KBP Biosciences USA, Inc.

When the Food and Drug Administration expanded approval of Novo Nordisks weight loss medicine Wegovy to also protect heart health, the Danish drug giant had already made a pipeline commitment to developing new cardiovascular treatments.The March 8 approval was followed by news this week that Novo plans to buy German cardiovascular specialist Cardior Pharmaceuticals for north of $1 billion. The heart is back, Cardior CEO and co-founder Claudia Ulbrich told PharmaVoice. Its back for venture capital, and its back for the pharma industry.As revenue from Wegovy sales pour in, Novo Nordisk is in position to bolster its pipeline further. The deal to buy Cardior, whose lead candidate CDR132L is a RNA-based treatment for heart failure, serves that purpose.Cardior is a 2016 spinout from Germanys Hannover Medical School, building on the work of Professor Thomas Thum, now the companys chief scientific and medical officer. Rather than turning to messenger RNA, Cardiors approach makes use of non-coding RNAs that arent translated into proteins, but regulate processes like cardiovascular function, Ulbrich said. CDR132L is an antisense oligonucleotide.Overall, the compound targets heart failure, and under this joint collaboration, we can address a large patient population, Ulbrich said.The cardiovascular drug field hasnt advanced as quickly in recent decades as has oncology and immunology. Over the last 20 years, we haven't really seen innovation in the cardiovascular space we had only symptomatic treatments [like] ACE inhibitors, beta blockers or diuretics, Ulbrich said.GLP-1 drugs like Wegovy, and their ability to reduce cardiovascular risk, give physicians new options for certain people and could lay the foundation for new combinations.It's too early to state whether there is potential for our drug to be a combination product because we have a unique and completely different mode of action, Ulbrich said. But Novo is clearly striving to strengthen its pipeline in cardiovascular disease coming from diabetes and obesity.Novo said in a statement that the acquisition is an important step forward for the company to establish a presence in cardiovascular disease. The biotech has invested in other pipeline assets as well, including a $1.3 billion dollar investment for a hypertension drug developed by KBP Biosciences last October. Across Novos pipeline, the company is developing cardiovascular treatments that range from monoclonal antibodies to immunotherapies to cell therapy.For Cardior, the deal provides a way to reach more patients, Ulbrich said.Our first trial was in post-myocardial heart failure, and this is a niche gap where there arent any causal treatments where patients would clearly fit our treatment, Ulbrich said. But now, we will pursue development in a chronic situation, which is a large patient population.Cardior expects results from a Phase 2 trial by the end of the year or the beginning of 2025, Ulbrich said.While the success of mRNA vaccines for COVID-19 didnt directly influence Cardior, Ulbrich said companies like Germanys BioNTech improved the industrys understanding of RNA technology, particularly among large pharmaceutical companies.Although not all the details of the transaction are set in stone, Cardior will stay as is for the moment, Ulbrich said.I want to oversee the transition and the next development steps because, having worked seven years for this company and for this program, it affects me personally, Ulbrich said. Overall, this looks like the right partnership and the right deal at the right point in time. '

