CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [2]

Active Indication

Multiple sclerosis relapseMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis+ [5]

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaB-Cell LymphomaB-cell lymphoma recurrent+ [24]

Originator Organization

Genmab A/S

Active Organization

Novartis Pharmaceuticals Corp.

Novartis AGNovartis Pharma AG

+ [4]

Inactive Organization

GlaxoSmithKline (China) Investment Co., Ltd.

Cephalon, Inc.

Glaxo Group Ltd.

License Organization

Genmab A/SNovartis Pharma AG

Novartis AG

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (26 Oct 2009),

Chronic Lymphocytic Leukemia

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States)

Structure/Sequence

Sequence Code 143593H

Source: *****

Sequence Code 143818L

Source: *****

194

Clinical Trials associated with Ofatumumab

NCT06869785

/ RecruitingPhase 3

An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

Start Date13 Mar 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06486779

/ RecruitingNot Applicable

A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)

This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)

Start Date10 Dec 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06444113

/ RecruitingPhase 4

A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab

This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.

Start Date25 Nov 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Ofatumumab

100 Translational Medicine associated with Ofatumumab

100 Patents (Medical) associated with Ofatumumab

836

Literatures (Medical) associated with Ofatumumab

01 Jun 2025·JOURNAL OF NEUROIMMUNOLOGY

Ofatumumab for the treatment of COVID-19-associated autoimmune encephalitis: A case report

Article

Author: Du, Xiaoping ; Wang, Zhuoran ; Guo, Junhong ; Wang, Qiong ; Wang, Huifang ; Zhang, Yating

Autoimmune encephalitis is a rare but severe complication of Coronavirus disease 2019 (COVID-19) infection. Typically, treatment involves immunomodulatory approaches such as steroids, intravenous immunoglobulin (IVIG), or plasma exchange. While for some patients, the above treatment is not effective. Here, we report a case of COVID-19-associated encephalitis, who exhibited cognitive impairment, epileptic seizures, tachycardia, and diaphoresis, with cranial MRI findings resembling those seen in limbic encephalitis. Initially, the patient exhibited a suboptimal response to antiviral therapy, high-dose steroids, and IVIG treatment. Nevertheless, his clinical symptoms and cranial MRI abnormalities markedly improved following the administration of Ofatumumab. Administering Ofatumumab early in COVID-19-related autoimmune encephalitis may benefit patients more.

01 May 2025·Multiple Sclerosis and Related Disorders

Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study

Article

Author: Wyse, Kerri ; Steingo, Brian ; Weinstock-Guttman, Bianca ; Gitt, Jeffrey ; Stankiewicz, James ; Piccolo, Rebecca ; Subei, Adnan ; Riser, Emily

BACKGROUND:

There is currently a need for data regarding whether treatment with ofatumumab (OMB) impacts humoral immune response to vaccines, including the influenza vaccine, in patients with relapsing multiple sclerosis (RMS).

METHODS:

Patients with RMS aged 18-55 years were grouped into three cohorts: cohort 1 (C1) received the influenza vaccine ≥2 weeks before starting OMB; cohort 2 (C2) received the vaccine ≥4 weeks after starting OMB; and cohort 3 (C3) was currently being treated with interferon/glatiramer acetate and received the influenza vaccine ≥4 weeks after enrollment. Patients with recent major infections were excluded. All groups underwent a hemagglutination inhibition (HI) titer before vaccination and 4 weeks after vaccination. The primary endpoint was achieving seroprotection to influenza at week 4 (post-vaccination antibody titer ≥40). Secondary endpoints included achieving seroconversion (post-vaccination HI titers ≥4-fold increase or ≥40 in those with pre-vaccination titers ≥10 or <10, respectively), change in HI titer, and adverse events (AEs).

