AMGN Amgen Inc.

214.7
-0.66  -0%
Previous Close 215.36
Open 216.56
52 Week Low 210.28
52 Week High 276.69
Market Cap $121,917,900,189
Shares 567,852,353
Float 566,434,467
Enterprise Value $147,378,822,342
Volume 767,120
Av. Daily Volume 2,472,960
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Upcoming Catalysts

Drug Stage Catalyst Date
KHK4083/AMG 451
Atopic dermatitis
Phase 2
Phase 2
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OTEZLA
Plaque psoriasis
PDUFA
PDUFA
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Efavaleukin alfa (AMG 592)
Systemic Lupus Erythematosus
Phase 1/2
Phase 1/2
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LUMAKRAS (Sotorasib)
Colorectal cancer
Phase 2
Phase 2
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Tezepelumab
Asthma
PDUFA priority review
PDUFA priority review
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Omecamtiv mecarbil METEORIC-HF
Acute heart failure
Phase 3
Phase 3
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Olpasiran (AMG 890)
Cardiovascular disease / Elevated Lipoprotein
Phase 2
Phase 2
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LUMAKRAS (Sotorasib) - CodeBreaK 200
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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AMG 714 / PRV-015
Celiac disease
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
LUMAKRAS (Sotorasib) + Vectibix (panitumumab) - CodeBreak 101
KRAS G12C-mutated solid tumors
Phase 3
Phase 3
Phase 1/2 data showed objective response rate (ORR) was 27% among 26 patients. The disease control rate (DCR) was 81%. In the expansion cohort of sotorasib-naïve patients with refractory CRC (18), 33% of patients experienced a response, noted September 16, 2021. Initated Phase 3 trial with Vectiblix September 16, 2021.
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 trial data showed treatment in black patients is consistent with the overall population and white patients. Among black patients, treatment resulted in a trend towards reduction in the primary endpoint by 18%, corresponding to a reduction in the primary event rate of 7.7/100 patient-years with a number-needed-to-treat of 13 patients noted September 12, 2021.
Tezepelumab (NAVIGATOR)
Asthma and comorbid nasal polyps
Phase 3
Phase 3
Phase 3 data showed an 86% reduction in the annualized asthma exacerbation rate (AAER) September 5, 2021.
LUMAKRAS (Sotorasib)
Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA approval announced May 28, 2021.
Repatha (evolocumab)
Coronary Artery Disease (CAD)
Phase 3
Phase 3
Phase 3 trial met primary endpoint. Data presented August 27, 2021.
Pavurutamab (AMG 701)
Multiple Myeloma
Phase 1
Phase 1
Phase 1 enrollment has resumed - noted August 3, 2021.
Bemarituzumab (FPA144) + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 2
Phase 2
Phase 2 data presented at ASCO June 4, 2021. Median OS of 19.2 months versus 13.5 months for chemotherapy alone. Phase 3 trial planned for 4Q 2021.
Tarlatamab (AMG 757)
Small Cell Lung Cancer
Phase 2
Phase 2
Phase 2 potentially pivotal trial planned.
FPT155
Solid tumors
Phase 1
Phase 1
Phase 1 second cohort is open for enrollment.
Tezepelumab
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 trial is enrolling.
Tezepelumab
Chronic spontaneous urticaria
Phase 2b
Phase 2b
Phase 2b study is enrolling patients.
Rozibafusp alfa (AMG 570)
Systemic Lupus Erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial is enrolling.
Efavaleukin alfa (AMG 592)
Ulcerative colitis
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
ABP 980 (Kanjinti; trastuzumab-anns)
Herceptin biosimilar
Approved
Approved
FDA approval announced June 13, 2019.
LUMAKRAS (Sotorasib)
Non-small cell lung cancer (NSCLC) first line including STK11 mutations
Phase 2
Phase 2
Phase 2 trial to commence 3Q 2021.
AIMOVIG (Erenumab)
Migraine
Approved
Approved
Approval announced May 17, 2018.
REPATHA (evolocumab)
Cardiovascular disease
Approved
Approved
Approval announced December 1, 2017.
CORLANOR (ivabradine)
Chronic Heart Failure
Approved
Approved
Approved April 15, 2015.
NPLATE (Romiplostim)
Hematopoietic Syndrome of Acute Radiation Syndrome
Approved
Approved
FDA approval announced in earnings release - February 2, 2021.
NPLATE (Romiplostim)
Immune thrombocytopenia (ITP)
Approved
Approved
FDA Approval announced October 18, 2019.
NPLATE (Romiplostim)
Immune Thrombocytopenia (Pediatric)
Approved
Approved
FDA approval announced December 14, 2018.
Tezepelumab (WAYPOINT)
Chronic Rhinosinusitis With Nasal Polyps
Phase 3
Phase 3
Phase 3 trial has been initiated.
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
FDA approval announced October 1, 2018.
Tezepelumab - SOURCE
Oral corticosteroid dependent asthma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 22, 2020.
RIABNI (rituximab-arrx)
RITUXAN biosimilar - non-Hodgkin lymphoma
Approved
Approved
FDA approval announced December 17, 2020.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
OTEZLA
Scalp Psoriasis
Approved
Approved
FDA approval announced April 2020.
ABP 710
REMICADE biosimilar - rheumatoid arthritis
Approved
Approved
FDA Approval announced December 6, 2019.
OTEZLA - PSA-006
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 - primary endpoint met.
OTEZLA
Behçet’s Disease
Approved
Approved
FDA Approval announced July 19, 2019.
BLINCYTO
Acute lymphoblastic leukemia (ALL) - pediatric
Phase 3
Phase 3
Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
EVENITY (Romosozumab)
Osteoporosis
Approved
Approved
FDA Approval announced April 9, 2019.
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.
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.
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
Approved
Approved
sBLA approval announced June 29, 2017.

