AMGN Amgen Inc.

226.56
+1.48  (+1%)
Previous Close 225.08
Open 225.08
52 Week Low 177.05
52 Week High 264.97
Market Cap $131,896,120,735
Shares 582,168,612
Float 580,768,178
Enterprise Value $151,191,718,608
Volume 2,650,764
Av. Daily Volume 2,654,656
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Upcoming Catalysts

Drug Stage Catalyst Date
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
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 701
Multiple Myeloma
Phase 1
Phase 1
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ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma
PDUFA
PDUFA
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Tezepelumab - SOURCE
Oral corticosteroid dependent asthma.
Phase 3
Phase 3
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AMG 510
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
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Nplate
Hematopoietic Syndrome of Acute Radiation Syndrome
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
Tezepelumab
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 trial is enrolling.
Omecamtiv mecarbil METEORIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 enrollment to be completed 1H 2021.
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.
Tezepelumab - NAVIGATOR
Asthma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 10, 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.
AMG 594
Healthy volunteers
Phase 1
Phase 1
Phase 2 trial planned.
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.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
AMG 592
Systemic Lupus Erythematosus
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
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 890
Cardiovascular disease / Elevated Lipoprotein
Phase 2
Phase 2
Phase 2 trial has commenced - noted July 28, 2020.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
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.
AMG 510
Solid tumors
Phase 1
Phase 1
Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
AMG 570
Systemic Lupus Erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial is enrolling.
OTEZLA
Psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - May 6, 2020.
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.
Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved
Approved February 7, 2017.
BLINCYTO
Ph+ R/R ALL
Approved
Approved
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
XGEVA
Multiple Myeloma
Approved
Approved
sBLA approval announced January 5, 2017.
Repatha
Cardiovascular disease
Approved
Approved
Approval announced December 1, 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., Nov. 30, 2020 /PRNewswire/ -- Three members of the COVID R&D Alliance - Amgen Inc. (NASDAQ:AMGN), Takeda Pharmaceutical Co. Ltd. (NYSE:TAK), and UCB (Euronext BR: UCB) - today announced the first patient enrolled in the COMMUNITY Trial (COVID-19 Multiple Agents and Modulators Unified Industry Members). COMMUNITY is a randomized, double-blind, placebo-controlled, adaptive platform trial that enables an array of therapeutic candidates to be studied in hospitalized COVID-19 patients.

    With worldwide COVID-19 deaths exceeding one million and a resurgence of cases globally, life science companies are working urgently to identify treatments that can potentially reduce clinical severity of COVID-19 in hospitalized patients. COMMUNITY is the first platform trial designed and launched by members of the COVID R&D Alliance, a group of more than 20 leading pharmaceutical and biotech companies who are devoting significant time, insights and company resources to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.

    "As this insidious virus rapidly spreads around the globe, doctors need options to treat hospitalized patients who are actively sick and experiencing a range of symptoms as the disease progresses," said David M. Reese, M.D., Executive Vice President Research & Development, Amgen. "Working hand-in-hand with our peers, we hope to find options that could potentially save lives of the patients who will need treatments for COVID-19 before widespread availability of a vaccine."

    COMMUNITY uses an adaptive design which allows for the addition, removal and simultaneous study of multiple therapeutic candidates during the course of the trial. Multiple candidates will be tested against a shared placebo-controlled arm. The design allows for a streamlined approach which may accelerate execution of the study and save time as we search for therapeutics in the fight against the pandemic. Immunomodulating therapies will be the first candidates to enter COMMUNITY. Other therapies may join in the future, such as antivirals.

    The trial's design and global footprint were selected to address potential barriers in the study of COVID-19 therapeutics. This includes anticipating and activating trial sites to align with the rise and fall of COVID cases across geographic regions as well as streamlining an influx in trial-related inquiries faced by some hospitals and health systems. COMMUNITY will onboard global sites in the United States, Brazil, Mexico, Russia, South Africa and other countries.  This geographic diversity will allow the trial sites to be active when cases spike locally. COMMUNITY aims to simplify the study of investigational therapies that may result in potential treatment options and address the needs of hospitals in treating patients.

