Nordic Bioscience A/S

Eli Lilly said Thursday that its fourth-quarter revenue jumped 45% to $13.53 billion over the prior year, though this fell short of earlier projections. The drugmaker also reiterated the $58 billion to $61 billion in anticipated 2025 revenue it outlined last month. The revenue miss was not a surprise. At the annual JP Morgan Healthcare Conference last month, Lilly anticipated it would fall $400 million below its fourth-quarter revenue estimate as wholesalers bought less of its obesity drug Zepbound than expected. The guidance sent Lilly’s shares down about 7% on Jan. 14. It marked two quarters in a row of lower-than-expected sales for the Indianapolis drug giant. Lilly’s earnings came a day after its obesity and diabetes rival, Novo Nordisk, reported its performance over the past 12 months. The Danish drugmaker disclosed a 26% spike in sales over 2023. Novo anticipates less growth this year, though, at about 16% to 24%. The two obesity competitors are attempting to expand the scope of their current medicines — Zepbound and Wegovy — and get a whole new line of treatments approved as dozens of drug development rivals try to play catch-up in the most lucrative pharmaceutical market. To meet demand and stay ahead of the pack, Lilly and Novo have each spent more than $10 billion buying up, building and revamping manufacturing facilities. Both have also been fending off compounding pharmacies. Lilly also disclosed the culling of four programs, including an unnamed dual amylin and calcitonin receptor agonist for obesity that was in Phase 1. A spokesperson said the program was part of Lilly’s partnership with KeyBioscience . Lilly also removed three Phase 2 programs, including a failed Alzheimer’s drug , an atopic dermatitis candidate known as ucenprubart and an experimental heart failure medicine known as volenrelaxin. Endpoints News reported on the axed heart failure program last week. Meanwhile, the world’s largest pharmaceutical maker (by market cap) said it ramped up R&D spending 18% to $3.02 billion in the fourth quarter. Lilly also took a $344 million asset impairment and restructuring charge in the fourth quarter, compared to $67.7 million in the same period of 2023. The latest charges “primarily included an intangible asset impairment associated with Vitrakvi.” Lilly got the cancer drug via its Loxo Oncology acquisition, and Bayer eventually took the full rights to Vitrakvi. So far this year, Lilly has been busy. It’s made a small cancer biotech acquisition , earned an FDA approval for treating Crohn’s disease and funneled $500 million into a new VC fund . Toward the end of last year, Lilly also said it would spend another $15 billion to repurchase shares after completing a prior $5 billion share buyback program earlier that quarter.

HERLEV, Denmark, Nov. 11, 2024 /PRNewswire/ -- Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). For the past thirty years, Nordic Bioscience has continuously advanced its ProteinFingerprint Biomarker Technology™, driven by its scientific breakthroughs published in high-impact journals, ongoing enhancements to its high-precision automated instruments[1], and consistent regulatory approvals from official authorities. Continue Reading CPa9-HNE identifies true neutrophil activation, measured in the blood "This trifecta of scientific excellence, high-quality biomarkers, and regulatory support sets us apart from the competition" commented Morten A. Karsdal, CEO of Nordic Bioscience. "The CPa9-HNE Letter of Support is not only another landmark achievement signifying our success story, but also something that our hard-working teams can be very proud of." The CPa9-HNE biomarker measures a fragment of calprotectin S100a9, produced by human neutrophil elastase. It is detected in the serum and plasma of individuals with inflammatory bowel disease (IBD) and quantifies activated neutrophils, offering a non-invasive indicator of disease activity. In IBD trials, a frequent drug evaluation target is treating patients with moderate to severe ulcerative colitis or Crohn's disease. Neutrophils are important immune cells contributing to IBD, and CPa9-HNE can improve disease activity monitoring. "The Letter of Supports underlines what we have sought to achieve with CPa9-HNE: this marker has the potential to be applied as a patient enriching tool for clinical trials in the future, by identifying patients more likely to have moderate or severe endoscopic disease activity" added Joachim Høg Mortensen, Scientific Director of Gastrointestinal Diseases, Nordic Bioscience. "This can significantly streamline patient recruitment, ensuring you target the right profiles. In addition, CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity, and has the potential to be used for monitoring of disease activity and treatment response." Nordic Bioscience has a strong history in ECM remodeling research, earning FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The Company has transferred the FDA-approved bone biomarker CTX-I and fibrogenesis biomarker PRO-C3 to the Roche COBAS platform. With over 125 ELISA biomarkers developed to quantify unique ECM fragments, Nordic Bioscience's tools are used across all stages of drug development and patient selection in various diseases. [1] CPa9-HNE is currently measured in hand-held ELISA assays, though development is ongoing for high precision automated platforms. Not for use in diagnostic procedures. Contact: Elijah Aighobahi, [email protected], +45 4452 5252 Photo - Logo - SOURCE Nordic Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

