Enrollment to phase II study on NeuroSTAT® continues

Enrollment to the ongoing clinical phase IIa study with NeuroVive’s drug
candidate NeuroSTAT® for treating patients with severe traumatic brain injury
(TBI) is continuing, and another two patients have been enrolled. Accordingly,
at present, seven of a total of 20 patients have been enrolled in the study.
The enrollment of new patients to the study has taken somewhat longer time than
scheduled, but NeuroVive assumes that the ten patients to be treated with a
lower dose will have been enrolled by year-end, or during Q1 2015 at the latest.
Subsequently, the plan is to conduct interim analysis of data from these first
ten patients with the aim of forming an opinion of treatment safety.  If there
are no safety concerns, the objective is for another ten patients to be enrolled
during 2015 with treatment at a higher dose. In addition to planned interim
analysis, continuous assessment treatment safety is being conducted. Based on
safety assessments of the first patients, treatment with NeuroSTAT at the lower
dose is considered to be safe and patient enrollment is continuing as planned.

This phase IIa study is an open, non-comparative study involving a total number
of 20 patients. Its primary endpoint is to evaluate NeuroSTAT’s®
pharmacokinetics* (http://file:///Q:/Neurovive/Pressreleaser/Skarpa/2014-08
-14%20-%20NeuroStat/NVP_PM-20140814_eng.docx#_ftn1) and safety in TBI. Secondly,
a number of measurements will be conducted, firstly to study NeuroSTAT’s®
efficacy at the mitochondrial level, and to study how biochemical processes are
affected by NeuroSTAT® post-TBI. TBI is a segment subject to a major medical
need, where there are no registered pharmaceutical therapies at present.

About NeuroVive Pharmaceutical

NeuroVive Pharmaceutical AB (publ), a leading 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 anti-viral indications
(Hepatitis B/C), 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. The
share is also traded on the OTC market in the US, under the NEVPF ticker symbol.

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* Pharmacokinetics is the study of a pharmaceutical’s transformation in the
body, i.e. how content of the pharmaceutical in the body changes through
absorption, distribution, metabolism and excretion.

Current status of NeuroVive’s products

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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.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with 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 7 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.

NVP018
NVP018 is NeuroVive’s primary drug candidate in the company’s new portfolio of
potent cyclophilin inhibitors. These cyclophilin inhibitors, previously
acquired, are part of a family of molecules known as Sangamides, whose molecular
structures are based on a new and unique chemical platform of what are termed
polyketides. It has undergone extensive pre-clinical development and has been
developed for the treatment of Hepatitis B/C. The product has demonstrated high
potency against virus replication and has a positive safety and pharmacokinetic
profile. Cyclophilin inhibitors have broad-based applications and NeuroVive is
currently evaluating NVP018’s potential for other anti-viral indications.

NVP019
NVP019 is based on the same active compound as NVP018, and is being developed as
the next generation of cyclophilin inhibitors to treat acute cardiovascular and
neurological conditions, as well as for other acute cardiac conditions and acute
conditions where general protection of vital organs is central to the course of
the condition. An intravenous preparation will be evaluated for these purposes
in collaboration with external partners such as Hospices Civils de Lyon within
the auspices of the OPeRA program.

Other products
More information on all the products NeuroVive is developing is at
http://www.neurovive.se/index.php/en/research-development/research-overview

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 via 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 14 August 2014, at
10:00 a.m. CET.
NeuroVive Pharmaceutical AB (publ) is a leading 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, under the
ticker symbol NEVPFUS