Latest News

  1. THOUSAND OAKS, Calif., Sept. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today released the 8th edition of the Biosimilar Trends Report, which examines the current state of the U.S. biosimilars marketplace across inflammation, oncology and nephrology categories, while a new feature considers how advancements in biosimilars can support the long-term success and sustainability of the U.S. healthcare system. To access the full report, visit: www.amgenbiosimilars.com/commitment/trends-report.

    To view the multimedia assets associated with this release, please click: https://www.multivu.com/players/English/8812854-amgen-8th-edition-biosimilar-trends-report/  

    2021 Biosimilar Trends Report One-pager

    The Report shows that competition created by biosimilars has saved the U.S. healthcare…

    THOUSAND OAKS, Calif., Sept. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today released the 8th edition of the Biosimilar Trends Report, which examines the current state of the U.S. biosimilars marketplace across inflammation, oncology and nephrology categories, while a new feature considers how advancements in biosimilars can support the long-term success and sustainability of the U.S. healthcare system. To access the full report, visit: www.amgenbiosimilars.com/commitment/trends-report.

    To view the multimedia assets associated with this release, please click: https://www.multivu.com/players/English/8812854-amgen-8th-edition-biosimilar-trends-report/  

    2021 Biosimilar Trends Report One-pager

    The Report shows that competition created by biosimilars has saved the U.S. healthcare system $9.8 billion over the past five years,i and has the potential to reduce out-of-pocket spending by $238 million for patients in the nine biologic drug classes where biosimilars have been approved. According to the Report:

    • Biosimilars contribute to competition that drives down healthcare costs by providing significant wholesale acquisition cost (WAC) and average sales price (ASP) discounts at launch, resulting in additional savings over time.
    • Biosimilars are launching at a price that is generally 15% to 37% lower than the reference product.ii Furthermore, the ASP is declining for both reference products and biosimilars over time, while the rate of biosimilar uptake is generally increasing over time.iii,iv
    • Biosimilars have gained substantial share in the majority of therapeutic areas where they have been introduced.v For therapeutic areas with biosimilars launched in the last two years, the average share was 65%.vi

    This year's Report features a new section, Future State of the Marketplace, which outlines how biosimilars can continue to offer more affordable treatment options, drive cost savings through increased competition between biosimilars and with reference biologics, and promote a more resilient U.S. healthcare marketplace. The U.S. marketplace is poised to see further growth in biosimilars approved to date and welcome many new biosimilars in the years to come.

