AMGN Amgen Inc.

252.38
+1  (+0%)
Previous Close 251.38
Open 252.29
52 Week Low 210.28
52 Week High 276.69
Market Cap $145,005,934,987
Shares 574,553,986
Float 573,136,100
Enterprise Value $166,550,381,000
Volume 1,922,180
Av. Daily Volume 2,835,503
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
AMG 510 (Sotorasib)
Colorectal cancer
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
AMG 510 - sotorasib (CodeBreak 100)
Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA priority review
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
OTEZLA
Plaque psoriasis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Efavaleukin alfa (AMG 592)
Systemic Lupus Erythematosus
Phase 1/2
Phase 1/2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Omecamtiv mecarbil METEORIC-HF
Acute heart failure
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Olpasiran (AMG 890)
Cardiovascular disease / Elevated Lipoprotein
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
AMG 714 / PRV-015
Celiac disease
Phase 2b
Phase 2b
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Tezepelumab - NAVIGATOR
Asthma
BLA Filing
BLA Filing
Phase 3 trial met primary endpoint - November 10, 2020. BLA filing announced November 10, 2021.
Tezepelumab (WAYPOINT)
Chronic Rhinosinusitis With Nasal Polyps
Phase 3
Phase 3
Phase 3 trial has been initiated.
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 2
Phase 2
Phase 2 data released November 10, 2020. All three efficacy endpoints met. Data presented at ASCO GI January 15, 2021.
AMG 510 (sotorasib)
KRAS G12C-mutated solid tumors
Phase 2
Phase 2
Phase 2 trial has completed enrollment with data due 1H 2022.
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
FDA approval announced October 1, 2018.
Tezepelumab
Chronic spontaneous urticaria
Phase 2b
Phase 2b
Phase 2b study is enrolling patients.
Tezepelumab
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 trial is enrolling.
Rozibafusp alfa (AMG 570)
Systemic Lupus Erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial is enrolling.
FPT155
Solid tumors
Phase 1
Phase 1
Phase 1 second cohort is open for enrollment.
Efavaleukin alfa (AMG 592)
Chronic Graft Versus Host Disease
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
CK-136 (AMG 594)
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial has been completed.
AMG 701
Multiple Myeloma
Phase 1
Phase 1
Phase 1 enrollment has been paused to discuss changes to safety monitoring and mitigation, expects to resume patient enrollment in 1H 2021.
AMG 510 (Sotorasib)
Non-small cell lung cancer (NSCLC) first line including STK11 mutations
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
Nplate
Hematopoietic Syndrome of Acute Radiation Syndrome
Approved
Approved
FDA approval announced in earnings release - February 2, 2021.
Tezepelumab - SOURCE
Oral corticosteroid dependent asthma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 22, 2020.
RIABNI (rituximab-arrx)
RITUXAN biosimilar - non-Hodgkin lymphoma
Approved
Approved
FDA approval announced December 17, 2020.
AMG 757
Small Cell Lung Cancer
Phase 1
Phase 1
Phase 1 data presented at SITC November 9-14, 2020. Partial response 6/38.
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 top-line data met primary composite endpoint of reduction in cardiovascular death or heart failure but did not meet secondary endpoint of reduction in cardiovascular death - October 8, 2020.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)
Phase 1
Phase 1
Phase 1 data ASCO June 2, 2019. Overall response rate 70% (7/10) in high dose, 13/42 response across all cohorts.
AMG 510 CodeBreaK 200
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial is enrolling.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
OTEZLA
Scalp Psoriasis
Approved
Approved
FDA approval announced April 2020.
ABP 710
REMICADE biosimilar - rheumatoid arthritis
Approved
Approved
FDA Approval announced December 6, 2019.
OTEZLA - PSA-006
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 - primary endpoint met.
OTEZLA
Behçet’s Disease
Approved
Approved
FDA Approval announced July 19, 2019.
BLINCYTO
Acute lymphoblastic leukemia (ALL) - pediatric
Phase 3
Phase 3
Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
Nplate (Romiplostim)
Immune thrombocytopenia (ITP)
Approved
Approved
FDA Approval announced October 18, 2019.
ABP 980 (Kanjinti; trastuzumab-anns)
Herceptin biosimilar
CRL
CRL
FDA approval announced June 13, 2019.
EVENITY (Romosozumab)
Osteoporosis
Approved
Approved
FDA Approval announced April 9, 2019.
Nplate (Romiplostim)
Immune Thrombocytopenia (Pediatric)
Approved
Approved
FDA approval announced December 14, 2018.
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approval announced June 11, 2018.
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
Approved
Approved
Approval announced May 21, 2018.
Erenumab
Migraine
Approved
Approved
Approval announced May 17, 2018.
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approved January 17, 2018.
Repatha
Cardiovascular disease
Approved
Approved
Approval announced December 1, 2017.
Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved
Approved February 7, 2017.
XGEVA
Multiple Myeloma
Approved
Approved
sBLA approval announced January 5, 2017.
BLINCYTO
Ph+ R/R ALL
Approved
Approved
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
Corlanor
Chronic Heart Failure
Approved
Approved
Approved April 15, 2015.
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
Approved
Approved
sBLA approval announced June 29, 2017.

