Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. If the next dose is already due, then administer as planned. Furthermore,Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 0
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., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. 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 such as the ongoing COVID-19 pandemic on our business, and other such estimates and results. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Type 2 inflammation in asthma--present in most, absent in many. ", "Severe asthma continues to have a debilitating impact on many of the 34 million people living with the disease worldwide, affecting their breathing and limiting aspects of day-to-day life. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Centers for Disease Control and Prevention. For scenario analyses within the allergic and eosinophilic asthma populations, we find similar results to the base case, ICER reviewers wrote. In addition,Amgencompetes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. Also,Amgenor others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. . News - UCB, Tezspire, Neurological Flurry of Japanese drug approvals. SoC was treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without daily oral corticosteroid treatment. Our business may be impacted by government investigations, litigation and product liability claims. Key secondary endpoints included the effect of TEZSPIRE on lung function, asthma control and health-related quality of life.3. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? ", Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.3It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3 Tezspire is the first and only biologic for severe asthma that does not have a phenotypeeosinophilic or allergicor biomarker limitation within its approved label.4-11, "Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life," said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and the principal investigator of the NAVIGATOR trial. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty toAmgen. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. 1996-2022 Amgen Inc. All Rights Reserved. The Minnesota Department of Human Services ("Department") supports the use of "People First" language. tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (tslp), an epithelial cytokine. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2, "Today's approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. HCPCS Code Description J2356 . Product Packages NDC 55513-112-01 Package Description: 1 SYRINGE in 1 CARTON > 1.91 mL in 1 SYRINGE For more information, please refer to the Tezspire website, patient information, and/or prescribing information . The October 2022 Medicare Part B Drug and Biological Average Sales Price Quarterly Payment files are located in the "Downloads" section below. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. Please see the TEZSPIRE full Prescribing Information. In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. No income requirements or financial documentation needed. You may report side effects related to AstraZeneca products by clickinghere. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Commitment to Patient SupportAmgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire with affordable access to the medicine. In July 2021, TEZSPIRE was the first and only biologic to be granted Priority Reviewin the U.S. for the treatment of asthma by the FDA. About GoodRx Prices and Tezspire Coupons. TEZSPIREwas approved for a broad population of people living with severe asthma, and we look forward to getting this important medicine into the hands of millions of patients who have had an unmet medical need. Examining Evolving Treatment Paradigms in the Hemophilia B Space, Payer Provider Perspectives: Prescription Digital Therapeutics: Reimagining Care in Behavior-Driven Conditions. In addition,Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. The quality-adjusted life year (QALY) is the academic standard for measuring how well different kinds of medical treatments lengthen and/or improve patients lives. About the NAVIGATOR and the PATHFINDER Clinical Trial ProgramIn addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATORand SOURCE. In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. TEZSPIRE is not a rescue medication. Visit www.TEZSPIRETogether.com or call 1-888-TZSPIRE for full Terms and Conditions. In addition, sales ofAmgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Experienced Market Access/Reimbursement Manager with extensive experience in biotechnology access/ reimbursement, as well as vaccine, pharmaceutical, and medical device sales. NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP.2 These results support the U.S.Food and Drug Administration Breakthrough Therapy Designationgranted to TezspireinSeptember 2018for patients with severe asthma, without an eosinophilic phenotype. From a health system perspective and using a placeholder net price of approximately $28,000 per year, ICER estimates a cost of $430,000 per QALY gained and $422,000 per evLY gained. Tezspireis not indicated for the relief of acute bronchospasm or status asthmaticus. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. endstream
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TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Acute Asthma Symptoms or Deteriorating DiseaseTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. All patients received their prescribed controller medications without change throughout the trial.2, The primary efficacy endpoint was the AAER during the 52-week treatment period. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. Further, any scientific information discussed in this news release relating to new indications forAmgen's products is preliminary and investigative and is not part of the labeling approved by theU.S. Food and Drug Administrationfor the products. Wenzel S. Severe Asthma in Adults. You will be referred to your doctor's office for clinical advice. Peters MC, Mekonnen ZK, Yuan S, et al. TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). It is not known if Tezspire is safe and effective in children younger than 12 years of age. AstraZeneca continues to lead development andAmgencontinues to lead manufacturing. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. TEZSPIRE (tezepelumab-ekko) U.S. IndicationTEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. A new medical policy listing coverage criteria for the drug will become effective April 11, 2022. 