Published data indicates protective effect of cyclosporine in patients with stroke

The results of a clinical phase II study indicating that cyclosporine
counteracts brain injury in a subset of stroke patients undergoing thrombolysis
has been published in an article co-authored by one of NeuroVive’s research
partners, professor Michel Ovize of Hospices Civils de Lyon (HCL).
The French phase II study investigated the neuroprotective effect of
cyclosporine, the active substance in NeuroVive’s product NeuroSTAT®, in 127
stroke patients who also received thrombolysis treatment (to reinstate the
occluded blood flow) in the period 2009-2013. For all patients included in the
study, the extent of brain injury was 24% lower in the cyclosporine group which
was not statistically significant. In a smaller sub-cohort of patients with
blood clots in major arteries (proximal occlusion) and where thrombolysis had
been successful, however, cyclosporine demonstrated a statistically significant
reduction of as much as 69% of the volume of brain injury compared to placebo.
No differences were observed between the groups in terms of behavior or
neurological function three months after treatment.

The results are outlined in the article “Cyclosporine in Acute Ischemic Stroke”
by Professor Norbert Nighoghossian, Professor Michel Ovize and other
participants in the multicenter trial. The article was published in the
scientific journal Neurology. For an online version of the article, go to:

http://www.neurology.org/content/early/2015/05/06/WNL.0000000000001639.short

“The neuroprotective qualities demonstrated in the study are very promising, and
we’re prioritizing a follow-up study within the framework of our partnership
with Professor Ovize and Hospices Civils de Lyon (HCL), using our product
NeuroSTAT®. Our castor oil-free formulation of cyclosporine is a pre-requisite
for treating larger patient groups. Further, the findings confirm and justify
our sustained focus on developing new cyclophilin inhibitors aimed at this
patient group,” commented Mikael Brönnegård, NeuroVive’s CEO.

“It’s important to note that the cyclophilin inhibitor cyclosporine didn’t
significantly reduce brain injury in all patients undergoing thrombolysis to
restore blood flow to the brain after stroke. A significant effect was noted
only by a so called post-hoc analysis in a smaller patient cohort where
impending major brain attack was suspected due to a proximal occlusion of the
culprit artery in combination with successful restoration of blood flow.
Efficacy needs to be confirmed in larger studies focusing on this specific
patient group, or using a cyclophilin inhibitor with improved penetration across
the blood-brain barrier,” commented Eskil Elmér, NeuroVive’s CSO.

Current status of NeuroVive’s projects and drug candidates

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CicloMulsion®
NeuroVive’s product CicloMulsion® is the first cyclophilin inhibitor developed
for the treatment of reperfusion injury. The product’s potential in the
treatment of myocardial infarction is currently being evaluated in a clinical
phase III study. The last of a total of 972 patients was enrolled on 16 February
2014. The results of the study are due to be announced in 2015 following the
completion of the one-year follow-up of all patients and the analysis of the
study data. CicloMulsion will also be evaluated in a number of clinical phase II
studies for the treatment of other acute heart and kidney injuries within the
framework of the collaboration with Hospices Civils de Lyon and Skåne University
Hospital in Lund, Sweden.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with moderate
or severe traumatic brain injury. NeuroSTAT® is currently being evaluated in a
clinical phase IIa study at Copenhagen University Hospital. The study focuses on
safety and pharmacokinetics, and 10 of 20 planned patients have been enrolled so
far. A phase III study is currently being planned and designed. NeuroVive has
secured orphan drug designation for NeuroSTAT® for moderate and severe traumatic
brain injury in the US and EU, which implies market exclusivity for seven years
in the US and ten years in the EU, from the date NeuroVive obtains market
authorization.

NVP019
NVP019 is NeuroVive’s primary drug candidate in the company’s new portfolio of
potent cyclophilin inhibitors belonging to a family of molecules known as
Sangamides based on a new and unique polyketide engineering technology. NVP019
is being developed as the next generation cyclophilin inhibitor for reperfusion
injury in heart attack, but also for other acute conditions where general
protection of vital organs is central to counteracting the progression of the
disease. An intravenous formulation will be evaluated for this purpose in
collaboration with external parties such as Hospices Civils de Lyon within the
framework of the OPeRa program.

NVP018
NVP018 is an oral formulation based on the same active substance as NVP019. It
has been developed for treatment of Hepatitis B and was outlicensed to OnCore
Biopharma (www.oncorebiopharma.com) in September 2014.

Other products
More information about all products developed by NeuroVive can be found at
http://www.neurovive.se/index.php/en/research-development/research-overview

About NeuroVive Pharmaceutical
NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, is
developing a portfolio of products to treat acute cardiovascular and
neurological conditions through mitochondrial protection. These medical
conditions are characterized by a pressing medical need and have no approved
pharmaceutical treatment options at present. NeuroVive’s products CicloMulsion®
(heart attack) and NeuroSTAT® (traumatic brain injury) are currently being
evaluated in phase III and phase II studies, respectively. NeuroVive’s research
programs also include products for the treatment of brain cell injury in stroke
patients, and drug candidates for cellular protection and treating mitochondria
-related energy regulation diseases. 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 7 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
NVP. The share is also traded on the OTC market in the US. NeuroVive
Pharmaceutical (OTC: NEVPF) trades on the OTC Grey Market. Investors can find
Real-Time quotes and market information for the company
at www.otcmarkets.com/stock/NEVPF/quote (http://htt://www.otcmarkets.com/stock/N
E 
VPF/quot)