NeuroVive signs USD 150 m agreement with OnCore BioPharma for the outlicensing of NVP018 for the treatment of chronic Hepatitis B virus infection

NeuroVive Pharmaceutial AB, a leading mitochondrial medicine company, has signed
an exclusive global outlicensing agreement with the US biotechnology company
OnCore BioPharma, Inc. related to the development and commercialization of
NeuroVive’s drug candidate NVP018 for oral treatment of chronic Hepatitis B
Virus (HBV) infection. The agreement can give NeuroVive in total $150 million in
conditional milestone payments plus royalties on future drug sales.
“After extensive discussions with a number of leading pharmaceutical companies,
I am delighted to announce that we have signed this agreement with OnCore, a
strong partner that provides optimal resources to develop NVP018 from a stage of
a promising drug candidate to a complete treatment for a global medical
challenge. This confirms the financial potential inherent in our pharmaceuticals
portfolio, and the revenues will allow us to further intensify our work in
prioritized areas of mitochondrial medicine. I would also like to take the
opportunity to put the spotlight on our COO Jan Nilsson, whose work has been
critical to get this agreement in place,” commented NeuroVive’s CEO Mikael
Brönnegård.

The licensing agreement provides OnCore with the exclusive global rights to
develop oral formulations of NVP018 for the treatment of chronic Hepatitis B
infection. The compensation to NeuroVive consists of an initial upfront payment
plus a number of conditional payments based on pre-determined milestones and as
well payments relating to sales targets. In addition, NeuroVive will receive
incremental royalty payments based on gross revenue from future sales of NVP018.
The total value of the agreement is $150 million excluding royalty payments. The
exact terms of the agreement regarding payments and royalty figures are not
disclosed.

“OnCore stood out in the negotiations, which included several leading
pharmaceutical companies, because of its exclusive focus on Hepatitis B and its
plan to bring the drug candidate to market as quickly and efficiently as
possible. In addition, the company’s senior managers have delivered
exceptionally strong results in the form of a pioneering treatment for Hepatitis
C while working at Pharmasset. I am convinced that OnCore is the right
collaboration partner for us,” commented Jan Nilsson, NeuroVive’s Chief
Operating Officer.

“We perceive considerable potential in NVP018 and consider this agreement to be
an important step towards developing a successful treatment for chronic
Hepatitis B. Our objective is to cure chronic Hepatitis B, building on our
success in Hepatitis C at Pharmasset.” commented Dr. Michael Sofia, Chief
Scientific Officer at OnCore.

Cyclophilin inhibitors and NVP018
NVP018 is an orally-available, sangamide-based, second generation cyclophilin
inhibitor with a well-differentiated preclinical profile when compared to other
cyclophilin inhibitors. Data presented in April at The International Liver
Congress™ 2014, the annual meeting of the European Association for the Study of
the Liver (EASL), showed that NVP018 appears to inhibit the Hepatitis B virus by
two mechanisms in vitro. First, NVP018 directly inhibits several stages of viral
replication in liver cells and second, NVP018 acts indirectly by strengthening
the host immune response via interferon regulatory factors (IRFs), including
potent inhibition of an interaction between cyclophilin A and IRF9, a key
component of the Jak/Stat pathway that transports chemical signals through the
cell membrane. Data also indicates that the risk of developing resistance, a
significant clinical problem with current therapies for Hepatitis B, is very low
with NVP018.

Hepatitis B — a global medical challenge
Hepatitis B is a serious infection of the liver caused by the Hepatitis B virus
(HBV) and is considered a major global health problem. Hepatitis B infection can
cause chronic liver disease, which increases a patient’s risk of death from
liver cirrhosis and liver cancer. Estimates from the Centers for Disease Control
and Prevention (CDC) indicate that up to 350 million people globally may be
chronically infected with Hepatitis B and, according to the World Health
Organization (WHO), more than 780,000 people die every year due to Hepatitis B.
Most currently-available therapies aim to suppress this viral infection but do
not lead to a cure in the overwhelming majority of patients. Identifying a
functional or complete cure for Hepatitis B infection remains a significant area
of unmet medical need.

About OnCore Biopharma
OnCore Biopharma, Inc. is a privately held biotechnology company focused on the
research, development, and commercialization of therapies for the treatment of
chronic Hepatitis B virus (HBV) infection. The Company was founded by former
executives of Pharmasset, Inc., which was acquired by Gilead Sciences in January
2012. OnCore has assembled a portfolio of novel product candidates with unique
mechanisms of action for the treatment of Hepatitis B and is focused on
delivering a cure. It is widely believed that eradicating covalently closed
circular DNA (cccDNA) in HBV-infected hepatocytes represents the ultimate
solution for curing chronic Hepatitis B infected patients. OnCore is currently
addressing an all-oral, permanent HBV cure by targeting cccDNA with the goal of
achieving a "functional cure," wherein the risk of death from liver disease due
to HBV is the same as a person with a naturally resolved infection. OnCore is
combining agents against cccDNA with other novel direct acting antiviral
mechanisms and strategies that engage host immune response. OnCore believes that
combination therapy will be required to achieve complete eradication of HBV from
the liver. OnCore is located at the Pennsylvania Biotechnology Center in
Doylestown, Pennsylvania, which is also home to the Hepatitis B Foundation and
the Foundation’s research center, the Baruch S. Blumberg Institute. For more
information, please visit www.oncorebiopharma.com. To be added to the Company's
e-mail list to receive news directly, please send an email to
ir@oncorebiopharma.com.

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 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

[image]

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 analysis of the
study data.

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 7 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
NVP018 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. Sangamides are analogs of the naturally-occurring polyketide
Sanglifehrin A and are derived from a new and unique polyketide engineering
technology. NVP018 has undergone extensive pre-clinical development for the
treatment of chronic Hepatitis B and C and is outlicensed to OnCore Biopharma
for further development and commercialization for the treatment of chronic
Hepatitis B. The product has demonstrated high potency against virus replication
and has a positive safety and pharmacokinetic profile. Cyclophilin inhibitors
potentially have a wide range of applications.

NVP019
NVP019 is based on the same active substance as NVP018 and is being developed as
the next generation cyclophilin inhibitor for acute heart and nerve cell damage,
but also for other acute heart conditions and acute conditions where general
protection of vital organs is central to 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.

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

For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting (http://www.laika.se), Tel: +46 (0)46 275 62
21 or ir@neurovive.com
It is also possible to arrange an interview with NeuroVive’s COO Jan Nilsson or
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 9 September 2014, at 8.00 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.
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