Latest News

  1. THOUSAND OAKS, Calif., May 13, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced detailed results for tezepelumab, a potential first-in-class treatment, from the pivotal NAVIGATOR Phase 3 trial demonstrating superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of care (SoC). These results were published in the New England Journal of Medicine and will be presented this week at the American Thoracic Society (ATS) 2021 International Conference.1,2

    In one of the pre-specified exploratory analyses of NAVIGATOR, reductions in annualized asthma exacerbation rates (AAERs) were observed over 52 weeks in tezepelumab-treated patients…

    THOUSAND OAKS, Calif., May 13, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced detailed results for tezepelumab, a potential first-in-class treatment, from the pivotal NAVIGATOR Phase 3 trial demonstrating superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of care (SoC). These results were published in the New England Journal of Medicine and will be presented this week at the American Thoracic Society (ATS) 2021 International Conference.1,2

    In one of the pre-specified exploratory analyses of NAVIGATOR, reductions in annualized asthma exacerbation rates (AAERs) were observed over 52 weeks in tezepelumab-treated patients compared to placebo when added to SoC across four patient subgroups, based on blood eosinophil count and fractional exhaled nitric oxide (FeNO) levels. Blood eosinophil counts and FeNO levels are two key inflammatory biomarkers used by clinicians to inform treatment options and were defined as blood eosinophil count (≥300 or <300 cells per microlitre) and FeNO (≥25 or <25 parts per billion).

    In patients with elevated baseline blood eosinophil counts (≥300 cells per microlitre) and FeNO levels (≥25 parts per billion), tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared to placebo.1,2

    In a separate exploratory analysis of exacerbations requiring hospitalizations, tezepelumab showed an 85% reduction over 52 weeks compared to placebo when added to SoC.

    Tezepelumab also demonstrated statistically significant improvements in key secondary endpoints compared to placebo in lung function, asthma control and health-related quality of life. Improvements were observed in tezepelumab-treated patients as early as week two of treatment or the first time point assessment and were sustained throughout the treatment period.1

    These results build on the NAVIGATOR data presented in February 2021 which showed a statistically significant and clinically meaningful3 reduction in the primary endpoint of AAER over 52 weeks in the overall patient population. Clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of blood eosinophil counts, allergy status or FeNO level.1

    "Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation," said Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase 3 trial.

    "Severe, uncontrolled asthma is debilitating, with patients experiencing frequent exacerbations that lead to hospitalization. For this reason, we were incredibly pleased to see that patients who received tezepelumab during the trial had a reduction in both ER visits and hospitalizations," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Advancing the science to address unmet patient needs such as these has been the driving force behind Amgen's inflammation research for more than two decades. Along with our partner AstraZeneca, we are incredibly proud of these results and tezepelumab's potential for a broad population of patients with asthma."

    Additional Data to be Presented

    Further results from the tezepelumab PATHFINDER clinical trial program will be presented at the ATS conference this week, including the primary analyses from the SOURCE Phase 3 and CASCADE Phase 2 trials.

