1. THOUSAND OAKS, Calif., Jan. 26, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2020 World Conference on Lung Cancer (WCLC) on Friday, Jan. 29, at 8:00 p.m. ETDavid M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical trial investigators, will discuss the registrational Phase 2 non-small cell lung cancer (NSCLC) data being presented on the Company's investigational KRASG12C inhibitor sotorasib.

    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…

    THOUSAND OAKS, Calif., Jan. 26, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2020 World Conference on Lung Cancer (WCLC) on Friday, Jan. 29, at 8:00 p.m. ETDavid M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical trial investigators, will discuss the registrational Phase 2 non-small cell lung cancer (NSCLC) data being presented on the Company's investigational KRASG12C inhibitor sotorasib.

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

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

    About Amgen 

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

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

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

    CONTACT: Amgen, Thousand Oaks 

    Jessica Akopyan, 805-447-0974 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

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  2. THOUSAND OAKS, Calif., Jan. 12, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from its oncology pipeline in lung cancer will be presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer taking place virtually from Jan. 28-31, 2021.

    Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib (AMG 510) in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will be presented as part of the WCLC Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29. Additionally, updated Phase 1 data from AMG 757, an investigational first-in-class BiTE® molecule that is uniquely designed to target delta-like…

    THOUSAND OAKS, Calif., Jan. 12, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from its oncology pipeline in lung cancer will be presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer taking place virtually from Jan. 28-31, 2021.

    Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib (AMG 510) in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will be presented as part of the WCLC Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29. Additionally, updated Phase 1 data from AMG 757, an investigational first-in-class BiTE® molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in small cell lung cancer (SCLC), will also be presented in an oral presentation.

    "We are incredibly excited to present the first complete Phase 2 non-small cell lung cancer data set for an investigational KRASG12C inhibitor, including novel biomarker analyses," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This is an historic moment not only for us, but for the scientific community working on the 40-year quest to target KRAS, one of cancer research's toughest challenges. Additionally, following recent regulatory submissions to the FDA and European Medicines Agency, we remain focused on rapidly bringing this potential foundational KRAS G12C therapy to patients with advanced non-small cell lung cancer harboring this mutation."

    "KRAS G12C is one of the most common driver mutations in non-small cell lung cancer; each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated non-small cell lung cancer," said Suresh S. Ramalingam, M.D., deputy director of Winship Cancer Institute at Emory University in Atlanta. "The sotorasib data that will be presented at WCLC represents an important step forward in addressing the high unmet need for patients with this mutation."

    Abstracts not featured in the Presidential Symposium are available at https://wclc2020.iaslc.org/.

    Learn more about how Amgen Oncology is advancing its pioneering science with the relentless pursuit of innovative modalities and unique pathways for cancer patients and their families at AmgenOncology.com/medical.  

    Clinical Abstracts and Presentation Times:

    • Registrational Phase 2 Trial of Sotorasib in KRAS p.G12C Mutant NSCLC: First Disclosure of the CodeBreaK 100 Primary Analysis

      Presentation #PS01.07, Presidential Symposium, Saturday, Jan. 30 from 7:50-8 a.m. SGT / Friday, Jan. 29 from 3:50-4 p.m. PST
    • Clinical Characteristics and Outcomes in Advanced KRAS Mutant NSCLC – A Multi-Centre Collaboration in Asia (ATORG-005)

      Presentation #MA04.06, Mini-oral Presentation, Friday, Jan. 29 from 5:15-5:20 p.m. SGT / Friday, Jan. 29 from 1:15-1:20 a.m. PST
    • A Phase 1 Study of AMG 757, Half-Life Extended Bispecific T-Cell Engager (BiTE®) Immune Therapy Against DLL3, in SCLC

      Presentation #OA11.03, Oral Presentation, Sunday, Jan. 31 from 3:30-3:40 p.m. SGT / Saturday, Jan. 30 from 11:30-11:40 p.m. PST
    • AMG 757, a Half-Life Extended Bispecific T-Cell Engager (HLE BiTE® Immuno-Oncology Therapy) Targeting DLL3, for the Treatment of Small Cell Lung Cancer

      Presentation #P15.01, e-Poster Presentation

    Amgen Webcast Investor Call

    Amgen will host a webcast call for the investment community in conjunction with WCLC 2020. On Friday, Jan. 29, 2021 at 5 p.m. PST, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team and clinical trial investigators, will discuss the registrational Phase 2 NSCLC data being presented on the Company's investigational KRASG12C inhibitor sotorasib.

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

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

    About Sotorasib

    Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning four continents. In just over two years, the sotorasib clinical program CodeBreaK has established the deepest clinical data set with nearly 700 patients studied across 13 tumor types.

    Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.1

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's investigational 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.

    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, 123 of whom had centrally evaluable lesions by RECIST 1.1 at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC patients (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b sotorasib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

    For information, please visit www.codebreaktrials.com.

    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-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 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 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 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.  Kim D, et al. Cell. 2020;183 :850-859.

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  3. Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that José M. Vega, M.D. joined Moderna as Chief Safety Officer effective Monday, January 11, 2021. Dr. Vega will report to Chief Medical Officer Tal Zaks, M.D., Ph.D.

    "José brings a strategic level of leadership and deep experience in drug development and pharmacovigilance in global biopharmaceutical companies including Merck and Amgen," said Dr. Zaks. "I am thrilled to welcome José to the Moderna team as we enter the next phase of growth of our company."

