A Multicenter, Open-label, Single-arm, Multiple-dose Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Ianalumab in Chinese Adult Participants With Autoimmune Diseases

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

Start Date25 Nov 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06293365 / Not yet recruitingPhase 2

A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

Start Date26 Jun 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06133972 / RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Start Date21 May 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Ianalumab

100 Translational Medicine associated with Ianalumab

100 Patents (Medical) associated with Ianalumab

Literatures (Medical) associated with Ianalumab

02 Dec 2023·Expert opinion on biological therapy

Antibody based therapeutics for autoimmune hemolytic anemia

Review

Author: Fattizzo, Bruno ; Cavallaro, Francesca ; Barcellini, Wilma

INTRODUCTION:

Autoimmune hemolytic anemia (AIHA) treatment has been revolutionized by the introduction of target therapies, mainly monoclonal antibodies (MoAbs).

AREAS COVERED:

The anti-CD20 rituximab, which targets Ab production by B-cells, induces 80% of response in warm-type AIHA (wAIHA) and 50-60% in cold agglutinin disease (CAD). Other B-cell targeting MoAbs including ianalumab, povetacicept, and obexelimab are under active study. The anti-CD38 MoAb daratumumab has been used in several reports to target long-lived plasma-cells responsible for AIHA relapse, being effective even in multi-refractory cases. Anti-complement MoAbs will soon change the treatment paradigm in CAD; the anti-C1s sutimlimab rapidly increased Hb in more than 80% of the cases. Finally, MoAbs inhibiting the neonatal Fc receptor (FcRn), such as nipocalimab, can reduce the half-life of the pathogenic autoAbs, representing a promising treatment for wAIHA.

EXPERT OPINION:

MoAbs offer the potential to improve efficacy by reducing toxicity. However, there is a huge need for clinical trials exploring response duration rather than short-term efficacy. Complement inhibitors and anti-FcRns do not abrogate autoAb production and are being developed as long-term therapies. Thus, the combination of B-cell/plasma cell targeting drugs deserves to be explored. On the other hand, their rapid efficacy should be exploited for the acute AIHA phase.

01 Nov 2022·Digestive diseases and sciencesQ3 · MEDICINE

Advancing Biologic Therapy for Refractory Autoimmune Hepatitis

Q3 · MEDICINE

Review

Author: Czaja, Albert J

Biologic agents may satisfy an unmet clinical need for treatment of refractory autoimmune hepatitis. The goals of this review are to present the types and results of biologic therapy for refractory autoimmune hepatitis, indicate opportunities to improve and expand biologic treatment, and encourage comparative clinical trials. English abstracts were identified in PubMed by multiple search terms. Full-length articles were selected for review, and secondary and tertiary bibliographies were developed. Rituximab (monoclonal antibodies against CD20 on B cells), infliximab (monoclonal antibodies against tumor necrosis factor-alpha), low-dose recombinant interleukin 2 (regulatory T cell promoter), and belimumab (monoclonal antibodies against B cell activating factor) have induced laboratory improvement in small cohorts with refractory autoimmune hepatitis. Ianalumab (monoclonal antibodies against the receptor for B cell activating factor) is in clinical trial. These agents target critical pathogenic pathways, but they may also have serious side effects. Blockade of the B cell activating factor or its receptors may disrupt pivotal B and T cell responses, and recombinant interleukin 2 complexed with certain interleukin 2 antibodies may selectively expand the regulatory T cell population. A proliferation-inducing ligand that enhances T cell proliferation and survival is an unevaluated, potentially pivotal, therapeutic target. Fully human antibodies, expanded target options, improved targeting precision, more effective delivery systems, and biosimilar agents promise to improve efficacy, safety, and accessibility. In conclusion, biologic agents target key pathogenic pathways in autoimmune hepatitis, and early experiences in refractory disease encourage clarification of the preferred target, rigorous clinical trial, and comparative evaluations.

