Merger between OnCore and Tekmira includes development of NVP018 for the treatment of Hepatitis B

US biotechnology company OnCore Biopharma, Inc. (OnCore), which has licensed NeuroVive’s drug candidate NVP018 for the treatment of chronic Hepatitis B virus infection (HBV), has agreed to merge with Canadian listed RNAi therapeutics company Tekmira Pharmaceuticals Corporation (Tekmira). OnCore would continue as a subsidiary of Tekmira, and the licensing agreement for NVP018 between NeuroVive and OnCore will remain in force following the merger as the combined company continues to work in the HBV area.

OnCore and Tekmira announced on January 11, 2015 that they have agreed to merge; the merger itself is subject to Tekmira stockholder approval and other customary closing conditions. A joint press release issued by the two companies states, among other things, that they intend to advance a robust pipeline of assets, including NVP018, with the ultimate goal of delivering a curative regimen for HBV. Hepatitis B is a major global health problem with up to 350 million people chronically infected.   Most currently available therapies aim to suppress this infection but do not lead to a cure in the overwhelming majority of patients. Please note that NVP018 is referred to as OCB-030 in OnCore’s portfolio of product candidates.

“I walk away with a very positive view of the merger as the synergies between the companies’ technology platforms increases the probability of their success in developing a clinically effective treatment for Hepatitis B and may also reduce the time to market of such a treatment,” commented NeuroVive’s COO Jan Nilsson.

As previously communicated, NeuroVive has outlicensed its candidate drug NVP018 to OnCore for the oral treatment of Hepatitis B. Under the licensing agreement with OnCore, NeuroVive’s remuneration consists of an upfront payment alongside a number of conditional payments based on pre-determined milestones, including sales targets. In addition, NeuroVive will receive incremental royalty payments based on gross revenue from future sales of NVP018. The exact terms of the agreement are not disclosed. The license agreement is unaffected by the merger agreement and will remain in force following the closing of the merger.

Current status of NeuroVive’s projects and drug candidates 


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 . CicloMulsion® will also be evaluated in a number of clinical phase II studies for the treatment of other acute heart and kidney injury within the framework of the collaboration with Hospices Civils de Lyon and 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 9 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 .

NVP019
NVP019 i s 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 i s being developed as the next generation cyclophilin inhibitor for reperfusion injury in heart attack, but also for other acute conditions where general protection of vital organs is central to counteracting 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 .

NVP018
NVP018 is an oral formulation based on the same active substance as NVP019. It has been developed for treatment of Hepatitis B and was outlicensed to OnCore Biopharma, Inc. ( www.oncorebiopharma.com ) in September 2014. OnCore Biopharma has termed the drug candidate OCB-030.

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 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.

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 19 January 2014, at 3.30 p.m. CET.


NeuroVive Pharmaceutical AB (publ) -  the 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.  NeuroVive Pharmaceutical (OTC: NEVPF) trades on the OTC Grey Market. Investors can find Real-Time quotes and market information for the company at  www. otc markets.com/stock/ NEVPF /quote  


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About Us

NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. The company’s strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). www.neurovive.com

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