RESULTS:

Sixty-three patients (mean [standard deviation] age, 41.1 [8.5] years; 76.2 % female; 85.7 % White) were included (C1, n = 22; C2, n = 22; C3, n = 19). At week 4, seroprotection rates for influenza A Cambodia (C1, 86.7 %, 13/15; C2, 80.0 %, 4/5; C3, 66.7 %, 6/9) and influenza A Victoria (C1, 86.7 %, 13/15; C2, 100 %, 5/5; C3, 77.8 %, 7/9) were generally high. Seroprotection rates for influenza A Wisconsin (C1, 53.3 %, 8/15; C2, 40.0 %, 8/20; C3, 61.1 %, 11/18), influenza B Phuket (C1, 63.6 %, 14/22; C2, 68.2 %, 15/22; C3, 68.4 %, 13/19), and influenza B Washington (C1, 66.7 %, 10/15; C2, 20.0 %, 1/5; C3, 55.6 %, 5/9) were lower across all cohorts. Seroconversion rates at week 4 were variable across vaccine influenza strains. However, trends for lower rates of seroconversion in cohort 2 vs. cohorts 1 and 3 were broadly consistent across strains. Over the entire study, 16/22 (72.7 %) patients from cohort 1, 6/22 (27.3 %) patients from cohort 2, and 2/19 (10.5 %) patients from cohort 3 experienced one or more AEs. The higher frequency of AEs in cohort 1 is likely related to OMB initiation (i.e., systemic and injection-related reactions). One patient from cohort 2 experienced a serious AE (MS pseudo-relapse). No AEs resulting in discontinuation were reported.

CONCLUSION:

Some OMB-treated patients with RMS were able to mount an immune response following inactivated influenza vaccination. Patients who were vaccinated before OMB initiation generally had a better immune response than those vaccinated after OMB initiation. No T-cell analyses were performed.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov: NCT04667117 (https://clinicaltrials.gov/study/NCT04667117).

01 May 2025·CLINICAL NEUROLOGY AND NEUROSURGERY

Effective treatment of immune mediated peripheral neuropathy with Ofatumumab - A case report

Article

Author: Hao, Yong ; Zhang, Ying ; Guan, Yangtai ; Yao, Xiaoying ; Jiang, Xianguo ; Zhu, Desheng ; Gao, Meichun ; Zhou, Xiajun ; Ding, Jie ; Lin, Yan

Recurrent immune-mediated peripheral neuropathy is a rare immune disorder that presents significant therapeutic challenges. Ofatumumab (OFA) is a fully humanized anti-CD20 monoclonal antibody with low immunogenicity. We report a patient with recurrent immune-mediated peripheral neuropathy who achieved sustained remission following OFA treatment after multiple relapses. Over a two-year period, the patient experienced over 20 episodes of bilateral upper and lower limb weakness. Furthermore, the patient was unresponsive to intravenous immunoglobulin, plasma exchange, corticosteroids, mycophenolate mofetil, and Telitacicept. Subcutaneous OFA administration resulted in marked reductions in CD19⁺ and CD20⁺ B-cell counts and a relapse-free period exceeding 20 months, with no adverse events observed. This case provides early evidence supporting OFA as a safe and effective alternative for recurrent immune-mediated peripheral neuropathy.

155

News (Medical) associated with Ofatumumab

05 May 2025

·www.fiercepharma.com

US net drug spending surged 11.4% last year, boosted by obesity and oncology meds: IQVIA

