Granulomatosis With Polyangiitis

Breadth of Research Reflects Amgen 's Commitment to Rheumatology Data Include Sjögren's Syndrome, Uncontrolled Gout, Severe Active ANCA-Associated Vasculitis and Psoriatic Arthritis THOUSAND OAKS, Calif. , Nov. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its expanded rheumatology pipeline and portfolio, following the recent acquisition of Horizon Therapeutics. More than 20 abstracts will be presented during the American College of Rheumatology (ACR) Convergence 2023 , taking place Nov. 10-15 , in San Diego . "The data at ACR will illustrate our continued growth in rheumatology as we advance unique treatment approaches across a broader range of diseases," said David M. Reese , M.D., executive vice president of Research and Development at Amgen . "Drawing on our decades of experience in inflammation, we're looking forward to advancing new treatment areas like Sjögren's syndrome and uncontrolled gout." At ACR, new results will be presented from the Phase 2 study of dazodalibep, an investigational therapy for Sjögren's. Other research highlights include new TAVNEOS ® (avacopan) data from the Phase 3 ADVOCATE study evaluating diffuse alveolar hemorrhage (DAH) in patients with severe active ANCA-associated vasculitis (GPA/MPA), as well as an oral presentation on Otezla ® (apremilast) in FOREMOST, the first placebo-controlled study designed to specifically assess people with early oligoarticular psoriatic arthritis. Additionally, new real-world data showing a significant uptake in the use of KRYSTEXXA ® (pegloticase) with methotrexate or other immunomodulators by clinicians following the U.S. labeling update, will be delivered at the meeting. Abstracts and Presentation Times: Amgen Sponsored Abstracts AMJEVITA ® (adalimumab-atto) Enbrel ® (etanercept) KRYSTEXXA ® (pegloticase) Otezla ® (apremilast) Prolia ® (denosumab) TAVNEOS ® (avacopan) AMG 570 (rozibafusp alfa) Dazodalibep Partner-Led Abstracts EVENITY ® (romosozumab-aqqg) TAVNEOS ® (avacopan) About KRYSTEXXA ® (pegloticase) KRYSTEXXA ® (pegloticase) is the first and only biologic approved by the FDA to treat adults living with uncontrolled gout, a painful and debilitating inflammatory condition with which people continue to have abnormally high levels of uric acid and symptoms despite the use of conventional therapies. In 2022, the FDA approved expanding labeling to include co-administration with the immunomodulator methotrexate, based on results from the MIRROR randomized controlled trial, which showed significant improvements in efficacy and safety, including a reduction in infusion reactions. About Uncontrolled Gout Gout is a chronic, progressive inflammatory form of arthritis that is caused by high urate levels in the body. Tiny needle-like crystals can form and build up almost anywhere in the body. Patients with uncontrolled gout continue to have high levels of uric acid and ongoing symptoms of gout despite the use of oral urate-lowering therapies. Uncontrolled gout is a chronic, systemic disease, and if not addressed can have significant clinical consequences. KRYSTEXXA INDICATION KRYSTEXXA (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Caution should be exercised in patients who have congestive heart failure and patients should be closely monitored following infusion. ADVERSE REACTIONS The most commonly reported adverse reactions (≥5%) are: Please see Full Prescribing Information , including Boxed Warning . About Otezla ® (apremilast) Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide. About Psoriatic Arthritis Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Around a third of people living with psoriasis may go on to develop psoriatic arthritis. If left untreated, psoriatic arthritis can cause disability. Otezla U.S. INDICATIONS Otezla (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis. Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Otezla U.S. IMPORTANT SAFETY INFORMATION Contraindications Warnings and Precautions Adverse Reactions Use in Specific Populations Please click here for Otezla ® Full Prescribing Information. About TAVNEOS ® (avacopan) TAVNEOS ® (avacopan), approved by the FDA as an adjunctive treatment of severe active ANCA-associated vasculitis (GPA/MPA), is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action. While the precise mechanism in ANCA-associated vasculitis (GPA/MPA) has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be a driver of ANCA-associated vasculitis (GPA/MPA). About ANCA-Associated Vasculitis ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound impairment in the kidneys, lungs and other organs. Prior to the approval of TAVNEOS in severe active ANCA-associated vasculitis, treatment for ANCA-associated vasculitis was limited