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. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. 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. For patients with allergic, asthma Tezspires improvements in symptoms was similar to Xolair, although Tezspire achieved a higher improvement in the exacerbation rate. TEZSPIRE (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONSKnown hypersensitivity to tezepelumab-ekko or excipients. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. ADVERSE REACTIONS The most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain. 2,12-14 The program includes additional mechanistic and long-term safety trials.15, NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). Varricchi G, et al. Tezspire is a prescription medicine used to treat the symptoms of Severe Asthma. When typing in this field, a list of search results will appear and be automatically updated as you type. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO). Tezspire, and . 3 it is the first and only biologic to consistently and significantly reduce asthma exacerbations across phase 2 and 3 clinical trials, which included a broad population Our business may be impacted by government investigations, litigation and product liability claims. . The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. About Severe AsthmaGlobally, there are approximately 2.5 million patients with severe asthma who are uncontrolled or biologic eligible, with approximately 1 million in theU.S. Qualifying biosimilars are noted in the notes column. TEZSPIRE is a treatment for severe asthma that proactively reduces inflammation, which means you could experience: Fewer asthma attacks Better breathing and improved lung function Improved asthma symptom control Results may vary. Am J Respir Crit Care Med. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO). In the United States, asthma is more than twice as common among Black children as among White children and remains somewhat more common among Black adults. 2005;172;14960. Tezspireis also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). The discovery of significant problems with a product similar to one ofAmgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. SoC was treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without daily oral corticosteroid treatment. For more information, visitwww.amgen.comand follow us onwww.twitter.com/amgen. No forward-looking statement can be guaranteed and actual results may differ materially from thoseAmgenprojects. ", TEZSPIREis a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2TEZSPIRE is the first and only biologic for severe asthma that does not have a phenotypeeosinophilic or allergicor biomarker limitation within its approved label.4-11 TEZSPIRE consistently and significantly reduced asthma attacks across Phase 2 and 3 clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3, The most common adverse reactions (incidence 3% and more common than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back pain.1. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. Please see Full including International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine. Tezspire is a prescription medicine used with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine. The Company generated $2.8 billion of free cash flow for the third quarter versus $2.2 billion in the third quarter of 2021. 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. 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. Terminology disclaimer. ICERs analysis finds that Tezspire, which is under review at the FDA, provides clinical benefit for patients with severe asthma, but with increased costs to the healthcare system. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability ofAmgen's systems andAmgen's data. All patients received their prescribed controller medications without change throughout the trial.2, The primary efficacy endpoint was the AAER during the 52-week treatment period. Retroactively effective to December 17, 2021, Tezspire is eligible for coverage under the medical benefit. The most frequently reported adverse events for Tezspire were nasopharyngitis, upper respiratory tract infection and headache.2. The most frequently reported adverse events for TEZSPIRE were nasopharyngitis, upper respiratory tract infection and headache.2. In July 2021, TEZSPIRE was the first and only biologic to be granted Priority Reviewin the U.S. for the treatment of asthma by the FDA. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. All rights reserved. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. VABYSMO (faricimab-svoa) Injectable Medication Precertification Request For Medicare Advantage Part B: FAX: 1-844-268-7263 . 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 forAmgen's manufacturing activities, the distribution ofAmgen's products, the commercialization ofAmgen's product candidates, andAmgen's clinical trial operations, and any such events may have a material adverse effect onAmgen's product development, product sales, business and results of operations. IfAmgenfails to meet the compliance obligations in the corporate integrity agreement betweenAmgenand theU.S.government,Amgencould become subject to significant sanctions. Amgen's stock price may be volatile and may be affected by a number of events. For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com. For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Avastin (C9257), Alymsys, Mvasi, and Zirabev do not require. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Key secondary endpoints included the effect of Tezspire on lung function, asthma control and health-related quality of life.3. Chung KF, et al. AboutAmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Tezspire 210 mg every 4 weeks, tezepelumab -ekko 280 mg every 2 weeks, or placebo. Li Y, et al. For additional information, patients and caregivers may contact Tezspire Together. WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. About theAmgenand AstraZeneca CollaborationIn 2020,Amgenand AstraZeneca updated the 2012 collaboration agreement for Tezspire. But at an anticipated price of $28,000 per year, the therapy would exceed cost-effectiveness standards, and cost-effectiveness is only modestly improved when productivity and other effects are considered, according to the report. Godar M, Blanchetot C, de Haard H, et al. TSLP is a cytokine derived from epithelial cells . As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO). Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions.