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标题: [news] Bristol-Myers Squibb to stop BMS-986094 [打印本页]

作者: StephenW    时间: 2012-8-24 12:15     标题: [news] Bristol-Myers Squibb to stop BMS-986094

http://www.fiercebiotech.com/story/deadly-tox-threat-kills-bristol-myers-once-brilliant-25b-hep-c-prospect/2012-08-23
Deadly tox threat kills Bristol-Myers' once-brilliant $2.5B hep C prospect
August 23, 2012 | By John Carroll


Less than 8 months after Bristol-Myers Squibb ($BMY) bought out Inhibitex and its lead hepatitis C drug for $2.5 billion, the company has officially opted to write off the therapy as a complete waste of money and a threat to human safety.

Bristol-Myers has reported that it has a $1.8 billion carrying cost for BMS-986094, a key part of its plan to develop an all-oral therapy for hepatitis C. But almost all of the eggs in that $2.5 billion acquisition were in the lead program's basket. Bristol is among the leaders in a mad scramble to advance new "nucs" and NS5A inhibitors that can be combined into an all-oral hep C regimen with megamarket potential.

Early this month the company reported that it had halted a mid-stage study of the drug after one of the participants experienced heart failure. Today, Bristol reported that the patient died, and 8 others have been hospitalized; two of those remain in the hospital.

The company said the adverse events "involved heart and kidney toxicity," but cautioned that no definitive causal link to the drug has been found.

"The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, the CSO for Bristol-Myers Squibb, in a prepared statement. "In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community."

News of the debacle was issued Thursday night. Shares of Idenix ($IDIX), which has a program that has been compared (roughly) to the BMS drug in development, immediately tumbled 10%. The FDA placed a partial hold on the Idenix program a few weeks after Bristol-Myers found that it had a public relations disaster on its hands.

Over the past year the prospect of multibillion-dollar sales for any new hep C therapy that does away with the need for interferon has driven a fierce race in the clinic among a group of contenders. Regulators seem intent on slamming the brakes if they see any indication that patient safety is being put at risk, which could significantly change the odds among the lead players.

- here's the press release

Related Articles:
Analyst reads last rites after heart failure scuttles Bristol hep C study
Hep C drug deal frenzy can't be slowed by growing doubts
Bristol bags hot hep C drug developer Inhibitex for $2.5B
J&J, BMS join forces in race to develop interferon-free hep C combos

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作者: StephenW    时间: 2012-8-24 12:15

本帖最后由 StephenW 于 2012-8-24 12:16 编辑

致命TOX的威胁杀死了百时美施贵宝的一次辉煌的25亿美元丙肝前景
2012年8月23日|由约翰·卡罗尔


不到8个月后,施贵宝公司(BMY)买下了Inhibitex和其领先的C型肝炎药物为2.5亿美元,该公司已正式选择,核销的治疗,完全是在浪费金钱和对人类安全的威胁。

百时美施贵宝已经报道,它有一个1.8亿美元的账面成本为BMS-986094,一个关键组成部分,其规划发展的所有的口服治疗C型肝炎,但几乎所有的鸡蛋中,25亿美元的收购是处于领先地位程序的篮子里。布里斯托尔是在一个疯狂的争夺领导人之间的新的“nucs”和NS5A抑制剂,可以组合成口服丙肝治疗方案megamarket潜在推进。

本月初该公司宣布,它已经停止了中期阶段研究的参与者经验丰富的心脏衰竭的药物后。今天,布里斯托尔,病人死亡,8人已经住院,两个人留在医院。

该公司表示,不良事件“涉及心脏和肾毒性”,但警告说,没有明确的因果关系已被发现的药物。

“指导我们的首要保护患者的权益,已决定停止发展的BMS-986094,埃利奥特说:”希格,百时美施贵宝(Bristol-Myers公司Squibb)的CSO,在一份事先准备好的声明。 “在所有患者的利益参与丙型肝炎的临床研究,并在与美国FDA合作,我们将BMS-986094提供相关信息告知其他研究的化合物来治疗丙型肝炎的发展,我们也将尽快落实我们进一步的调查更广泛的医疗和科学界分享成果。“

周四晚发布新闻的崩溃。的Idenix公司($ IDIX)的,它有一个程序,进行了比较(大约)的BMS药物开发,股价立即下跌了10%。美国食品和药物管理局将部分保持Idenix公司计划在几个星期后,百时美施贵宝在其手中,它有一个公关灾难。

在过去的一年中的任何新的丙肝治疗与干扰素的需要的数十亿美元的销售前景带动了激烈的角逐,在临床上的竞争者之间的一组。监管机构似乎砰的一声刹车的意图,如果他们看到任何迹象表明,正在把病人的安全风险,这可能会显着改变的可能性之间的主角。

- 这里的新闻稿

相关文章:
分析师读取最后的仪式后击沉了布里斯托尔心脏衰竭丙肝的研究
丙肝不能减缓了越来越大的怀疑毒品交易狂潮
布里斯托尔袋热丙肝药物开发商Inhibitex为25亿美元
J&J,百时美施贵宝在比赛中联手开发丙肝干扰素无连击

了解更多:致命的的TOX威胁杀死百时美施贵宝的一次辉煌的25亿美元丙肝前景 - 媒体FierceBiotech
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作者: laoyu567    时间: 2012-11-26 08:37

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作者: svjpq    时间: 2013-3-6 04:47

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