    "COVID is not confined to one country, making it imperative that we share the challenges, successes and insights in real-time," said Dhavalkumar Patel, Executive Vice President and Chief Scientific Officer, UCB. "By sharing our expertise and resources, we hope to arm care teams with promising investigational therapies to help patients who cannot wait."

    Uncontrolled vascular and immune inflammatory responses have proven to be hallmark symptoms in patients facing severe COVID-19 infections. These patients may face increased risk of acute respiratory distress syndrome (ARDS), stroke and death. Initial therapies entering into COMMUNITY were selected based upon their potential to suppress or control the immune response or the resulting inflammation. None of these therapies have been approved by the FDA, EMA, or other health authorities for the treatment of COVID-19 or its symptoms and are still investigational. These include:

    • Amgen's OTEZLA® (apremilast), which may suppress immune response inflammation;
    • Takeda's investigational intravenous administration of lanadelumab, which modulates the kallikrein-kinin system and suppresses production of bradykinin, potentially lessening inflammation;
    • UCB's zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to ARDS.

    OTEZLA entered COMMUNITY this week. It is expected lanadelumab and zilucoplan will enter in the coming weeks. Other anti-viral, immunomodulating and vascular agents may enter in the coming months.

    COMMUNITY is studying hospitalized COVID-19 patients. This includes confirmed COVID-19 patients who may require either ongoing medical care, supplemental oxygen, noninvasive ventilation or high-flow oxygen devices, or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). By enrolling both hospitalized Intensive Care Unit and non-Intensive Care Unit patients, the trial seeks to yield greater understanding of how therapeutic interventions may be used with hospitalized COVID-19 patients experiencing a range of symptoms.

    About COMMUNITY

    COMMUNITY is an adaptive, randomized, double-blind, placebo-controlled platform study designed to assess multiple candidates as a potential treatment for hospitalized patients with COVID-19, a disease caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2). The focus of the trial is to identify an effective treatment(s) for hospitalized COVID-19 patients, who are Grade 2 to Grade 5 on a Clinical Severity Status 8-Point Ordinal Scale.

    The primary endpoint of COMMUNITY is time to confirmed clinical recovery without being re-hospitalized through Day 29 based on the clinical severity status scale, which is defined as achieving a score of 6, 7, or 8. Key secondary endpoints are oxygen-free recovery, improvement from baseline or fit for discharge from baseline, and all-cause mortality.

    Patients will be randomized equally to either the candidate agent plus the standard of care or a placebo plus standard of care in a double-blind fashion. Patients who are randomized to placebo plus standard of care will be subsequently randomized equally to a matching placebo corresponding to an available agent.

    About the COVID R&D Alliance

    Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating the study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for hospitalized patients who need treatment options. Activities are testing re-purposed molecules and early stage candidates. Member companies have 40 trials expected to have findings in the coming months.

    Additional information on the COVID R&D Alliance is available at www.CovidRDAlliance.com.

    About Otezla® (apremilast)

    OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients is not well defined.

    Otezla is currently approved for use in more than 50 countries as an oral treatment for inflammatory diseases such as psoriasis and psoriatic arthritis. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Amgen plans to collaborate with platform trials to investigate Otezla in treatment of hospitalized COVID-19 patients.

    Otezla® (apremilast) U.S. INDICATIONS

    Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

    Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

    Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

    Contraindications

    • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

    Warnings and Precautions

    • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
    • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur
      • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
      • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
      • Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
    • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
      • Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
      • Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
      • Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
    • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

    Adverse Reactions

    • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
    • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
    • Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

    Use in Specific Populations

    • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
    • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
    • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

    Please click here for Otezla® Full Prescribing Information.

    About lanadelumab

    Lanadelumab is a fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein activity. Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

    Based on its mechanism of action, lanadelumab may prevent the pro-inflammatory effects of SARS-COV2 and the extravasation and accumulation of fluid within the lungs during a serious and prolonged COVID-19 illness by decreasing plasma kallikrein activity and regulating excess bradykinin signaling. In addition, lanadelumab-induced plasma kallikrein inhibition may help to reduce inflammation and coagulation driven by FXII, which is activated by plasma kallikrein through a positive feedback loop. An investigational intravenous administration of lanadelumab is being studied.

