BMS Suspends Study of Nucleotide BMS094 Formerly INX189

StephenW

BMS Suspends Study of Nucleotide BMS094 Formerly INX189


      Aug. 1, 2012

Bristol Myers acquired BMS-986094 through its $2.5 billion purchase of Inhibitex Inc earlier this year.

The drug belongs to a promising new type of hepatitis C medicines called nucleotide polymerase inhibitors, which work by targeting polymerase -- an enzyme essential for replication of the hepatitis C virus.

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Bristol-Myers Suspends Hepatitis C Drug Clinical Trial

Bloomberg By Andrew Pollack and Jason Gale on August 02, 2012

Bristol-Myers Squibb Co. said it suspended a mid-stage study of an experimental hepatitis C drug obtained in its $2.5 billion January acquisition of Inhibitex Inc. after a patient developed heart failure.

Bristol-Myers suspended the clinical trial of the medicine, known as BMS-986094, "on the emergence of a serious safety issue," the New York-based drugmaker said in a statement. Administration of the drug to about 30 patients enrolled in a so-called Phase 2b study has been stopped pending an investigation, Sonia Choi, a Bristol-Myers spokeswoman, said yesterday in a telephone interview. Heart failure occurred in one patient receiving the highest daily dose of 200 milligrams, she said.

"Although the issue presented in a patient receiving that dose, it doesn't preclude the possibility of issues with other patients at other doses," Choi said. "At this point, we don't know what the cause of the safety issue is. We are taking the time to evaluate information on all patients receiving this compound."

Bristol-Myers has made acquisitions to gain new experimental medicines as it seeks to replace revenue from Plavix, a blood thinner that produced 33 percent of the company's 2011 sales and began facing generic competition in May. The company is competing with Gilead Sciences Inc., among other drugmakers, to gain approval of a new generation of medicines to treat the 170 million patients worldwide with hepatitis C. The market is estimated at $20 billion for the new pills designed to work more quickly with fewer side effects for those with the liver infection.

The clinical trial, the second of three phases usually needed for regulatory approval, involved BMS-986094 in combination with daclatasvir, another of the company's experimental hepatitis C treatments, according to data compiled by Bloomberg.

StephenW

拜耳暂停核苷酸BMS094研究以前INX189


  2012年8月1日，

布里斯托尔迈尔斯通过收购其约2.5亿美元Inhibitex公司今年初收购：BMS-986094。

该药物属于一种很有前途的C型肝炎药物的新类型，称为核苷酸聚合酶抑制剂，针对聚合酶 -  C型肝炎病毒复制所必需的酶。

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百时美施贵宝暂停“C型肝炎药物临床试验

彭博于2012年8月02，安德鲁·波拉克和贾森烈风

施贵宝公司表示，暂停的中期阶段的研究丙型肝炎的实验获得的$ 2.5十亿一月Inhibitex公司收购后，病人的心脏衰竭的药物。

百时美施贵宝暂停药物的临床试验，被称为：BMS-986094“，出现一个严重的安全问题上，”纽约为基础的制药公司在一份声明中说。招收约30名患者在所谓的第2b期研究药物管理局已停止，待调查，索尼娅彩，百时美施贵宝发言人昨天表示，在接受电话采访。她说，在一个接受最高剂量为每日200毫克的病人发生心脏衰竭。

“虽然在接受该剂量的病人提出的问题，它并不排除与其他剂量的患者的问题的可能性，”崔京周说。 “在这一点上，我们不知道安全问题的原因是什么，我们正在采取的时间来评估所有患者接受这种化合物的信息。”

百时美施贵宝收购，以获得新的实验性药物，因为它旨在取代，产生了该公司2011年销售的33％，并开始面临着仿制药的竞争五月一种血液稀释剂Plavix的收入。公司Gilead Sciences公司的竞争，其他制药公司中，获得批准​​的药品治疗170万患者丙型肝炎全球市场设计工作更迅速的新丸估计为$ 20亿美元的新一代与肝感染者的副作用较少。

参与结合daclatasvir，另一个公司的实验C型肝炎治疗的临床试验中，第二，监管部门的批准通常需要三个阶段：BMS-986094，根据彭博汇编的数据。