|[June 04, 2014]
Neurovive Pharmaceutical: NeuroVive signs new agreement with Hospices Civils de Lyon
STOCKHOLM --(Business Wire)--
NeuroVive (STO:NVP)�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
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 cadiovascular 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 Br�nneg�rd.
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.
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.
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.
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.
More information about all products developed by NeuroVive can be found
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
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.
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