    As previously disclosed, the SOURCE Phase 3 trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. Data to be presented show the number of patients that achieved a ≥90% reduction in OCS dose was numerically higher for tezepelumab-treated patients at 54.1% compared to 46.1% in the placebo group.4

    In SOURCE, tezepelumab-treated patients showed improvements in exacerbations, forced expiratory volume in one second and patient-reported outcomes compared to placebo,4 consistent with improvements shown in pooled post-hoc analyses in OCS dependent patients from the PATHWAY Phase 2 and NAVIGATOR Phase 3 trials. New trials are being planned to evaluate the ability of tezepelumab to reduce OCS use while maintaining asthma control in patients with chronic maintenance OCS therapy. Any new trial would aim to address unique aspects of the SOURCE trial design that may have contributed to the result of the primary endpoint.

    Also being presented at the ATS Conference, results from the CASCADE Phase 2 mechanistic trial showed that in a broad population of patients with moderate to severe asthma, tezepelumab reduced eosinophils in airway tissue compared to placebo across subgroups of baseline blood eosinophil count, FeNO level and allergic status.5 Importantly, tezepelumab was also associated with a reduction in airway hyper-responsiveness compared to placebo,5 which is a major hallmark of asthma irrespective of eosinophilic airway inflammation.

    There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in NAVIGATOR,1 SOURCE4 and CASCADE.5 The most frequently reported adverse events for tezepelumab in the NAVIGATOR trial were nasopharyngitis, upper respiratory tract infection, headache and asthma,1 in the SOURCE trial were nasopharyngitis, upper respiratory tract infection, asthma, and bronchitis bacterial, and in the CASCADE trial were nasopharyngitis, post-procedural (bronchoscopy) complications and headache.

    About Severe Asthma

    Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.6-8 Uncontrolled asthma occurs when symptoms persist despite treatment. Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.6-8 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.9,10 There is also a significant socio-economic burden, with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.11

    Multiple inflammatory pathways are involved in the pathogenesis of asthma.12-14 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.14 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).15,16 However, 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.16

    NAVIGATOR and the PATHFINDER Clinical Trial Program

    Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR1,17 and SOURCE.4,18 The program includes an additional planned long-term safety trial, DESTINATION and a mechanistic trial, CASCADE.5

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells pstoper microliter.25

    NAVIGATOR endpoint: AAER in patients grouped by baseline blood eosinophil count and FeNO1

    Biomarker subgroup

    Results over 52 weeks

    Tezepelumab added to SoC versus placebo added to SoC

    Blood eosinophil count ≥300 cells/mcl FeNO ≥25 parts per billion

    77% reduction (95% CI: 67, 84)

    Blood eosinophil count ≥300 cells/mcl FeNO <25 parts per billion

    39% reduction (95% CI: -7, 65)

    Blood eosinophil count <300 cells/mcl FeNO ≥25 parts per billion

    53% reduction (95% CI: 33, 67)

    Blood eosinophil count <300 cells/mcl FeNO <25 parts per billion

    29% reduction (95% CI: 0, 50)

    CI: Confidence interval

    NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting the thymic stromal lymphopoietin (TSLP). The U.S. Food and Drug Administration Breakthrough Therapy Designation was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy. In the trial, patients were randomized to receive tezepelumab 210 mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.

    CASCADE is a Phase 2 mechanistic, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults aged 18–75 years with moderate to severe, uncontrolled asthma. The primary endpoint was the change from baseline (pre-dose) to end of treatment in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies.5

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.19

    About Tezepelumab

    Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below) as an investigational, potential 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. Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (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.20,21

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.20,21 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.20,22 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.20,22 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.20,22

    Amgen and AstraZeneca collaboration

    In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab; Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada.  Outside the U.S., Amgen will record sales as collaboration revenue.

    Amgen Inflammation

    Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

    For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

    Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It's a commitment that extends beyond introducing novel therapies. We are focused on improving the entire patient journey.

    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.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    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 any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), 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 Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, 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 its 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 Amgen projects. 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. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 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 as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

    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. In addition, sales of Amgen'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. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto 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. 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 Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies 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. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen'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. 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 technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

    Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. 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.

    CONTACT: Amgen, Thousand Oaks

    Michael Strapazon, 805-313-5553 (media)

    Megan Fox, 805-447-1423 (media)

    Arvind Sood, 805-447-1060 (investors)

    References





    1.

    Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2034975

    2.

    Corren J, Bourdin A, Chupp G, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma grouped by baseline blood eosinophil count and fractional exhaled nitric oxide level: results from the NAVIGATOR phase 3 study. Am J Respir Crit Care Med. 2021;203:A1198.

