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 $2.5 billion acquisition were in the lead program's basket. Bristol is among the leaders in a mad scramble to advance new "nucs" and NS5A inhibitors that can be combined into an all-oral hep C regimen with megamarket potential.Early this month the company reported that it had halted a mid-stage study of the drug after one of the participants experienced heart failure. Today, Bristol reported that the patient died, and 8 others have been hospitalized; two of those remain in the hospital. A new set of FDA regulations, covering a field the agency has chosen not to supervise in the past, could be a danger on both sides. As many labs, test developers, consultants and FDA lawyers have said, it's the kind of regulation that threatens to stifle innovation with more government red tape. Learn more. Sign up for our FREE newsletter for more news like this sent to your inbox! The company said the adverse events "involved heart and kidney toxicity," but cautioned that no definitive causal link to the drug has been found."The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, the CSO for Bristol-Myers Squibb, in a prepared statement. "In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community." News of the debacle was issued Thursday night. Shares of Idenix ($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.