Pictured: A semiglutide injector rocket rapidly approaches its destination/Nicole Bean for BioSpace The burgeoning weight loss industry, currently led by Novo Nordisk and Eli Lilly, looks set to grow in the near future to include earlier-stage contenders like AstraZeneca and Pfizer, making it one of the industry’s most aggressively expanding spaces. Last month, Novo Holdings CEO Kasim Kutay cited estimates that Novo’s Wegovy (active ingredient semaglutide) and similar drugs could generate returns exceeding $12 billion in coming years, while other analysts have placed the total global market at as high as $200 billion within the next decade. “You can’t overstate the demand for these drugs, and there’s still a lot of room to grow,” said Jon Wolleben, a senior research analyst at JMP Securities who focuses on biotechnology. Roughly three-quarters of American adults are classified as obese or overweight, and the desire for weight loss products has far outstripped their supply. As manufacturing capabilities inevitably catch up and new players enter the space, “This could become the largest therapeutic class of drugs that the biopharma industry has ever seen,” Wolleben told BioSpace. The success of offerings like Novo’s Ozempic and Wegovy or Lilly’s Mounjaro and newly approved Zepbound (active ingredient tirzepatide) may seem sudden, but they are, in fact, based on drugs developed throughout the 1970s and 80s as treatments for diabetes. Early iterations included glucose-dependent insulinotropic polypeptide (GIP) agonists that regulated insulin by stimulating its production in the body, followed later by dual agonists that also targeted glucagon-like peptide-1 (GLP-1) receptors. Together, the two work synergistically to improve glycemic control and induce weight loss. Semaglutide is a GLP-1 agonist, while tirzepatide combines both GIP and GLP-1 into a single peptide. Allison Schneider, Novo’s director of media relations, told BioSpace that the reinvigorated interest in weight management and popularity of these drugs reflects not only technological advances but an evolving understanding that “obesity impairs health and requires long-term, holistic approaches to care and treatment.” Based on their success, she noted that there is plenty of territory left to explore. The Next Generation Moving forward, those companies looking to stake a claim in the therapeutic weight loss market—or to retain their competitive edge—are approaching drug development from three angles: layering on additional targets, interrogating new ways of delivery and refining their formulas to either dampen unwanted side effects or boost potential protective effects. Lilly’s next candidate, retatrutide, leverages a “triple G” approach that binds and activates the GIP, GLP-1 and glucagon receptors. Together, the three receptors regulate insulin, decrease appetite and increase thermogenesis, and results for a mid-stage trial of the candidate showed that patients achieved weight loss of up to 24.2% after 48 weeks of treatment—the most compelling results yet reported for any weight loss drug. Earlier in the summer, Lilly also demonstrated that retatrutide induced an 86% decrease in liver fat over 48 weeks among 98 patients with nonalcoholic fatty liver disease. “We have here the making of a new class of medicines, and there’s a lot to celebrate,” said Richard DiMarchi, a molecular biologist at Indiana University who previously spent decades at Eli Lilly overseeing endocrine research, including with glucagon, which he continues to pursue in his academic position. “We’re now achieving things that virtually no one thought were possible—weight loss that previously required surgical procedures.” Among the next challenges will be shifting away from peptide-based injections toward something like an oral pill based on small molecule technology, which DiMarchi said will be cheaper to manufacture, driving down costs and improving accessibility. “What we hear today is patients vastly prefer a once-a-day pill,” he said. Wollenben agreed, noting, “I think you’re going to see more investment in the small molecule space,” with a goal of attaining similar efficacy. AstraZeneca recently signed an exclusive license agreement with Eccogene, a China-based biotech developing a daily, oral GLP-1 agonist. Following an up-front payment of $185 million, Eccogene stands to net up to an additional $1.83 billion if the candidate hits future clinical, regulatory and commercial milestones. The molecule, called ECC5004, is currently being tested in a Phase I trial and has returned “promising” preliminary data, Sharon Barr, Astra’s executive vice president of biopharmaceuticals R&D, said in a statement at the time of the announcement. Pfizer has taken a similar approach, partnering with the Japanese biopharmaceutical company Sosei Heptares on a small molecule–based oral GLP-1 agonist, PF-06954522, which is currently in Phase I trials. The candidate was discovered by Pfizer using Sosei Heptares’ proprietary stabilized receptor (StaR) technology. Successful—But Not Satisfied Hoping to push into new territory, Novo and Lilly have begun snapping up products and smaller companies with promising candidates to address the unwanted side effects of their drugs and bolster the medications’ other potential health benefits. In July, Lilly paid up to $1.9 billion to acquire Versanis and its lead asset, bimagrumab, a monoclonal antibody that aims to reduce fat without affecting muscle mass—a common complaint among patients taking semaglutide. Bimagrumab works by preventing proteins from binding to receptors that inhibit muscle growth and encourage fat mass to build. The candidate is currently being studied in combination with semaglutide to see if the pair can preserve or increase muscle mass concurrent with weight loss. In another study published this summer, an oral semaglutide formula was found to avoid the loss of muscle mass. For its part, Novo recently purchased the small molecule ocedurenone from KBP Biosciences for a potential $1.3 billion to advance its cardiovascular portfolio, which is increasingly being dovetailed with weight loss objectives. At the American Heart Association’s annual conference, held this month in Philadelphia, Novo presented early data showing that Wegovy led to a 20% risk reduction in major adverse cardiovascular events. “If the clinical data bear out and these [next candidates] get approved, these are going to be drugs that almost everyone who’s obese can go on, and it’s going to be a really nice microcosm of drug development impacting health and how the system should work,” Wolleben said. “It’s going to be great for investors, for patients and for companies, so it’s going to be really fun to watch.” Amanda Heidt is a freelance science writer and editor based in Moab, Utah. To learn more, follow her on BlueSky (@scattercushion.bsky.social) or visit .

Novo Nordisk has agreed to acquire ocedurenone, a drug for uncontrolled hypertension, from KBP Biosciences in a deal worth up to $1.3bn. Ocedurenone, an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist, is currently being evaluated in the late-stage CLARION-CKD trial as a treatment option for patients with uncontrolled hypertension as well as for those with advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments. An estimated 1.28 billion adults aged 30 to 79 years worldwide have hypertension and only about 21% have it under control, marking a significant unmet need in the treatment of the condition. Martin Holst Lange, executive vice president and head of development at Novo, said: “Hypertension is a leading risk factor for cardiovascular events, heart failure, CKD 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 CKD.” The drug has already been assessed in nine clinical trials, including the phase 2b BLOCK-CKD trial, in which it demonstrated a clinically meaningful and statistically significant improvement in systolic blood pressure from baseline to day 84 in patients with stage 3b/4 CKD and uncontrolled hypertension. Beyond CLARION-CKD, Novo said it expects to initiate late-stage trials in additional cardiovascular and kidney disease indications in the coming years to "maximise the full potential” of ocedurenone. Commenting on the acquisition, which is expected to close before the end of the year, Dr Zhenhua Huang, founder and chairman of KBP Biosciences, said: "We believe this transition could unlock the full potential of ocedurenone and benefit more patients with cardiovascular and kidney disease worldwide.” The deal comes just a few weeks after Novo announced an agreement with Valo Health aimed at developing new treatments for cardiometabolic diseases. The collaboration will utilise Valo’s large human dataset and computation powered by artificial intelligence and will see Valo receive an upfront payment and a potential near-term milestone payment of $60m. Valo is also eligible to receive milestone payments for up to 11 programmes, totalling up to $2.7bn, plus research and development funding and potential royalty payments.