Ocedurenone

With their arbitration case underway in New York, Novo Nordisk and KBP appear ready to fight in court. But a settlement may be a better option for both companies.\n KBP Biosciences is looking to reclaim ownership of the ill-fated heart drug ocedurenone from Novo Nordisk following a botched $1.3 billion deal and fraud allegations, Fierce Biotech has learned. The Singapore biotech has assembled experts to take a closer look at ocedurenone’s clinical value despite a failed phase 3 trial in 2024, a person close to the situation told Fierce.KBP could move to conduct another phase 3 trial, potentially pursuing a smaller indication with the FDA than the broad population of chronic kidney disease patients with uncontrolled hypertension examined in the failed Clarion-CKD study, according to the person, who was given anonymity to discuss private matters.But to do that, KBP will first need to get the drug back from Novo and also find additional funding to support another phase 3 study, both of which can be difficult given the two companies’ arbitration case against each other in New York. In a statement to Fierce sent on Tuesday, KBP declined to comment on the legal proceedings but said it will “continue to steadfastly defend our position and vigorously pursue our rights.” The company argued that ocedurenone “not only offers important, vital and necessary clinical treatment for the tens of millions of patients worldwide with hypertension who still lack effective therapeutic options, but it also carries significant value for society.”The biotech added that it is willing to work with Novo if the pharma giant decides to restart the relevant clinical trials.Novo declined to comment on ongoing legal proceedings.  The Danish pharma called time on ocedurenone in November 2024, a few months after Clarion-CKD failed to deliver on its main goal of change in systolic blood pressure (SBP). By taking a nearly $820 million impairment loss, Novo assigned no commercial value to the mineralocorticoid receptor antagonist. The drugmaker acquired the asset in 2023 for over $800 million upfront and $500 million in milestones. But court documents obtained by Fierce last year showed that, following the futility determination of the phase 3 trial, a final analysis performed after addressing some warnings in the statistical analysis system found that the study only met one—not two—of the futility criteria.  In the more recent analysis, ocedurenone’s treatment effect on SBP was a 4.3 mmHg reduction versus placebo—just shy of the 5 mmHg futility threshold—and the p-value was 0.002, which met statistical significance. Although the trial’s design required only one item to determine futility, KBP has argued that Novo was too hasty in its decision to abandon the entire program while disregarding the remaining value of ocedurenone. But as Novo sees it, a Bulgarian site appeared to be the main driver behind the previous positive phase 2 data that led to the $1.3 billion deal, as well as a potential positive sign from the overall failed Clarion-CKD study. Novo has alleged that KBP intentionally withheld that information to trick it into buying ocedurenone, whereas KBP has argued that the large pharma simply didn’t perform due diligence properly.“We reiterate that the so-called ‘fraud’ allegations are merely a pretext employed by Novo to justify terminating the project and are wholly unsupported by the facts,” KBP said in its statement to Fierce yesterday.While Novo continues to suspect data integrity issues at the Bulgarian site, KBP still holds that results from the site may provide valuable insight into a potential future study. For example, KBP has argued that the site may have enrolled a “truly resistant” hypertension population, as patients from the site assigned to the placebo group showed almost no changes in blood pressure during the study, while placebo patients from other sites experienced large reductions. For now, with the arbitration case underway in New York, both companies appear ready to fight in court. But a settlement may be a better option for both sides.The assets of both KBP and the biotech’s founder Huang Zhenhua have been frozen by a Singapore court at the request of Novo. In drug development, speed matters. If ocedurenone indeed holds any clinical value, a day spent in court is a day lost in R&D and future commercialization. As for Novo, the diabetes and obesity drug giant is in a legal quagmire and a business pinch, marked by a steep decline in its stock price, disappointing financial outlook and intense competition. The company is entangled in lawsuits with GLP-1 compounders, investor accusations of misleading statements, as well as thousands of personal injury claims stemming from the use of its GLP-1 products.Under new CEO Maziar Mike Doustdar, Novo has narrowed its focus to obesity, diabetes and other related complications and is not looking for deals outside of those areas, Tamara Darsow, Novo’s group VP of global business development, told Fierce in January on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco.