development as it is the first time Sihuan Pharmaceutical is collaborating with a renowned international pharmaceutical company. 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. "
Scope of the agreement
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 (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.
NeuroVive's lead product is CicloMulsion®, the first cyclophilin D inhibitor for the treatment of reperfusion injuries following stenting. CicloMulsion® is currently in a 1000 patient Phase III clinical trial evaluating its ability to reduce reperfusion injuries in patients with myocardial infarction.
NeuroVive is also developing NeuroSTAT®, a cyclophilin D inhibitor, which is expected to enter a Phase IIa clinical trial in patients with severe traumatic brain injury before the end of 2012. Both indications have huge medical need and for which there are currently no approved pharmaceutical treatment options. CicloMulsion® and NeuroSTAT® are special formulations of cyclosporine for use in acute cardiac and brain injury indications.
NeuroVive's pipeline also includes a cyclophilin D inhibitor for stroke and drug candidates that act on mitochondria to address energy regulation disorders.
NeuroVive´s shares are listed on the Swedish trading platform AktieTorget (www.aktietorget.se). The AktieTorget market is focused on emerging, entrepreneurial businesses through an electronic trading system supplied by the OMX Nordic stock exchange in Stockholm, Sweden.
About Sihuan Pharmaceutical
Sihuan Pharmaceutical (www.sihuanpharm.com) is a leading pharmaceutical company and the largest cardio-cerebral vascular (CCV) drug franchise in China's prescription drug market. It has a successful track record in R&D, manufacturing, sales and marketing of drug products in the top five medical therapeutic areas in China: cardio cerebral vascular system, central nervous system, metabolism, oncology and anti-infective.
Sihuan has a differentiated sales and marketing model and well-managed network of over 3,000 distributors who promote and sell its products to hospitals and medical institutions throughout China and has market-leading R&D capabilities, focusing on innovative and first-to-market generic drugs. Sihuan Pharmaceutical has been listed on the Main Board of the Hong Kong Stock Exchange since October 2010.
Key Contact NeuroVive Pharmaceutical: Mikael Brönnegård
Phone No: +46 (0) 70 299 62 64