    "As part of Amgen's commitment to staying at the forefront of biosimilar education, Amgen is pleased to announce the launch of the 2021 Biosimilar Trends Report," said Jennifer Norton, vice president, Head of U.S. Value and Access at Amgen. "The increasing availability and adoption of biosimilars means these treatments are delivering on the fundamental promise of reducing healthcare costs for payers, employers, and patients in the United States."

    The 2021 Biosimilar Trends Report also outlines the four key elements that Amgen believes are necessary for sustaining biosimilars' growth:

    • Implementing scientifically appropriate regulatory standards for the approval, manufacture, and uninterrupted availability of safe and effective biological products, including biosimilars;
    • Maintaining a marketplace that encourages competition on a level playing field to achieve meaningful savings and long-term stability;
    • Providing scientifically accurate educational outreach to drive confidence with healthcare providers, patients, payers, and employers; and
    • Ensuring a foundation of strong intellectual property to encourage innovation and investment.

    "The U.S. marketplace with biosimilars is well established and accelerating across key therapeutic areas, creating cost savings, and additional treatment options for physicians and patients," said Chad Pettit, executive director, Marketing, Global Biosimilars Commercial Lead at Amgen, adding, "By continuing to advance science-based policies that support competition and enhance confidence from patients, physicians, and other stakeholders, the U.S. can help promote a robust and resilient healthcare system needed for the long term."



    About Amgen Biosimilars

    Amgen is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

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



    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) 

    i Data on file, Amgen; Biosimilars Spend Analysis; July 2021.

    ii Data on file, Amgen; Product and Biosimilars - WAC and ASP Price; July 2021.

    iii Data on file, Amgen; Product and Biosimilars - WAC and ASP Price; July 2021

    iv Data on file, Amgen; Biosimilars Market Share Trends; July 2021

    v Data on file, Amgen; Biosimilars Market Share Trends; July 2021

    vi Data on file, Amgen; Biosimilars Market Share Trends; July 2021

    The Promise of Biosimilars Factsheet

     

    Cision View original content:https://www.prnewswire.com/news-releases/amgen-releases-8th-edition-of-biosimilar-trends-report-301382173.html

    SOURCE Amgen

    View Full Article Hide Full Article
  2. THOUSAND OAKS, Calif., Sept. 20, 2021 /PRNewswire/ -- Amgen today announced that the U.S. District Court for the District of New Jersey has upheld patents that protect Amgen's psoriasis therapy Otezla® (apremilast) in a patent infringement lawsuit against Sandoz Inc. ("Sandoz") and Zydus Pharmaceuticals (USA), Inc. ("Zydus"). The asserted patents claim apremilast as a composition of matter ("COM"), methods of treating psoriasis with apremilast, and crystalline forms of apremilast. The court found infringement and upheld the validity of four patents – three against each defendant -- but ruled against Amgen on claims in U.S. Patent No. 10,092,541 covering methods of treating psoriasis with apremilast according to a specific dosing schedule. Today's…

    THOUSAND OAKS, Calif., Sept. 20, 2021 /PRNewswire/ -- Amgen today announced that the U.S. District Court for the District of New Jersey has upheld patents that protect Amgen's psoriasis therapy Otezla® (apremilast) in a patent infringement lawsuit against Sandoz Inc. ("Sandoz") and Zydus Pharmaceuticals (USA), Inc. ("Zydus"). The asserted patents claim apremilast as a composition of matter ("COM"), methods of treating psoriasis with apremilast, and crystalline forms of apremilast. The court found infringement and upheld the validity of four patents – three against each defendant -- but ruled against Amgen on claims in U.S. Patent No. 10,092,541 covering methods of treating psoriasis with apremilast according to a specific dosing schedule. Today's decision will prevent Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until expiration of the COM patent, U.S. Patent No. 7,427,638, in Feb. 2028.

