NeuroVive Asia signs collaboration agreement with Sanofi for the development and commercialization of CicloMulsion® in South Korea

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company,
announces that NeuroVive Pharmaceutical Asia group has signed a collaboration
agreement with Sanofi’s local affiliate for the development and
commercialization of CicloMulsion® in South Korea. Under the agreement NeuroVive
Asia will get an upfront payment, a conditional milestone payment and royalty on
potential future sales in South Korea. CicloMulsion® is being developed for the
treatment of reperfusion injury in cardiovascular disease.
Sanofi is one of the largest global pharmaceutical companies with a prominent
position in the expanding market for the treatment of cardiovascular disease.
The agreement encompasses the registration, launch, promotion and sale of
CicloMulsion® in South Korea.

The NeuroVive group is carrying out an extensive international program for the
clinical development and commercialization of CicloMulsion® ahead of the
product’s potential market launch. The collaboration agreement between NeuroVive
Pharmaceutical Asia Limited, a subsidiary of NeuroVive Pharmaceutical Asia,
Inc., and Sanofi’s local affiliate represents another step in this process.
NeuroVive Pharmaceutical Asia, Inc. is a subsidiary of NeuroVive Pharmaceutical
AB (publ).

“The collaboration with Sanofi will enable us to broaden the commercialization
of CicloMulsion® for the treatment of cardiovascular disease. South Korea is an
important market in Asia and this collaboration with Sanofi is further
confirmation of CicloMulsion®’s clinical and commercial potential. I look
forward to a long and productive partnership with Sanofi, with the aim of
launching CicloMulsion® for the treatment of acute cardiovascular indications on
the South Korean market,” commented Mikael Brönnegård, NeuroVive’s CEO.
CicloMulsion® is currently being evaluated for the treatment of reperfusion
injury following myocardial infarct in a European clinical phase III study (the
CIRCUS study). The product is also being evaluated for the treatment of other
acute heart and kidney injuries within the framework of the collaboration with
Hospices Civils de Lyon and in a clinical phase II study in collaboration with
Skåne University Hospital in Lund, Sweden.
Scope of the agreement
Under the collaboration agreement, Sanofi’s local affiliate will be responsible
for regulatory processes and market approval, launch, marketing, distribution
and sales of CicloMulsion® in South Korea. After its potential market launch,
NeuroVive Pharmaceutical Asia will supply CicloMulsion® to Sanofi for
distribution and sale in South Korea. NeuroVive Pharmaceutical Asia’s
remuneration comprises an upfront payment plus a conditional payment based on a
pre-defined milestone. In addition, NeuroVive Pharmaceutical Asia will receive
royalty based on potential future sales of CicloMulsion®.
Potential positive results from a planned Asian phase III study, alongside
additional data from NeuroVive, including the results of the current European
phase III study, will be used to seek market approval for CicloMulsion® in a
number of Asian countries for the treatment of reperfusion injury following
myocardial infarct. The planned Asian phase III study will be conducted by
NeuroVive Asia alongside its collaboration partner Sihuan Pharmaceuticals in
China and possibly other collaboration partners.
Additional information about the agreement
The right to receive royalty under the agreement continues until the product is
no longer sold in South Korea by Sanofi. The agreement term may be shorter
should the agreement be terminated, for example if the product fails to
demonstrate satisfactory efficacy, safety or commercial viability. Remuneration
received by NeuroVive Asia under the agreement will be included in NeuroVive’s
consolidated quarterly financial reports. Payments covered by the agreement are
conditional on uncertain future events occurring.  This means that should such
events fail to materialise, such as if the product fails to demonstrate
satisfactory efficacy or safety or commercial viability, the payments
attributable to these events will not be made.

CicloMulsion® is in a clinical development phase, which means that the
probability of reaching the market is dependent on a number of factors outside
of NeuroVive’s control. These include research-related and clinical risks such
as the product failing to demonstrate satisfactory efficacy or safety during
development, and regulatory risk in the form of regulatory authorities
withholding market approval or pricing reimbursement or requiring an extension
of or delay in the time required before the product can reach the market.  There
are numerous other circumstances attributable to the general development
process, as for all products of a similar kind in clinical development.
Investors are urged to evaluate the publically available documents NeuroVive has
published for further general information regarding the development of
NeuroVive’s products.
Current status of NeuroVive’s projects and drug candidates

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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 infarct is currently being evaluated in a clinical phase
III study. The last of a total of 975 patients was enrolled on 16 February 2014.
The final results of the analysis of the 12-month data are expected to be
presented in the third quarter of 2015. CicloMulsion® is also being evaluated
for the treatment of other acute heart and kidney injury within the framework of
the collaboration with Hospices Civils de Lyon and in a clinical phase II study
in collaboration with Skåne University Hospital in Lund, Sweden.
NeuroSTAT®
NeuroVive is developing NeuroSTAT® for the treatment of patients with moderate
or 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 10 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 cranial
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.
NVP019
NVP019 is NeuroVive’s primary drug candidate in the company’s new portfolio of
potent cyclophilin inhibitors belonging to a family of molecules known as
Sangamides based on a new and unique polyketide engineering technology. NVP019
is being developed as the next generation cyclophilin inhibitor for the
treatment of reperfusion injury in myocardial infarct, but also for other acute
conditions where general protection of vital organs is central to preventing the
progression of the disease. An intravenous formulation will be evaluated for
this purpose in collaboration with external parties such as Hospices Civils de
Lyon within the framework of the OPeRa program.
OCB030
OCB030 is an oral formulation based on the same substance as NVP019. It has been
developed for the treatment of Hepatitis B and was outlicensed to Tekmira
Pharmaceuticals (www.tekmira.com) in September 2014.
Other products
More information about all products developed by NeuroVive can be found at
http://www.neurovive.se/index.php/en/research-development/research-overview
About NeuroVive
NeuroVive Pharmaceutical AB (publ), the 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®
(myocardial infarct) 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 brain cell protection in stroke patients and
drug substances for treating mitochondrial disorders causing energy deficiency.
NeuroVive’s shares are listed on NASDAQ OMX, Stockholm, Sweden.
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 or COO Jan Nilsson 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 26 May 2015, at 10.15 a.m. CET.