In its quest to stay at the top of the obesity drug market, Eli Lilly is following in Novo Nordisk’s footsteps by pursuing a new class of weight loss drugs. The Indianapolis drug giant said this month it is paying up to $1.4 billion to KeyBioscience to again try to develop dual amylin and calcitonin receptor agonists, or DACRAs, which aim to reduce body weight, control glucose levels and improve insulin action. It’s been seven years in the making. Lilly originally teamed up with the Swiss biotech in 2017 , with plans to develop DACRAs for diabetes and nonalcoholic steatohepatitis. The companies eventually slashed three daily compounds in favor of a once-weekly option, according to Morten Karsdal, CEO of KeyBioscience’s parent company Nordic Bioscience. DACRAs are now shedding its niche status amid the soaring popularity of GLP-1s like Lilly’s weight management drug Zepbound and the hunt for better obesity drugs. Ten years from now, Stifel bankers predict DACRAs, amylin agonists and GIP antagonists could be “good options” for patients who “can’t tolerate GLP-1s.” Novo Nordisk is the furthest along with CagriSema, a combination of its megablockbuster semaglutide — known as Wegovy for weight loss — and an amylin agonist asset known as cagrilintide. It’s expected to have Phase 3 data by the end of the year. Other companies are prepping for the clinic, including Viking Therapeutics and Metsera , which announced a manufacturing deal earlier this month to shore up development capabilities well in advance of commercialization. AstraZeneca , Zealand Pharma and Gubra are also working in the broader amylin class. “As we’re looking for ways to go beyond what a GLP-1 mono-agonist or what a dual-agonist can do in terms of maximum weight loss, adding amylin is probably the next priority in your order of operations for mechanisms you’d want to look at,” Metsera CEO Whit Bernard told Endpoints News . Bernard said Metsera will “soon” enter the clinic with its experimental therapy, a combination of a DACRA, dubbed MET-233, and a GLP-1 injectable, MET-097, which had encouraging early-stage data last month. Executive chair Clive Meanwell previously told Endpoints the combo would be “very competitive” if it induces weight loss of 25% to 30%. Beyond weight loss, Karsdal makes the pitch that DACRAs have additional benefits. “This mode of action should be protecting bone and muscle and other organs,” he said, “so there’s clearly a space for this in the future.” KeyBioscience has been on a winding journey. Its parent company is Danish biomarker and lab services company Nordic Bioscience, which partnered with peptide biotech Unigene Laboratories in 2011 to form a joint venture to create new medicines. Unigene went bankrupt in mid-2013, and Nordic bought out its stake. By 2017, it received $55 million upfront and an undisclosed amount of biobucks as part of a deal with Lilly. But all three assets in that tie-up, including a Phase 2 diabetes drug, wound up on the shelf. Again, KeyBioscience was at a crossroads. “We actually decided with Lilly to terminate those because we wanted to focus on weekly formulations,” Karsdal said, though he declined to detail what led the partners to switch to the once-weekly route after having gone into clinical trials. “I unfortunately cannot comment publicly because the amylin receptor and calcitonin receptor biology is a hot topic for many, and there are some tricks that I cannot disclose,” Karsdal said. KeyBioscience’s once-weekly DACRA known as KBP-336 is now set to enter a global Phase 2 trial investigating the injectable’s ability to reduce weight and tame osteoarthritis pain in people with obesity by the end of the year. KeyBioscience will run the trial, and Lilly has the rights to continue developing it after that, Karsdal said. The trial may include patients who are already on GLP-1s, he said. KBP-336, which is derived from salmon calcitonin , could have broad utility. The calcitonin hormone helps keep bones healthy and can help thwart pain, lending confidence to KeyBioscience’s plans to also test it in osteoarthritis . “We’ve actually been in two Phase 3 studies before with an oral formulation of salmon calcitonin that had an effect on pain in one of the studies, so we’re reasonably convinced that we will get a superior effect on pain,” Karsdal said.