Daily Newsletter

17 October 2023

Daily Newsletter

17 October 2023

Novo Nordisk to acquire hypertension therapy ocedurenone

The $1.3bn deal with KBP Biosciences will be completed by the end of 2023.

RanjithKumar Dharma October 17 2023

Novo Nordisk has signed an agreement to acquire ocedurenone to treat uncontrolled hypertension from KBP Biosciences for $1.3bn.

Uncontrolled hypertension is a condition in which an individual's blood pressure remains elevated, even after two or more treatments to lower it.

Ocedurenone, an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist, is currently under assessment in the CLARION-CKD Phase III study of patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

This Phase III trial began in the US, Europe and Asia, with the first patient receiving dosage at the end of 2021.

A total of 600 patients at 150 sites will be randomised as the trial continues.

So far, ocedurenone has been evaluated in nine clinical studies, including the BLOCK-CKD Phase IIb study, which attained its primary endpoint.

The drug candidate in the Phase IIb trial indicated a clinically meaningful and statistically significant improvement in systolic blood pressure from baseline to day 84 in patients suffering stage 3b/4 CKD and uncontrolled hypertension.

Novo Nordisk plans to begin Phase III trials in further cardiovascular and kidney disease indications in the coming years.

Novo Nordisk development head and executive vice-president Martin Holst Lange stated: “Hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death.

“With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating uncontrolled hypertension and could help address a major unmet medical need in people living with cardiovascular disease and chronic kidney disease.”

Subject to regulatory approvals, the transaction is anticipated to be completed before the end of 2023.

Significant unmet need in the Diabetic nephropathy (DN) market

With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.

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