    Dr. Vega joins Moderna from Merck (NYSE:MRK) where he led the Global Clinical Safety and Pharmacovigilance organization and served as the Chief Safety Officer for…

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that José M. Vega, M.D. joined Moderna as Chief Safety Officer effective Monday, January 11, 2021. Dr. Vega will report to Chief Medical Officer Tal Zaks, M.D., Ph.D.

    "José brings a strategic level of leadership and deep experience in drug development and pharmacovigilance in global biopharmaceutical companies including Merck and Amgen," said Dr. Zaks. "I am thrilled to welcome José to the Moderna team as we enter the next phase of growth of our company."

    Dr. Vega joins Moderna from Merck (NYSE:MRK) where he led the Global Clinical Safety and Pharmacovigilance organization and served as the Chief Safety Officer for Merck Research Laboratories (MRL) since 2013. In this role, he led a global team of nearly 600 safety and pharmacovigilance professionals in Clinical Safety Risk Management, Medical Safety Review, Global Pharmacovigilance, and the EU Qualified Person for Pharmacovigilance (QPPV) groups.

    Prior to Merck, Dr. Vega spent 10 years at Amgen (NASDAQ:AMGN), where he held the role of Vice President, Global Safety for more than 5 years and led global efforts for safety signal detection and assessment, pharmacovigilance, pharmacoepidemiology, and therapeutic area safety. Upon joining Amgen in 2003, Dr. Vega led the Proof of Concept Group in Early Development and served for several years as the Vice President and Therapeutic Area Head for General Medicine in Global Clinical Development.

    Between 1997 and 2003, Dr. Vega served in roles of increasing responsibility at Merck Research Laboratories, initially in Clinical Pharmacology and then in the role of Senior Director in Clinical Drug Metabolism. Prior to joining Merck, Dr. Vega practiced and taught at the Massachusetts General Hospital and Harvard Medical School as an emergency department attending physician for 5 years and as part of an academic primary care and internal medicine practice for more than 2 years.

    "I am delighted to join Moderna and look forward to supporting its mission to deliver on the promise of mRNA science to create a new generation of transformative medicines for patients by fulfilling our uncompromising commitment to patient safety and ensuring the highest standards of quality and compliance," said Dr. Vega.

    Dr. Vega has been a member of the Clinical Trials Transformation Initiative (CTTI) Steering Committee since 2008, representing Amgen from 2008 to 2013 and Merck since 2014. He has been a member of the TransCelerate Pharmacovigilance Steering Committee since 2016 and chaired the committee from 2016 to 2018.

    Dr. Vega received a B.A. in Biochemical Sciences summa cum laude from Harvard College and an M.A. in Biochemistry and Molecular Biology from Harvard University. Dr. Vega received his M.D. degree from Harvard Medical School and completed his internal medicine internship and residency at Massachusetts General Hospital.

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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  4. THOUSAND OAKS, Calif., Jan. 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the launch of a new seven-year environmental sustainability plan, which includes a commitment to achieve carbon neutrality, while also reducing water use by 40% and waste disposed by 75%.

    "As a science-based company with a mission to serve patients, we understand the profound impact that climate change is having on human health around the world," said Robert A. Bradway, chairman and chief executive officer at Amgen.  "Our new commitments expand on our previous achievements and drive Amgen's continued leadership on environmental sustainability that will benefit our patients, staff, shareholders and communities."

    Since 2007, Amgen has implemented projects…

    THOUSAND OAKS, Calif., Jan. 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the launch of a new seven-year environmental sustainability plan, which includes a commitment to achieve carbon neutrality, while also reducing water use by 40% and waste disposed by 75%.

    "As a science-based company with a mission to serve patients, we understand the profound impact that climate change is having on human health around the world," said Robert A. Bradway, chairman and chief executive officer at Amgen.  "Our new commitments expand on our previous achievements and drive Amgen's continued leadership on environmental sustainability that will benefit our patients, staff, shareholders and communities."

    Since 2007, Amgen has implemented projects resulting in a 33% reduction in carbon emissions, a 30% reduction in water use and a 28% reduction in waste. These reductions were achieved even as the company increased production capacity, expanded our presence to more than 100 countries and grew revenues significantly.

    Amgen will invest more than $200 million to achieve these 2027 environmental commitments, and expects that such investment will help us to become not just more environmentally sustainable but also more flexible and productive, resulting in reductions in operating costs from such efficiencies over the same period. The company will focus on the use of innovative technologies to significantly reduce carbon emissions from Amgen-owned operations, as well as on sourcing renewable energy. For example, Amgen's newest biomanufacturing plant in Singapore generates 70% less carbon than traditional biomanufacturing facilities. The company has built a second such plant in Rhode Island.

    Where carbon emissions cannot be eliminated from its operations, Amgen will invest in sustainability projects that sequester or avoid greenhouse gas emissions. In addition, Amgen will engage with its suppliers to assist and encourage carbon reductions throughout its value chain.

    More information about Amgen's environmental plans can be found here.

    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 Adaptive Biotechnologies (including statements regarding such collaboration's ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), BeiGene, Ltd., or the Otezla 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. 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. 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

    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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    SOURCE Amgen

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  5. GRAIL, Inc., a healthcare company whose mission is to detect cancer early, today announced collaborations with global biopharmaceutical companies Amgen (NASDAQ:AMGN), AstraZeneca (NASDAQ:AZN), and Bristol Myers Squibb (NYSE:BMY) to evaluate GRAIL's methylation-based technology for the detection of minimal residual disease (MRD).

