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.
Thursday, August 23, 2012
Deadly tox threat kills Bristol-Myers' once-brilliant $2.5B hep C prospect
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