    The decision comes after the New Jersey court held a bench trial in June 2021. Prior to trial, Sandoz acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 7,893,101, 8,455,536, and 10,092,541, and Zydus acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 8,093,283, 8,455,536, and 10,092,541, leaving only the issues of whether Zydus's generic version of Otezla infringes U.S. Patent No. 7,893,101 and the validity of the asserted patent claims to be addressed by the court.   

    Amgen believes in the value of intellectual property and will continue to vigorously defend its intellectual property rights.

    In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet's Disease. 

    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® (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
      • Behcet'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 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., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on 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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. 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. 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, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (media)

    Michael Strapazon, 805-313-5553 (media)

    Arvind Sood, 805-447-1060 (investors)

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

     

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  3. THOUSAND OAKS, Calif., Sept. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first combination study results from the Phase 1b/2 CodeBreaK 101 study, the most comprehensive global clinical development program in patients with KRAS G12C-mutated advanced colorectal cancer (CRC). These new data show that combining LUMAKRAS™ (sotorasib) with Vectibix® (panitumumab), Amgen's monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor, demonstrated encouraging efficacy and safety. Overall, the objective response rate (ORR) was 27% (confirmed and unconfirmed) among 26 patients in the efficacy analysis set (which included 5 patients who had progressed with prior sotorasib monotherapy). The disease control rate (DCR) was 81…

    THOUSAND OAKS, Calif., Sept. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first combination study results from the Phase 1b/2 CodeBreaK 101 study, the most comprehensive global clinical development program in patients with KRAS G12C-mutated advanced colorectal cancer (CRC). These new data show that combining LUMAKRAS™ (sotorasib) with Vectibix® (panitumumab), Amgen's monoclonal antibody epidermal growth factor receptor (EGFR) inhibitor, demonstrated encouraging efficacy and safety. Overall, the objective response rate (ORR) was 27% (confirmed and unconfirmed) among 26 patients in the efficacy analysis set (which included 5 patients who had progressed with prior sotorasib monotherapy). The disease control rate (DCR) was 81%. ORR and DCR were secondary endpoints. In the expansion cohort of sotorasib-naïve patients with refractory CRC (n=18), 33% of patients experienced a response (confirmed and unconfirmed). These data are being featured during the European Society of Medical Oncology 2021 (ESMO21) Virtual Congress.

    "We are excited by these CodeBreaK 101 data, which show encouraging response rates that were much higher than the 9.7% response rate observed with LUMAKRAS monotherapy and highlight the importance of combination therapy for patients with KRAS G12C-mutated advanced colorectal cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Based on these results and the urgent need for new therapies, we are pleased to announce the initiation of a new Phase 3 trial with LUMAKRAS plus Vectibix in the third-line setting. This new trial, along with our doublet and triplet combination trials in colorectal cancer, demonstrates our commitment to delivering a new treatment option for metastatic CRC patients who harbor the KRAS G12C mutation."

    In total, 31 patients with heavily pretreated (median of two prior lines of therapy; range 1-10) KRAS G12C-mutated metastatic CRC were enrolled in the dose exploration and dose expansion cohorts for the combination of LUMAKRAS and Vectibix. No patients experienced dose-limiting toxicities during the 28 days following initial treatment. The majority of treatment-related adverse events (TRAEs) were Grade 1-2 in severity, and no Grade 4 or fatal TRAEs were observed. The most common TRAEs (occurring in > 10% of patients) were consistent with known adverse events for LUMAKRAS and Vectibix and included dermatitis acneiform, dry skin, nausea, diarrhea, hypokalemia, hypomagnesemia, pruritus and rash. No new safety concerns were identified.

    "With treatment response rates being as low as 2% in patients with colorectal cancer who progress in advanced stages, developing new treatment approaches for these patients is of critical interest," said Marwan G. Fakih, M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. "Preclinical research has indicated that the addition of an EGFR inhibitor to KRASG12C inhibition can be synergistic, and now we have the first clinical data indicating the combination of sotorasib and panitumumab has the potential to be a safe and effective treatment for patients with KRAS G12C-mutated advanced CRC."