31 products drove the $50 billion increase in drug spending witnessed in 2024, IQVIA reported. As sure as the sun rises, prescription medicine use and total drug spending continue to increase in the U.S.To better understand how these trends will play out in the near term, the life sciences intelligence firm IQVIA Institute recently dropped a deep dive on medicine usage patterns backed by findings from 2024.Last year saw total U.S. prescription medicine use rise by 1.7%, which came out to a staggering 215 billion days of therapy on daily doses, according to IQVIA’s Understanding the Use of Medicines in the U.S. 2025 report. Along with the uptick in usage came a significant spending rise, with the U.S. market (at net prices) growing 11.4%, up from the 4.9% increase recorded in 2023. IQVIA found that the 11.4% increase in net spending represented a $50 billion increase—to $487 billion in aggregate spending—driven by 31 key high-growth products. In all, the firm said 2025 marked a year of “historic growth” only surpassed by 2021’s COVID vaccine push.The group of growth drivers was largely made up of popular GLP-1 agonist medicines for diabetes and obesity and drugs that won significant label expansions into large populations, or drugs that established themselves as “backbone therapies,” IQVIA noted. Only three of those 31 meds are newer launches that hit the market in 2023 or 2024. Those were Roche’s age-related macular degeneration treatment Vabysmo, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus and Novartis’ multiple sclerosis therapy Kesimpta. IQVIA also spotlighted AbbVie’s Skyrizi as the highest contributor of immunology spending growth, largely in its psoriasis indication.GLP-1 drugs on their own accounted for 29% of the spending growth in 2024, IQVIA found. Elsewhere, the last five years have seen several prominent drugs—such as AbbVie’s Humira—fall off the patent cliff, giving room for copycat drugs to take a bite of the market. The impact of recent losses of exclusivity totaled $77.5 billion, most of which was driven by biologics and biosimilars rather than small molecules facing generic rivals. It’s a factor that is only expected to increase in the near-term, as blockbusters such as Amgen’s bone meds Prolia and Xgeva and Johnson & Johnson’s immunology star Stelara—and several others—face the impacts of biosimilar competition in 2025. Looking out a few years, oncology mainstays like Merck’s Keytruda and Bristol Myers Squibb’s Opdivo are expected to lose their exclusivity near the end of the decade.Five-year forecastOver the next five years, IQVIA expects a widening gap between list price spending, which is expected to grow annually between 5% to 8%, and manufacturer net revenues, which are slated for 3% to 6% average annual growth. All in all, total net spending in 2029 should reach more than $600 billion. Oncology and obesity products are expected to continue to lead the growth, IQVIA said. More than 100 new drug launches and label expansions in oncology are anticipated through 2029, IQVIA pointed out, prompting an expected $165 billion in oncology spending through 2029. Obesity, however, is a bit of a trickier case to forecast given “a wide range of scenarios” that could play out on the reimbursement side. Still, IQVIA’s “optimistic” base case estimates $60 billion in 2029 net spending on obesity meds.

Vaccine

29 Apr 2025

·www.globenewswire.com

Novartis continues strong momentum with double-digit sales growth, robust margin expansion and multiple approvals in Q1

