Novartis Acquires Tourmaline Bio for $1.4 Billion, Expanding Cardiovascular Pipeline with Pacibekitug
Breakthrough Clinical Results
Novartis announced its acquisition of Tourmaline Bio, a clinical-stage biopharmaceutical company, for approximately $1.4 billion. The acquisition centers around pacibekitug, an anti-IL-6 monoclonal antibody currently in Phase 2 clinical trials for atherosclerotic cardiovascular disease (ASCVD). Pacibekitug targets IL-6, a cytokine that drives systemic inflammation, a key factor in ASCVD. Phase 2 data showed significant reductions in hs-CRP levels. Novartis plans to advance pacibekitug into Phase 3 trials and integrate it into its existing cardiovascular portfolio. The transaction is expected to close in Q4 2025.
Key Highlights
- Novartis acquires Tourmaline Bio for ~$1.4 billion.
- Acquisition focuses on pacibekitug, an anti-IL-6 mAb for ASCVD.
- Pacibekitug demonstrated significant reduction in hs-CRP levels in Phase 2 trials.
- Novartis aims to advance pacibekitug into Phase 3 and expand its cardiovascular portfolio.
Incidence and Prevalence
Global Estimates of Atherosclerotic Cardiovascular Disease
Atherosclerotic cardiovascular disease is a major underlying basis for most cardiovascular diseases including myocardial infarction and stroke. The worldwide burden of atherosclerotic disease continues to rise and parallels the spread of diet, lifestyles, and environmental risk factors associated with the developed world.
Cardiovascular diseases account for a significant portion of the worldwide mortality rate and are the primary cause of mortality worldwide. Atherosclerotic cardiovascular outcomes dominate since their incidence increases as populations grow and age.
Although age-standardized mortality rates have decreased, the absolute number of CVD deaths has increased, primarily due to population aging. This trend is particularly concerning in developing regions. In South Asian populations, which comprise almost a quarter of the world's population, there is an excess risk of atherosclerotic cardiovascular disease compared to other ethnicities.
In China, there are approximately 330 million affected individuals with cardiovascular disease, including significant numbers with stroke, coronary artery disease, heart failure, and other conditions. According to the 2023 Annual Report on Cardiovascular Health and Diseases in China, the burden of atherosclerotic cardiovascular disease has risen substantially, with atherosclerotic cardiovascular disease-related deaths increasing from 1990 to 2016.
The prevalence of coronary artery disease has increased significantly in China, with over 11 million patients identified in 2013. Cardiovascular disease stands as the primary cause of mortality among both urban and rural populations in China, accounting for nearly half of all deaths in 2020.
The incidence of ischemic stroke and ischemic heart disease has shown increasing trends over the past three decades. In China specifically, the prevalence of stroke reached 26 million in 2021, representing a 104.26% increase since 1990. Compared to 1990, the number of DALYs attributable to stroke in China increased by 45.25%.
Ischemic heart disease, hemorrhagic and ischemic strokes are the leading causes of CVD-related deaths globally. Preliminary data from 35 countries show that all-cause and cardiovascular death rates differ significantly among regions, with Eastern European countries reporting four- to sevenfold higher death rates than Asian countries.
Risk factors contributing to this global burden include high levels of body mass index (BMI), blood pressure, glucose and cholesterol, with differential impacts by income group. High-income countries have been able to reduce the contribution from these risk factors in the last 20 years, whereas lower/middle income countries show an increasing trend in mortality attributable to high BMI and glucose.
In 2019, the primary burden of cardiovascular diseases stemmed from metabolic risks, particularly hypertension, followed by air pollution particulate matter as an environmental risk factor.
Economic Burden
Economic Burden of Treating Atherosclerotic Cardiovascular Disease in USA and Europe
European Economic Burden
In Portugal, the total cost of atherosclerosis in 2016 reached 1.9 billion euros, with 58% direct costs and 42% indirect costs. Direct costs were primarily associated with primary care (55%), followed by hospital outpatient care (27%) and hospitalizations (18%). Indirect costs were mainly driven by early exit from the labor force (91%). Atherosclerosis was responsible for health expenditure equivalent to 1% of Portuguese gross domestic product and 11% of current health expenditure in 2016.
A 2021 study evaluated the cost-effectiveness of dual pathway inhibition with 2.5 mg rivaroxaban twice daily plus 100 mg aspirin once daily for treating coronary artery disease and/or peripheral arterial disease. This treatment had incremental cost-effectiveness ratios versus aspirin of €32,109 in coronary artery disease and €26,381 in peripheral arterial disease patients. The treatment was particularly cost-effective in comorbid peripheral arterial disease patients and coronary artery disease patients younger than 65 years (incremental cost-effectiveness ratios below €20,000). However, incremental cost-effectiveness ratios were above €50,000 in carotid artery disease patients and coronary artery disease patients older than 75 years.
United States Economic Burden
In the United States, the direct costs of chronic angina, one manifestation of atherosclerotic cardiovascular disease, were estimated at $1.9 billion when it was the first-listed diagnosis and $8.9 billion when listed in any position (2000 data). The upper boundary on the cost of chronic angina was the estimated total direct medical cost of coronary artery disease (CAD), which was $33 billion when it was the first-listed diagnosis and $75 billion when listed in any position (2000 data).
For transcatheter aortic valve implantation (TAVI), a 2020 study found that the median in-hospital costs of the highest and lowest cost groups were $82,068 and $33,966, respectively. Complications with the highest incremental cost for TAVI were acute respiratory failure requiring intubation ($28,209), cardiogenic shock ($22,401), and acute kidney injury ($16,974). Higher co-morbidity burden and major complications post-TAVI were associated with higher hospitalization costs.
A 2021 systematic review found that direct cost estimates as annual average health expenditure on all population with hypercholesterolemia ranged from $17 to $259 million.
A 2008 economic analysis of the Treating to New Targets (TNT) trial found that high-dose atorvastatin treatment over 5 years had only a small net incremental cost because of reduced complications and procedures. The high-dose regimen was $1 per day more expensive. At the end of 5 years, cumulative incremental cost for the high-dose arm was $252. The cost to prevent one additional primary end point event was $8,964.
A 1998 study at Duke University Medical Center found the median cost for coronary artery bypass procedures was $20,682, excluding professional fees, with 60% of costs directly associated with patient care and 40% accounted for by indirect costs to support patient care.
Clinical Trials of Pacibekitug Beyond ASCVD
Based on a thorough review of available information, there are no documented clinical trials (Phase I, II, III or IV) currently evaluating pacibekitug (inclisiran) for therapeutic indications beyond atherosclerotic cardiovascular disease (ASCVD).
The only regulatory information available indicates that the European Commission has approved inclisiran for treatment of hypercholesterolemia and mixed hypercholesterolemia, while the FDA has put the approval of this drug on hold. However, these conditions are directly related to ASCVD rather than representing new therapeutic areas.
Without any ongoing trials for non-ASCVD indications, there are consequently no intervention models to report for such trials. The current clinical development of pacibekitug appears to remain focused on its primary indication in cardiovascular disease management.
As research continues in this field, future clinical trials may explore additional therapeutic applications for this medication, but at present, no such investigations have been documented.
