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肝胆相照论坛 论坛 学术讨论& HBV English NeuroVive制药(STO:NVP)已经解决了与杨梅生物制药(A ...
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发表于 2016-10-22 09:45 |只看该作者 |倒序浏览 |打印
NeuroVive Pharmaceutical (STO:NVP) has resolved its standoff with Arbutus Biopharma ($ABUS) and regained control of a hepatitis B candidate. The asset, NVP018, has spent the past year in limbo as NeuroVive and Arbutus have tried to figure out a path forward for it, but is now poised to resume its progress.

Lund, Sweden-based NeuroVive outlicensed the oral antiviral candidate to Arbutus, then known as OnCore Biopharma, in 2014 in a deal that could have been worth up to $150 million (€138 million). OnCore subsequently merged with Tekmira. At the time, NeuroVive spun the merger as a boost for NVP018. But, one year ago, NeuroVive learned Arbutus had halted development of NVP018, leaving the future of the asset in doubt.

The status of the drug became murkier still in July when NeuroVive received what it called a “purported notice of termination” from Arbutus. NeuroVive said it questioned the notice “on several grounds,” adding that “the fate of the license remains under discussion.” NeuroVive later warned investors that Arbutus’ decision to halt development “may have some financial consequences.”

Now, three months after Arbutus submitted its termination notice and one year after it stopped work on NVP018, the companies have reached an agreement.

NeuroVive has regained rights to NVP018 in all indications. And the Swedish mitochondrial medicine specialist has picked up $1.5 million worth of drug product and material manufactured by Arbutus. NeuroVive isn’t paying anything for the drug product and material.

With Arbutus also transferring its preclinical and CMC data, NeuroVive thinks it has a platform from which to advance NVP018. Exactly how NeuroVive proceeds is still being decided.

“As we see several very exciting potential treatments with NVP018 in areas with unmet medical need, the R&D team is currently exploring various options for further development of these opportunities. The material provided by Arbutus will be most useful in these activities," NeuroVive CEO Erik Kinnman said in a statement.

The opening up of a preclinical research opportunity comes at a time when NeuroVive needs fresh candidates to soften the blows of clinical-phase failures. NeuroVive scrapped an acute kidney injury program earlier this month after the drug came up short in a Phase II trial. That marked the second time in 18 months the drug, CicloMulsion, had failed in the clinic. The missteps gutted NeuroVive’s late-phase pipeline and left question marks over the likelihood of its other clinical program delivering positive data.
Read more on hepatitis B, NeuroVive Pharm

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发表于 2016-10-22 09:45 |只看该作者
NeuroVive制药(STO:NVP)已经解决了与杨梅生物制药(ABUS)的对立,并重新控制乙型肝炎候选人。该资产NVP018已经花费了过去一年的时间,因为NeuroVive和Arbutus试图找出一条前进的道路,但现在准备恢复其进展。

Lund,瑞典NeuroVive公司在Arbutus公司(当时被称为OnCore Biopharma公司)上证实了口服抗病毒药物的候选者,2014年的交易价值高达1.5亿美元(1.38亿欧元)。 OnCore随后与Tekmira合并。当时,NeuroVive将合并作为NVP018的推动。但是,一年前,NeuroVive学会了Arbutus停止了NVP018的开发,留下了资产的未来的怀疑。

这种药物的状态在7月仍然是阴谋,当NeuroVive收到它所谓的“据称终止通知”从杨梅。 NeuroVive说,它“质疑”通知“,有几个理由,”补充说,“许可的命运仍在讨论中。”NeuroVive后来警告投资者,杨梅的决定停止发展“可能会有一些财政后果。

现在,在Arbutus提交终止通知的三个月后,以及在NVP018停止工作后一年,这些公司已达成协议。

NeuroVive在所有适应症中恢复了NVP018的权利。瑞典线粒体医学专家收购了价值150万美元的药物产品和由杨梅制造的材料。 NeuroVive不为药品和材料支付任何费用。

随着Arbutus也转移其临床前和CMC数据,NeuroVive认为它有一个从其推进NVP018的平台。 NeuroVive的收益是如何确定的。

“由于我们看到NVP018在医疗需求尚未得到满足的领域有几种非常令人兴奋的潜在治疗方法,研发团队正在探索各种选择,以进一步发展这些机会。 Arbutus提供的材料在这些活动中将是最有用的,“NeuroVive的CEO Erik Kinnman在一份声明中说。

临床前研究机会的开放是在NeuroVive需要新的候选者以软化临床阶段失败的打击时。 NeuroVive在该药物在第二阶段试验中出现短缺之后,本月早些时候报废了急性肾损伤计划。这标志着第二次在18个月的药物,CicloMulsion,在诊所失败。这些错误导致了NeuroVive的后期管道问题,并留下了其他临床程序提供正面数据的可能性。
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发表于 2016-10-22 15:53 |只看该作者
没看明白。到底的意思 是。

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发表于 2016-10-22 18:44 |只看该作者
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Arbutus从NeuroVive买了NVP018 (亲环蛋白抑制剂, Cyclophilin inhibitor)作为hbv的治疗.
但Arbutus宣布停止发展NVP018.现在NeuroVive恢复了NVP018的权利.
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