    3.

    Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020;29:190137.

    4.

    Wechsler ME, Mezies-Gow A, Brightling CE, et al. Oral corticosteroid-sparing effect of tezepelumab in adults with severe asthma. Am J Respir Crit Care Med. 2021;203:A1197.

    5.

    Diver S, Khalfaoui L, Emson C, et al. Effect of Tezepelumab on Airway Inflammation in Patients with Moderate-to-Severe Uncontrolled Asthma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study (CASCADE). Am J Respir Crit Care Med. 2021;203:A1456.

    6.

    Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.

    7.

    Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 149–60.

    8.

    Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.

    9.

    Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.

    10.

    World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php  [Last accessed: April 2021].

    11.

    Busse WW. Biological Treatments for Severe Asthma: A Major Advance in Asthma Care. Allergol Int 2019; 68: 158–66.

    12.

    Godar M, Blanchetot C, de Haard H, et al. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. MAbs. 2018; 10 (1): 34–45.

    13.

    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. EMJ Allergy Immunol. 2018; 3: 60-9.

    14.

    Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94.

    15.

    Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: April 2021].

    16.

    Fahy JV. Type 2 inflammation in asthma--present in most, absent in many. Nat Rev Immunol. 2015; 15: 57-65.

    17.

    Menzies-Gow A, Colice G, Griffiths JM et al. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020;21:266.

    18.

    Weschler ME, Colice G, Griffiths JM, et al. SOURCE: A Phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res. 2020;21:264.

    19.

    Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: April 2021].

    20.

    Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019;380:2082]. N Engl J Med. 2017;377:936-946.

    21.

    Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.

    22.

    Li Y, Wang W, LV Z et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. The Journal of Immunology. 2018;200:2253–2262

     

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/new-tezepelumab-data-continue-to-strengthen-profile-for-a-broad-population-of-severe-asthma-patients-301290490.html

    SOURCE Amgen

    View Full Article Hide Full Article
  2. THOUSAND OAKS, Calif., May 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of four cardiovascular research abstracts, including final data from the Repatha® (evolocumab) open label extension trial of patients living with HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events, including complex revascularization procedures. Additional abstracts to be presented include a simulation comparing the impact of different LDL-C guidelines on CV risk reduction, as well as negative control outcomes to assess residual bias when comparing PCSK9 inhibitors to other treatments. These analyses will be presented at the American College of Cardiology's 70th Annual…

    THOUSAND OAKS, Calif., May 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of four cardiovascular research abstracts, including final data from the Repatha® (evolocumab) open label extension trial of patients living with HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events, including complex revascularization procedures. Additional abstracts to be presented include a simulation comparing the impact of different LDL-C guidelines on CV risk reduction, as well as negative control outcomes to assess residual bias when comparing PCSK9 inhibitors to other treatments. These analyses will be presented at the American College of Cardiology's 70th Annual Scientific Session & Expo (ACC.21), May 15-17, 2021.

    The data in HIV confirm the safety and efficacy of Repatha across different patient populations and contribute to Amgen's PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations) program of clinical and real-world evidence studies investigating the impact of Repatha on cardiovascular disease. To date, the PROFICIO program consists of 50 clinical trials including more than 47,000 patients worldwide with eight real-world evidence studies1. These studies provide the body of evidence for treatment in a variety of high-risk patients and have contributed to Repatha being approved in more than 75 countries. Notably, Amgen recently passed the milestone of more than one million patients receiving Repatha worldwide2.

    "We're excited to have reached more than one million patients with Repatha ® – a significant achievement through our unwavering commitment to advancing CV treatment and addressing unmet needs, especially in vulnerable, at-risk populations," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Our commitment to helping improve outcomes for CV patients goes beyond developing treatment; it's the guiding force behind our partnerships with leading advocacy organizations on a variety of programs, including the American College of Cardiology (ACC) on the TRANSFORM: ACS program, which aims to initiate lipid lowering treatment sooner to help patients reduce the risk of subsequent CV events."

    TRANSFORM: Accelerating Lipid Lowering Post ACS (TRANSFORM: ACS), is a collaboration with ACC and Veradigm which is focused on helping patients with Acute Coronary Syndrome (ACS) receive cholesterol testing in the hospital and guideline-recommended therapies to reduce their LDL-C after discharge. The goal of this program is to improve the rate of lipid panel testing and lipid lowering treatment intensification in ACS patients.

