NeuroVive Pharmaceutial AB, a leading mitochondrial medicine company, has signed an exclusive global outlicencing agreement with the US biotechnology company OnCore BioPharma, Inc. related to the development and commercialisation 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 prioritised 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 chief executive officer,
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.

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 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.