Ad hoc announcement pursuant to Art. 53 LR Net sales grew +15% (cc1, +12% USD) with core operating income1 up +27% (cc, +23% USD) Sales growth driven by continued strong performance from Entresto (+22% cc), Kisqali (+56% cc), Kesimpta (+43% cc), Cosentyx (+18% cc), Leqvio (+72% cc) and Scemblix (+76% cc) Core operating income margin1 reached 42.1%, +400 basis points (cc), mainly driven by higher net sales Operating income grew +44% (cc, +38% USD); net income up +37% (cc, +34% USD)Core EPS1 grew +31% (cc, +27% USD) to USD 2.28Free cash flow1 of USD 3.4 billion (+66% USD) driven by higher net cash flows from operating activities Selected innovation milestones: Pluvicto FDA approval for pre-taxane mCRPC Vanrafia (atrasentan) FDA accelerated approval for IgA nephropathy Fabhalta (iptacopan) FDA, EC and China NMPA approvals for C3G Remibrutinib global submissions for CSU, with priority review voucher in US OAV101 IT Phase III STEER study positive readout in SMA Full-year 2025 guidance2 raised: Sales expected to grow high single digit, core operating income expected to grow low double-digit Basel, April 29, 2025 – Commenting on Q1 2025 results, Vas Narasimhan, CEO of Novartis, said:“Novartis has had a strong start to the year, delivering a +15% cc increase in sales and a +27% cc rise in core operating income in Q1. Our priority brands, including Kisqali, Kesimpta and Leqvio, continue to show strong momentum, which we anticipate will drive our growth through 2030 and beyond. We also achieved significant innovation milestones in the quarter, with new approvals for Pluvicto in the pre-taxane setting, Vanrafia for IgA nephropathy, and Fabhalta for C3G. Additionally, we completed global submissions for remibrutinib in CSU, the first indication for this promising pipeline-in-a-pill. We remain focused on advancing our leading pipeline and confident in achieving our growth outlook.” Key figures Q1 2025Q1 2024% change USD m USD mUSDccNet sales to third parties13 23311 8291215Operating income4 6633 3733844Net income3 6092 6883437EPS (USD)1.831.314042Free cash flow3 3912 03866 Core operating income5 5754 5372327Core net income4 4823 6812226Core EPS (USD)2.281.802731 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 5. Strategy Our focus Novartis is a “pure-play” innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan. Our priorities Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility. Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. Financials Net sales were USD 13.2 billion (+12%, +15% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a positive impact of 2 percentage points, benefiting from revenue deduction adjustments mainly in the US. Operating income was USD 4.7 billion (+38%, +44% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Net income was USD 3.6 billion (+34%, +37% cc), mainly driven by higher operating income, partly offset by higher income taxes. EPS was USD 1.83 (+40%, +42% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.6 billion (+23%, +27% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches, and R&D investments. Core operating income margin was 42.1% of net sales, increasing 3.7 percentage points (4.0 percentage points cc). Core net income was USD 4.5 billion (+22%, +26% cc), mainly due to higher core operating income. Core EPS was USD 2.28 (+27%, +31% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 3.4 billion (+66% USD), compared with USD 2.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities. Q1 priority brands Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q1 growth) including: Entresto(USD 2 261 million, +22% cc) sustained robust, demand-led growth globally, including in China and Japan with increased penetration in hypertensionKisqali(USD 956 million, +56% cc) sales grew strongly across all regions, including +87% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancerKesimpta(USD 899 million, +43% cc) sales grew across all regions driven by increased demand and strong accessCosentyx(USD 1 534 million, +18% cc) sales grew mainly in the US, emerging growth markets and Europe, driven by recent launches as well as volume growth in core indicationsLeqvio(USD 257 million, +72% cc) continued steady growth, with a focus on increasing account and patient adoption, and continuing medical educationScemblix(USD 238 million, +76% cc) sales grew across all regions, demonstrating the continued high unmet need in CML and strong momentum from the recently launched early-line indication in the USFabhalta(USD 81 million) sales grew driven by continued launch execution across all markets in PNH as well as the recent launch in IgAN in the USPluvicto(USD 371 million, +21% cc) continued stable performance in the US and grew in Europe in the mCRPC post-taxane setting. With the FDA’s approval for earlier use before chemotherapy, which approximately triples the eligible patient population, the focus is on driving demand in established RLT sites while activating new sites and supporting referring providers to enable patient accessZolgensma(USD 327 million, +13% cc) sales grew as it continues to demonstrate strong performance in the incident populationLutathera(USD 193 million, +15% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier line adoption particularly in the US and Japan Net sales of the top 20 brands in the first quarter Q1 2025 % change USD mUSDccEntresto2 2612022Cosentyx1 5341618Kisqali 9565256Kesimpta 8994143Tafinlar + Mekinist 5521619Promacta/Revolade 54658Jakavi 49237Xolair 4561419Ilaris 4191820Tasigna 377-5-2Pluvicto 3712021Zolgensma 3271113Sandostatin Group 317-11-9Leqvio 2577072Scemblix 2387576Lutathera 1931415Lucentis 189-40-38Exforge Group 179-7-1Diovan Group 150712Galvus Group 124-17-11Top 20 brands total10 8371719 R&D update - key developments from the first quarter New approvals Pluvicto(lutetium Lu177 vipivotide tetraxetan)FDA expanded the indication for Pluvicto to include patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor and are considered appropriate to delay chemotherapy, approximately tripling the eligible patient population. Vanrafia(atrasentan)FDA granted an accelerated approval for Vanrafia for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy.Fabhalta(iptacopan)Fabhalta was approved by the US FDA, European Commission and China’s NMPA for adult patients with C3 glomerulopathy (C3G), making it the first and only treatment approved for this condition in all three markets. Regulatory updates RemibrutinibRegulatory