Bristol-Myers Squibb ends development of hepatitis C drug over safety issues; to take $1.8 billion charge

Bristol-Myers Squibb announced that it ended development of the experimental hepatitis C drug BMS-986094, which it gained through the $2.5-billion acquisition of Inhibitex, due to safety concerns. The company suspended dosing in a mid-stage trial of the nucleotide polymerase inhibitor earlier this month after a patient developed heart failure and was hospitalised.

The drugmaker began studies of BMS-986094 in May, investigating various doses, as well as all-oral combinations involving the compound. Bristol-Myers Squibb had enrolled 113 patients of the 210 planned for the Phase II trial. The company indicated that to date, nine patients who have received the drug have been hospitalised, including the initial patient who later died, with two remaining in hospital. "The cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established," Bristol-Myers Squibb noted.

According to a spokeswoman, the company is now monitoring the health of more than 100 other patients who had participated in the study, and is notifying nearly 150 others who were part of earlier testing of the drug. She added that Bristol-Myers Squibb will conduct studies to understand how the kidney and heart problems arose, and will share the findings with other drugmakers and researchers.

Bristol-Myers Squibb indicated that as a result of ending the development programme for BMS-986094 it will record an impairment charge of $1.8 billion in the third quarter of 2012.

Other companies developing nucleotide polymerase inhibitors include Idenix Pharmaceuticals, whose experimental drug IDX184 was placed on clinical hold by the FDA shortly after Bristol-Myers Squibb reported the first serious cardiac-related adverse event linked to BMS-986094. At the time, Idenix CEO Ron Renaud said the agency was also looking at other compounds from the same drug class.

Vertex Pharmaceuticals spokeswoman Megan Pace said the company hadn’t been contacted by the FDA regarding safety issues for its nucleotide polymerase inhibitor drug, adding "our drug is structurally different" than those from Bristol-Myers Squibb and Idenix. Meanwhile, Gilead Sciences' spokeswoman Cara Miller noted that the company's nucleotide polymerase inhibitor, GS-7977, which was gained through the $11-billion purchase of Pharmasset, hasn’t had the same safety issues as Bristol-Myers Squibb's drug. "In all studies to date, GS-7977 has been well tolerated and has exhibited a favourable safety profile," Miller commented.

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