Novartis Bolsters Cardiovascular Leadership Amid Entresto Patent Expiry with Strategic Acquisitions and Pipeline Expansion

In the flagship product Entresto(Sacubitril Valsartan) is about to face a situation of being surrounded by generic drugs, Novartis once again aims at the cardiovascular field and places active bets.

9Month9On [date], Novartis announced that14Billion-dollar acquisitionTourmaline Bio, which refers to the latter's only pipeline assetIL-6Monoclonal AntibodyPacibekitug, further strengthening the layout in the cardiovascular field. Notably, Novartis a few days agoJust reached a super achievement in the cardiovascular field50A Billion-Dollar Collaboration: Partnering with Bowang Pharmaceutical to Develop Cardiovascular Disease TreatmentssiRNATherapy.

Continuous moves in a short period of time showNovartis' Decisive Move in the Cardiovascular Business:Through active absorptionAdvanced Technology andNew forces, consolidating their established dominant position in the field, defending their own glory.

Behind the Increased Focus on Cardiovascular Field

All along, Novartis has demonstrated a non-conformist and strategically determined characteristic in the R&D layout of cutting-edge innovative products. It is this strategic determination that has enabled it to differentially build up competitive barriers in technology tracks such as nuclear medicine and small nucleic acids.

In terms of disease area layout, Novartis also demonstrates a clear strategic focus, concentrating on cardiovascular diseases.-Kidneys-Metabolism, immunity, neuroscience, and oncology4A major field, and the cardiovascular disease sector can be considered the cornerstone of its business layout.

In recent years, Novartis has shown a very clear trend of heavy investment in the cardiovascular field, with continuous increases.BDAnd the acquisition deal is a case in point.From2022Since the year, Novartis has conducted annually in the cardiovascular fieldBDThe amount of transaction cooperation continues to rise and has reached a new peak this year.。

2022Trend of BD Transaction Amounts in Novartis' Cardiovascular Field Since [Year]

In terms of acquisitions, Novartis started this year by2Monthly Splurge30More than a billion US dollars acquisitionAnthos Therapeutics, only for the targeted coagulation factorFXI/FXIaMonoclonal antibodyAbelacimabSecured in the bag, the drug outperformed the standard anticoagulant rivaroxaban for atrial fibrillation in a head-to-head study; now it has斥14Billion-dollar acquisitionIL-6Monoclonal AntibodyPacibekitug。

Under continuous heavy investment, Novartis's cardiovascular portfolio is expanding, gathering the richest product pipeline globally. According to the PharmaCube database,Novartis Ranks First Globally in the Number of Innovative Cardiovascular Drugs Under Development, Reach97Installments. Among them, there are75A cardiovascular drug has been approved for marketing,12In clinical stage.

Global Pharmaceutical Companies' Cardiovascular Innovation Pipeline (ActiveStatus) Quantity Ranking

Such a scaled product portfolio demonstrates that Novartis has established a distinct competitive edge in the cardiovascular field. Just as immunology is to AbbVie and multiple myeloma is to Johnson & Johnson, the cardiovascular field has become Novartis' most prominent and differentiated business label.

However, a layer of concern can be seen from the stage distribution of pipeline projects: Novartis has dozens of marketed products in the cardiovascular field, but the number of products in the research pipeline is slightly insufficient. This might be an important reason why the company has been continuously strengthening its layout in this field through external innovation in recent years.

Moreover, another driving force behind Novartis' recent frequent investments in the cardiovascular field is its best-selling product, a heart failure drug.Entresto(Sacubitril Valsartan) sales growth is facing a double whammy.

On the one hand,EntrestoThe core patent in the United States has expired, includingTorrent, Dr. Reddy's Laboratories,Zydus、MSNPharmaceuticals,AlkemAndLupinDeveloped by multiple pharmaceutical companies, includingEntrestoGeneric drugs have been approvedFDAApproval, the entry of generic drugs into the market is already a certainty; on the other hand,EntrestoHas also been included in the first round of US Medicare negotiation list, with a price reduction reaching53%, the new price will take effect on2026Effective year.

Based on this, Novartis has this year3Announced in the month to adjust the commercialization strategy of the cardiovascular business, shifting the focus to other high-potential cardiovascular drugs.

As a new-generation product in Novartis' cardiovascular field, a revolutionary lipid-lowering drug that requires only one injection every six months.Leqvio(Inclisiran) sales are still on the rise, with revenue growth in the first half of this year.66%To5.55Hundreds of millions of dollars, securing a blockbuster position in advance. However, in terms of current performance,LeqvioThe sales increase may not be enough to fill the gap.EntrestoFuture Decline Gap.

