NeuroVive: European phase III study approaches its final stage

NeuroVive Pharmaceutical AB (publ), a leading mitochondrial medicine company,
announces that the ongoing international multicenter phase III study on the
company´s drug candidate CicloMulsion® (the CIRCUS study) for the treatment of
reperfusion injury in connection with heart attack is continuing according to
plan and is approaching its final stage. If nothing unexpected occurs the study
is estimated to be completed near the end of 2014, when the one year follow-up
assessment of the last patient is completed. The study is conducted by Hospices
Civils de Lyon (HCL) in Lyon, France and more than 700 of the study´s total of
972 patients has been included so far.
In addition to the inclusion of more than 70 % of the patients in the phase III
study, several other milestones have been reached during the spring. A new
safety review, that did not lead to any changes in the study, was completed in
April, and the planned one year follow-up assessments of the first patients are
being conducted according to plan.

On May 15th NeuroVive met with the French health care regulatory agency ANSM in
Paris together with Professor Michel Ovize, a leading expert in cardiology and
the study´s Principal Investigator. The purpose of the meeting was to present
the scientific and clinical background to the study, and to discuss clinical
endpoints as well as practical and statistical questions. ANSM were positive
towards the design of the study and NeuroVive´s regulatory strategy to initiate
a decentralized registration process with France as a reference country for
CicloMulsion® in Europe. ANSM gave positive feedback on the majority of
NeuroVive´s questions and suggested different strategies to evaluate the effect
of CicloMulsion® regarding the treatment´s clinical advantages. The effect on
the risk of heart failure following a heart attack was considered important and
will be evaluated during the CIRCUS study. ANSM recommended scheduling a new
meeting with NeuroVive when the final application for market registration is to
be compiled.

The work on completing an application to the Chinese health care regulation
agency CFDA for a clinical trial on CicloMulsion® based upon the completed
studies in Europe is also continuing. A clinical trial in China, in the form of
a separate phase III study, would complement the European phase III study and
bring CicloMulsion® closer to a market introduction in China. The company Sihuan
Pharmaceutical, NeuroVive´s collaboration partner in China, is responsible for
submitting the application to CFDA.

Concurrently with the phase III study and the application for a clinical trial
in China NeuroVive has initiated a market preparation project together with
Quintiles, one of the world’s largest companies within support and service
functions as well as marketing and commercialization work related to
pharmaceutical development. Quintiles will use different strategies to position
CicloMulsion® on the market for treatment of reperfusion injury after a heart
attack.

Mikael Brönnegård, CEO of NeuroVive Pharmaceutical said: “It is exciting that
the phase III study on CicloMulsion® is beginning to approach its final stage,
which means that we can continue with the market preparation work in Europe and
our application for a clinical trial in China with great confidence. The fact
that the French health care regulatory agency ANSM shows a strong interest in
the phase III study bodes well for our plan to select France as our reference
country in Europe. It is however important to point out that the study is not
yet completely finished and compiled.”

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.
NeuroVives´ research programs also include a product for the treatment of brain
cell injury of stroke patients and drug candidates for cellular protection and
for 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 schedule 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 status in
both the US and in Europe for the treatment of patients with moderate and severe
traumatic brain injury. The Orphan Drug Designation status 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/