First patient recruited to clinical phase II study for treatment of traumatic brain injury

NeuroVive Pharmaceutical AB (publ), a leading mitochondrial medicine company,
has recruited the first patient in a Phase IIa clinical trial to evaluate the
company´s drug candidate NeuroSTAT® for the treatment of traumatic brain injury.
The trial is being conducted at the Department of Neurosurgery, Copenhagen
University Hospital under the supervision of Professor Bertil Romner and Dr
Walter Fischer. Bertil Romner is a leading expert in the treatment of traumatic
brain injury, and Walter Fischer is the study’s principal investigator.
The phase IIa trial is an open label, uncontrolled study that will recruit a
total of 20 patients. The primary endpoint of the study is to evaluate
NeuroSTAT®´s pharmacokinetic properties and safety in patients with severe
traumatic brain injury. In addition, secondary endpoints include several
monitoring techniques to study the effect of NeuroSTAT® at the mitochondrial
level and how different biochemical processes are influenced by NeuroSTAT® after
a brain injury has occurred.

Traumatic brain injury is an area of huge medical need for which there are
currently no approved pharmaceutical treatment options.

Mikael Brönnegård, CEO of NeuroVive Pharmaceutical said: “The inclusion of the
first patient in our phase IIa trial to evaluate NeuroSTAT® for traumatic brain
injury is an important milestone for NeuroVive. The study is designed to
generate safety data and dosage information for the treatment of traumatic brain
injury. This data will be vital for the upcoming phase III study with the
purpose of evaluating NeuroSTAT®´s treatment potential for traumatic brain
injury. The design work and planning of the phase III study have already begun.”

Bertil Romner, Professor of Neurosurgery, added: “I am glad to take part in the
development of a long-awaited pharmacological treatment for patients suffering
from traumatic brain injury, a disease with highly unmet medical need.”

More detailed information on the Phase IIa study can be found by accessing the
following link:
www.clinicaltrials.gov/ct2/show/NCT01825044

About NeuroVive
NeuroVive Pharmaceutical AB, 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 high medical needs and that there are currently
no approved pharmaceutical treatments options. 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 a product for the treatment of brain
injury in stroke patients and drug candidates for cellular protection and the
treatment of mitochondria-related energy regulation diseases. NeuroVive´s shares
are listed on the NASDAQ OMX stock exchange in Stockholm, Sweden.

Media and Investor Relations-related questions are referred to:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46-275 62 21, Email:
ir@neurovive.com
It is also possible to book an interview with CEO Mikael Brönnegård or CSO Eskil
Elmér via the contact information above.

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

Current status for 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 potential of the product as a
treatment for heart attack patients is currently being evaluated in a clinical
phase III study with 972 patients.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with traumatic
brain injury. NeuroSTAT® is currently being evaluated in a clinical phase IIa
-study with 20 patients. The designing and planning of a phase III study has
been initiated. NeuroSTAT® has been granted Orphan Drug Designation in both the
US and in Europe for the treatment of patients with moderate and severe
traumatic brain injury. The Orphan Drug Designation guarantees NeuroSTAT® market
exclusivity in the US for seven years and in the EU for ten years after the
product attains marketing authorization.

Other products
More information about NeuroVive´s product portfolio can be found on
http://www.neurovive.com/Research--Development/Our-products/

NeuroVive Pharmaceutical AB (publ) is obligated to publish the information
contained in this press release in accordance with the Swedish Securities Market
Act. This information was provided to the media for publication 08:15 a.m. CEST
on June 5, 2013.