    Cancer MRD testing is used in clinical and research applications to detect the presence or absence of residual disease. Many MRD tests available today for solid tumors require tissue samples and development of patient-specific assays, which contributes to longer turnaround times and potential delay in treatment decisions. GRAIL's targeted methylation platform could enable a blood-based MRD detection assay for solid…

    GRAIL, Inc., a healthcare company whose mission is to detect cancer early, today announced collaborations with global biopharmaceutical companies Amgen (NASDAQ:AMGN), AstraZeneca (NASDAQ:AZN), and Bristol Myers Squibb (NYSE:BMY) to evaluate GRAIL's methylation-based technology for the detection of minimal residual disease (MRD).

    Cancer MRD testing is used in clinical and research applications to detect the presence or absence of residual disease. Many MRD tests available today for solid tumors require tissue samples and development of patient-specific assays, which contributes to longer turnaround times and potential delay in treatment decisions. GRAIL's targeted methylation platform could enable a blood-based MRD detection assay for solid tumors that perform comparably to bespoke tissue-based assays, while reducing complexity and processing times.

    "GRAIL has developed and validated a novel approach to detect early cancer signals in blood and now we are excited to collaborate with leading companies Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate the benefits of using our technology to find minimal residual disease after treatment or to detect early recurrent cancers," said Joshua Ofman, MD, MSHS, GRAIL chief medical officer and head of external affairs. "Cancer never quits, making the detection of residual disease and early recurrences critical to helping patients and care providers stay ahead of the disease."

    "Amgen is pleased to partner with GRAIL to understand how this technology can provide deeper insights into tumor biology and a patient's prognosis," said Narimon Honarpour, vice president, Translational Medicine, Amgen. "Achieving better clinical outcomes relies upon our understanding of cancer progression and the field needs more robust testing capabilities."

    "Research has shown that we can improve outcomes across cancer types by treating patients as early as possible and intervening early if cancer recurs, which underpins our strategy," said Carl Barrett, vice president, Translational Science, Oncology R&D, AstraZeneca. "This collaboration with GRAIL will allow us to test a promising approach for monitoring MRD and detecting recurrence – tools that will provide critical information that we hope can optimize patient treatment plans."

    "We are committed to leveraging the latest science and technologies to bring continued innovation to the healthcare community and patients we serve," said Sarah Hersey, vice president, Precision Medicine, Translational Medicine, Bristol Myers Squibb. "Our collaboration with GRAIL and other leaders in the industry will help enhance our ability to address the outstanding challenges of detecting and treating cancer head-on."

    About GRAIL

    GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on saving lives and improving health by pioneering new technologies for early cancer detection. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges with Galleri™, GRAIL's multi-cancer early detection test. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers -- over 45 of which lack recommended screening tests today -- with a low false-positive rate of less than 1%. When cancer is detected, Galleri localizes the cancer signal with high accuracy, all from a single blood draw. GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

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  6. Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

    HIV vaccine program to accelerate human validation of novel vaccination strategies

    Nipah vaccine program established against a virus of public health concern

    Moderna now has one commercial medicine and 24 development programs

    Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement…

    Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

    HIV vaccine program to accelerate human validation of novel vaccination strategies

    Nipah vaccine program established against a virus of public health concern

    Moderna now has one commercial medicine and 24 development programs

    Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement reflects the Company's commitment to accelerating its infectious disease portfolio based on Moderna's experience with its COVID-19 vaccine. The development programs announced today are mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.

    "The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna," said Stéphane Bancel, Moderna's chief executive officer. "Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas."

    Mr. Bancel will present an update on the Company and its pipeline of mRNA development programs on Monday, January 11, 2021 at 4:30 p.m. ET at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will be followed by a question-and-answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna's website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for 30 days following the presentation.

    Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic. The Company's updated pipeline can be found at www.modernatx.com/pipeline.

    About Moderna's New Infectious Disease Vaccine Development Programs

    • Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year in the US, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin phase 1 clinical trials for the program in 2021.



    • HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF), is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. The Company expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 in 2021.



    • Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).

    Moderna's pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. The Company's approach is to leverage early programs within a modality to generate clinical data and insights that reduce the technology risk of subsequent programs and accelerate the expansion of the pipeline in that modality. Positive phase 1, 2 and 3 data from Moderna's infectious disease vaccine portfolio and positive phase 1 data from its chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics & cell surface modalities respectively. Beyond these core modalities, the Company has four exploratory modalities in which it is actively pursuing clinical proof of concept.

    Summary of Program Updates by Modality:

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases and often developed in collaborations with governments and non-profit organizations.

    Vaccines requiring complex antigens and against highly prevalent infections

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from the phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. Based on the interim analysis of the phase 2 study, the 100 μg dose has been chosen for the phase 3 pivotal study, which is expected to begin this year. Moderna owns worldwide commercial rights for mRNA-1647.
    • Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.



    Vaccines against respiratory infections

    • Moderna COVID-19 Vaccine (mRNA-1273) authorization: On December 18, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is also authorized by Canada, Israel, the United Kingdom and the European Union. Additional authorizations are currently under review in additional markets including Singapore, Switzerland and by the WHO. On December 30, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. The primary endpoint of the Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001). The most common solicited adverse reactions (ARs) after the two-dose series was injection site pain (86.0%). Solicited systemic adverse events occurred more often in the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group after both the first dose and the second dose respectively and were most commonly headache, fatigue and myalgia. While the majority of these ARs were mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions in the Moderna COVID-19 Vaccine group after the first (2.9%) and second (15.8%) injections. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. A summary of the Company's work to date on COVID-19 can be found here. Moderna retains worldwide rights to develop and commercialize mRNA-1273.
    • Moderna COVID-19 Vaccine (mRNA-1273) additional clinical studies: Moderna is also conducting a phase 2/3 study of the Moderna COVID-19 Vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.
    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Sites have resumed dosing seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653) following the COVID-19 related study disruption. Moderna owns worldwide commercial rights to mRNA-1653.
    • Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The first cohort of the phase 1 study of mRNA-1345 is fully enrolled. This phase 1 study includes initial dosing in younger adults, followed by age de-escalation into children. The Company today, announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults who are also at risk of significant RSV disease. Going forward, the Company intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.

    Public Health Vaccines

    • Zika virus vaccine (mRNA-1893): All dose cohorts (10, 30, 100 and 250 µg) in the phase 1 study of mRNA-1893 have completed enrollment. Moderna is preparing for a phase 2 study of mRNA-1893. mRNA-1893 is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893.
    • Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.

    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.

    Exploratory Modalities

    Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

    • Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. The Phase 1 study is ongoing. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.



    • Mutant KRAS vaccine (mRNA-5671 or V941): The phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.



    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L (mRNA-2416): The phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.



    • OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.



    • IL-12 (MEDI1191): The phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

    Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

    • VEGF-A (AZD8601): The phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.

    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Propionic acidemia (PA) (mRNA-3927): Sites are being initiated, with entry into the clinic expected in 2021. The Company will be looking for biomarkers as early indicators for therapeutic impact. Moderna owns worldwide commercial rights to mRNA-3927.

    Information about each development candidate in Moderna's pipeline, including those discussed in this press release, can be found on the investor relations page of Moderna's website: https://investors.modernatx.com.

    Corporate Updates

    • Continued growth across organization: Moderna ended 2020 with approximately 1,300 full time employees, an increase from approximately 820 full time employees at the end of 2019. Moderna was named a top employer by Science for the sixth year in a row.

    • Announced additions to the Moderna team:

      • Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. Dr. Le Goff served as senior vice president and president of the U.S. Business Organization at Amgen (NASDAQ:AMGN). Prior to that, Dr. Le Goff held a number of senior international roles at Roche Group (SWX: RO), including President of Roche France and Global Product Strategy Head of Neuroscience & Rare Diseases, and leadership roles at Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) in the United States.

      • Ruchira Glaser, M.D., MSCE, joined Moderna as the Senior Vice President, Therapeutic Area Head for the Rare Disease, Autoimmune, and Cardiovascular Therapeutic Areas, where she will oversee development for our broad therapeutics portfolio outside of oncology. Dr. Glaser joins from GlaxoSmithKline (NYSE:GSK), where she was most recently Head of Clinical Sciences for the Respiratory and Specialty areas, including rare diseases, immunology and anemia. Prior to that, Dr. Glaser spent 10 years as an interventional cardiologist and clinical researcher at the University of Pennsylvania.

    • Continued strong cash position: The Company expects cash, cash equivalents, and investments as of December 31, 2020 to be approximately $5.25 billion (unaudited), as compared to $1.26 billion as of December 31, 2019, including customer deposits of $2.81 billion for future supply of product.

    • Moderna has signed Advance Purchase Agreements (APAs) for the delivery of its COVID-19 Vaccine. To date, the product revenue associated with these APAs for FY 2021 is $11.7 billion. These doses of Moderna COVID-19 Vaccine are expected to be delivered in 2021. The company is in active discussions to sign additional APAs for deliveries in 2021 and 2022. Moderna has also made a proposal to COVAX via a UNICEF tender to supply low-and-mid income countries.

    • Commitment to access: The Company published seven principles as part of its Commitment to Vaccines and Therapeutics Access.

    • Shareholder Letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.

    Key 2021 Investor and Analyst Event Dates

    • Vaccines Day– April 14
    • Science Day – May 27
    • R&D Day – September 9

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: development programs for vaccines against influenza, HIV and the Nipah virus and the specifics of those programs, including the timing of potential clinical trials; the timing for receipt of proof of concept clinical data from multiple therapeutics; the potential advantages of infectious disease vaccines; the development of combination vaccines against multiple diseases; the conduct of studies for the Company's vaccines against CMV, Zika virus, anti-cancer vaccines (i.e., OX40L, OX40L/IL-23/IL-36γ and IL-12), VEGF-A and PA; the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, the safety profile for the Moderna COVID-19 Vaccine; plans for further clinical trials for the Moderna COVID-19 Vaccine; the potential for repeat dosing of certain therapeutics; the Company's plans for research and development and timelines for any individual product or the platform as a whole; cash, cash equivalents and investment balances; and discussions related to further sales of the Moderna COVID-19 Vaccine. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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  7. Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. She will serve on Moderna's Executive Committee and report to Chief Executive Officer Stéphane Bancel.

    "I am thrilled to welcome Corinne to Moderna as our Chief Commercial Officer and to the Executive Committee. Corinne is joining us at an important time as we launch our COVID-19 vaccine, prepare to start the Phase 3 study of our CMV vaccine and pivot to a commercial stage company," said Stéphane Bancel, Chief Executive Officer of Moderna. "Corinne's impressive track record of execution and leading…

    Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. She will serve on Moderna's Executive Committee and report to Chief Executive Officer Stéphane Bancel.

    "I am thrilled to welcome Corinne to Moderna as our Chief Commercial Officer and to the Executive Committee. Corinne is joining us at an important time as we launch our COVID-19 vaccine, prepare to start the Phase 3 study of our CMV vaccine and pivot to a commercial stage company," said Stéphane Bancel, Chief Executive Officer of Moderna. "Corinne's impressive track record of execution and leading high-performing teams at global biopharma companies including Amgen and Roche, as well as her passion for creating value through scientific innovation, will position Moderna well as we continue building a best-in-class commercial team."

    Dr. Le Goff comes to Moderna from Amgen (NASDAQ:AMGN), where she served as SVP and President of the U.S. Business Organization. In this role, she was credited with the valuation and the successful commercial integration of Otezla®1, and for driving the growth strategy with increased contributions from Repatha®2 and Aimovig®3. During her nearly 6-year tenure at Amgen, she also served as SVP of the Europe Region and oversaw 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality and affordable healthcare. She represented Amgen as a member of the Healthcare Leadership Council.

    Prior to joining Amgen, Dr. Le Goff held a number of senior international roles at Roche (SWX: RO) including President of Roche France, a major affiliate of the Roche Group, and Global Product Strategy Head of Neuroscience & Rare Diseases. Earlier in her career, Dr. Le Goff spent 11 years in various leadership roles at Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) in the United States.

    "I am delighted to join Moderna at this crucial time of the launch of the Moderna COVID-19 Vaccine, as the company pivots to becoming a global commercial organization," said Dr. Le Goff. "The Moderna technology is game-changing and will undoubtedly disrupt the traditional biotechnology world and in time lead to life-altering therapies."

    Dr. Le Goff is a Director of CFAO, a trading company that operates in 36 markets in Africa. Dr. Le Goff received a Doctorate in Pharmacy from Rene Descartes University in Paris and a Master of Business Administration from La Sorbonne University and INSEAD.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.


    1 Otezla® is a registered trademark of Amgen

    2 Repatha® is a registered trademark of Amgen

    3 Aimovig® is a registered trademark of Amgen

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  8. THOUSAND OAKS, Calif., Jan. 6, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 39th Annual J.P. Morgan Healthcare Conference at 11:50 a.m. PT on Monday, Jan. 11, 2021. Robert A. Bradway, chairman and chief executive 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…

    THOUSAND OAKS, Calif., Jan. 6, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 39th Annual J.P. Morgan Healthcare Conference at 11:50 a.m. PT on Monday, Jan. 11, 2021. Robert A. Bradway, chairman and chief executive 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) 

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  9. THOUSAND OAKS, Calif. and MELBOURNE, Australia, Dec. 22, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Medicines Development for Global Health (MDGH), a non-profit biopharmaceutical company, today announced that the companies have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy.  The compound is in Phase 2 development with studies led by the Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study). Amgen had acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. Under the terms…

    THOUSAND OAKS, Calif. and MELBOURNE, Australia, Dec. 22, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Medicines Development for Global Health (MDGH), a non-profit biopharmaceutical company, today announced that the companies have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy.  The compound is in Phase 2 development with studies led by the Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study). Amgen had acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. Under the terms of the agreement, MDGH will assume full responsibility for the further development and commercialization of AMG 634.

    "Since tuberculosis and erythema nodosum leprosum remain challenging diseases in many countries around the world, Amgen sought an organization that could support the development of AMG 634 to address the global health unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "MDGH's track record and experience in product development, global health, and neglected infectious diseases makes them an ideal company to further develop AMG 634 for the benefit of patients."

    Amgen will continue to support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug to both studies and funding the ENL study. This support will help ensure a seamless transition in development to MDGH.

    "We are excited by the potential of AMG 634 for patients with ENL and TB and are honored to take over the stewardship of this compound from Amgen," said Mark Sullivan, founder and managing director of MDGH. "MDGH is dedicated to developing and delivering medicines for diseases that disproportionally affect people in low- and middle-income countries.  We broke new ground as the first not-for-profit biopharmaceutical company to achieve FDA approval for a treatment for river blindness in 2018 and we will now undertake full development of AMG 634 in hopes of bringing it to patients in need of a treatment for their disease."

    According to the World Health Organization (WHO), in 2019, an estimated 10 million people were infected with TB, including over 1 million children, and 1.4 million people died of TB.1  Leprosy, also known as Hansen's disease, affects the skin, peripheral nerves mucosal surfaces of the upper respiratory tract and the eyes.2 ENL is an autoimmune complication that can occur many years after being cured of leprosy, and can cause permanent nerve damage and disability.3

    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 Medicines Development for Global Health

    MDGH is an independent not-for-profit biopharmaceutical company headquartered in Melbourne, Australia. Established in 2005, this unique organization is dedicated to the development of affordable medicines and vaccines for infectious and neglected diseases prevalent in low- and middle-income countries.

    For additional information about MDGH, please visit www.medicinesdevelopment.com.

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration 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

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631 (media)

    Arvind Sood, 805-447-1060 (investors)

    MDGH, Melbourne, Australia

    Mark Sullivan, +61 419 576575 (media)

    Ranya Alkadamani, +61 434 664 589 (media)

    1 World Health Organization website https://www.who.int/tb/publications/factsheet_global.pdf?ua=1 (last accessed Dec. 15, 2020)

    2 World Health Organization website https://www.who.int/health-topics/leprosy#tab=tab_1 (last accessed Dec. 15, 2020)

    3 Saunderson P, Gebre S, Byass P. ENL reactions in the multi bacillary cases of the AMFES cohort in central Ethiopia: incidence and risk factors. Lepr Rev (2000) 71, 3 1 8-324

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  10. THOUSAND OAKS, Calif., Dec. 22, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

    "Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the KRAS G12C mutation," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "With this submission to EMA, Amgen is continuing to rapidly…

    THOUSAND OAKS, Calif., Dec. 22, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

    "Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the KRAS G12C mutation," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "With this submission to EMA, Amgen is continuing to rapidly advance the KRASG12C inhibitor clinical program to bring this innovative potential therapy to patients globally as quickly as possible."

