Date: 2016-10-21
Type of information: Termination of an agreement
Compound: NVP018 (second-generation cyclophilin inhibitor)
Company: NeuroVive Pharmaceutical (Sweden) OnCore Biopharma, now Arbutus Biopharma (USA - PA)
Therapeutic area: Infectious diseases
Type agreement: licensing
Action mechanism: cyclophilin inhibitor. NVP018 is an orally-available, sangamide-based, second generation cyclophilin inhibitor. 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.
Disease: hepatitis B
Details: * On September 9, 2014, NeuroVive Pharmaceutial, a swedish mitochondrial medicine company, has signed an exclusive global outlicensing agreement with the US biotechnology company OnCore BioPharma, related to the development and commercialization of NeuroVive’s drug candidate NVP018 for oral treatment of chronic hepatitis B virus (HBV) infection. 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 agreement can give NeuroVive in total $150 million in conditional milestone payments plus royalties on future drug sales. OnCore anticipates that NVP018 will be evaluated in clinical trials in 2015.
Financial terms: 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.
Latest news: * On October 21, 2016, NeuroVive Pharmaceutical announced that the license agreement with Arbutus Biopharma (formerly OnCore Biopharma, Inc.) has been terminated and all rights to the NVP018 compound have been reverted back to NeuroVive. In its portfolio of several Hepatitis B compounds, Arbutus has previously made the decision to proceed with other compounds and to discontinue the development of NVP018 for this indication. As a consequence, the agreement between Arbutus and NeuroVive has now been terminated. * On October 28, 2015, NeuroVive Pharmaceutical announced that they will seek to find a suitable path forward to continue the development of the compound, which is currently out-licenced to Arbutus Biopharma. After extensive preclinical evaluation of OCB-030 and other cyclophilin inhibitors against HBV, Arbutus Biopharma, formerly OnCore Biopharma, has concluded that the data do not support further development of OCB-030 as a single agent or in combination with our other drug candidates. As a result, Arbutus is discontinuing development of OCB-030 and has suspended interest in the cyclophilin inhibitor class so the company can focus its resources on higher priority agents that directly target HBV. NeuroVive believes that the compound still has future potential based on the extensive, independent evidence that supports its application in this area. * On February 5, 2015, NeuroVive Pharmaceutial has presented further details regarding the previously communicated exclusive, worldwide licensing agreement with OnCore Biopharma for the oral treatment of hepatitis B virus (HBV). This information will be made public with NeuroVive´s consent as a part of OnCore´s current process towards a merger with Tekmira Pharmaceutical. OnCore and Tekmira filed a registration statement with the Securities and Exchange Commission (SEC) on February 4, 2015. To comply with SEC rules, OnCore included a summary of the material terms of its license agreement with NeuroVive in the registration statement. Highlights about the agreement in OnCore´s registration statement: The up-front licensing fee is $1 million. NeuroVive will receive OnCore stock worth $1 million upon the closing of an initial public offering for OnCore. The compay will also receive up to $47.0 million in clinical development and regulatory milestones per indication. and up to $102.5 million in sales performance milestones per licensed product and indication. The gross sales royalty is tiered and in the mid-single to low double digit range. OnCore can expand the exclusive license to include treatment of viral diseases other than HBV. Under special conditions, OnCore can expand the exclusive license to include non-oral variations of licensed products. If OnCore terminates the license agreement for convenience prior to the first commercial sale, OnCore will be obligated to pay NeuroVive $2 million. If the agreement is terminated early without material breach from NeuroVive, OnCore is obligated to grant NeuroVive an exclusive license to all regulatory approvals, know-how and trademarks related to the terminated licensed products in the terminated countries.
Under the termination agreement, NeuroVive will at no cost receive NVP018 drug product and material produced by Arbutus Biopharma, representing a value of approximately $ 1.5 million. Data from preclinical and CMC development have been transferred. Furthermore, all license rights to the NVP018 compound have been reverted to NeuroVive for further development in any potential indication.