submissions for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) were completed in the US, EU and China. A priority review voucher was used in the US and approval is anticipated in H2 2025, and priority review was granted in China. Scemblix(asciminib)Regulatory submission for Scemblix in adults with newly diagnosed CML was completed in the EU based on 96-week data from the Phase III ASC4FIRST study. Results from ongoing trials and other highlights OAV101 IT(onasemnogene abeparvovec)Novartis announced positive safety and efficacy results from the Phase III program for investigational intrathecal OAV101 IT in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA). In the Phase III STEER study, treatment with OAV101 IT led to a statistically significant and clinically meaningful 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded vs. 0.51 points in the sham control arm. In addition, in the Phase IIIb STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with nusinersen or risdiplam demonstrated stabilization of motor function over 52 weeks of follow-up. OAV101 IT demonstrated a favorable safety profile, consistent in both treatment-naïve and treatment-experienced patients. Data were presented at MDA.RemibrutinibThe New England Journal of Medicine published data from the 24-week double-blind placebo-controlled period of the Phase III REMIX-1 and -2 studies. Remibrutinib showed early symptom improvement and sustained efficacy, with improvements in CSU symptoms compared to placebo observed as early as week 1 and response rate maintained through the double-blind treatment period. Remibrutinib was well tolerated, with overall adverse event rates comparable to placebo. Multiple analyses of the REMIX-1 and -2 trials were presented at medical congresses in Q1. At AAAAI, long-term results showed that patients experienced improved urticaria control within two weeks of starting treatment. Patients who switched from placebo to remibrutinib at week 24 achieved similar improvements through week 52. At AAD, data was presented showing that treatment with remibrutinib had positive effects on sleep and daily activities for CSU patients.IanalumabThe results of Phase II VAYHIT3 study in adult patients with advanced primary ITP, previously treated with at least a corticosteroid and a thrombopoietin receptor agonist, indicate that a short course of ianalumab has clinically meaningful efficacy and is well tolerated in these patients. These results will be presented at a future medical meeting and are expected to support a filing in second-line ITP, based on the Phase III VAYHIT2 study, expected to read out in H2 2025.Selected transactionsNovartis has completed the acquisition of Anthos Therapeutics, a clinical-stage biopharmaceutical company developing abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathway in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The acquisition adds a Phase III asset and is aligned with the Novartis growth strategy and expertise in the cardiovascular therapeutic area. Capital structure and net debt Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority. In Q1 2025, Novartis repurchased a total of 24.8 million shares for USD 2.6 billion on the SIX Swiss Exchange second trading line under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 2.7 billion still to be executed). In addition, 1.5 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 10.5 million shares (equity value of USD 0.3 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 15.8 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 2.5 billion and a net cash outflow of USD 2.7 billion. Net debt increased to USD 22.3 billion at March 31, 2025, compared with USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 3.4 billion being more than offset by the USD 5.3 billion annual net dividend payment in March (which is the gross dividend of USD 7.8 billion reduced by the USD 2.5 billion Swiss withholding tax that was paid in April 2025, according to its due date), cash outflows for treasury share transactions of USD 2.7 billion and cash outflows for purchases of intangible assets of USD 1.2 billion. As of Q1 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2025 outlook Barring unforeseen events; growth vs. prior year in ccNet salesExpected to grow high single-digitCore operating incomeExpected to grow low double-digit Key assumptions: We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes Foreign exchange impact If late-April exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be 0 percentage points on net sales and negative 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Q1 2025Q1 2024% change USD m USD mUSDccNet sales to third parties13 23311 8291215Operating income4 6633 3733844As a % of sales35.228.5 Net income3 6092 6883437EPS (USD)1.831.314042Net cash flows from operating activities3 6452 26561 Non-IFRS measures Free cash flow 3 3912 03866 Core operating income5 5754 5372327As a % of sales42.138.4 Core net income4 4823 6812226Core EPS (USD)2.281.802731 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 31 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below:https://ml-eu.globenewswire.com/resource/download/f5843473-7c9e-4c13-b263-db739fdcf6d6/ DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “anticipate,” “can,” “will,” “continue,” “ongoing,” “growth,” “launch,” “expect,” “expand,” “deliver,” “accelerate,” “deliver,” “guidance,” “outlook,” “priority,” “potential,” “momentum,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: uncertainties concerning global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; uncertainties in the development or adoption of potentially transformational digital technologies, including artificial intelligence, and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X and Instagram. Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar. Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at https://www.novartis.com/investors/event-calendar. Important datesJuly 17, 2025October 28, 2025November 19-20, 2025Second quarter & half year 2025 resultsThird quarter & nine months 2025 resultsMeet Novartis Management 2025 (London, UK) Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Please find full media release in English attached and on the following link: Media release (PDF) Further language versions are available through the following links: German version is available through the following link: Medienmitteilung (PDF)