    KRAS G12C is the most common KRAS mutation in NSCLC.1 Approximately 13% of patients with NSCLC harbor the KRAS G12C mutation and each year approximately 33,000 new patients in the EU-27 are diagnosed with KRAS G12C-mutated NSCLC.1,2 There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRAS G12C targeted therapies approved. 3,4,5

    The submission is supported by positive Phase 2 results in patients with locally advanced or metastatic NSCLC with KRAS G12C mutation from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the Phase 1 study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.6 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.

    About Sotorasib

    Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.7 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning four continents. In just over two years, the sotorasib clinical program CodeBreaK has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

    Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.7

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's investigational 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 KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 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-mutated 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, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

    For information, please visit www.codebreaktrials.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.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. 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. 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 European Cancer Information System. Data explorer. Incidence and mortality 2020. EU-27. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-AE27$2-All$4-1,2$3-All$6-0,85$5-2008,2008$7-7,8$CEstByCancer$X0_8-3$CEstRelativeCanc$X1_8-3$X1_9-AE27 Accessed December 2020.

    Lung Cancer Europe. Types of lung cancer and staging. Available at: https://www.lungcancereurope.eu/lung-cancer/types-of-lung-cancer-and-staging/ Accessed December 2020.

    3 Aggarwal S, et al. Presented at: The European Society for Medical Oncology; September 2020; Virtual Congress. Poster 1339P.

    4 McCormick F. K-Ras protein as a drug target. J Mol Med (Berl). 2016;94(3):253-258.

    5 Román M, Baraibar I, López I, et al.  KRAS oncogene in non-small cell lung cancer: clinical perspectives on the treatment of an old target. Mol Cancer. 2018;17(1):33. 

    6 Hong DS, et al. N Engl J Med. 2020; 383:1207-1217.

    7 Kim D, et al. Cell. 2020;183 :850-859.

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  11. THOUSAND OAKS, Calif., Dec. 21, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo.

    The 48-week trial assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC). Tezepelumab's effect on other efficacy parameters was similar to those observed in previous studies, including the registrational Phase 3 NAVIGATOR study. Further analyses of the data are ongoing.

    The safety…

    THOUSAND OAKS, Calif., Dec. 21, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo.

    The 48-week trial assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC). Tezepelumab's effect on other efficacy parameters was similar to those observed in previous studies, including the registrational Phase 3 NAVIGATOR study. Further analyses of the data are ongoing.

    The safety profile of tezepelumab in the trial was consistent with previous trials. Detailed results from the SOURCE trial will be presented at a future medical meeting.

    "The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. While the SOURCE results were surprising, they provide important insights into the use of oral corticosteroids and the patients who are receiving them, which we look forward to exploring further," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "On initial review, the study design may have contributed to the results observed on the primary endpoint." 

    On November 10th, 2020, AstraZeneca and Amgen announced positive results from the NAVIGATOR Phase 3 trial which met the primary endpoint and demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in a broad population of patients with severe asthma, including those with low levels of eosinophils.

    Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial derived cytokine that plays a key role across the spectrum of asthma inflammation.2,3      

    Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics.5-8

    In September 2018, the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype.4 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below).

    Amgen and AstraZeneca Collaboration

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

    About Tezepelumab

    Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.2,3,12

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.2,3 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,12 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 3,12 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.3,12

    PATHFINDER Clinical Trial Program

    Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, the registrational NAVIGATOR study and SOURCE.12-15 The program includes additional planned mechanistic and long-term safety trials.

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy.13  In the trial, patients were randomized to receive tezepelumab 210mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.13

    The primary efficacy endpoint was the percentage reduction from baseline in the prescribed daily OCS maintenance dose at 48 weeks while not losing asthma control. Secondary endpoints included the effect of tezepelumab on annualized asthma exacerbation rate, lung function, asthma control, quality of life, work productivity and activity impairment. The SOURCE trial population included approximately 35% of subjects with high (≥ 300 cells/µL) and 65% with low (<300 cells/µL) blood eosinophil counts.13

    Patient's OCS dose was optimized during an 8-week optimization period. For the first eight  weeks of the 48-week treatment period, patients remained on their optimized OCS dose. OCS dose reduction was started at week four, with the possibility of a dose reduction every 4 weeks if asthma control was maintained up until week 40. From week 40 onwards, patients remained on the OCS dose reached at week 40 (or earlier if the OCS dose reduction failed because of clinical deterioration) or remained on complete OCS elimination if possible.13

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microliter.15

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long term safety and efficacy.16

    Amgen Inflammation

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

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

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

    About Amgen 

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

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

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

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration 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 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    References

    1. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.
    2. Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.
    3. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23; 380 (21): 2082]. N Engl J Med. 2017; 377 (10): 936-946.
    4. AstraZeneca plc. Tezepelumab granted Breakthrough Therapy Designation by US FDA. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2018/tezepelumab-granted-breakthrough-therapy-designation-by-us-fda-07092018.html. [Last accessed: November 2020].
    5. Winders TA, Wilson AM, Fletcher MJ, McGuinness A, Price DB. A Patient-Centered Description of Severe Asthma: Patient Understanding Leading to Assessment for a Severe Asthma Referral (PULSAR). Patient. 2019;12(5):539-549.
    6. Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005; 172: 149-160.
    7. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43 (2): 343-373.
    8. Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006: 100 (7): 1139-51.
    9. Voorham J, Xu X, Price DB, et al. Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma. Allergy. 2019;74 (2): 273-283.
    10. Sweeney J, Patterson CC, Menzies-Gow A, et al. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Thorax. 2016; 71 (4): 339-346.
    11. Sullivan PW, Ghushchyan VH, Globe G, Schatz M. Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy Clin Immunol. 2018; 141 (1): 110-116.
    12. Roseti S, Corren J, Parnes JR, et al. Efficacy and safety of tezepelumab in adults with severe asthma: A randomized phase 2 study. European Respiratory Journal 2017; 50: OA3189.
    13. Wechsler, M.E., Colice, G., Griffiths, J.M. et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res 2020; 21: 264.
    14. Clinicaltrials.gov. Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03347279. [Last accessed: November 2020].
    15. AstraZeneca plc. Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tezepelumab-navigator-phase-iii-trial-met-primary-endpoint.html. [Last accessed: November 2020].
    16. Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: November 2020].

