Big Pharma Setbacks

Bristol-Myers Squibb has stopped development of BMS-986094, a nucleotide polymerase inhibitor that was in Phase II development for treatment of hepatitis C. Tests of the compound, which BMS acquired with its purchase of Inhibitex for $2.5 billion earlier this year, led to the death of one patient from heart failure; eight others required hospitalization.

The company says the adverse reactions involved heart and kidney toxicity, but a direct cause has not been “definitely established.” In a filing with the Securities & Exchange Commission last week, the drug firm reports a $1.8 billion pretax impairment charge for the third quarter of 2012 related to its decision to stop development of the drug.

Meanwhile, Eli Lilly & Co. says its Alzheimer’s disease candidate, solanezumab, did not meet primary cognitive and functional endpoints for patients in Phase III trials. Secondary analysis of data, however, showed statistically significant slowing of cognitive decline in the overall study population of patients with mild to moderate Alzheimer’s disease.

Lilly says it will make decisions on future development of solanezumab after consultation with regulators. Lilly also reports that Phase III trials of prasugrel, a drug it developed with partner Daiichi Sankyo for acute coronary syndrome, failed to meet primary endpoints in a study that compared its use in combination with aspirin to clopidogrel, BMS and Sanofi’s Plavix, with aspirin. Prasugrel, marketed as Effient, was approved by the Food & Drug Administration in 2009.