Topline result of Phase III study of CicloMulsion® in acute myocardial infarction expected this quarter

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, expects
to announce the topline result of the phase III CIRCUS study of CicloMulsion® in
patients with a specific type of heart attack known as ST-segment elevation
acute myocardial infarction (STEMI) this quarter due to an earlier than
previously expected database lock. The final results of the analysis of the 12
-month data are expected in the third quarter 2015.
The topline result will provide baseline information on whether the primary
endpoint has been met or not. This result will not contain specific data
concerning the level of significance for neither the combined composite endpoint
itself nor for each individual element of the composite, which will be revealed
in the subsequent detailed analysis. The primary endpoint is a composite of
three separate outcomes: mortality, hospitalizations for heart failure and left
-ventricular remodeling.

The impact of these results on the future development of CicloMulsion® will be
communicated in the second half of 2015.

About CicloMulsion®
NeuroVive’s drug candidate CicloMulsion®, a lipid emulsion formulation of
cyclosporine, is the first cyclophilin inhibitor in development for the
treatment of reperfusion injury. It is designed to prevent mitochondrial death
in damaged cells and limit the numerous biochemical processes that lead to
secondary tissue damage following heart attack. By protecting the cells’
mitochondria, CicloMulsion® may safeguard continued energy production and ensure
that the damaged cells’ normal regenerative mechanisms are able to carry out
repairs and maintain cell functionality. CicloMulsion®’s potential for treatment
in connection with myocardial infarction is currently being evaluated in a
clinical phase III study. CicloMulsion® is also being evaluated in a phase II
study for the prevention of renal injury during major heart surgery with Skåne
University Hospital in Lund, Sweden. CicloMulsion® is an investigational product
and has not been approved by regulatory agencies for the treatment of any
medical condition.

About the ongoing phase III study on CicloMulsion®
The ongoing European phase III study on CicloMulsion® (the CIRCUS study) is
being conducted in France, Belgium and Spain. The study evaluates CicloMulsion®
for the treatment of reperfusion injury in patients that have undergone
percutaneous coronary intervention (PCI) following myocardial infarct. The
researcher responsible for the study is Professor Michel Ovize at Hospices
Civils de Lyon (HCL) in Lyon, France. The study is a double-blind, placebo
-controlled study, and the final of a total 975 patients included in the study
was enrolled in February 2014. The top-line result (met or did not meet primary
endpoint) based on the 12-month follow-up of all patients is expected to be
announced in the second quarter of 2015, and the full results of the 12-month
data are expected in the third quarter of 2015. The study will also evaluate
outcomes at 36 months.

About NeuroVive
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is
developing a portfolio of products to treat acute cardiovascular and
neurological conditions through mitochondrial protection. NeuroVive’s drug
candidate CicloMulsion® is being evaluated in an ongoing phase III study,
CIRCUS, in myocardial infarction and a phase II study, CiPRICS, in acute kidney
injury. The drug candidate NeuroSTAT® is currently being evaluated in a phase II
study in traumatic brain injury. NeuroVive’s research programs also include
development of drug substances against brain injury in stroke patients and for
cellular protection and energy regulation in mitochondrial disease. NeuroVive’s
shares are listed on NASDAQ OMX, Stockholm, Sweden.

For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46 275 62 21 or ir@neurovive.se
It is also possible to arrange an interview with NeuroVive’s CEO Mikael
Brönnegård or COO Jan Nilsson at the above contact.

NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: +46 (0)46 888 83 48
info@neurovive.se, www.neurovive.se

NeuroVive Pharmaceutical AB (publ) is required to publish the information in
this news release under The Swedish Securities Market Act. The information was
submitted for publication on 25 May 2015, at 8:30 a.m. CET.
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company. The
company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol
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