At this moment of great change, actively planning the next generation of cardiovascular products to defend its glory has become an inevitable choice for Novartis.

Why isTourmaline Bio？

For a long time, traditional treatment methods for cardiovascular diseases such as atherosclerosis, myocardial infarction, and heart failure have mainly focused on reducing risk factors such as cholesterol levels, blood pressure, and blood sugar, for example, statins.PCSK9Inhibitor,GLP-1Drugs, etc. However, an increasing body of research evidence suggests that inflammation is also a key factor in the development and progression of cardiovascular diseases.“Push Hands”, especially pro-inflammatory cytokinesIL-6Plays a central role in this [1,2]. Based on this biological discovery, targeted inhibitionIL-6Has become a new direction in the treatment of cardiovascular diseases.

DespiteIL-6Already approved as a target for autoimmune diseases, but no products have entered the marketing stage in the cardiovascular field, with only a few drugs currently in clinical research. In such a blue ocean landscape, holding the key to stepping into...IIIPhase StageIL-6Monoclonal AntibodyPacibekitugTheTourmaline BioNaturally, it has come into Novartis' view.

Source:Tourmaline BioCompany ProfilePPT（8Month)

Tourmaline BioIs a typical small and beautifulBiotech, onlyPacibekitugA pipeline asset. This drug is not its self-developed product, but rather a "discarded" asset from Pfizer in the autoimmune field [3].. Upon obtainingPacibekitugOne year after the equity,Tourmaline BioObtained sufficient R&D funding through the reverse merger of a listed company [4]`, Promote`PacibekitugThe development quickly got on the right track.

The timing of Novartis' move this time is exactly inPacibekitugClinical Research Data on Chronic Kidney Disease Released4Months later. InIIPeriodTRANQUILITYIn the study, treatment90Empress,PacibekitugBoth the monthly dosing group and the quarterly dosing group achieved rapid, deep, and long-lasting high sensitivity.CC-reactive protein (hs-CRP, andIL-6Mediated inflammation-related biomarker) levels decreased, wherein25mgAnd50mgThe reductions in the quarterly dosing group were75%And86%，15mgMonthly Dosing Group Decrease Reached85%, while the placebo group only decreased15%[5]. In addition tohs-CRPLevel,PacibekitugSignificantly reduced lipoprotein as well(a), Fibrinogen and Serum Amyloid ProteinAIncluding key biomarkers associated with cardiovascular risk, further confirming the broad benefits of its anti-inflammatory mechanism.

Source:Tourmaline BioCompany ProfilePPT（8Month)

Currently the fastest progressing in the cardiovascular fieldIL-6The drug is from Novo Nordisk.Ziltivekimab, the drug has been launched4Large-scaleIIIPhase research, covering three major indications: heart failure, chronic kidney disease, and myocardial infarction. InIIPeriodRESCUEIn the study, monthly1TimeZiltivekimabTreatment12Weeks can significantly reduce chronic kidney diseasehs-CRPLevel, including15mgAnd30mgGroup reduction is88%And92%, while the placebo group only decreased4%[6]。

Source:Tourmaline BioCompany ProfilePPT（8Month)

From the clinical data,PacibekitugThe performance ofZiltivekimabClose. More importantly,PacibekitugWith the potential advantage of once-quarterly dosing, it can significantly improve patient compliance – a crucial factor in chronic disease management.

Moreover, across different clinical subgroups, including gender,BMI, Whether you have diabetes,GLP-1Medication usage, etc.,PacibekitugAll showed consistenths-CRPThe effect of reducing levels shows wide applicability. In terms of safety,PacibekitugThe overall incidence of adverse events and serious adverse events was comparable to that of the placebo group.

In addition to the cardiovascular field,Tourmaline BioActively exploringPacibekitugIn thyroid eye disease (TED) The therapeutic potential in the population, itsIIbThe interim research data is planned to be released in2026Announced at the beginning of the year. In addition,Tourmaline BioAlso planned for2025Launched in the second half of the yearPacibekitugTreatment of Abdominal Aortic Aneurysm (AAA) ofIIPhase Proof-of-Concept Study. The potential for multi-indication applications has significantly improved.PacibekitugThe overall value.

Source:Tourmaline BioCompany ProfilePPT（8Month)

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