BMS Stumbles in Hep C Race; Heart Issue Halts Trial
Bristol-Myers Squibb suspended its ongoing Phase II clinical study of a liver disease Hepatitis C drug just months after paying $2.5 billion to buy the company that developed it—a move that positions the company as an also-ran in the scramble among drug developers to bring to market treatments for the disease.
BMS stopped its trial on BMS-986094 (formerly INX-189), a nucleotide polymerase inhibitor or “nuc,” after a patient who had received a 200 mg dose of the drug experienced heart failure, BMS spokeswoman Sonia Choi told several news outlets, including The Wall Street Journal and Bloomberg News.
“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,” BMS said in a statement.
BMS acquired the drug in January when it bought Inhibitex, hoping to have a leg up on rival drug companies in developing a treatment for Hep C, which afflicts 170 million patients worldwide. Gilead Sciences said last week it plans to start a combination study of Hep C medicine GS-7977 with another drug in a trial of 800 patients starting in the fourth quarter, putting it on track to request U.S. regulatory approval in 2014. Abbott Laboratories earlier this year presented promising results from two Phase II studies for drug combinations aimed at Hep C, with additional data set to be presented later this year at the American Association for the Study of Liver Diseases meeting.
“We recommend that investors assume BMY’s nuc is dead,” Mark Schoenebaum, an analyst with ISI Group, said in a note to clients, adding a prediction that the stock would drop: “We expect to continue to see BMY lag the group as it has much if this year.”
“This is perhaps yet another chink in the armor of a relatively expensive stock that has earned its multiple via R&D and business development successes,” Schoenebaum added in the note, cited by Bloomberg along with a note to clients by Timothy Anderson, an analyst with Sanford C. Bernstein & Co.
Anderson cut his estimate of 2016 sales of Bristol-Myers’ hepatitis C franchise from $2 billion to $1.2 billion, but also cautioned that more information was needed on the heart failure: “Sometimes companies take the conservative step of suspending dosing when new safety issues arise until the data can be analyzed and excessive harm can be ruled out.”