Certain ofAmgen's distributors, customers and payers have substantial purchasing leverage in their dealings withAmgen. 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 Recall those results included $400 million recorded in R&D expense related to our upfront payment to license rights to AMG 451 . Chung KF, et al. About theAmgenand AstraZeneca CollaborationIn 2020,Amgenand AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. In 2021, Amgen was named one of the 25 World's Best Workplaces by Fortune and Great Place to Work and one of the 100 most sustainable companies in the world by Barron's. 04-11-2022. 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. For more information about. endstream endobj startxref Clinical Trial Diversity and Representation, Clinical Trial Transparency, Data Sharing and Disclosure Practices, Adverse Event and Product Complaint Reporting, Environmental, Social & Governance Report 2021, Environment, Social and Governance Strategy, Community Investment and Amgen Foundation, TEZSPIRE (TEZEPELUMAB-EKKO) NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA, U.S.Food and Drug Administration Breakthrough Therapy Designation, https://clinicaltrials.gov/ct2/show/NCT04851964, https://clinicaltrials.gov/ct2/show/NCT03706079, https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm, https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php, https://clinicaltrials.gov/ct2/show/NCT03406078, https://www.prnewswire.com/news-releases/tezspire-tezepelumab-ekko-now-available-in-the-united-states-for-the-treatment-of-severe-asthma-301460118.html, Corren J, et al. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe asAmgenmay have believed at the time of entering into such relationship. 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). Amgen will record product sales in the U.S., with AZ recording its share of US profits as Collaboration Revenue. Amgen's stock price may be volatile and may be affected by a number of events. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.3,17 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.3,17Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,18Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.3,18By working at the top of the cascade, TEZSPIREhelps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.3,18. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. All aspects of the collaboration are under the oversight of joint governing bodies. Tezspire 210 mg every 4 weeks, tezepelumab -ekko 280 mg every 2 weeks, or placebo. ICER reviewers pointed that that although Tezspire improved symptom scores compared with placebo, these improvements were smaller than the minimal clinically important differences on the scales used. Key secondary endpoints included the effect of TEZSPIRE on lung function, asthma control and health-related quality of life.3. ADVERSE REACTIONS The most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain. Please see the TEZSPIRE full Prescribing Information. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. 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. The Company generated $2.8 billion of free cash flow for the third quarter versus $2.2 billion in the third quarter of 2021. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize Tezspire in North America. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Fahy JV. Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. 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. If the next dose is already due, then administer as planned. Other Policies and Guidelines may apply. Tezspire (tezepelumab), a monoclonal antibody under review at the FDA to treat patients with asthma, would need to be priced at between $9,000 and $12,000 annually to meet standard thresholds for cost-effectiveness, according to a review by the Institute for Clinical and Economic Review (ICER). All rights reserved. Tezspire is a potential first-in-class monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key cytokine that in allergic, eosinophilic and other airway inflammation associated with severe asthma. 2022 MJH Life Sciences and Managed Healthcare Executive. 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. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Parasitic (Helminth) InfectionIt is unknown if TEZSPIRE will influence a patient's response against helminth infections. AstraZeneca's Fasenra Future Weakened By Pivotal Eosinophilic Esophagitis Trial Flop. %%EOF Our stock price is volatile and may be affected by a number of events. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. For additional information, patients and caregivers may contact Tezspire Together. 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. You may report side effects related to AstraZeneca products by clickinghere. Available at: Clinicaltrials.gov. The For scenario analyses within the allergic and eosinophilic asthma populations, we find similar results to the base case, ICER reviewers wrote. 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. . 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. 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. This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. Treatment with Tezspire results in gains of 1.09 quality adjusted life year and 1.12 equal value life year. Global economic conditions may magnify certain risks that affect our business. Many patients with severe asthma have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.19-24Uncontrolled asthma occurs when symptoms persist despite treatment. Patients who participated in our Phase 3 clinical trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.16, About TEZSPIRE (tezepelumab-ekko)TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. 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. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Tezspire (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONSKnown hypersensitivity to tezepelumab-ekko or excipients. The companies submitted a biologic license application to the FDA in July 2021, and the FDA granted Tezepelumab priority review. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. For more information, please refer to the Tezspire website, patient information, and/or prescribing information . Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. 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. 0 . Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). AboutAmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. reimbursement assistance programs, drug coverage verification, nurse educator services, adherence program and . Amgendevelops product candidates internally and through licensing collaborations, partnerships and joint ventures. For more information, visitwww.amgen.comand follow us onwww.twitter.com/amgen. Peters MC, Mekonnen ZK, Yuan S, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. endstream endobj 440 0 obj <>/Metadata 91 0 R/Pages 437 0 R/StructTreeRoot 173 0 R/Type/Catalog/ViewerPreferences<>>> endobj 441 0 obj <. . 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). As we've noted before, near term, the market . Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. 27-09-2022. A new medical policy listing coverage criteria for the drug will become effective April 11, 2022. Tezspire (tezepelumab) has been cleared for use in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product, based on the results of the PATHFINDER clinical trial programme. Some members may not be eligible for . The most frequently reported adverse events for TEZSPIRE were nasopharyngitis, upper respiratory tract infection and headache.2. ICER reviewers point out that symptom control, rather than exacerbation rate, remains a priorty for both physicians and patients. Thereafter, the patient can continue (resume) dosing on the usual day of administration. Tezspire may be used alone or with other medications. In the interim, requests for Tezspire will be reviewed in accordance with FDA prescribing information and Independence-recognized drug compendia. Amgenperforms a substantial amount of its commercial manufacturing activities at a few key facilities, including inPuerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed TEZSPIRE with affordable access to the medicine. 439 0 obj <> endobj My name is RJ, and I will be your conference facilitator today for Amgen's First Quarter 2022 Financial Results Conference Call. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. 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. CONTACT: Amgen, Thousand OaksMichael Strapazon, 805-313-5553 (media)Megan Fox, 805-447-1423 (media)Arvind Sood, 805-447-1060 (investors), Cision Distribution 888-776-0942 Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. You will be referred to your doctor's office for clinical advice. Clinicaltrials.gov. Retroactively effective to December 17, 2021, Tezspire is eligible for coverage under the medical benefit. Yes No (if asthma) Will your patient use Tezspire with other Monoclonal Antibodies for Asthma (Cinqair, Fasenra, Nucala, Dupixent, or Xolair)? The Prescription Drug User Fee Act action date is set for the first quarter of 2022. As we've noted before, near term, the . PHONE: 1-866-503-0857 . For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com. 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. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operat About theAmgenand AstraZeneca CollaborationIn 2020,Amgenand AstraZeneca updated the 2012 collaboration agreement for Tezspire. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technologyAmgenhas acquired, may not be successful. You may report side effects related to AstraZeneca products by clickinghere. Tezspireis under regulatory review in the EU, Japan and several other countries around the world. Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.20-22 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.25,26 There is also a significant socio-economic burden with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.28, Multiple inflammatory pathways are involved in the pathogenesis of asthma.27-29Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.29These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and FeNO.30,31However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.31. For patients with eosinophilic asthma, Tezspires improvement in annualized asthma exacerbation rate (AAER) was similar to that seen with Dupixent. Amgenmay not be able to access the capital and credit markets on terms that are favorable to it, or at all. 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. News - UCB, Tezspire, Neurological Flurry of Japanese drug approvals. World Allergy Organization (WAO). Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. Amgenrelies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed TEZSPIRE with affordable access to the medicine. Peters MC, Mekonnen ZK, Yuan S, et al. 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. Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. 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. 2022 MJH Life Sciences and Managed Healthcare Executive. Key secondary endpoints included the effect of Tezspire on lung function, asthma control and health-related quality of life.3. In data the companies released, Tezspire significantly improved exacerbation rate, its primary end point, and met secondary end points of improvements in lung function, asthma control and quality of life. 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. 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. Connect with a Reimbursement Specialist by calling 1-888-TZSPIRE ( 1-888-897-7473) or submitting a request through the Healthcare Provider Portal. 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