01 Sep 2022·Lancet (London, England)Q1 · MEDICINE

Ianalumab in Sjögren's syndrome: what can we learn from lupus trials? – Authors' reply

Q1 · MEDICINE

Letter

Author: Mariette, Xavier ; Bowman, Simon J ; Luo, Wen-Lin ; Hueber, Wolfgang ; Dorner, Thomas

News (Medical) associated with Ianalumab

16 May 2024

·www.globenewswire.com

Novartis meets all tender offer conditions to acquire MorphoSys AG for EUR 68 per share in cash

Novartis secured 79.6 percent acceptance by MorphoSys shareholders during the initial acceptance period, reaching the minimum 65% acceptance thresholdSettlement of the shares tendered during the initial acceptance period is expected to occur on 23 May 2024Additional statutory acceptance period is expected to end on 30 May 2024 at 24:00 hours CESTTransaction strengthens the Novartis pipeline in oncology, adding pelabresib, a late-stage BET inhibitor for myelofibrosis and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomas Basel, 16 May 2024 – Today, Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, announced the result of its voluntary public takeover offer (the “Offer”) for the shares of MorphoSys AG (“MorphoSys”), including all shares represented by MorphoSys American Depositary Shares (“ADS”). As of the expiry of the acceptance period at 24:00 hours CEST on 13 May 2024, the Offer has been accepted by approximately 79.6 percent of the total share capital of MorphoSys, including purchases by Novartis BidCo AG outside the Offer for approximately 11.6 percent of the share capital. All conditions of the Offer, including the minimum acceptance threshold of 65%, were fulfilled by the end of the acceptance period. The settlement of the shares tendered during the initial acceptance period is scheduled for 23 May 2024. The statutory two-week additional acceptance period for the Offer will commence on 17 May 2024 and end on 30 May 2024 at 24:00 hours CEST and 18:00 hours EDT (also on 30 May 2024). During this time, shareholders who have not tendered their MorphoSys shares, including shares represented by MorphoSys ADS, can still accept the Offer.With all offer conditions fulfilled, Novartis can now begin the necessary steps to progress the integration of MorphoSys, including full access to pelabresib (CPI-0610), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis. The integration also allows full access to tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of EZH1 and EZH2 currently being tested in patients with solid tumors or lymphomas, as well as a broad portfolio of partnered assets, some of which are in partnership with Novartis, including ianalumab (VAY736). In the context of the integration Novartis continues to progress the workstreams for implementation of both a delisting of MorphoSys and a domination and profit and loss transfer agreement with MorphoSys. Georgeson is acting as information agent for Novartis for the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer. The offer document for the Offer and additional information are available at www.novartis.com/investors/morphosys-acquisition. A takeover offer hotline for retail shareholders is available between 9:00-18:00 hours CEST from Monday through Friday at +49 89 38038187 (for German callers) and +44 203 005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 hours EDT from Monday through Friday and 12:00-18:00 hours EDT on Saturdays at +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S.). Additional Information and Where to Find it This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the “Bidder”). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The solicitation and offer to buy shares of MorphoSys is only being made pursuant the offer document. In connection with the Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the “Offer Documents”), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the “Recommendation Statements”). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944. In addition to the Offer to Purchase, including the means to tender and certain other Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov. In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Offer in the manner described in the offer document. Acceptance of the Offer by stockholders residing outside Germany and the U.S. may be subject to further legal requirements. With respect to the acceptance of the Offer outside Germany and the U.S., no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction. DisclaimerThis press release contains forward-looking statements concerning Novartis AG, the Bidder, MorphoSys and the Offer that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this communication, forward-looking statements include statements about the parties’ ability to satisfy the conditions to the consummation of the Offer; statements about the expected timetable for the consummation of the Offer; the plans, objectives, expectations and intentions of Novartis AG and the Bidder; and the financial condition, results of operations and business of MorphoSys and Novartis AG. The forward-looking statements contained in this communication represent the judgment of the Bidder and Novartis AG as at the date of this communication and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of Novartis AG, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if the results, performance, financial condition and liquidity of Novartis AG, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the timing of the Offer; uncertainties as to how many of the MorphoSys stockholders will tender their stock in the Offer; the possibility that competing offers will be made; the possibility that various conditions for the Offer may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Offer; the effects of the Offer on relationships with employees, other business partners or governmental entities; that the Bidder and Novartis AG may not realize the potential benefits of the Offer; transaction costs associated with the Offer; that expectations may be incorrect; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission, as well as the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by MorphoSys and the Tender Offer Statement on Schedule TO and related Offer Documents to be filed by the Bidder and Novartis AG. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this communication. The Bidder, Novartis AG and MorphoSys expressly disclaim any obligation to update any such forward-looking statements in this communication to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. 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 more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Marlena Abdinoor +1 617 335 9525 SwitzerlandSatoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck +41 61 324 7188 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 8269 Parag Mahanti +1 973 876 4912

Acquisition

06 Feb 2024

·www.globenewswire.com

Novartis to strengthen oncology pipeline with agreement to acquire MorphoSys AG for EUR 68 per share or an aggregate of EUR 2.7bn in cash

Transaction to include pelabresib, a late-stage BET inhibitor for myelofibrosis (MF) and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomas Pelabresib recently met its primary endpoint of spleen volume reduction and demonstrated favorable trends in symptom improvement with a well-tolerated safety profile in Phase 3 MANIFEST-2 study, when administered in combination with ruxolitinib in JAK inhibitor-naive MF patients1 Pelabresib and ruxolitinib combination offers potential for practice changing, first line of treatment in myelofibrosis with regulatory filing with the U.S. FDA planned for H2 2024 Transaction aligns with Novartis strategic focus on oncology, and strengthens company’s efforts in developing next-generation treatment options for cancer EUR 68 per share (or EUR 2.7bn aggregate) all-cash transaction unanimously approved by Novartis and MorphoSys Boards, expected to close in H1 2024, subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals February 05, 2024 – Novartis today announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys AG (FSE: MOR; NASDAQ: MOR), a Germany-based, global biopharmaceutical company developing innovative medicines in oncology. The acquisition, which is subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals, further expands and complements Novartis pipeline in oncology, one of its priority therapeutic areas, while also enhancing Novartis global footprint in hematology. Upon completion of the acquisition, Novartis will own pelabresib (CPI-0610), a novel and potentially practice changing treatment option with a well-tolerated safety profile provided in combination with ruxolitinib for patients with myelofibrosis (MF). It will also include tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins currently being tested in patients with solid tumors or lymphomas. Pelabresib in combination with ruxolitinib recently met its primary endpoint of spleen volume reduction in the Phase 3 MANIFEST-2 study in JAK inhibitor-naive MF patients1. The combination also demonstrated favorable trends in symptom improvement as evidenced by key secondary endpoints of absolute and 50% change in total symptom score (TSS) at week 24 compared to baseline. All four clinical hallmarks of disease in myelofibrosis – splenomegaly, disease-associated symptoms, anemia and bone marrow fibrosis – were improved with the pelabresib and ruxolitinib combination. In the earlier Phase 2 MANIFEST trial, the third arm of the study with a patient population comparable to MANIFEST-2, showed durable improvements in both spleen volume and total symptom score up to week 602. Regulatory filing with the U.S. FDA is planned for the second half of 2024. “We are excited about the opportunity of bringing pelabresib, a potential next-generation treatment combined with ruxolitinib, to people living with myelofibrosis, a rare and debilitating form of blood cancer,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer of Novartis. “With the planned acquisition of MorphoSys, we aim to further strengthen our leading pipeline and portfolio in oncology, adding to our capabilities and expertise. Building on our long-standing development partnership with MorphoSys, we look forward to continuing our work together to realize the full impact and value of their investigational medicines for patients with unmet needs.” Pelabresib is an investigational small molecule designed to promote anti-tumor activity by selectively inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is also being studied in patients with essential thrombocythemia (ET), which is currently in Phase 2 in second line of treatment. Besides pelabresib, MorphoSys’ pipeline includes a broad portfolio of partnered assets of which some are in partnership with Novartis, including ianalumab (VAY736) which is studied across multiple immunological diseases and in hematology. Under the agreed transaction, which has been unanimously approved by the Board of Directors of both companies, Novartis will make a voluntary public takeover offer for all no-par value bearer shares of MorphoSys AG for EUR 68 per share (or an aggregate of EUR 2.7bn). The transaction is subject to customary closing conditions, including acceptance of the takeover offer by at least 65% of MorphoSys AG’s outstanding shares and receipt of regulatory approvals and is expected to close in the first half of 2024. Until the transaction closes, MorphoSys AG will continue to operate as a separate, independent company. Pelabresib (CPI-0610) is an investigational small molecule designed to promote anti-tumor activity selectively by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been approved by any regulatory authorities. The development of pelabresib was funded in part by The Leukemia and Lymphoma Society®. Myelofibrosis is a blood cancer – belonging to a group of diseases called myeloproliferative neoplasms – caused by genetic abnormalities in bone marrow stem cells and characterized by four hallmarks: enlarged spleen, anemia, impaired bone marrow microenvironment causing fibrosis, and debilitating disease-associated symptoms, including severe fatigue, night sweats, itching, increased bleeding and significant pain caused by their enlarged spleen. For many living with myelofibrosis, the combination of symptoms often severely impacts their quality of life. At diagnosis, several factors, such as age, genetics and bloodwork, help determine a patient’s long-term prognosis. About 90% of newly diagnosed patients have intermediate- to high-risk disease, which has a worse prognosis and a higher likelihood of disease-associated symptoms. While JAK inhibitors, the current standard of care, address some aspects of the disease, no agent provides broad disease control. There is an urgent need for novel, well-tolerated therapeutic options capable of changing the natural course of myelofibrosis to provide patients with deep and durable responses across its four hallmarks. Tulmimetostat (CPI-0209) is an investigational compound designed to exert anti-tumor activity by inhibiting the function of enhancer of zeste homolog 1 and 2 (EZH2 and EZH1) proteins to reactivate silenced genes like tumor suppressor genes. Tulmimetostat is being tested as a once-daily oral treatment in a Phase 1/2 trial (NCT04104776) in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian clear cell carcinoma and endometrial carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. 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 more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References 2023-12-11_Rampal R_MANIFEST-2_ASH 2023_Oral 628 2023_Manifest Arm 3 results_Mascarenas et al J Clin Oncol 41:4993-5004 The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultAcquisition

