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news.US biotechnology company OnCore Biopharma (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 (Tekmira).
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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.
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.
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.