to courses of immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical consequences. TAVNEOS U.S. PRESCRIBING INFORMATION TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS U.S. IMPORTANT SAFETY INFORMATION Contraindications Serious hypersensitivity to avacopan or to any of the excipients. Warning and Precautions Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common. Adverse Reactions The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. Drug Interactions Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates. Please see Full Prescribing Information and Medication Guide. About Dazodalibep Dazodalibep is a CD40 ligand antagonist that blocks T cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway. Several autoimmune diseases are associated with the overactivation of this pathway. Amgen also plans to investigate dazodalibep in focal segmental glomerulosclerosis, a rare kidney disorder characterized by scarring of glomeruli. About Sjögren's Syndrome Sjögren's syndrome is a chronic, systemic autoimmune disease affecting exocrine glands, primarily the salivary and tear glands, with severe cases affecting multiple organs. Like other autoimmune diseases, Sjögren's syndrome primarily affects women. The disease also has an increased risk of non-Hodgkin's B-cell lymphoma and there is an unmet medical need for patients with extraglandular disease manifestations, as currently there is no therapy that can improve or slow the course of the disease. Disease manifestations include dry mouth, dry eyes, arthritis and kidney or lung dysfunction. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME. For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads . Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen . All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc acquisition (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. 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An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. 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CONTACT: Amgen , Thousand Oaks Madison Howard , 872-202-6221(media) Jessica Akopyan , 805-440-5721 (media) Justin Claeys , 805-313-9775 (investors) View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-to-present-data-at-acr-2023-across-expanded-rheumatology-pipeline-and-portfolio-301973426.html SOURCE Amgen

DUBLIN, July 26, 2023 /PRNewswire/ -- The "Anti-Neutrophil Cytoplasmic Antibody - Associated Vasculitis - Market Insight, Epidemiology and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. The market for ANCA Associated Vasculitis is a growing segment within the healthcare industry. ANCA Associated Vasculitis is a group of rare autoimmune conditions that cause inflammation of blood vessels. It includes three main diseases: granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA), and microscopic polyangiitis (MPA). Patients suffering from ANCA Associated Vasculitis often have general symptoms initially, and the disease requires multiple specialties like rheumatologists, pulmonologists, and nephrologists to diagnose. Due to advancements in healthcare infrastructure and new diagnostic techniques, the tendency toward diagnosis is rising in the United States. In 2022, the market size of ANCA Associated Vasculitis was highest in the US among the 7MM (United States, EU4, and Japan), accounting for approximately USD 620 million. This market size is expected to increase by 2032. Key Marketed Drugs: TAVNEOS (avacopan) by Chemocentryx/Amgen: TAVNEOS is an add-on treatment for severe active ANCA-associated vasculitis, including GPA and MPA. It is an orally administered small molecule that blocks the complement 5a receptor, which is responsible for the inflammatory response in ANCA-associated vasculitis. NUCALA (mepolizumab) by GlaxoSmithKline: NUCALA is the first and only FDA-approved treatment for adults with EGPA. It is a monoclonal antibody that targets the IL-5 receptor on eosinophils, reducing eosinophilic inflammation in EGPA. Emerging Therapies: FASENRA (benralizumab) by AstraZeneca: FASENRA is a monoclonal antibody that depletes blood and tissue eosinophils by binding to the IL-5 receptor. It is being evaluated in clinical trials for the treatment of EGPA and is expected to compete with NUCALA in the EGPA patient segment. Depemokimab (GSK3511294) by GlaxoSmithKline: Depemokimab is being developed as a potential treatment for ANCA Associated Vasculitis. It is an interleukin-17A antagonist that targets the inflammatory response in the disease. IFX-1 (vilobelimab) by InflaRx: IFX-1 is a monoclonal antibody that inhibits the complement system's C5a receptor, reducing the inflammatory response in ANCA-associated vasculitis. ANCA Associated Vasculitis Epidemiology The total diagnosed prevalent cases of ANCA-associated vasculitis in the 7MM were approximately 207,900 cases in 2022. The United States had the highest number of cases, accounting for around 70,700 cases. Among the EU4 countries, Germany had the highest number of cases, followed by the UK. Japan had diagnosed prevalent cases of MPA, GPA, and EGPA in 2022, and these cases are projected to increase during the forecast period. Treatment Landscape The current treatment for ANCA Associated Vasculitis involves remission induction with cyclophosphamide, rituximab, and high-dose steroids. Maintenance of remission is usually done with methotrexate or azathioprine. Rituximab is the dominant drug in the market. However, TAVNEOS and NUCALA are expected to capture a significant share of the market. Market Outlook The ANCA Associated Vasculitis market is expected to grow substantially in the coming years. The market size in the 7MM is projected to increase at a compound annual growth rate of 6.9%. The emerging therapies, including TAVNEOS, NUCALA, and other potential treatments, are expected to drive market growth. Vilobelimab and depemokimab are projected to generate the highest revenue among the emerging therapies. Conclusion The ANCA Associated Vasculitis market is experiencing growth due to increased awareness and advancements in healthcare infrastructure. TAVNEOS and NUCALA are approved treatments for different subtypes of ANCA-associated vasculitis, and emerging therapies like benralizumab, depemokimab, and vilobelimab show promise in improving treatment options. The market size is expected to expand, and there is a need for innovative treatments to address the unmet needs of patients. Access and reimbursement policies, as well as the availability of generics, will also impact the market dynamics. Key Topics Covered 1. Key Insights 2. Report Introduction 3. ANCA Associated Vasculitis Market Overview at a Glance 4. Executive Summary of ANCA Associated Vasculitis 5. Epidemiology and Market Methodology 6. Disease Background and Overview 7. Epidemiology and Patient Population 8. Patient Journey 9. Key Endpoints in ANCA Associated Vasculitis Clinical Trials 10. Marketed Therapies 11. Emerging Therapies 12. Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis (ANCA Associated Vasculitis): The 7MM Analysis 13. Market Access and Reimbursement 14. KOL Views 15. SWOT Analysis 16. Unmet Needs 17. Appendix A selection of companies mentioned in this report includes: GlaxoSmithKline AstraZeneca InflaRx For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

In January 2023, the company had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate DRL_RI, with the intention to the United States, European Union and other regions Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA). This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). In January 2023, Dr. Reddy’s had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU* and U.S.** reference products. DRL_RI is being developed as a biosimilar of Rituxan® / MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan® / MabThera® is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option for patients across the globe. Development and commercialisation of biological drugs is an important growth lever for our business. We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030.” Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly. About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI: RI-01-003: This study demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product* and U.S. reference product**. RI-01-006 (FLINTER): This study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product* in patients with Low Tumour Burden Follicular Lymphoma RI-01-007: This study demonstrated similar safety and immunogenicity pro the DRL_RI, EU reference medicinal product* and U.S. reference product** groups upon single transition from either of them, in subjects with active rheumatoid arthritis. *EU reference medicinal product is MabThera® **U.S. reference product is Rituxan® MabThera® and Rituxan® are registered trademarks of Roche. About Dr. Reddy’s biosimilars programme: Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 20 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India and over 27 Emerging Markets. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. Recently, we announced the successful completion of Phase I study and initiation of Phase III study of DRL_TC, our proposed biosimilar of tocilizumab via both the subcutaneous and intravenous routes, for global markets. We are also ramping up manufacturing capacity to support our global expansion plans. About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2023. 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