28 Nov 2023

·www.globenewswire.com

Novartis upgrades mid-term sales growth guidance, showcases its differentiated innovative medicines strategy and robust pipeline at R&D Day

Ad hoc announcement pursuant to Art. 53 LR ‘Pure-play’ innovative medicines strategy focused on four therapeutic areas and five technology platforms, which offer potential for consistent growth Mid-term sales guidance upgrade to 5% CAGR (2022-27), with core operating income margin of ~40%+ by 2027, driven by continued strong momentum of key growth drivers Confidence to grow mid-single digit longer-term based on the foundational strength of de-risked existing brands and pipeline assets Focused strategy and financial discipline has delivered robust sales, core operating income and free cash flow growth Industry-leading performance across priority ESG ratings and remain committed to creating value through focusing on material ESG factors Basel, November 28, 2023 — Novartis executives are meeting investors and analysts today at an event in London, U.K., to showcase the company’s ‘pure play’ innovative medicines strategy and focused Research and Development pipeline. “Novartis has now completed its transformation into a ‘pure-play’ innovative medicines company, delivering robust increases in core margin and free cash flow, while also continuing strong operational performance. We remain committed to executing our focused strategy, and creating significant shareholder value in the short-, mid-, and long-term as illustrated by our upgraded mid-term sales guidance to 5% CAGR and ~40%+ core operating income margin.”, said Vas Narasimhan M.D., CEO of Novartis. “ Our pipeline is focused on delivering high value assets across our four core therapeutic areas and fully realizing the potential of our advanced technology platforms, which could unlock future substantial growth.” Novartis today outlines progress made in delivering its pure-play strategy, focused on four core therapeutic areas (Cardiovascular-Renal-Metabolic, Immunology, Neuroscience, Oncology), two plus three technology platforms (Chemistry, Biotherapeutics, xRNA, Radioligand, Gene & Cell Therapy) in four priority geographies (US, China, Germany, Japan). Strengthening R&D pipeline, improving productivityThe company continues to make significant progress in improving the performance of R&D through active prioritization of the pipeline to focus on high-value assets, and driving operational excellence within the organization. This has enabled increased resourcing for priority projects and strengthening functional capabilities. Across Biomedical Research and Development, resources have been streamlined to maximize focus and enhance competencies. The strong, streamlined portfolio now comprises 103 projects1 including 46 NMEs, with up to 15 key submissions for regulatory approval expected in the 2024-2027 timeframe, each targeted to address major unmet needs and with significant sales potential. Four core Therapeutic Areas; advanced technology platforms*Oncology disease areas include breast, prostate and lung cancer as well as CML, NHL, MM, AML, MDS, PNH, ITP, wAIHA. Submissions planned by 2027 include Kisqali for HR+/HER2- breast cancer, in the adjuvant setting, Pluvicto for mCRPC in both the pre-taxane setting and for mHSPC, and Scemblix in first line CML, as well as iptacopan for PNH.Radioligand therapy in solid tumors offers patients better efficacy with lower side effects. Cardiovascular, Renal and Metabolic (CRM) disease areas include heart failure & hypertension, atherosclerosis, rare renal diseases and acute kidney injury. Submissions planned by 2027 include iptacopan, atrasentan and zigakibart for treatment of IgAN, iptacopan for the treatment of C3G, pelacarsen to lower Lp(a) for CV risk reduction and Leqvio for pediatric hyperlipidemia.siRNA offers improved adherence while maintaining efficacy in cardiovascular diseases. Immunology disease areas include psoriasis, psoriatic arthritis, spondylitis / spondylarthritis, HS, CSU, CINDU, Sjögren’s, SLE, LN and food allergy. Submissions planned by 2027 include multiple filings to extend Cosentyx indications, remibrutinib for CSU and CINDU and ianalumab for Sjögren’s syndrome.CAR-T offers potential in SLE, Sjögren’s, severe rheumatoid arthritis. Neuroscience disease areas include multiple sclerosis, neurodegeneration (Alzheimer’s and Parkinson’s) and neuromuscular disease (building on Spinal Muscular Atrophy, including ALS). Submissions planned by 2027 include an intrathecal formulation for Zolgensma and remibrutinib for multiple sclerosis.Technologies delivering nucleic assets to the brain have shown promising data. 1 Ph1 to approval, excl. Global Health. * for abbreviations, see below. The R&D Day will be webcast at 14:30 CET and can be watched here: R&D Day 2023. