NeuroVive signs new agreement with Hospices Civils de Lyon

NeuroVive is extending its collaboration with Hospices Civils de Lyon (HCL) and
Professor Ovize, which broadens the scope of NeuroVive’s cardiovascular business
area and creates the right conditions for the company to retain its leading
position in mitochondrial medicine. The new collaboration agreement, designated
OPeRA (Organ Protection & Replacement Institute), includes pre-clinical research
and development programs as well as clinical phase II programs, providing
NeuroVive with access to medical technology and patient groups for the
evaluation of its drug candidates.
NeuroVive began its collaboration with HCL, and the ongoing phase III study in
CicloMulsion in Europe, in 2011. Research into CicloMulsion’s efficacy beyond
the treatment of reperfusion injury following heart attack grew out of the
concept of mitochondrial protection in connection with organ injury focusing on
heart disease. The OPeRA program has received financial backing from the French
government and from several industry players including NeuroVive and covers the
period up until 2018. The program encompasses a number of different medical
areas and is based on multidisciplinary programs in diabetes, metabolic
disorders, transplantation, cardiovascular diseases, inflammatory conditions and
infectious diseases.

By becoming an industrial partner in the OPeRA program, NeuroVive has secured
access to a unique scientific platform in mitochondrial medicine where its
already developed cyclophilin inhibitors such as CicloMulsion, and new drug
candidates, can be studied in various animal models for efficacy against
cardiovascular diseases before being tested in humans. The clinical studies
program at HCL plans to study CicloMulsion in several phase II studies with the
intention of generating proof of concept, i.e. demonstrating CicloMulsion’s
efficacy in a smaller patient group before a decision is made to move on to a
larger phase II study. A number of phase II studies in CicloMulsion are
scheduled in the period up until 2018.

The partnership under the OPeRA program not only gives NeuroVive the rights to
the projects directly covered by the collaboration with HCL, but also provides
access to research findings for potential commercial development across all
areas of the program.

“The collaboration with HCL in Lyon has been extremely positive, and we now
perceive commercial benefits from extending the number of indications in the
cardiovascular area for CicloMulsion, based on a highly developed pre-clinical
platform and the potential for completing several phase II studies,” commented
NeuroVive’s CEO Mikael Brönnegård.

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.

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 presentation 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 5 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
The recently acquired cyclophilin inhibitors are part of a family of molecules
known as Sangamides, and are based on a new and unique chemistry platform of
what are termed polyketides. NVP018 is NeuroVive’s primary drug candidate in the
company’s new portfolio of potent cyclophilin inhibitors. 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.

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

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 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 4 June 2014, at 8.30 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 NEVPF:US.