NeuroVive and Sihuan Pharmaceutical to Develop and Commercialise CicloMulsion®
and NeuroSTAT® for Cardio- and Neuroprotection in China
BEIJING and LUND, Sweden, November 20, 2012
BEIJING and LUND, Sweden, November 20, 2012 /PRNewswire/ --
NeuroVive, the leading mitochondrial medicine company, today announces 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®.
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
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 Bronnegard, 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
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
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
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
NeuroVive´s shares are listed on the Swedish trading platform AktieTorget (
http://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 ( http://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 Bronnegard Email:
email@example.com Phone No: +46(0)70-299-62-64
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