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “planned,” “could,” “expected,” “anticipated,” “committed,” “pipeline,” “commitment,” “guidance,” “focused,” “confidence,” “to grow,” “remain,” “continuing,” “continue,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release; or regarding potential future revenues from such products; or regarding our transformation into a pure-play innovative medicines company focused on four therapeutic areas and five technology platforms; or regarding our mid-term sales guidance; or regarding potential future, pending or announced transactions; or regarding our approximate estimated peak sales, sales potential and other financial information; or regarding our commitment to operational excellence; or regarding our expanding use of our technology platforms across core therapeutic areas; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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. There can be no guarantee that the investigational or approved products described in this presentation 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, or that any estimated peak sales or other estimated financial figures referenced will be reached. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. About NovartisNovartis 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 more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. AbbreviationsLDL-C; CVRR-Lp(a) - Cardiovascular risk reduction - Lp(a); C3G - Complement 3 Glomerulopathy; IgAN - IgA Nephropathy; HS - Hidradenitis suppurativa; CSU - Chronic Spontaneous Urticaria; CINDU - Chronic Inducible Urticaria; SMA IT - Spinal Muscular Atrophy - Intrathecal; MS - Multiple sclerosis; HR+/HER2- BC - Hormone receptor positive/ human epidermal growth factor receptor 2 positive breast cancer; mCRPC - Metastatic Castration-Resistant Prostate Cancer; mHSPC - Metastatic Hormone-Sensitive Prostate Cancer; NSCLC - Non-Small Cell Lung Cancer Treatment; PNH - Paroxysmal nocturnal hemoglobinuria; CML - Chronic myelogenous leukemia; HR-MDS - Higher-Risk Myelodysplastic Syndromes; NHL – Non-Hodgkins’ Lymphoma; MM – multiple myeloma; MDS – myelodysplatic syndrome; ITP – immune thrombocytopenia; wAIHA -Warm antibody hemolytic anemia; CINDU - Chronic inducible urticaria; SLE – systemic lupus erythematosus; LN- lupus nephritis # # # Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Richard Jarvis +41 79 584 2326 Julie Masow +1 862 579 8456 Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Marlena Abdinoor +1 617 335 9525 Switzerland Satoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Samir Shah +41 61 324 79 44 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 38 09 Parag Mahanti +1 973 876 4912 Isabella Zinck +41 61 324 71 88 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 82 69 Zain Iqbal +41 61 324 03 90

100 Deals associated with Ianalumab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	JP	Novartis Pharma AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	JP	China Novartis Institutes for BioMedical Research Co., Ltd.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	JP	Novartis Pharma Stein AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	JP	Novartis Pharmaceuticals Corp.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	BR	China Novartis Institutes for BioMedical Research Co., Ltd.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	BR	Novartis Pharma AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	BR	Novartis Pharma Stein AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	BG	Novartis Pharmaceuticals Corp.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	CA	Novartis Pharma AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	CA	Novartis Pharma Stein AG	02 Mar 2023

