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Oncore候选药物是亲环素抑制剂:NYP018 [复制链接]

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发表于 2014-9-10 11:53 |只看该作者 |倒序浏览 |打印
Neurovive Pharmaceutical: NeuroVive signs USD 150 m agreement with OnCore BioPharma for the outlicensing of NVP018 for the treatment of chronic Hepatitis B virus infection

Published: Sept 9, 2014 2:11 a.m. ET


STOCKHOLM, Sep 09, 2014 (BUSINESS WIRE) -- Regulatory News:

NeuroVive Pharmaceutial AB (sto:NVP), 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.

NVP018

NVP018 is NeuroVive’s primary drug candidate in the company’s new portfolio of potent cyclophilin inhibitors belonging to a family of molecules known as Sangamides. Sangamides are analogs of the naturally-occurring polyketide Sanglifehrin A and are derived from a new and unique polyketide engineering technology. NVP018 has undergone extensive pre-clinical development for the treatment of chronic Hepatitis B and C and is outlicensed to OnCore Biopharma for further development and commercialization for the treatment of chronic Hepatitis B. The product has demonstrated high potency against virus replication and has a positive safety and pharmacokinetic profile. Cyclophilin inhibitors potentially have a wide range of applications.

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发表于 2014-9-10 11:54 |只看该作者
Neurovive药业:NeuroVive签署了OnCore生物制药美元150米协议NVP018的慢性乙肝病毒感染的治疗outlicensing

发布时间:2014年9月9日上午02点11分的ET


斯德哥尔摩,2014年9月9日(美国商业资讯) - 监管新闻:

NeuroVive Pharmaceutial公司(STO:NVP)是一家领先的线粒体药材公司,已与美国生物技术公司OnCore BioPharma公司相关NeuroVive的候选药物NVP018的开发和商业化的口腔治疗慢性乙型肝炎的全球独家outlicensing协议病毒(HBV)感染。该协议可以在共1.5亿美元的对未来药品销售条件的里程碑付款加上稿费给NeuroVive。

“经过与多家领先的制药企业进行广泛的讨论,我很高兴地宣布,我们已经与OnCore,强大的合作伙伴,提供了最佳的资源,从一个有前途的候选药物的阶段发展NVP018到一个完整的处理这个协议全球医疗挑战。这证实了固有的在我们的医药组合中的金融潜力,收入将使我们能够进一步加强在线粒体医学的优先方面的工作。我也想借此机会,把目光对准我们的COO月尼尔森,他们的工作一直重要的是获得本协议的地方,“评论NeuroVive的CEO的MikaelBrönnegård。

该许可协议提供OnCore的全球独家开发权NVP018口服制剂用于治疗慢性B型肝炎感染的治疗。该补偿NeuroVive由最初的预付款以及一些基于预先确定的条件的里程碑付款和作为有关销售目标及付款。此外,NeuroVive将根据从NVP018未来的销售总收入增量收到版权费。该协议的总价值为1.5亿美元不包括特许使用金。有关于支付和版税的数字协议的具体条款没有披露。

“OnCore站着,因为其独特的专注于乙型肝炎和计划带来的候选药物,以快速,高效地市场走出了谈判,其中包括一些领先的制药公司。此外,该公司的高级管理人员,开拓治疗丙型肝炎的形式提供特强的结果在Pharmasset在工作。我深信,OnCore对我们来说是合适的合作伙伴,“评论一月尼尔森,NeuroVive的首席营运官。

“我们认为相当大的潜力在NVP018并考虑这一协议是朝着制定一个成功的治疗慢性乙型肝炎我们的目标迈出的重要一步,是治疗慢性乙肝,巩固我们在丙型肝炎在Pharmasset的成功。”评论迈克尔博士索菲亚,首席科学官OnCore。

亲环素抑制剂和NVP018

NVP018是一种口服用,sangamide为主,第二代环素抑制剂,具有分化良好的临床前轮廓相对于其他亲环蛋白抑制剂。在国际肝病会议™2014年,欧洲肝脏研究协会(EASL)的研究年会上公布的4月份数据,表明NVP018出现在体外两种机制来抑制乙肝病毒。首先,NVP018直接抑制病毒复制的数个阶段中的肝细胞和第二,NVP018通过加强通过干扰素调节因子的宿主免疫应答(脉冲响应函数),其中包括一个相互作用的亲环素A和IRF9之间强效抑制,的一个关键部件间接作用JAK / STAT通路,通过细胞膜转运的化学信号。数据还表明,显影性的风险,这种显著临床问题,目前的治疗乙型肝炎,非常低,NVP018。

NVP018

NVP018是公司新的属于一个家庭被称为Sangamides分子的强效亲环蛋白抑制剂组合NeuroVive的主要候选药物。 Sangamides是自然产生的聚酮Sanglifehrin A的类似物,并从一个新的和独特的聚酮工程技术而得。 NVP018进行了广泛的临床前开发用于治疗慢性乙型和丙型肝炎的治疗,并outlicensed到OnCore生物医药为治疗慢性乙型肝炎的产品治疗的进一步发展和商业化已经表现出对病毒复制的高效力,并具有良好的安全和药代动力学特性。亲环蛋白抑制剂可能具有广泛的应用前景。

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发表于 2014-9-10 14:38 |只看该作者
不知道亲环蛋白抑制剂与以往的那些口服药有没有本质的区别?

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发表于 2014-9-10 15:17 |只看该作者
看上去是非根治型药剂

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发表于 2014-9-10 15:39 |只看该作者
本帖最后由 StephenW 于 2014-9-10 15:39 编辑

回复 肝肠欲断 的帖子

是不同的,不是核苷类, 不是逆转录酶抑制.

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发表于 2014-9-10 15:51 |只看该作者
回复 kite2002005 的帖子

它可以调节免疫系统.

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发表于 2014-9-10 16:09 |只看该作者
hbv  每个靶点都有代表药,一个药研发12年以上,太长了,最快到来的只有arc520,和莫非赛定了

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发表于 2014-9-10 18:20 |只看该作者
回复 newchinabok 的帖子

有没有根治性靶点的药物呢?。。。

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发表于 2014-9-11 15:30 |只看该作者
回复 StephenW 的帖子

是不是有点像干扰素

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发表于 2014-9-11 17:33 |只看该作者
本帖最后由 StephenW 于 2014-9-11 17:33 编辑

回复 肝肠欲断 的帖子

你问的问题非常好, 我不知道答案,我的理解是(可以是错误的):
1,它的作用不同干扰素
2,但像干扰素,它可以抑制病毒的复制,同时也可减少HBV病毒诱发的免疫抑制.
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