KBP Biosciences Co., Ltd.

Novo Nordisk will record an impairment charge of DKK 5.7 billion ($816 million) after the experimental drug ocedurenone failed to meet the primary endpoint of a Phase III study in patients with uncontrolled hypertension and advanced chronic kidney disease (CKD). The company added that it will also review further development of the non-steroidal mineralocorticoid receptor in other indications.Last October, Novo Nordisk agreed to acquire ocedurenone from KBP Biosciences for up to $1.3 billion. At the time of the deal, the orally administered, small molecule was already being investigated in the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced CKD.Novo Nordisk noted that the trial, which was conducted by KBP Biosciences, included a prespecified interim analysis after participants had completed 12 weeks of treatment. At the analysis, an independent data monitoring committee concluded that the study did not meet its main goal of change in systolic blood pressure from baseline to week 12 and will be halted.The Danish drugmaker indicated that the impairment charge corresponds to an estimated negative impact of around 6 percentage points on operating profit growth at constant exchange rates this year.More to come.