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2023	Not Applicable	Systemic Lupus Erythematosus	67	Ianalumab	qnouypegec(trxahmdosu) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) qghtbvloim (mqmcqdhidb ) View more	-	31 May 2023
				Placebo
NCT03400176 (AACR2023) Manual	Phase 1	Chronic Lymphocytic Leukemia	39	VAY736+ibrutinib	exvgvhjwhz(jvwaqrkufw) = fawtfvkvba mosvgdbnmq (rupbyzwaze ) View more	Positive	15 Apr 2023
				VAY736+ibrutinib (1L)	exvgvhjwhz(jvwaqrkufw) = voyvjqpkqo mosvgdbnmq (rupbyzwaze ) View more
NCT03287414 (CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	30	Standard of Care (SoC)+VAY736 (VAY736)	ypoubxdmpk(haoljdpxjb) = dtyxykgpqa xhnytvwpig (dkyxdtsafc, ravspahzau - gmyvigdbob) View more	-	10 Mar 2023
				Placebo (Placebo)	ypoubxdmpk(haoljdpxjb) = kaqznxagjl xhnytvwpig (dkyxdtsafc, bcxjjedqaj - vkgglbirzh) View more
NCT03400176 (ASH2021) Manual	Phase 1	Chronic Lymphocytic Leukemia First line \| Second line	32	Ibrutinib+Ianalumab	upwcypggqw(zapdgtvxhz) = rpmzgkxobx uuihnfindl (onhuatwjbj ) View more	Positive	05 Nov 2021
NCT01930175 (CTgov)	Phase 2	Pemphigus	13	VAY736 (VAY736 3 mg/kg)	hhxbhiiprn(pitnihakjs) = omapvqxaui lngyxyqjhx (vdlldxyjhd, xxruuypnqq - sujzqrkygm) View more	-	19 Oct 2020
				VAY736 (VAY736 10 mg/kg)	hhxbhiiprn(pitnihakjs) = ekzhrxkdbn lngyxyqjhx (vdlldxyjhd, hthtmbopha - cizlmxbrfc) View more
NCT02038049 (CTgov)	Phase 2	Multiple Sclerosis, Relapsing-Remitting	8	VAY736 (VAY736)	qjtxcszhuw(ukbliwsjtz) = fgizeuuppz awrxsknzot (kfemqnvvuw, dxekfnypul - ssrupafcvo) View more	-	30 Oct 2019
				Placebo (Placebo to VAY736)	qjtxcszhuw(ukbliwsjtz) = zbnhlukztq awrxsknzot (kfemqnvvuw, fibnuvmdcd - nzdhbqnmti) View more
NCT02149420 (CVAY736X2201, Pubmed) Manual	Phase 2	Primary Sjögren's syndrome	27	ianalumab	dxbaxbushc(yvfuerdbyx) = A similar trend showing positive therapeutic effect by ianalumab was observed across the primary clinical outcome (ESSDAI) and all secondary clinical outcomes (ESSPRI, Multidimensional Fatigue Inventory, Short Form-36, global assessments by physician and patient) versus the placebo-treated group. pozxtqlncy (vgwxnwfulc ) View more	Positive	01 May 2019
				Placebo
NCT02149420 (CVAY736X2201, CTgov)	Phase 2	Primary Sjögren's syndrome	27	Placebo (Placebo)	ydoiognkwk(nhvffvbdza) = bxygbnqfrg qymtbkmedl (qirnonaozk, izcmqpying - pnnbzqjbxh) View more	-	12 Feb 2019
				VAY736 (VAY736 3 mg/kg)	ydoiognkwk(nhvffvbdza) = qshxvyoege qymtbkmedl (qirnonaozk, vwhyltezuw - jfpywzxgny) View more
NCT02149420 (Phase IIa Clinical Trial for VAY736 in Primary Sjögren’s Syndrome, ACR2017)	Phase 2	Primary Sjögren's syndrome	-	VAY736	onccijagwt(kwhesspldj) = wielthwnlt clytwqyjqa (ooadmzcoon )	Positive	05 Nov 2017

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