    Lanadelumab (marketed under the tradename TAKHZYRO®) is approved as a subcutaneous formulation for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

    U.S. INDICATION AND IMPORTANT SAFETY INFORMATION 

    INDICATION

    TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

    IMPORTANT SAFETY INFORMATION

    Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

    Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

    Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

    No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

    To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-828-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    For U.S. audiences, please see the full Prescribing Information including Patient Information for TAKHZYRO®.

    About Zilucoplan

    Zilucoplan, an investigational drug product, is a once-daily self-administered, subcutaneous peptide inhibitor of C5 which is in Phase III development for the treatment of generalized Myasthenia Gravis (gMG). Zilucoplan is also being investigated in immune-mediated necrotizing myopathy (IMNM), amyotrophic lateral sclerosis (ALS) and other tissue-based complement-mediated disorders. Zilucoplan has not been approved by any regulatory authority for any indication.

    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.

    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 or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat 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. 

    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.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing better health and a brighter future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Takeda Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

    About UCB

    UCB (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7,600 people in approximately 40 countries, the company generated revenue of €4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB).

    UCB Forward-Looking Statements

    This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.

    Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

    There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

    Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement. 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/worlds-leading-life-science-companies-now-enrolling-community-a-global-platform-trial-for-hospitalized-patients-with-covid-19-301181830.html

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  2. THOUSAND OAKS, Calif., Nov. 30, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced several upcoming data presentations from its oncology and hematology pipeline and marketed product portfolio at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 5-8, 2020.

    Amgen will present updated data from its bispecific T cell engager (BiTE®) portfolio in two oral presentations. Data include the first safety and efficacy findings from the ongoing Phase 1 dose escalation study of AMG 701, an investigational half-life extended BiTE immuno-oncology therapy targeting B-cell maturation antigen (BCMA), in patients with heavily pre-treated relapsed/refractory multiple myeloma. Analyses from the BLINCYTO® (blinatumomab) Phase…

    THOUSAND OAKS, Calif., Nov. 30, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced several upcoming data presentations from its oncology and hematology pipeline and marketed product portfolio at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 5-8, 2020.

    Amgen will present updated data from its bispecific T cell engager (BiTE®) portfolio in two oral presentations. Data include the first safety and efficacy findings from the ongoing Phase 1 dose escalation study of AMG 701, an investigational half-life extended BiTE immuno-oncology therapy targeting B-cell maturation antigen (BCMA), in patients with heavily pre-treated relapsed/refractory multiple myeloma. Analyses from the BLINCYTO® (blinatumomab) Phase 3 '215 study in children with high-risk first relapse of B-cell precursor acute lymphoblastic leukemia (BCP-ALL) will also be presented.

    "Amgen is advancing one of the most robust bispecific pipelines in the industry," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "In 2020 alone, we are presenting first-in-human data for four assets from the BiTE platform, including these data at ASH with our BCMA-targeted half-life extended BiTE therapy AMG 701."

    Updated progression-free survival and additional MRD-negativity analyses from the KYPROLIS® (carfilzomib) Phase 3 CANDOR study will also be presented.

    Abstracts are available at https://www.hematology.org/meetings/annual-meeting/abstracts. Learn more about Amgen's development of innovative medicines for novel targets in difficult-to-treat tumors at AmgenOncology.com/medical.  

