News Feature | September 11, 2014

NeuroVive, OnCore BioPharma Sign $150M Licensing Agreement For HBV Infection Treatment

By C. Rajan, contributing writer

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Sweden based NeuroVive Pharmaceutial has just entered into an exclusive worldwide licensing agreement with U.S. biotech company OnCore BioPharma for the development and commercialization of NeuroVive’s drug candidate NVP018 for chronic Hepatitis B Virus (HBV) infection.

Under the terms of the agreement, NeuroVive stands to receive up to $150 million in milestone payments as well as additional royalties on future drug sales. The licensing agreement grants OnCore the exclusive global rights to develop oral formulations of NVP018 for the treatment of chronic Hepatitis B infection. In exchange, NeuroVive receives an initial upfront payment, several conditional milestone payments, and payments relating to sales targets.

“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 COO.

Pennsylvania based OnCore, a spin-out from Pharmasett, is already working on developing solutions for treating chronic HBV infections. The company is currently looking at targeting cccDNA as a potential treatment option, while also working on combination therapies to fight persistent HBV infections. OnCore believes that NeuroVive's NVP018 will complement its existing pipeline directed at achieving an oral cure for HBV. OnCore intends to evaluate NVP018 in clinical trials in 2015.

“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, CSO at OnCore.

Chronic Hepatitis B is a serious liver infection caused by the Hepatitis B virus (HBV), which increases a patient’s risk of death from liver cirrhosis and liver cancer. According to the World Health Organization (WHO) estimates, more than 780,000 people die every year due to Hepatitis B, with over 350 million people infected with the virus globally. Most currently available therapies only manage to suppress the infection but do not completely eradicate the HBV infection from the liver.

NVP018 is an oral, sangamide-based, second generation cyclophilin inhibitor that has undergone extensive pre-clinical development and demonstrated high potency against virus replication with a positive safety and pharmacokinetic profile.

NeuroVive has recently entered into several other collaborations to improve its research and commercial capabilities. In June, NeuroVive extended its agreement with the Hospices Civils de Lyon to help with clinical development programs of its drug candidates. Earlier, NeuroVive initiated a research collaboration in mitochondrial medicine with A1M Pharma. In January, NeuroVive extended its partnership agreement with InVentiv Health to prepare for the upcoming market launch of its drugs.

NeuroVive's leading products, CicloMulsion (for heart attack) and NeuroSTAT (for traumatic brain injury), are currently being evaluated in phase III and phase II studies. NeuroVive has also secured orphan drug designation for NeuroSTAT in the U.S. and EU for moderate and severe traumatic brain injury.