    Advancing Tarlatamab (formerly AMG 757) and AMG 404 in Small Cell Lung Cancer

    In addition to the LUMAKRAS combination research, a presentation will detail the design of an ongoing study of half-life extended (HLE) bispecific T cell engager (BiTE®) molecule tarlatamab with anti-PD-1 antibody AMG 404 in patients with small cell lung cancer. The multicenter, open-label, Phase 1b study will evaluate the safety and tolerability of the combination and determine dosing as primary objectives, as well as examine preliminary antitumor activity and pharmacokinetics as secondary objectives.

    Amgen to Webcast Investor Call at ESMO 2021

    Amgen will host a webcast call for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2021 Congress. On Thursday, Sept. 16, 2021, at 8:30 a.m. ET,  David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with other members of Amgen's management team, will discuss clinical data being presented on the Company's KRASG12C inhibitor LUMAKRAS™ (sotorasib) in combination with Vectibix® (panitumumab).

    Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. 

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

    About LUMAKRASTM (sotorasib)

    Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C inhibitor.1 LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.2

    In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS is also approved in the United Arab Emirates, and in Great Britain and Canada under Project Orbis.

    Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, LUMAKRAS has treated almost 3,000 patients around the world through the clinical development program and commercial use.

    In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA's Project Orbis initiative and through the initiative, has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia and Brazil. Additionally, Amgen has submitted an MAA in the European Union, Japan, Switzerland, South Korea, Singapore, Israel, Turkey, Taiwan, Colombia, Thailand, Mexico and Hong Kong.

    LUMAKRAS is also being studied in multiple other solid tumors.1

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRASG12C inhibitor clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.

    CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication. 

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).

    For information, please visit www.hcp.codebreaktrials.com.

    About Advanced Colorectal Cancer and the KRAS G12C Mutation

    Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 10% of all cancer diagnoses.3 It is also the third most commonly diagnosed cancer globally.4

    Patients with previously treated metastatic CRC need more effective treatment options, as standard therapies yield median PFS times of about two months and patients' response rates are less than 2%. 5,6

    KRAS mutations are among the most common genetic alterations in colorectal cancers, with the KRAS G12C mutation present in approximately 3-5% of colorectal cancers.7,8,9

    About BiTE® Technology

    BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-specific 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-specific 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 BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

    LUMAKRASTM (sotorasib) U.S. Indication

    LUMAKRASTM is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

    This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    LUMAKRAS™ (sotorasib) Important Safety Information

    Hepatotoxicity

    • LUMAKRAS™ can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
    • Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS™ had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
    • Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS™, every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
    • Withhold, dose reduce or permanently discontinue LUMAKRAS™ based on severity of adverse reaction.

    Interstitial Lung Disease (ILD)/Pneumonitis

    • LUMAKRAS™ can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS™ in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS™ was discontinued due to ILD/pneumonitis in 0.6% of patients.
    • Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS™ in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS™ if no other potential causes of ILD/pneumonitis are identified.

    Most Common Adverse Reactions

    • The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.

    Drug Interactions

    • Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
    • Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS™.
    • If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS™ 4 hours before or 10 hours after a locally acting antacid.

    Please see LUMAKRASTM full Prescribing Information

    About Vectibix® (panitumumab)

    Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

    In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.

    In June 2017, the FDA approved a refined indication for Vectibix for use in in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this usemCRC.

    INDICATION AND LIMITATION OF USE 

    Vectibix® is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): as first-line therapy in combination with FOLFOX, and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

    Limitation of Use: Vectibix® is not indicated for the treatment of patients with RAS mutant mCRC or for whom RAS mutation status is unknown.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: DERMATOLOGIC TOXICITY

    Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

    • In Study 20020408, dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients with mCRC receiving Vectibix®. The clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
    • Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix®. Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix®. It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune- related effects (e.g., Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix® concerning dermatologic toxicity are provided in the product labeling.
    • Vectibix® is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as "RAS."
    • Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS-mutant mCRC tumors received Vectibix® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysisOS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS-mutant mCRC who received Vectibix® and FOLFOX versus FOLFOX alone.
    • Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study 20080763) of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix® treatment, periodically during Vectibix® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
    • In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
    • Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix® in combination with chemotherapy.
    • Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix®. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix®. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix® therapy. Discontinue Vectibix® therapy if ILD is confirmed.
    • In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix® versus the risk of pulmonary complications must be carefully considered.
    • Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix®.
    • Keratitis and serious cases of keratitis, ulcerative keratitis, known risk factors for and corneal perforation, have occurrred with Vectibix use. Monitor for evidence of keratitis , ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
    • In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in Vectibix®-treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs < 1%), and hypomagnesemia (4% vs 0).
    • NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix®-treated patients (7% vs 3%) and included fatal events in three (< 1%) Vectibix®-treated patients. As a result of the toxicities experienced, patients randomized to Vectibix®, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
    • Vectibix® can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix®.
    • In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
    • The most commonly reported adverse reactions (≥ 20%) with Vectibix® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. The most common serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.

    To see the Vectibix® Prescribing Information, including Boxed Warning visit www.vectibix.com.

    About Amgen Oncology

    At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

    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're advancing oncology at the speed of life™.

    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 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., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

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

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (media)

    Megan Fox, 805-447-1423 (media)

    Arvind Sood, 805-447-1060 (investors)

    References:

    1. Hong DS, et al. N Engl J Med. 2020;383:1207-1217.
    2. Skoulidis F, Li BT, Dy GK, et al. N Engl J Med. 2021;384(25):2371-2381. doi:10.1056/NEJMoa2103695.
    3. Rawla, P., Sunkara, T., & Barsouk, A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Gastroenterology Review, 2019: 14(2), 89-103.
    4. World Health Organization. 2020 Statistics. Accessed at: https://www.who.int/en/news-room/fact-sheets/detail/cancer on August 26, 2021.
    5. Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909-1919. doi:10.1056/NEJMoa1414325.
    6. Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-312. doi:10.1016/S0140-6736(12)61900-X.
    7. Neumann J, Zeindl-Eberhart E, Kirchner T, Jung A. Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol Res Pract. 2009;205(12):858-862. doi:10.1016/j.prp.2009.07.010.
    8. Jones RP, Sutton PA, Evans JP, et al. Specific mutations in KRAS codon 12 are associated with worse overall survival in patients with advanced and recurrent colorectal cancer. Br J Cancer. 2017;116(7):923-929. doi:10.1038/bjc.2017.37.
    9. Wiesweg M, Kasper S, Worm K, et al. Impact of RAS mutation subtype on clinical outcome-a cross-entity comparison of patients with advanced non-small cell lung cancer and colorectal cancer. Oncogene. 2019;38(16):2953-2966. doi:10.1038/s41388-018-0634-0.

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  4. THOUSAND OAKS, Calif., Sept. 14, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and The Lundquist Institute today announced that Diadem Biotherapeutics, Inc., has been awarded the first Amgen Golden Ticket in Southern California. Diadem will receive one year of lab space at BioLabs LA at The Lundquist Institute (TLI) as well as additional facility benefits and connections to Amgen's scientific and business leaders.

    The 2021 Amgen Golden Ticket winner was chosen by an internal team of Amgen scientific leaders at a virtual pitch event. Five finalists pitched their business plans before Amgen's internal committee that evaluated the strength and novelty of their scientific rationale, subject matter expertise and business plan viability. This is the first…

    THOUSAND OAKS, Calif., Sept. 14, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and The Lundquist Institute today announced that Diadem Biotherapeutics, Inc., has been awarded the first Amgen Golden Ticket in Southern California. Diadem will receive one year of lab space at BioLabs LA at The Lundquist Institute (TLI) as well as additional facility benefits and connections to Amgen's scientific and business leaders.

    The 2021 Amgen Golden Ticket winner was chosen by an internal team of Amgen scientific leaders at a virtual pitch event. Five finalists pitched their business plans before Amgen's internal committee that evaluated the strength and novelty of their scientific rationale, subject matter expertise and business plan viability. This is the first of three Amgen Golden Tickets to be awarded over the next three years to help accelerate life science start-ups in Southern California.

