Novo Nordisk (NYSE:NVO) has unveiled its plans to acquire ocedurenone, an experimental drug from KBP Biosciences, for a deal valued at up to $1.3 billion. This acquisition is set to be completed before the end of the year.
Ocedurenone is an orally administered, small-molecule, non-steroidal mineralocorticoid receptor antagonist. It is currently under evaluation in the late-stage CLARION-CKD study involving patients with uncontrolled hypertension and advanced chronic kidney disease (CKD). The phase III CLARION-CKD study is ongoing in the United States, Europe, and Asia, with over 600 patients expected to be randomized at more than 150 sites.
Novo Nordisk also plans to initiate phase III trials for ocedurenone in additional cardiovascular and kidney disease indications. The drug has undergone assessment in nine clinical trials, including the phase IIb BLOCK-CKD study, where it successfully met its primary endpoint by demonstrating a clinically meaningful and statistically significant improvement in systolic blood pressure in patients with stage 3b/4 CKD and uncontrolled hypertension. Importantly, the study reported no severe hyperkalemia or acute kidney injury.
Given that hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease, and premature death, Novo Nordisk aims to harness ocedurenone’s potential as a best-in-class treatment for uncontrolled hypertension while addressing cardiovascular and chronic kidney disease.
The acquisition of ocedurenone will have no impact on Novo Nordisk’s operating profit outlook for 2023 or its ongoing share buy-back program.
Novo Nordisk’s shares have experienced significant growth, surging by 49.5% year-to-date, outperforming the industry’s growth of 8.5%.
Additionally, Novo Nordisk made headlines recently when it decided to halt the kidney outcomes study, FLOW, involving its drug Ozempic. This decision was based on the positive recommendation of an independent data monitoring committee. The FLOW study evaluates the effectiveness of Ozempic in preventing the progression of renal impairment in people with type II diabetes and CKD, in comparison to a placebo. Data from an interim analysis of the FLOW study is expected in the first half of 2024.
Furthermore, the company raised its sales and operating profit forecast for 2023 due to increased demand for its diabetes drug Ozempic (semaglutide) and obesity drug Wegovy. Sales for 2023 are now projected to grow by 32-38%, up from the previous estimate of 27-33%, while operating profit growth is estimated at 40-46%, up from the previous estimate of 31-37%.
Novo Nordisk’s impressive performance in 2023 can be attributed to the robust adoption of its key drugs and the positive developments surrounding them.
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