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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.


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.


Bristol-Myers Squibb Suspends Administration of Study Drug in Clinical Trial of Investigational NS5B Nucleotide for the Treatment of Hepatitis C

PRINCETON, N.J., Aug 01, 2012 (BUSINESS WIRE) -- Bristol-Myers Squibb Company BMY 0.00% announced today that the Company has suspended study drug administration in an ongoing Phase II study of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor in development for the treatment of hepatitis C. This voluntary action was taken to protect patient safety based on the emergence of a serious safety issue. The cause of the safety issue and any potential relationship to study drug are unknown at this time.

With patient safety as the priority, the Company is undertaking an immediate assessment of all patients in the study and following an evaluation of the patient data, will take appropriate actions.

SOURCE: Bristol-Myers Squibb Company


Bristol's Hep C Drug Blow Up May Benefit Gilead, Idenix, Vertex Pharma


PRINCETON, NJ (TheStreet) -- Bristol-Myers Squibb suspended a mid-stage study of its experimental hepatitis C drug BMS-094 due to a serious safety issue -- a major blow to the company's research pipeline that is also likely to rejigger the way Wall Street views other companies' efforts to develop an all-oral therapy against the viral liver disease.

BMS-094 belongs to the highly coveted and potent class of hepatitis C drugs known as nucleotide polymerase inhibitors, or "nuc" for short. If Bristol is forced to shelve BMS-094 permanently, competitors with their own nucs still in development -- Gilead Sciences Idenix Pharmaceuticals and Vertex Pharmaceuticals -- stand to benefit as long as the toxicity that derailed BMS-094 is specific to that drug and is not a class effect.

For Bristol, the blowup of BMS-094 is even more painful because the drug was the sole reason behind the $2.5 billion acquisition of Inhibitex last January.

The safety issue that forced Bristol to suspend the phase II study of BMS-094 is believed to be heart failure, according to ISI Group analyst Mark Schoenebaum. Bristol is not positive that BMS-094 caused the heart failure but the company is "very concerned" and is taking the extraordinary step of evaluating all patients treated with the drug for potential heart problems, said Schoenebaum in an email to clients.

"We recommend that investors assume BMY's [Bristol's] nuc is dead," writes Schoenebaum.

The blow up of BMS-094 due to toxicity is not necessarily a surprise. TheStreet contributor Nathan Sadeghi-Nejad first raised safety concerns about BMS-094 in a column last May after returning from a European liver disease meeting where the drug was conspicuously absent.

"I suspect something is wrong with Bristol-Myers' INX-189, which has since been renamed by the company as BMS-094," wrote Sadeghi in the very prescient column last May. "The red flags are popping up everywhere. If I'm right about Bristol-Myers being in trouble, Gilead's lead in the race to develop all-oral therapies for hepatitis C will expand and Idenix Pharmaceuticals' hepatitis C drugs become more attractive."

Gilead's GS-7977 is the most advanced nuc in clinical development, with multiple phase III studies already underway. Idenix is moving its nuc IDX-184 into phase II combination studies. On Monday, Vertex announced the first erly-stage, proof-of-concept data for its nuc ALS-2200 that showed the drug's potency to be comparable to that of GS-7977.

--Written by Adam Feuerstein in Boston.

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