     

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  12. CAMBRIDGE, Mass., Dec. 17, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and LabCentral today announced that Octagon Therapeutics and Seranova Bio have each won an Amgen Golden Ticket to LabCentral, Cambridge's premier launchpad for high-potential life sciences and biotech start-ups. The two Golden Ticket winners were chosen by an internal team of Amgen scientific leaders and live audience members at a virtual pitch event on Dec. 9, 2020. Five finalists pitched their business plans to attendees where the audience members' votes served as input for the Amgen internal committee's decision.

    Amgen has served as a platinum sponsor of LabCentral since 2014, awarding Golden Tickets to 12 innovative start-ups to date. Each year, Amgen nominates two early-stage…

    CAMBRIDGE, Mass., Dec. 17, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and LabCentral today announced that Octagon Therapeutics and Seranova Bio have each won an Amgen Golden Ticket to LabCentral, Cambridge's premier launchpad for high-potential life sciences and biotech start-ups. The two Golden Ticket winners were chosen by an internal team of Amgen scientific leaders and live audience members at a virtual pitch event on Dec. 9, 2020. Five finalists pitched their business plans to attendees where the audience members' votes served as input for the Amgen internal committee's decision.

    Amgen has served as a platinum sponsor of LabCentral since 2014, awarding Golden Tickets to 12 innovative start-ups to date. Each year, Amgen nominates two early-stage companies to take up residence in LabCentral's Kendall Square facilities, which includes one year of free bench space for one scientist and access to the shared ammenties and resources offered by LabCentral. As recipients of the Amgen Golden Ticket, Octagon Therapeutics and Seranova Bio will also partner with Amgen scientists for ongoing mentoring throughout the year.

    "Our strategic partnership with LabCentral allows Amgen to identify and empower some of the most promising start-up companies and advance ground-breaking science underway here in Cambridge," said Rohini Deshpande, Ph.D., vice president of Drug Substance Technologies and site head at Amgen Massachusetts. "We are excited about innovative technology presented by Octagon Therapeutics and Seranova Bio and look forward to engaging with both as they continue working to better serve patients."

    "This is a tremendous opportunity for Octagon," said Isaac Stoner, president and chief executive officer of Octagon Therapeutics. "The resources and community available at LabCentral provide a huge advantage to fast-growing life science companies.  We are also excited to collaborate with Amgen scientists as we advance our important class of medicines towards the clinic and expand the platform into new disease areas."

    About Octagon Therapeutics 

     Octagon is developing a new class of targeted immunomodulators for severe autoimmune disease. The company was founded on novel biological insights into the pathological activation of lymphocytes that cause autoimmune disease; the metabolic processes in these immune cells are subtly altered when compared to a healthy immune response.  These insights have led to the development of a differentiated small molecule therapeutic strategy that leverages these differences to specifically target aberrant immune activation while sparing healthy immune functioning.  Octagon's lead program, OTG177, specifically inhibits autoreactive B cells involved in pemphigus/pemphigoid but the approach is relevant in a wide range of autoimmune disorders.  

    "Receiving the Amgen Golden Ticket will open doors for our company," said Aaron Ring, M.D. Ph.D., co-founder of Seranova Bio. "We are thrilled to receive the scientific, operational, and business development support from Amgen. We know this opportunity will help us advance our work to develop novel therapeutics using our unique target discovery platform.

    About Seranova Bio 

    Seranova Bio is striving to establish a new paradigm for therapeutic target discovery. The company's Rapid Extracellular Antigen Profiling (REAP) platform combines high-quality, comprehensive protein sampling with next-generation DNA sequencing to profile patients' autoantibodies with higher throughput and fidelity than existing technologies. Seranova Bio's technological breakthrough reveals, in much greater depth, the underlying humoral response to disease and provides critical insights to drug developers. Seranova Bio aims to collaborate with pharmaceutical partners to discover novel therapeutic targets and develop new treatments to autoimmune disease, neurodegeneration, and cancer.

    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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  13. THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA). RIABNI will be made available in the U.S. in January 2021.

    "The approval of RIABNI represents an important milestone across our biosimilar and oncology portfolios," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Following the proven success of KANJINTI® (trastuzumab-anns) and MVASI® (bevacizumab-awwb…

    THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA). RIABNI will be made available in the U.S. in January 2021.

    "The approval of RIABNI represents an important milestone across our biosimilar and oncology portfolios," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Following the proven success of KANJINTI® (trastuzumab-anns) and MVASI® (bevacizumab-awwb) in the U.S. marketplace, RIABNI reaffirms Amgen's long-term commitment to providing high quality biosimilars that can potentially offer more affordable, effective treatment options for cancer and other serious diseases and that contribute to the sustainability of healthcare systems."

    RIABNI, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study and a comparative clinical study.