    Perspectives on announcement:

    • "Amgen's partnership with BioLabs LA at The Lundquist Institute (TLI) recognizes the rapid growth of bioscience innovation in the Los Angeles area and aligns with our aspiration to bring breakthrough therapies for patients. We are enthusiastic about the exosome technology that is being advanced by Diadem Biosciences, and look forward to engaging with the team as they advance novel immunotherapies to treat serious illness" – Philip Tagari, Ph.D., vice president of Therapeutic Discovery at Amgen
    • "Biolabs LA at the Lundquist Institute is honored to be working with Amgen, a worldwide pioneer in biotechnology, to help identify and support innovative up and coming life-science companies in Southern California. Amgen's three-year Golden Ticket sponsorship provides a unique opportunity for BioLabs to help promote growth for startup companies in the rapidly developing Los Angeles market while relying on expert mentorship from Amgen, as the premier industry partner in the region. Amgen serves as a model and guidepost to encourage and champion companies to grow with local resources being a key to their success. We look forward to having Diadem join the BioLabs LA community and in assisting them, along with Amgen and The Lundquist Institute, in reaching their milestones. Together we will drive progress in the field of human biology and patient health." – Lindsay Bourgeois, director of BioLabs LA at the Lundquist Institute
    • "We are honored to have our approach to therapeutic signaling endorsed by an expert judging panel of Amgen's leading scientists. With the extensive resources at BioLabs LA and access to Amgen expertise we can accelerate the development of a new class of therapeutics that has the potential to enhance patient-care outcomes across a range of diseases. That BioLabs LA is now at full capacity speaks to the ambition of biotech startups in Los Angeles, and the fertile ground of this ecosystem." – Mickey Pentecost, Ph.D., co-founder and chief executive officer, Diadem Biotherapeutics, Inc.

    Amgen supports life science start-ups through Golden Ticket awards and affiliated engagement in other Biotech Innovative hubs, including San Francisco, Boston and Toronto.

    About Diadem Biotherapeutics, Inc.

    Diadem Biotherapeutics, Inc. is a platform therapeutics company developing a broad pipeline of first-in-class immunotherapies. Leveraging expertise in genetic engineering and scalable bioprocessing, Diadem is developing cell secreted nanovesicles precisely engineered to deliver signals that mimic natural cell-to-cell signaling. Diadem's unique approach enables precise modulation of targets that play a role in chronic inflammation, autoimmune diseases and immune control of cancers, addressing some critical unmet clinical needs.  For more information, visit www.diadembio.com.

    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.

    About The Lundquist Institute: Research with reach™

    The Lundquist Institute is an engine of innovation with a global reach and a 69-year reputation of improving and saving lives. With its new medical research building, its state-of-the-art incubator, "BioLabs at The Lundquist," existing laboratory and support infrastructure, and the development of a new 15-acre business tech park, the Lundquist Institute serves as a hub for the Los Angeles area's burgeoning biotech scene. The research institute has over 100 principal investigators (Ph.D.s, M.D.s, and M.D./Ph.D.s) working on more than 600 research studies, including therapies for numerous, and often fatal orphan diseases. Find out more at https://lundquist.org.

    About BioLabs LA at The Lundquist Institute

    Encompassing the entire third floor of The Lundquist Institute's new Medical Research Lab building, BioLabs LA offers shared lab facilities designed for high-potential, early-stage life since companies. BioLabs creates co-working communities that pair premium, fully equipped and supported lab and office space with unparalleled access for entrepreneurs to networking, industry partners, and capital. Find out more at https://www.biolabs.io/la.

    CONTACT:

    Amgen

    Michael Strapazon, 805-313-5553 (media)

    The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Keith B. Hoffman, Ph.D., (310) 974-9301, keith.hoffman@lundquist.org

    BioLabs LA

    Lindsay Bourgeois, (978) 852-1081, lbourgeois@biolabs.io

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

     

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  5. THOUSAND OAKS, Calif., Sept. 13, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference at 11:45 a.m. ET on Friday, Sept. 17, 2021. Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability…

    THOUSAND OAKS, Calif., Sept. 13, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference at 11:45 a.m. ET on Friday, Sept. 17, 2021. Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

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

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631 (media)

    Arvind Sood, 805-447-1060 (investors) 

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

     

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