September 20, 2024 Source: drugdu 60
In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow.
The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk's total revenue.
While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same time, it is also gradually extending the boundaries of chronic disease treatment.
Pay attention to new forces
According to Novo Nordisk's 2024 interim report, Novo Nordisk regards diabetes and obesity business as key priority research and development areas in terms of corporate strategic development. The main strategic initiative is to further enrich the product portfolio in related therapeutic areas, and the layout will be more extensive and in-depth.
In the field of weight loss, Wegovy has opened up the obesity market. In the future, Novo Nordisk will focus on building a differentiated product portfolio, expanding from simple weight loss to health status management for obese patients. In addition to Wegovy, the compound preparation CagriSema has started a global Phase III clinical trial, and the weight loss efficacy of two new weight loss drugs GLP-1R/amylin receptor dual-target agonist Amycretin and oral small molecule CB1R inverse agonist Monlunabant is also highly anticipated.
CagriSema is a compound preparation that contains 2.4mg of long-acting amylin receptor analog Cagrilintide and 2.4mg of long-acting GLP-1RA semaglutide. Phase II clinical data of CagriSema showed that after 32 weeks of treatment, the body weight of the CagriSema treatment group decreased by 15.6%, and the weight loss effect was better than that of canagliflozin and semaglutide alone. 53.6% of the subjects in the CagriSema group lost more than 15% of their weight.
Currently, CagriSema has launched a global Phase III clinical trial, mainly for overweight/obesity indications. In addition, global Phase III clinical trials for type 2 diabetes with overweight/obesity and global Phase III clinical trials for obese people with cardiovascular disease are also underway.
Novo Nordisk Amycretin has developed two dosage forms, oral and subcutaneous. Novo Nordisk announced preliminary Phase I clinical data for oral Amycretin at this year's CMD conference: patients who received oral Amycretin once a day had a 13.1% decrease in body weight from baseline in the 12th week of treatment, compared with a weight loss of only 1.1% in the placebo group. At present, oral Amycretin has completed Phase I clinical trials, and Phase I clinical trial data for subcutaneous Amycretin is expected to be read out in 2025.
Another new drug, Monlunabant (INV-202), is a CB1 inverse agonist, a cannabinoid receptor that plays an important role in regulating appetite and cardiac metabolism. In August 2023, Novo Nordisk acquired the Canadian company Inversago Pharma for US$1.057 billion, thereby acquiring the company's main asset, Monlunabant.
The Phase I clinical data of Monlunabant showed that on the 28th day of treatment, the average weight loss in the Monlunabant group was 3.3% (ie 3.5KG), and the weight gain in the placebo group was 0.5% (ie 0.6KG). Phase II clinical trials of Monlunabant for the treatment of obesity and diabetic nephropathy are underway.
In the field of hypoglycemia, Novo Nordisk's product portfolio currently covers insulin, injectable and oral GLP-1 drugs. In the future, Novo Nordisk will continue to advance its pipeline and expand innovative treatments for diabetes to diabetic comorbidities, such as diabetic nephropathy, to address unmet needs in diabetes management.
Extending the boundaries of chronic disease treatment
With the development of GLP-1 products, Novo Nordisk's research and development layout is constantly broadening its boundaries and heading towards a broader field of chronic diseases.
According to brokerage research data, as of the end of 2023, semaglutide has been involved in 148 clinical trials worldwide. In addition to indications for diabetes and obesity, it has also been deployed in NASH, pain, chronic kidney disease, stroke, and other aspects. Among them, the Phase II clinical trial of semaglutide for the treatment of NASH has achieved positive efficacy data, and a global Phase III clinical trial is currently underway. In addition, semaglutide has also achieved positive efficacy results in a Phase III clinical trial for the treatment of obese adult patients with heart failure with preserved ejection fraction.
It is worth mentioning that Eli Lilly, another giant of GLP-1, is also expanding the application field of tirpotide. According to Eli Lilly's 2024 interim report, Eli Lilly has submitted a marketing application for tirpotide to the FDA and EMA for the treatment of moderate to severe obstructive sleep apnea, and the FDA is expected to give a relevant response as early as the end of 2024.
In addition, Eli Lilly is negotiating with relevant regulatory agencies on the registration strategy for the Phase III clinical trial of tirpotide for the treatment of fatty hepatitis associated with metabolic dysfunction.
Entering the broader cardiovascular field
Compared with other multinational pharmaceutical companies that actively invest in mergers and acquisitions to expand their business areas, Novo Nordisk's mergers and acquisitions are more cautious. From 2010 to 2023, Novo Nordisk has only carried out 14 mergers and acquisitions. Before developing GLP-1 weight loss, heart failure and other indications, diabetes was the core of Novo Nordisk, and the high focus on the R&D pipeline was the core reason for Novo Nordisk's cautious mergers and acquisitions.
However, since 2020, Novo Nordisk's pace of mergers and acquisitions has continued to accelerate. In particular, in 2023, five mergers and acquisitions projects were announced successively from June to October, with a total transaction amount of up to US$3.5 billion. Among them, the acquisition of Inversago Pharma and Embark Biotech is to further strengthen the layout in the field of obesity. In addition to increasing the weight loss field, the three mergers and acquisitions of KBP Biosciences (2023), Prothena (2021), and Corvidia Therapeutics (2020) have strengthened the research and development capabilities in the field of cardiovascular diseases.
In October 2023, Novo Nordisk acquired Ocedurenone, a hypertension control drug for the treatment of cardiovascular and kidney diseases, from KBP Biosciences for US$1.3 billion to strengthen its own layout in the cardiovascular field. Ocedurenone is an oral small molecule non-steroidal mineralocorticoid receptor antagonist. Currently, a Phase III clinical trial for the treatment of uncontrolled hypertension with advanced chronic kidney disease is underway, which is expected to be completed in September 2024.
Previously, the Phase II clinical trial data of Ocedurenone showed that in a 12-week randomized trial, Ocedurenone was able to significantly reduce the systolic blood pressure of subjects. In addition, Ocedurenone has high safety, with a risk of hyperkalemia of less than 1%, and no steroid side effects.
In 2021, Novo Nordisk acquired Prothena for $1.2 billion and acquired the anti-amyloid immune drug PRX004 and its transthyretin amyloidosis (ATTR) project. The ATTR project is currently in Phase II clinical trials.
In 2020, Novo Nordisk acquired Corvidia Therapeutics for up to $2.1 billion and acquired the IL-6 monoclonal antibody Ziltivekimab, which blocks the IL-6 pathway to reduce inflammation, thereby reducing the risk of major adverse cardiovascular events in patients with ASCVD and CKD. Phase III clinical trials are currently underway. These
product pipelines that are being nurtured are like a "reservoir" for future performance growth. As they are fulfilled one by one in the future, they will continue to contribute revenue to Novo Nordisk and become a new important growth point. With the volume growth of core products, endogenous and exogenous development, and continued R&D progress, Novo Nordisk has a promising future.
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