    A list of Amgen-sponsored abstracts at ACC.21 can be found online and include:

    • Evolocumab Use in Patients with Human Immunodeficiency Virus and Dyslipidemia: Final Results of the Open Label Extension Period (BEIJERINCK) (Moderated Poster, Session 1056-05)
    • Biomarker Prediction of Major Coronary Events and Complex Revascularization Procedures in Patients with Stable Atherosclerosis (Oral, Session 910-08)
    • Comparison of Achieving 2019 ESC/EAS Versus 2018 ACC/AHA LDL-C Goals for Patients with Atherosclerotic Cardiovascular Disease: A Cardiovascular Risk Simulation from the DA VINCI Study (Poster, Session 2118)
    • Use of Negative Control Outcomes to Assess the Comparability of Treatments for Hypercholesterolemia (Poster, Session 2108)

    About the Repatha  CV Outcomes Trial FOURIER

    FOURIER (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, was designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces CV events. The primary endpoint is the time to CV death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to CV death, myocardial infarction or stroke. 

    Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident ASCVD at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event-driven and continued until at least 1,630 patients experienced a key secondary endpoint.

    FOURIER is part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations) program of clinical studies investigating the impact of Repatha on LDL-C and CVD across multiple populations at high CV risk, including those managed by statins, statin-intolerant patients, those with genetic disorders and patients with atherosclerosis. To date, the PROFICIO program consists of 50 trials including more than 43,000 patients worldwide.

    About BEIJERINCK Study Design

    EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and INcreased Cardiovascular RisK (BEIJERINCK) is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of 420 mg once-monthly treatment with evolocumab in HIV+ patients with hyperlipidemia or mixed dyslipidemia over 24 weeks. The study enrolled 467 adults with known HIV infection who have received stable HIV therapy for six months or more prior to randomization and have also been treated with maximally tolerated lipid-lowering therapy for four weeks or longer prior to randomization. Both background therapies were not expected to change during the duration of study participation. Statin-intolerant patients were also eligible for the study. Evolocumab-treated patients who completed the 24-week double-blind treatment period were enrolled in an open-label period through the end of the study at week 52.

    About Amgen in the Cardiovascular Therapeutic Area

    Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.3 Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as elevated lipids, including high cholesterol and Lp(a), and heart failure.

    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 biologics manufacturing 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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    About Repatha (evolocumab)

    Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.4

    Repatha is approved in more than 75 countries, including the U.S., Japan, Canada, Australia, China and in all 28 countries that are members of the European Union. Applications in other countries are pending.

    Indications

    Repatha is indicated:

    • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
    • As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C
    • As an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

    The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia.

    Important U.S. Safety Information

    • Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.



    • Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.



    • Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.



      From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).



    • Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha, 4.8% placebo). 



      Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha compared with 7.7% in patients that received placebo.

       
    • Adverse Reactions in HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.



    • Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha.

    Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha availability or find more information, including full Prescribing Information, at www.amgen.com and www.Repatha.com.

    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 any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), 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, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, 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. 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. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. 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 as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    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. 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. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. 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. 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. 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. 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. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. 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. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. 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.

    CONTACT: Amgen, Thousand Oaks 

    Michael Strapazon, 805-313-5553 (media)

    Megan Fox, 805-447-1423 (media)

    Arvind Sood, 805-447-1060 (investors) 

    References

    [1] Amgen Data on File. 2021.

    [2] Amgen Data on File. 2021.

    [3] World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed September 2020.

    [4] Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.

     

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/efficacy-of-repatha-evolocumab-across-high-risk-patient-populations-reinforced-at-acc21-301287882.html

    SOURCE Amgen

    View Full Article Hide Full Article
  3. REYKJAVIK, Iceland, May 10, 2021 /PRNewswire/ -- In a study published today, scientists at deCODE Genetics demonstrate for the first time how long-read DNA sequencing can be applied at population scale to unravel large structural variants that associate with human disease and other traits.

