Bristol-Myers Squibb Co. has suspended its study of a drug intended to treat hepatitis C after a patient suffered heart failure, which the company called a “serious safety issue.”
The move raises questions about the experimental drug’s potential and the $2.5 billion price tag Bristol paid earlier this year to buy the company that developed it. The suspension is considered a significant setback for the drugmaker that is already coping with weak sales of its Plavix anti-clotting drug that lost patent protection in May.
ISI Group analyst Mark Schoenebaum said investors should assume that the drug “is dead,” while Bernstein analyst Tim Anderson reduced his forecast for Bristol-Myers’ 2016 per-share earnings by nearly 10%.
The setback doesn’t leave Bristol-Myers empty-handed in hepatitis C drug research because it is developing other hepatitis C drugs. But those other drugs might not be enough to comprise a safe and effective all-oral regimen, which could force Bristol to try to partner with another company developing hepatitis C drugs.
Bristol-Myers said it voluntarily suspended an ongoing Phase 2 study of BMS-986094, which was formerly known as INX-189, a nucleotide polymerase inhibitor, or “nuke.” In a statement, the company said “the cause of the safety issue and any potential relationship to study drug are unknown at this time.”
A patient who had received a 200-milligram dose of the drug experienced heart failure, said Bristol-Myers spokeswoman Sonia Choi. The company can’t rule out the possibility of safety issues with patients who received other doses of the drug.
The drug company is currently assessing all patients in the study and following an evaluation of the patient data, will decide what to do. Assessments will include full physical exams and imaging tests to measure heart health, Ms. Choi said. Any clinically significant abnormalities detected will be reviewed by a consulting cardiologist as soon as possible.
The safety issue could hurt Bristol-Myers in its race with Gilead Sciences Inc., Abbott Laboratories and others to bring the first all-oral hepatitis C regimen to market, hoping to tap what is expected to be a multibillion-dollar market for such a therapy.
An all-oral regimen for hepatitis C would eliminate an injectable drug used in the current standard treatment, interferon, which can be difficult for patients to tolerate.
To strengthen its hepatitis C position, Bristol-Myers in February shelled out $2.5 billion to buy Inhibitex Inc. at a whopping 163% premium. Bristol was lured primarily by Inhibitex’s nuke for hepatitis C, though it did acquire other potential treatments for infectious disease in the deal.
Treatments for hepatitis C are considered lucrative because the disease is prevalent in large sections of the global population. The virus, which can be transmitted sexually or through use of shared needles and at tattoo parlors, affects some 170 million people world-wide.
The “nuke” class of drugs is seen as a cornerstone of potential all-oral regimens for hepatitis C.
Some analysts believe Gilead has the lead in the race for the all-oral regimen, which is likely to be bolstered by Bristol-Myers’ setback.
Abbott Labs is taking a different approach, developing a potential all-oral regimen without a nuke. Abbott has said it could bring an all-oral regimen to market in 2015. Other companies developing new hepatitis C drugs include Vertex Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc.[hr]