    Oncology Pipeline Abstracts

    • A Phase 1 First in Human (FIH) Study of AMG 701, an Anti-B-cell Maturation Antigen (BCMA) Half-life Extended (HLE) BiTE® (Bispecific T-cell engager) Molecule, in Relapsed/Refractory (RR) Multiple Myeloma (MM)

      Abstract #181, Oral Presentation, Saturday, Dec. 5, 2020 at 1:00 p.m. PT

    BLINCYTO Clinical Data Abstracts

    • Superior Event-free Survival with Blinatumomab versus Chemotherapy in Children with High-risk First Relapse of B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL): Results of a Randomized Controlled Phase 3 Trial

      Abstract #268, Oral Presentation, Saturday, Dec. 5 at 2:30 p.m. PT
    • Real-world Effectiveness and Safety of Blinatumomab in Adults with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Europe: 3-year Results in Philadelphia Chromosome-negative Patients and a Subset of patients with Late First Relapse

      Abstract #1933, Poster Presentation, Sunday, Dec. 6 from 7:00 a.m.3:30 p.m. PT
    • Blinatumomab in Children With Relapsed or Refractory B- Precursor Acute Lymphoblastic Leukemia (R/R ALL): Final Results of 110 Patients Treated in an Expanded Access Study (RIALTO)

      Abstract #977, Poster Presentation, Saturday, Dec. 5 from 7:00 a.m.3:30 p.m. PT

    BLINCYTO Investigator Led Abstracts

    • Hyper-CVAD and Sequential Blinatumomab in Adults with Newly Diagnosed Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia: Results from a Phase II study

      Abstract #464, Oral Presentation, Sunday, Dec. 6 at 2:00 p.m. PT

    KYPROLIS Clinical Data Abstracts

    • Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Efficacy and Safety Results of the Phase 3 CANDOR Study

      Abstract #2325, Poster Presentation, Sunday, Dec. 6 from 7:00 a.m.3:30 p.m. PT
    • Evaluation of Minimal Residual Disease (MRD) Negativity in Patients with Relapsed or Refractory Multiple Myeloma Treated in the CANDOR Study

      Abstract #2282, Poster Presentation, Sunday, Dec. 6 from 7:00 a.m.3:30 p.m. PT
    • Carfilzomib 56mg/m2 Twice-Weekly in Combination with Dexamethasone and Daratumumab (KdD) Versus Daratumumab in Combination with 8 Cycles of Bortezomib and Dexamethasone (DVd); a Matching-Adjusted Indirect Treatment Comparison

      Abstract #1655, Poster Presentation, Saturday, Dec. 5 from 7:00 a.m.3:30 p.m. PT

    KYPROLIS Investigator Led Abstracts

    • Survival Analysis of Newly Diagnosed Transplant-Eligible Multiple Myeloma Patients in the Randomized FORTE Trial

      Abstract #141, Oral Presentation, Saturday, Dec. 5 at 9:30 a.m. PT
    • Treatment of High Risk (HR) Smoldering Multiple Myeloma (SMM) with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed By Lenalidomide Maintenance (-R): A Phase 2 Clinical and Correlative Study

      Abstract #548, Oral Presentation, Monday, Dec. 7 at 7:00 a.m. PT

    About BiTE® Technology

    BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to any tumor-associated antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE® immuno-oncology platform has the potential to treat different tumor types through tumor-associated antigens. The BiTE® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

    About CANDOR

    CANDOR, a randomized, open-label Phase 3 study of KYPROLIS, DARZALEX® (daratumumab) and dexamethasone (DKd) compared to KYPROLIS and dexamethasone (Kd), has evaluated 466 relapsed or refractory multiple myeloma patients who have received one to three prior therapies. Patients were treated until disease progression. The primary endpoint was progression-free survival (PFS), and the key secondary endpoints were overall response rate, minimal residual disease and overall survival. PFS was defined as time from randomization until disease progression or death from any cause.

    In the first arm, patients received KYPROLIS twice weekly at 56 mg/m2 and dexamethasone in combination with DARZALEX. In the second arm (control), patients received KYPROLIS twice weekly at 56 mg/mand dexamethasone.

    CANDOR was initiated as part of a collaboration with Janssen, and under the terms of the agreement, Janssen co-funded the study. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.

    DARZALEX® is a registered trademark of Janssen Pharmaceutica NV.