    In a paper published today in Nature genetics, scientists at deCODE genetics, a subsidiary of the pharmaceutical company Amgen, have shown that long-read DNA sequencing can be applied at population scale to unravel large structural variants that associate with human disease and other traits. Up until now DNA sequence analysis has been performed using short-read sequencing, where the sequence examined is broken up into fragments…

    REYKJAVIK, Iceland, May 10, 2021 /PRNewswire/ -- In a study published today, scientists at deCODE Genetics demonstrate for the first time how long-read DNA sequencing can be applied at population scale to unravel large structural variants that associate with human disease and other traits.

    In a paper published today in Nature genetics, scientists at deCODE genetics, a subsidiary of the pharmaceutical company Amgen, have shown that long-read DNA sequencing can be applied at population scale to unravel large structural variants that associate with human disease and other traits. Up until now DNA sequence analysis has been performed using short-read sequencing, where the sequence examined is broken up into fragments that are no more than 151 base pairs.  Using short-read sequencing scientists have been able to discern most small variations in the genome and population studies have allowed them to determine how they associate with diseases and other traits. However of 133,886 reliably genotyped structural variants detected with long-read sequencing only 60% can be detected with short-reads.

    Using PromethION sequencers from Oxford Nanopore Technologies, researchers at deCODE genetics whole genome sequenced 3,622 Icelanders.  DNA base pairs in the genome were sequenced on average at least 10 times, allowing for accurate characterization of all genomic variation within the individual.  These variants were then imputed into a larger set of participants in various disease studies at deCODE genetics and associated with phenotypes. This has led to the discovery of several hitherto unknown associations of structural variants with diseases and other traits.

    "This technology and algorithms we developed enable us to characterize almost all structural variants reliably and consistently on a population scale," says Bjarni V. Halldórsson, head of Sequence analysis, deCODE genetics.

    The problem with short-read sequencing is that larger structural variants are difficult to discern directly.  This is a major stumbling block in the attempt to fully understand the relationship between variation in the sequence of the human genome and human diversity. Due to their size, these large structural variants usually have greater impact than the smaller variants most commonly considered. Large structural variants frequently delete or insert whole genes or large parts of genes, making them particularly harmful.

    "We are confident that the long-read sequencing applied at population level is going to help us to find much of the missing sequence diversity that we must have to fully understand how diversity in the sequence of the genome accounts for human diversity," says Kari Stefansson CEO and founder of deCODE genetics.

    Based in Reykjavik, Iceland, deCODE is a global leader in analyzing and understanding the human genome. Using its unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen (NASDAQ:AMGN).

    Contact: Thora Kristin Ásgeirsdóttir, PR and Communications, deCODE genetics, 00354 -570 1909, 00354 -894 1909

    Video - https://mma.prnewswire.com/media/1505767/deCODE_genetics.mp4  

    Photo - https://mma.prnewswire.com/media/1505739/deCODE_genetics_Halldorsson_and_Stefansson.jpg  

    Logo - https://mma.prnewswire.com/media/1505738/deCODE_genetics_with_Amgen_Logo.jpg

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/decode-genetics---rounding-off-the-human-genome-301286851.html

    SOURCE deCODE genetics

    View Full Article Hide Full Article
  4. THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma…

    THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials.

    "Severe asthma remains uncontrolled for many patients despite current therapies for this complex and often debilitating condition," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This submission brings us one step closer to providing this potentially transformative treatment option to a broad population of severe asthma patients, across phenotypes and irrespective of biomarkers."

    Tezepelumab targets and blocks the action of an epithelial cytokine called thymic stromal lymphopoietin (TSLP) which plays a key role across the spectrum of asthma inflammation.2,3 In NAVIGATOR, tezepelumab demonstrated exacerbation rate reduction irrespective of baseline eosinophil count and  improvements in lung function measurements, asthma control and health-related quality of life compared to placebo.4 The most frequently reported adverse events for tezepelumab were nasopharyngitis, upper respiratory tract infection and headache. These results support the FDA Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

    Data from the tezepelumab development program will be presented at upcoming scientific meetings including the American Thoracic Society 2021 International Conference later this month. 

    About Severe Asthma

    Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.5-7 Uncontrolled asthma occurs when symptoms persist despite treatment. Severe uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.5-7 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.8,9 There is also a significant socio-economic burden, with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.10

    Multiple inflammatory pathways are involved in the pathogenesis of asthma.11,12,13 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.13 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).14,15 However, 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.15

    NAVIGATOR and the PATHFINDER Clinical Trial Program

    Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE.16-19 The program includes additional planned mechanistic and long-term safety trials.

