NeuroVive presents significant hepatitis B data for its drug candidate NVP018

NeuroVive’s anti-viral preclinical program, with compound designated NVP018, has
generated significant data indicating that NVP018 has the potential to become an
effective alternative or addition to current drugs for treating chronic
hepatitis B infections. This new data will be presented at the EASL (European
Association for the Study of the Liver) congress in London, in April 2014
(www.ilc-congress.eu).
The results indicate that NVP018 has a dual effect against the hepatitis B
virus. Firstly, the data generated suggests that NVP018 directly inhibits
several stages in viral propagation in liver cells, and secondly, NVP018 also
operates indirectly by strengthening the immune response. The data also
indicates that the risk of developing resistance, a significant clinical problem
with current therapy alternatives for hepatitis B, is very low with NVP018.
Finally, NVP018 also demonstrates activity in an animal model of chronic
hepatitis B infection.

According to the WHO, over 2 billion people have been in contact with the
hepatitis B virus and 240 million people have developed chronic hepatitis B.
This means that the disease is one of the largest global medical challenges. The
chronic disease is estimated to cause more than 600,000 deaths yearly through
advanced cirrhosis of the liver or primary liver cancer. The disease is
worldwide, but most common in Southeast Asia, Eastern Europe and Africa, with
over 8% chronic carriers. In Western Europe and the US, the frequency is less
than 1%. Currently available pharmaceuticals display limited effectiveness and
there is a significant risk of the virus developing resistance, so accordingly,
there is a substantial need for new pharmaceuticals.

NVP018 is an oral preparation of NeuroVive’s leading drug candidate in the
company’s new portfolio of cyclophilin inhibitors. The preclinical development
program has demonstrated that NVP018 has unique characteristics that make it a
promising anti-viral drug candidate and the new research results underscore
NVP018’s clinical potential for treating chronic hepatitis B infection.

“The results of the preclinical tests of NVP018, conducted by bodies including
the prestigious Scripps Research Institute are very promising, with convincing
data that cyclophilin inhibitors have a positive effect to hepatitis B virus
infection. NVP018 is currently in a preclinical program, to be administered on
patients at a later stage in clinical trials,” commented Jan Nilsson, COO of
NeuroVive.

Current status of NeuroVive products

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CicloMulsion®
NeuroVive’s product CicloMulsion® is the first cyclophilin inhibitor developed
for treating reperfusion injury. The product’s potential for treatment of
myocardial infarction is currently being evaluated in a clinical phase III
study. The final participant of a total of 972 patients was enrolled on 16
February 2014. The results of this study are scheduled for presentation in 2015
after a one-year follow-up is completed on all patients and study data has been
compiled.

NeuroSTAT®
NeuroVive is developing NeuroSTAT® for treating patients with severe traumatic
brain injury (TBI). NeuroSTAT® is currently being evaluated in a clinical phase
IIa study at Rigshospitalet, the Copenhagen teaching hospital. The study is
focusing on safety and pharmacokinetics, and 5 of a planned 20 patients have
been enrolled. The design and planning work for a phase III study has commenced.
The company has obtained orphan drug designation for NeuroSTAT® for moderate to
severe traumatic brain injury in the US and EU. Orphan drug designation confers
market exclusivity for 7 years in the US and 10 years in the EU from the date
when the company secures marketing authorization.

NVP018
The recently acquired cyclophilin inhibitors are part of the family of molecules
called Sangamides, and based on a new and unique chemical platform of what are
known as polyketides. NVP018 is NeuroVive’s primary drug candidate in the
company’s new portfolio of potent cyclophilin inhibitors. It has undergone
extensive preclinical development and has been developed for treating hepatitis
B/C. This product demonstrates potent efficacy against virus replication and has
a positive safety and pharmacokinetic profile. Cyclophilin inhibitors have the
potential for broad-based application, and NeuroVive is currently evaluating
NVP018’s potential for other viral indications.

Other products
More information on all products developed by NeuroVive is available at
www.neurovive.se/index.php/en/research-development/our-products

About NeuroVive
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.

For media and investor relations 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 via the contact above.

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 28 March 2014, at 8:30 a.m. CET.