    About Multiple Myeloma

    Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis. 2

    About KYPROLIS® (carfilzomib)

    Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.4,5

    Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS.6 KYPROLIS is approved in the U.S. for the following:

    • for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with
      • Lenalidomide and dexamethasone; or
      • Dexamethasone; or
      • Daratumumab and dexamethasone.
    • as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

    KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, S. Africa, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.

    U.S. KYPROLIS® (carfilzomib) Important Safety Information

    INDICATIONS

    • KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
    • KYPROLIS® is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

    IMPORTANT SAFETY INFORMATION FOR KYPROLIS

    Cardiac Toxicities

    • New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
    • Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse reactions until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
    • While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
    • For patients ≥ 75 years of age, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.

    Acute Renal Failure

    • Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

    Tumor Lysis Syndrome

    • Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.

    Pulmonary Toxicity

    • Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug–induced pulmonary toxicity, discontinue KYPROLIS.

    Pulmonary Hypertension

    • Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.

    Dyspnea

    • Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.

    Hypertension

    • Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal.  Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.

    Venous Thrombosis

    • Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Provide thromboprophylaxis for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient's underlying risks.
    • For patients using hormonal contraception associated with a risk of thrombosis, consider an alternative method of effective contraception during treatment.

    Infusion-Related Reactions

    • Infusion-related reactions, including life–threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion-related reactions.

    Hemorrhage

    • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.

    Thrombocytopenia

    • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.

    Hepatic Toxicity and Hepatic Failure

    • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.

    Thrombotic Microangiopathy

    • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.

    Posterior Reversible Encephalopathy Syndrome (PRES)

    • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.

    Progressive Multifocal Leukoencephalopathy (PML)

    • Cases of PML, including fatal cases, have occurred. In addition to KYPROLIS, other contributary factors may include prior or concurrent use of immunosuppressive therapy. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. If PML is suspected, discontinue and initiate evaluation for PML including neurology consultation.

    Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

    • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse reactions was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.

    Embryo-fetal Toxicity

    • KYPROLIS can cause fetal harm when administered to a pregnant woman.
    • Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should use effective contraception during treatment with KYPROLIS and for 3 months following the final dose.

    Adverse Reactions

    • The most common adverse reactions in the combination therapy trials: anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection, thrombocytopenia, cough, dyspnea, and insomnia.
    • The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

    Please see accompanying full Prescribing Information.

    About BLINCYTO® (blinatumomab)

    BLINCYTO is a bispecific CD19-directed CD3 T cell engager (BiTE®) immuno-oncology molecule that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

    BiTE molecules are a type of immuno-oncology therapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells. The modified molecules are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE immuno-oncology molecules help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

    BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:

    • relapsed or refractory B-cell precursor ALL in adults and children.
    • B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

    In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

    • adults with Philadelphia chromosome negative CD19-positive relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
    • adults with Philadelphia chromosome negative CD19-positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
    • paediatric patients age 1 year or older with Philadelphia chromosome-negative CD19-positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

    IMPORTANT SAFETY INFORMATION

    WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

    • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended. 
    • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.

    Contraindications

    BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

    Warnings and Precautions

    • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in 15% of patients with R/R ALL and in 7% of patients with MRD-positive ALL. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
    • Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life–threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
    • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
    • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
    • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
    • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
    • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and TBILI prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
    • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
    • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
    • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
    • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
    • Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including "gasping syndrome," which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO® (with preservative). When prescribing BLINCYTO® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.

    Adverse Reactions

    • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with MRD-positive B-cell precursor ALL (BLAST Study) treated with BLINCYTO® were pyrexia (91%), infusion-related reactions (77%), headache (39%), infections (pathogen unspecified 39%), tremor (31%), and chills (28%). Serious adverse reactions were reported in 61% of patients. The most common serious adverse reactions (≥ 2%) included pyrexia, tremor, encephalopathy, aphasia, lymphopenia, neutropenia, overdose, device related infection, seizure, and staphylococcal infection.
    • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO® were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
    • Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adults with relapsed or refractory B-cell precursor ALL were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
    • In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).

    Dosage and Administration Guidelines

    • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
    • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

    Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.

    About Amgen Oncology

    Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

    For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

    At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do. 

