BMS halts the development of BMS-986094 due to patient death

Bristol-Myers halts mid-stage study of promising hepatitis C drug

Published: Thursday, August 23, 2012, 7:25 PM Updated: Thursday, August 23, 2012, 7:36 PM

 By Bloomberg NewsThe Star-Ledger

Bristol-Myers Squibb is abandoning an experimental hepatitis C pill it acquired for $2.5 billion earlier this year after one patient died and others were hospitalized while taking the drug in a clinical trial.

Bristol-Myers suspended mid-stage studies of the drug, which was known only as BMS-986094, earlier this month after a patient developed heart failure.

The drug maker, which is based in New York but has a large presence in New Jersey, said yesterday it had decided to halt development of the drug, part of a class of medicines called nucleotide polymerase inhibitors. The company also said it was consulting with U.S. regulators to assess the treatment’s effects.

The original patient subsequently died and eight others suffered from heart and kidney toxicity, the company said in a statement released last night. Two of the patients remain hospitalized.

The hepatitis C treatment was thought by researchers and analysts to be a key therapy in a push by companies, including Gilead Sciences to replace the standard treatment, a regimen including a year of interferon injections that carry flu-like side-effects.

“The decision to halt development of the BMS-986094 has been guided by our overriding interest in protecting patients,’’ said Elliott Sigal, Bristol’s executive vice president and chief scientific officer. “In the interest of all patients, we will make relevant information available to inform the development of other investigational compounds to treat hepatitis C.’’

Bristol-Myers gained the drug with its acquisition of Inhibitex Inc. for $2.5 billion earlier this year.

The company was among a number of drugmakers racing to develop a new generation of medicines to treat an estimated 170 million patients with hepatitis C.

In a statement released after the close of the financial markets, Bristol Myers said it would continue investigating into the cause of the toxicity. The company will also continue to monitor patients who have received the medicine.

Star-Ledger staffwriter Susan Todd contributed to this report.

Source - http://www.nj.com/business/index.ssf/2012/08/bristol-myers_halts_mid-stage.html


Hepatitis C Drug Proves Dangerous
Nine patients are hospitalized and one is dead after taking an experimental drug for hepatitis C developed by Bristol-Myers Squibb Company (NYSE: BMY). On Thursday the company announced it had halted development of the drug, aimed at treating lever disease.

"The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb.

Two of the original nine patients remain hospitalized and Bristol continues to monitor the health of over 100 patients who participating in the study. The company also notified nearly 150 others who were part of earlier test.
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Bristol Drops Hep C Drug After Patient Death
By Ed Silverman

You could see this coming. Last night, Bristol-Myers Squibb abandoned an experimental hepatitis C compound after one patient died of heart failure and nine others were hospitalized during a Phase II study. The move comes less than a month after the drugmaker suspended the trial due to safety issues among patients and that decision, not surprisingly, immediately raised questions about the future of the medication (back story).

The discontinuation is a huge disappointment for Bristol-Myers Squibb, which earlier this year agreed to pay $2.5 billion in cash for Inhibitex and its experimental compound, a nucelotide polymerase inhibitor that was renamed BMS-986094. The wisdom of that deal drew considerable skepticism, though, because the small drugmaker had completed only Phase I testing up to that point.

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BMS halts the development of BMS-986094 due to patient death

Bristol-Myers Squibb announced that it has discontinued the development of BMS-986094 for the treatment of hepatitis C

BMS-986094, formerly known as INX-189, is a nucleotide polymerase inhibitor that is currently being developed in the phase II clinical studies for the treatment of hepatitis C. The FDA has placed a clinical hold on the development of the compound which has also affected the development of Idenix's IDX184 and tanked Idenix shares.

The phase II trial was initially suspended on August 1, 2012 due to a heart failure case which now has resulted in death. As of now, nine patients have been hospitalized and two remained hospitalized. The company has yet to establish a definitive relation between the compound and kidney and heart toxicity. Hoever, for the interest of the patients, it has decided to halt the development of BMS-986094.