NeuroVive refocuses CicloMulsion development – discontinues acute myocardial infarction indication


CicloMulsion® development to continue in acute kidney injury and increased focus
on development of other drug candidates. Shareholder information meeting to be
held on 10th September 2015 in Lund, Sweden to present and discuss the NeuroVive
portfolio. NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine
company, announces it will not pursue development of CicloMulsion® in the
indication of acute myocardial infarction (AMI). The company will now place
strategic focus on progressing the research and development activities of
CicloMulsion® in acute kidney injury, the development of its other drug
candidates as well as accelerating its discovery programs.
This decision follows the data presentation from the investigator-initiated
Phase III CIRCUS study of CicloMulsion® in patients with a specific type of
heart attack known as ST-segment elevation myocardial infarction (STEMI) at the
European cardiology meeting in London, UK. The data presented showed that
CicloMulsion® had no therapeutic effect on AMI patients undergoing PCI
(percutaneous coronary intervention). However, the CIRCUS study confirmed the
safety profile of CicloMulsion®.

“The CIRCUS study has given us a better understanding of target therapeutic
areas and how our drug candidates may be best used. The lack of therapeutic
effect in AMI patients may be due to the administration time, as significant
injury to the cardiac muscle has already occurred at the time of PCI. We will
continue to evaluate our drug candidates in different organs and conditions. We
are confident in our research and development pipeline and the potential of
cyclophilin D inhibitors in a broad range of indications.” commented Eskil
Elmér, MD, CSO of NeuroVive.

NeuroVive remains committed to the Phase II CiPRICS study of CicloMulsion® in
pretreatment of acute kidney injury during major surgery, as well as the Phase
II CHIC study of NeuroSTAT® in traumatic brain injury. CicloMulsion® is one of
several investigational products in clinical and preclinical development.

Shareholder information meeting on Sept 10 at Medicon Village in Lund, Sweden

NeuroVive will host an information meeting on Thursday 10th September 2015 at
18:00 in the auditorium, Scheelevägen 2, to discuss the implications for
CicloMulsion® of the CIRCUS trial results, and present and discuss the NeuroVive
portfolio.

About NeuroVive

NeuroVive Pharmaceutical AB (publ) is a mitochondrial medicine company committed
to the discovery and development of therapeutic applications for mitochondrial
medicine in areas of significant unmet clinical need. NeuroVive’s business
strategy focuses on maximising value from its projects through strategic
partnerships and out-licensing.

NeuroVive’s portfolio, containing three cyclophilin D candidates in clinical and
preclinical development, is fuelled by three additional drug discovery platforms
in neurology, mitochondrial disorders and organ protection. NeuroVive’s product
CicloMulsion® is being evaluated in an ongoing Phase II study, CiPRICS, in acute
kidney injury during major surgery. The NeuroSTAT® product is currently being
evaluated in a Phase II study in traumatic brain injury.  NeuroVive’s shares are
listed on NASDAQ OMX, Stockholm, Sweden.

Disclaimer

This release may contain forward-looking statements that can be identified by
words such as “recommends,” “indicating,” “risk,” “recommended,” “believe,”
“could,” “commitment,” “will,” “implications,” “supports,” “thought,”
“designed,” “growing,” “continues,” or similar terms, or by express or implied
discussions regarding potential marketing approvals for CicloMulsion®, or
regarding potential future revenues from CicloMulsion®. You should not place
undue reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management regarding future events, and
are subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that
CicloMulsion® will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that CicloMulsion® will be
commercially successful in the future. In particular, management’s expectations
regarding CicloMulsion® could be affected by, among other things, the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally; the
company’s ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
manufacturing issues, and other risks and factors.

For investor relations and media questions in Sweden, please contact:

Johannes Nebel, Laika Consulting, Tel: +46 (0)735 81 71 68 or ir@neurovive.se

For media questions outside Sweden, please contact:

Gemma White, inVentiv Health, Tel: +44 (0)77 13 88 9992 or
gemma.white@inventivhealth.com

It is also possible to arrange an interview with NeuroVive’s CEO Mikael
Brönnegård or COO Jan Nilsson at the above contacts.

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.com

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 the 31st August 2015, at 08.30 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 Pink 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)

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