OnCore BioPharma acquires exclusive worldwide license to NVP018​

 

The team at Isomerase are delighted to announce that OnCore Biopharma Inc. have acquired an exclusive worldwide license from NeuroVive Pharmaceutical AB to develop NVP018 for the treatment of Chronic HBV infection. Sangamide cyclophilin inhibitors including NVP018 (previously known as BC556), were originally discovered and developed by the team at Isomerase using biosynthetic medicinal chemistry, and the Neurovive partnering efforts were carried out in collaboration with the Isomerase team. OnCore will pay NeuroVive an initial upfront payment, development and sales milestones, and royalties based on future sales. The total value of the license agreement is up to $150 million, excluding royalty payments.

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Oncore and Neurovive press releases are as follows:

NeuroVive

NeuroVive signs USD 150 m agreement with OnCore BioPharma for the outlicensing of NVP018 for the treatment of chronic Hepatitis B virus infection

NeuroVive Pharmaceutial AB, a leading mitochondrial medicine company, has signed an exclusive global outlicensing agreement with the US biotechnology company OnCore BioPharma, Inc. related to the development and commercialization 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 prioritized 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 CEO 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.

Cyclophilin inhibitors and NVP018
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 — a global medical challenge
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.

About OnCore Biopharma
OnCore Biopharma, Inc. is a privately held biotechnology company focused on the research, development, and commercialization of therapies for the treatment of chronic Hepatitis B virus (HBV) infection. The Company was founded by former executives of Pharmasset, Inc., which was acquired by Gilead Sciences in January 2012. OnCore has assembled a portfolio of novel product candidates with unique mechanisms of action for the treatment of Hepatitis B and is focused on delivering a cure. It is widely believed that eradicating covalently closed circular DNA (cccDNA) in HBV-infected hepatocytes represents the ultimate solution for curing chronic Hepatitis B infected patients. OnCore is currently addressing an all-oral, permanent HBV cure by targeting cccDNA with the goal of achieving a "functional cure," wherein the risk of death from liver disease due to HBV is the same as a person with a naturally resolved infection. OnCore is combining agents against cccDNA with other novel direct acting antiviral mechanisms and strategies that engage host immune response. OnCore believes that combination therapy will be required to achieve complete eradication of HBV from the liver. OnCore is located at the Pennsylvania Biotechnology Center in Doylestown, Pennsylvania, which is also home to the Hepatitis B Foundation and the Foundation’s research center, the Baruch S. Blumberg Institute. For more information, please visit www.oncorebiopharma.com. To be added to the Company's e-mail list to receive news directly, please send an email to This email address is being protected from spambots. You need JavaScript enabled to view it..

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.

 

OnCore

DOYLESTOWN, Pa., Sept. 9, 2014 (GLOBE NEWSWIRE) -- OnCore Biopharma, Inc. ("OnCore" or the "Company"), a biotechnology company focused on the research, development and commercialization of oral treatments for chronic hepatitis B virus (HBV) infection, announced today the exclusive worldwide license to a series of second-generation cyclophilin inhibitors for the treatment of HBV from NeuroVive Pharmaceutical AB ("NeuroVive"; STO: NVP), a leading mitochondrial medicine company located in Lund, Sweden. Under the terms of the agreement, OnCore will pay NeuroVive an initial upfront payment, development and sales milestones, and royalties based on future sales. The total value of the license agreement is up to $150 million, excluding royalty payments.

NeuroVive's cyclophilin inhibitors, known as sangamides, are based on a new and unique polyketide chemistry platform. NVP018 is the lead drug candidate in their cyclophilin program and has undergone extensive pre-clinical development. OnCore anticipates that NVP018 will be evaluated in clinical trials in 2015.

"NVP018 is a promising anti-viral drug candidate and has tremendous clinical potential for oral use as a novel treatment for patients with chronic hepatitis B infection," stated OnCore's Chief Scientific Officer, Michael Sofia, Ph.D. "We believe that a curative therapy for HBV will likely contain an immunomodulatory agent, such as NPV018, combined with multiple antiviral agents with differing mechanisms of action."

"OnCore stood out in 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," stated Jan Nilsson, NeuroVive's Chief Operating Officer. "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."

About Cyclophilin Inhibitors and NVP108

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 NVP108 appears to inhibit the hepatitis B virus by two mechanisms in vitro. First, the data indicate that NVP018 directly inhibits several stages of viral replication in liver cells. Second, NVP018 appears to act indirectly by strengthening the host immune response via IRFs, including potent inhibition of an interaction between cyclophilin A and IRF9, a key component of the Jak/Stat pathway. Data also indicates that the risk of developing resistance, a significant clinical problem with current therapies for hepatitis B, is very low with NVP018.

About Hepatitis B

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.

About NeuroVive Pharmaceutical ("NeuroVive"): NeuroVive Pharmaceutical AB, 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.

About OnCore

OnCore Biopharma, Inc. is a privately held biotechnology company focused on the research, development, and commercialization of therapies for the treatment of chronic hepatitis B virus (HBV) infection.  The Company was founded by former executives of Pharmasset, Inc., which was acquired by Gilead Sciences in January 2012.

OnCore has assembled a portfolio of novel product candidates with unique mechanisms of action for the treatment of hepatitis B and is focused on delivering a cure. It is widely believed that eradicating covalently closed circular DNA (cccDNA) in HBV-infected hepatocytes represents the ultimate solution for curing chronic hepatitis B infected patients.  OnCore is currently addressing an all-oral, permanent HBV cure by targeting cccDNA with the goal of achieving a "functional cure," wherein the risk of death from liver disease due to HBV is the same as that in a person with a naturally resolved infection.  OnCore is combining agents against cccDNA with other novel direct acting antiviral mechanisms and strategies that engage host immune response. OnCore believes that combination therapy will be required to achieve complete eradication of HBV from the liver.

OnCore is located at the Pennsylvania Biotechnology Center in Doylestown, Pennsylvania, which is also home to the Hepatitis B Foundation and the Foundation's research center, the Baruch S. Blumberg Institute.