    For more information, follow us on www.twitter.com/amgenoncology.

    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.

    Forward-Looking Statement

    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 or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat 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. 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

    Trish Rowland, 805-447-5631 (media)

    Jessica Akopyan, 805-447-0974 (media)

    Arvind Sood, 805-447-1060 (investors)

    References

    1. Kumar S., et al. NCCN Guidelines Insights: Multiple Myeloma. The Journal of the National Comprehensive Cancer Network. Jan 2018; Volume 16: Issue 1. https://doi.org/10.6004/jnccn.2018.0002.
    2. Jakubowiak A. Management strategies for relapsed/refractory multiple myeloma: current clinical perspectives. Semin Hematol. 2012 Jul; 49 Suppl 1: S16-S32.
    3.  GLOBOCAN 2018. Multiple Myeloma. Available at: http://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf. Accessed Accessed October 16, 2020.
    4. Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012 Aug 2;120(5):947-59.
    5. Kortuem KM and Stewart AK. Carfilzomib. Blood. 2013 Feb 7;121(6):893
    6. Amgen Data on File.

     

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  3. THOUSAND OAKS, Calif., Nov. 25, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Evercore ISI Virtual HealthCONx Conference at 1:50 p.m. ET on Tuesday, Dec. 1, 2020. David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event.

    About Amgen
    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing…

    THOUSAND OAKS, Calif., Nov. 25, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Evercore ISI Virtual HealthCONx Conference at 1:50 p.m. ET on Tuesday, Dec. 1, 2020. David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following 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)

    Trish Rowland, 805-447-5631 (media) 

    Arvind Sood, 805-447-1060 (investors) 

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

     

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  4. THOUSAND OAKS, Calif., Nov. 23, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Company has provided notice to Cytokinetics of termination of its collaboration and its intention to transition the development and commercialization rights for omecamtiv mecarbil and AMG 594. Omecamtiv mecarbil, an investigational selective cardiac myosin activator, was studied in GALACTIC-HF, a Phase 3 clinical trial in patients with chronic heart failure with reduced ejection fraction (HFrEF), and AMG 594, a novel mechanism selective cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure.

    Primary results of GALACTIC-HF were recently presented at the American Heart Association Scientific Sessions and simultaneously…

    THOUSAND OAKS, Calif., Nov. 23, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Company has provided notice to Cytokinetics of termination of its collaboration and its intention to transition the development and commercialization rights for omecamtiv mecarbil and AMG 594. Omecamtiv mecarbil, an investigational selective cardiac myosin activator, was studied in GALACTIC-HF, a Phase 3 clinical trial in patients with chronic heart failure with reduced ejection fraction (HFrEF), and AMG 594, a novel mechanism selective cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure.

    Primary results of GALACTIC-HF were recently presented at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine. The trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of time to CV death was observed.

    "Cardiovascular disease is one of the most significant public health issues in the world which means patients need more innovation, not less. Our commitment to cardiovascular disease remains steadfast, and we look forward to continuing to work closely with the cardiovascular community as we focus on advancing our innovative therapies, including our Lp(a) inhibitor olpasiran (AMG 890), which is currently in Phase 2," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are grateful to the investigators and patients who participated in GALACTIC-HF. Unfortunately, the results of GALACTIC-HF did not meet the high bar we had set for the program."

    Amgen thanks Cytokinetics and Servier for their productive collaboration over many years, and will work closely with them to facilitate a smooth transition of omecamtiv mecarbil. Servier provides funding and strategic support for the program.

    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 or potential collaboration in pursuit  of  therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or Amgen's, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat 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. 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 

    Jessica Akopyan, 805-447-0974 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

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

     

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  5. THOUSAND OAKS, Calif., Nov. 13, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Jefferies Virtual London Healthcare Conference at 12:00 p.m. ET on Wednesday, Nov. 18, 2020. Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following 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…

    THOUSAND OAKS, Calif., Nov. 13, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Jefferies Virtual London Healthcare Conference at 12:00 p.m. ET on Wednesday, Nov. 18, 2020. Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following 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)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

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

     

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