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microliter.19

    NAVIGATOR PRIMARY ENDPOINTS4

    Endpoint

    Timepoint

    Results

    Tezepelumab added to SoC vs placebo

    added to SoC

    AAER – overall patient

    population

    Over 52 weeks

    56% reduction* (95% CI: 47, 63; p<0.001)

    AAER – overall

    eosinophil counts < 300

    cells/µL

    Over 52 weeks

    41% reduction* (95% CI: 25, 54; p<0.001)

    CI: confidence interval







    NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP. The

    U.S. Food and Drug Administration Breakthrough Therapy Designation

     was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. The

    U.S. Food and Drug Administration Breakthrough Therapy Designation

     was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below). 

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy.17 In the trial, patients were randomized to receive tezepelumab 210 mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.17

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long term safety and efficacy.20

    About Tezepelumab

    Tezepelumab is an investigational, potential 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. Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (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.2,16,21

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. 2,21 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.2,16 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 2,16 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.2,16

    Amgen and AstraZeneca Collaboration

    In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab. Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada. Outside the U.S., Amgen will record sales as collaboration revenue.

    Amgen Inflammation

    Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

    For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

    Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It's a commitment that extends beyond introducing novel therapies. We are focused on improving the entire patient journey.

    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. 

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

    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 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), or the Five Prime Therapeutics, 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 Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential  treatment  for  COVID-19, 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 its 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 Amgen projects. 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. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 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 as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

    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. In addition, sales of Amgen'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. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto 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. 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 Amgen's manufacturing  activities,  the  distribution  of Amgen's products,  the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies 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. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen'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. 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 technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

    Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. 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.

    CONTACT: Amgen, Thousand Oaks 

    Michael Strapazon, 805-313-5553 (media)

    Megan Fox, 805-447-1423 (media)

    Arvind Sood, 805-447-1060 (investors) 

    References

    1. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.
    2. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23; 380 (21): 2082]. N Engl J Med. 2017; 377 (10): 936-946.
    3. Ortega HG, Liu MC, Pavord ID, et al; on behalf of the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207.
    4. Menzies-Gow A, Corre J, Bourdin A, et al. Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. L 46. AAAAI poster. February 2021.
    5. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.
    6. Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 149–60.
    7. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.
    8. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.
    9. Busse WW. Biological Treatments for Severe Asthma: A Major Advance in Asthma Care. Allergol Int 2019; 68: 158–66.
    10. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: May 2021].
    11. Godar M, Blanchetot C, de Haard H, et al. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. MAbs. 2018; 10 (1): 34–45.
    12. 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. EMJ Allergy Immunol. 2018; 3: 60-9.
    13. Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94.
    14. Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: May 2021].
    15. Fahy JV. Type 2 inflammation in asthma--present in most, absent in many. Nat Rev Immunol. 2015; 15: 57-65.
    16. Li Y, Wang W, LV Z et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. The Journal of Immunology. 2018;200:2253–2262
    17. Wechsler, M.E., Colice, G., Griffiths, J.M. et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res 2020; 21: 264.
    18. Clinicaltrials.gov. Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03347279. [Last accessed: May 2021].
    19. AstraZeneca plc. Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tezepelumab-navigator-phase-iii-trial-met-primary-endpoint.html. [Last accessed: May 2021].
    20. Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: May 2021].
    21. Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.

     

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-announces-tezepelumab-biologics-license-application-submitted-to-us-fda-301286900.html

    SOURCE Amgen

    View Full Article Hide Full Article
  5. THOUSAND OAKS, Calif., May 6, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2021 Bank of America Merrill Lynch Virtual Healthcare Conference at 11:00 a.m. ET on Tuesday, May 11, 2021. David M. Reese, M.D., executive vice president of Research and Development, Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor…

    THOUSAND OAKS, Calif., May 6, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2021 Bank of America Merrill Lynch Virtual Healthcare Conference at 11:00 a.m. ET on Tuesday, May 11, 2021. David M. Reese, M.D., executive vice president of Research and Development, Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    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.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Michael Strapazon, 805-313-5553 (media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-to-present-at-the-2021-bank-of-america-merrill-lynch-healthcare-conference-301286114.html

    SOURCE Amgen

    View Full Article Hide Full Article
View All Amgen Inc. News