Clinical ResultPhase 3Drug ApprovalPhase 2Acquisition

02 Apr 2025

·www.fiercepharma.com

Roche's high dose version of Ocrevus has come up short in a phase 3 trial. The company was hoping that the new formulation could extend its patent protection for the mega-blockbuster. With its multiple sclerosis powerhouse Ocrevus expected to lose patent protection by the end of the decade, Roche is looking for ways to extend the market exclusivity for the top-selling drug in the indication.But the Swiss company can check one potential solution off its list as a phase 3 trial of its high-dose version of Ocrevus in patients with relapsing multiple sclerosis (RMS) has failed to move the needle.A study testing intravenous formulations of 1,200 mg and 1,800 mg of the drug—depending on the weight of the patient—versus the approved 600 mg dose every 24 weeks failed to meet its primary endpoint. The higher doses showed no additional benefit in slowing the progression of the disease over at least 120 weeks of treatment, Roche said on Wednesday.The primary endpoint was the time to first onset of 12-week composite disability progression, which was defined by a variety of measures including the time to finish a 25-foot walk test and the time to perform a nine-hole peg test.“These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression,” Levi Garraway, M.D., Ph.D., the chief medical officer of Roche subsidiary Genentech, said in a release.The company said it will provide data for the trial at a future medical conference. Coming up short in the trial is a blow to Roche as it was hoping—as late as early this year—that a high-dose formulation could extend its intellectual property (IP) rights, according to Theresa Graham, the CEO of Roche Pharmaceuticals.“Should high dose be positive and we begin to look at putting it into devices, I think there is definitely some opportunity for expanded IP,” Graham said during the company’s fourth-quarter conference call in January.By “devices,” Graham was referring to Roche winning approval last year for a new formulation of Ocrevus, which is administered twice a year by way of a subcutaneous shot every six months as opposed to a less convenient infusion. Combining subcutaneous delivery of Ocrevus with a high-dose formulation could have added “another layer of IP,” Roche’s investor relations chief Bruno Eschil added during the Q4 call, “which should help us prolong the franchise.”Last year, Ocrevus generated sales of 7.6 billion Swiss francs ($8.1 billion), while fast-rising challenger, Novartis’ Kesimpta, a monthly subcutaneous shot which can be delivered at home, racked up sales of $3.2 billion. The Novartis drug delivered a 49% sales increase in 2024, compared with a 6% year-over-year gain for Ocrevus.

With biosimilar competition looming, Roche takes a hit with failure of high-dose Ocrevus

Phase 3Clinical ResultDrug Approval

100 Deals associated with Ofatumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09314	Ofatumumab	L01XC10	DB06650

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple sclerosis relapse	European Union	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Iceland	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Liechtenstein	Novartis Europharm Ltd.	26 Mar 2021
Multiple sclerosis relapse	Norway	Novartis Europharm Ltd.	26 Mar 2021
Multiple Sclerosis, Relapsing-Remitting	Canada	Novartis Pharma AG	22 Jan 2021
Multiple Sclerosis, Relapsing-Remitting	Canada	Novartis Pharmaceuticals Canada, Inc.	22 Jan 2021
Multiple Sclerosis	United States	Novartis Pharmaceuticals Corp.	20 Aug 2020
Lymphoid Leukemia	Japan	Novartis Pharma AG	23 Mar 2013
Chronic Lymphocytic Leukemia	United States	Novartis Pharmaceuticals Corp.	26 Oct 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rhabdomyosarcoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Bulgaria	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Czechia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Estonia	Novartis Pharmaceuticals Corp.	14 Jul 2020
Rhabdomyosarcoma	Phase 3	Germany	Novartis Pharmaceuticals Corp.	14 Jul 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P11-1.003 (AAN2025)	Phase 3	Disease Progression	-	Ofatumumab continuous group	rdmopkgsrn(qtbpnghtns) = rgqehgzxom ufkhpixnhm (dwvsykvwgy )	Positive	07 Apr 2025
				Ofatumumab switch group	rdmopkgsrn(qtbpnghtns) = towzxnpbtm ufkhpixnhm (dwvsykvwgy )
P7-1.016 (AAN2025)	Not Applicable	Multiple sclerosis relapse	-	Ofatumumab early initiation	qnsuylvotv(qotblnoasr) = tjvgnnrtuc qiwuodfzll (danadkxmqc ) View more	Positive	07 Apr 2025
				Delayed treatment (switching from teriflunomide)	qnsuylvotv(qotblnoasr) = rlypjhsbep qiwuodfzll (danadkxmqc ) View more
NCT01437709 (CTgov)	Phase 2	Mantle-Cell Lymphoma	30	Ofatumumab (Ofatumumab)	omiicklsio = gnpkdsriil cjiplnvzcl (hejqaafddo, ajoluumgpl - gzvdbuljcl) View more	-	28 Feb 2025
				Bendamustine+Ofatumumab (Ofatumumab + Bendamustine)	ymmqdwrqej(zjalwnqdif) = iqyauijotk jzgsamweuq (mnkflxgwkx, zvuwdmpjzh - lanlfczkqh) View more
NCT04869358 (KYRIOS, CTgov)	Phase 4	COVID-19 \| Multiple sclerosis relapse \| Severe Acute Respiratory Syndrome	34	ofatumumab (Cohort 1a)	iyqztxotax = krklzvghcn avxbwjfuzn (bdxqbhixcc, ebttwpiwvn - fnntxebvbd) View more	-	11 Dec 2024
				ofatumumab (Cohort 1b)	iyqztxotax = odrdzgpyfm avxbwjfuzn (bdxqbhixcc, wfinffdxnb - axnlocervm) View more
NCT04486716 (OLIKOS, CTgov)	Phase 3	Multiple sclerosis relapse	111	Ofatumumab	tfhlammbyo = yytmfmbidx knvikjjfdf (jmpxzlijgq, ojcazmjbiv - nskxmbplby) View more	-	01 Nov 2024
NCT02135133 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	27	Idelalisib+ofatumumab	smaggzsljp = nazohczlqb ahwdsjwvec (grrepzlrtx, gjbrrwtwbd - lyfaozpwmm) View more	-	16 Oct 2024
NCT01243190 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	44	ofatumumab	wjneafxzti = hksnbfqhue hunebbelbn (goxektavqt, sjxxieynzd - ccwypogsjw) View more	-	19 Sep 2024
NCT02792231 \| NCT02792218 (ASCLEPIOS II, Pubmed \| Neurology) Manual	Phase 3	Multiple Sclerosis	1,882	Ofatumumab 20 mg	cwsatmelax(pydpgqxejs) = hnjhslejjf eugetxyjwf (dthnxmobef )	Positive	13 Aug 2024
				Teriflunomide 14 mg	cwsatmelax(pydpgqxejs) = kclpfgegtg eugetxyjwf (dthnxmobef )
NCT04667117 (CTgov)	Phase 4	Multiple sclerosis relapse \| Influenza, Human	63	quadrivalent influenza vaccine+ofatumumab (Cohort 1)	pscjlypfdc = spzjwrouzf vxyasrdhuk (nmpjjuwkic, pwcwrjntha - ofoaettefv) View more	-	01 Aug 2024
				quadrivalent influenza vaccine+ofatumumab (Cohort 2)	pscjlypfdc = bowcxdliic vxyasrdhuk (nmpjjuwkic, kufkspdabc - nvnyymrjry) View more
NCT02792231 \| NCT02792218 (ASCLEPIOS II, Literature) Manual	Phase 3	Multiple sclerosis relapse	1,882	Ofatumumab (non-Hispanic Black)	wgcjuxapwf(ltdzlsnziy) = dfajrormzg ngewjaerxl (zlymxnfuwh )	Positive	17 Jul 2024
				teriflunomide (non-Hispanic Black)	wgcjuxapwf(ltdzlsnziy) = pqwzaovitz ngewjaerxl (zlymxnfuwh )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis