The deal also reflects Novo Nordisk’s desire to strengthen its cardiometabolic pipeline by using some of the money it has generated as a leader along with Eli Lilly in the category, which is projected to climb to $100 billion by 2030. Novo Nordisk developed the blockbuster treatment semaglutide, marketed to treat diabetes as Ozempic®—buoyed by considerable celebrity use—and to treat obesity as Wegovy®.
Cardior’s pipeline is led by CDR132L, a Phase II heart failure treatment candidate now under study in the HF-REVERT trial (NCT05350969) designed to assess the drug’s efficacy and safety in patients with reduced left ventricular ejection fraction (≤ 45%) after a heart attack.
HF-REVERT dosed its first patient in 2022, and had enrolled 294 patients as of the most recent update March 19 on Clinicaltrials.gov, according to which the trial’s estimated completion date is in September 2024.
Novo Nordisk said it plans to launch a second Phase II trial that will evaluate CDR132L in a chronic heart failure population with cardiac hypertrophy.
CDR132L is an oligonucleotide-based inhibitor directed against miRNA132 (miR-132), designed to halt and reverse the development of detrimental cardiac remodeling. CDR132L is designed to work by selectively blocking aberrant levels of the microRNA molecule miR-132, which Cardior has reasoned will lead to the reversal of cellular pathology and restoration of normal function in cardiomyocytes, contributing to improved cardiac systolic and diastolic function and thus prolonging life and improving the quality of life in heart failure patients.
In a 2021 paper published in the European Heart Journal, researchers reported results from a 28-patient Phase Ib trial (NCT04045405) showing CDR132L to be safe and well tolerated, confirming linear plasma pharmacokinetics with no signs of accumulation, and suggesting cardiac functional improvements in people with heart failure compared to placebo.
“Although this study is limited by the small patient numbers, the indicative efficacy of this drug is very encouraging justifying additional clinical studies to confirm the beneficial CDR132L pharmacodynamic effects for the treatment of HF [heart failure],” the researchers concluded.
CDR132L is also in Phase I study for heart failure with preserved ejection fraction; and safety/toxicology studies for dilated cardiomyopathy.
Also in Cardior’s pipeline are three additional programs:
- CDR348T, a preclinical hypertrophic cardiomyopathy candidate designed to work through modulation of non-coding RNAs (ncRNAs).
- CDR641L, a discovery-phase hypertrophic cardiomyopathy candidate whose method of action entails interaction with ncRNAs.
- An undisclosed program in safety/toxicology studies that is being developed for unspecified “diverse indications.” Like CDR641L, its method of action also involves interaction with ncRNAs.
“Impressed” by Cardior
“We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to halt or partially reverse the course of disease for people living with heart failure,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a statement. “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development.”
Novo Nordisk CEO Lars Fruergaard Jorgensen signaled his company’s intent to expand its cardiovascular pipeline earlier this year, in part by including the therapeutic area as one of four it focuses on, along with diabetes, obesity, and rare blood diseases.
“You can say cardiovascular and cardiometabolic space is an obvious place for us to invest. And you have seen that we are now increasingly using business development M&A to build a presence there,” Jorgensen said in January at the 42nd Annual J.P. Morgan Healthcare Conference. “From a position of strength, by moving early, we actually believe we can add a lot of value to our shareholders by taking assets in relatively early, and then use our core capability both in development but also in optimizing molecules manufacturing, et cetera and then the global reach we have.”
Cardior focuses on discovering and developing therapies designed to prevent, repair, and reverse diseases of the heart by targeting distinctive non-coding RNAs—a platform approach that according to the company addresses root causes of cardiac dysfunctions.
In acquiring Cardior, Novo Nordisk said it aims to build a focused, impactful portfolio of therapies through internal and external innovation to address the significant unmet needs that still exist within cardiovascular disease, the most common cause of death globally.
Novo Nordisk’s purchase price for privately-held Cardior consists of an upfront payment and payments tied to achieving development and commercial milestones, all undisclosed.
The deal marks a significant exit for Cardior’s largest shareholder EQT Life Sciences, whose predecessor LSP (Life Sciences Partners) led Cardior’s €15 million ($16 million) Series A financing in 2017 using capital from its LSP 5 fund. LSP added “significant” further investment into the company when it completed a €64 million ($69 million) Series B financing at the end of 2021, a year before the investor became EQT.
Novo Nordisk said its acquisition of Cardior will not impact previously communicated operating profit outlook for 2024 or its ongoing share buy-back program. The company said in January it expected its 2024 operating profit growth to be 21–29% at constant exchange rates (CER), or 1–2% lower if reported in Danish kroner.
Novo Nordisk finished 2023 with an operating profit of DKK 102.574 billion ($14.904 billion), up 37% (44% at CER) from DKK 74.809 billion ($10.87 billion) in 2022. The company’s net sales reached DKK 232.261 billion ($33.751 billion) last year, up 31% (36% at CER) from DKK 176.954 billion ($25.714 billion).
The acquisition will be funded from financial reserves, Novo Nordisk said.
The transaction is expected to close in the second quarter subject to applicable regulatory approvals and other customary conditions.
“This acquisition is a reflection of CDR132L’s transformative potential as a disease-modifying therapy for heart failure,” stated Claudia Ulbrich, MD, Cardior’s CEO and co-founder. “Novo Nordisk is the ideal partner based on its deep clinical and commercial expertise combined with its resources to accelerate our late-stage development program, including through larger registrational studies. We look forward to advancing CDR132L towards market approval.”