    The randomized, double-blind, comparative clinical study evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of RIABNI compared to Rituxan in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. There were 256 patients enrolled and randomized (1:1) to receive 375 mg/m2 intravenous infusion of either RIABNI or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for RIABNI compared to Rituxan, showing clinical equivalence. PK, PD, safety and immunogenicity of RIABNI were similar to Rituxan.

    The Wholesale Acquisition Cost (WAC or "list price") of RIABNI in the U.S. will be 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less than the WAC for Rituxan, 15.2% less than the WAC for Truxima® (biosimilar to Rituxan) and matching the WAC for Ruxience® (biosimilar to Rituxan). At launch, RIABNI will be priced 16.7% below the current Rituxan Average Selling Price (ASP). RIABNI will be available from both wholesalers and specialty distributors.

    Amgen has a total of 10 biosimilars in its portfolio, five of which have been approved in the U.S., and three that are approved in the European Union (EU).

    About RIABNI™ (rituximab-arrx) in the U.S.

    RIABNI is a biosimilar to Rituxan, an anti-CD20 monoclonal antibody. The active ingredient of RIABNI is a monoclonal antibody that has the same amino acid sequence as Rituxan. RIABNI also has the same strength as Rituxan, and the dosage form and route of administration are identical to the IV formulation of Rituxan.

    RIABNI is currently not yet available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S.

    In the U.S., RIABNI is approved for:

    Non-Hodgkin's Lymphoma (NHL)

    RIABNI (rituximab-arrx) is indicated for the treatment of adult patients with:

    • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
    • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
    • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
    • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

    Chronic Lymphocytic Leukemia (CLL)

    RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.

    Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

    RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

    Important Safety Information

    BOXED WARNINGS: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

    • Infusion-Related Reactions: Rituximab product administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RIABNITM infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.
    • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products. Discontinue RIABNITM in patients who experience a severe mucocutaneous reaction. The safety of readministration of RIABNITM to patients with severe mucocutaneous reactions has not been determined.
    • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RIABNITM. Discontinue RIABNITM and concomitant medications in the event of HBV reactivation.
    • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products. Discontinue RIABNITM and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

    Infusion-Related reactions (IRR)

    • Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes.
    • Rituximab-product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.
    • Premedicate patients with an antihistamine and acetaminophen prior to dosing. For patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA), methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g., glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue RIABNITM. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved.
    • Closely monitor the following patients: those with preexisting cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3).

    Severe Mucocutaneous Reactions

    • Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis.
    • The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue RIABNITM in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined.

    Hepatitis B Virus Reactivation

    • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive).
    • HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur.
    • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RIABNITM. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during RIABNITM treatment.
    • Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following RIABNITM therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.
    • In patients who develop reactivation of HBV while on RIABNITM, immediately discontinue RIABNITM and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming rituximab product treatment in patients who develop HBV reactivation. Resumption of RIABNITM treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

    Progressive Multifocal Leukoencephalopathy (PML)

    • JC virus infection resulting in multifocal leukoencephalopathy (PML) and death can occur in rituximab-product -treated patients with hematologic malignancies or with autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.
    • Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue RIABNITM and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

    Tumor Lysis Syndrome

    • Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12−24 hours after the first infusion of RIABNITM in patients with non-Hodgkin's lymphoma (NHL). A high number of circulating malignant cells (≥25,000/mm3), or high tumor burden, confers a greater risk of TLS.
    • Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

    Infections

    • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure).
    • New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue RIABNITM for serious infections and institute appropriate anti-infective therapy.
    • RIABNITM is not recommended for use in patients with severe, active infections.

    Cardiovascular Adverse Reactions

    • Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of RIABNITM for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

    Renal Toxicity

    • Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience TLS and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and RIABNITM is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue RIABNITM in patients with a rising serum creatinine or oliguria.

    Bowel Obstruction and Perforation

    • Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab products in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1−77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

    Immunization

    • The safety of immunization with live viral vaccines following rituximab product therapy has not been studied, and vaccination with live virus vaccines is not recommended before or during treatment.
    • For patients treated with RIABNITM, physicians should review the patient's vaccination status and patients should, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating RIABNITM; administer non-live vaccines at least 4 weeks prior to a course of RIABNITM.

    Embryo-Fetal Toxicity

    • Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed in utero. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception with RIABNITM and for at least 12 months after the last dose.

    Concomitant Use with Other Biologic Agents and Disease Modifying Antirheumatic Drugs (DMARDs) in GPA and MPA

    • Limited data are available on the safety of the use of biologic agents or DMARDs. Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly. Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products.

    Adverse Reactions

    • The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and chronic lymphocytic leukemia (CLL) were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials.
    • The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials.

    Nursing Mothers

    • There are no data on the presence of rituximab products in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential of serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with RIABNITM and for at least 6 months after the last dose.

    Clinical Trials Experience in GPA and MPA

    • Adverse reactions reported in ≥15% of rituximab-treated patients were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema (other important adverse reactions include infusion-related reactions).

    Induction Treatment of Patients with Active GPA/MPA (GPA/MPA Study 1)

    Infusion-Related Reactions

    • In GPA/MPA Study 1, 12% vs 11% (rituximab-treated vs cyclophosphamide-treated, respectively) of patients experienced at least one infusion-related reaction. Infusion-related reactions included cytokine release syndrome, flushing, throat irritation, and tremor. In the rituximab group, the proportion of patients experiencing an infusion reaction was 12%, 5%, 4%, and 1% following the first, second, third, and fourth infusions, respectively. Patients were premedicated with antihistamine and acetaminophen before each rituximab infusion and were on background oral corticosteroids, which may have mitigated or masked an infusion-related reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion-related reactions.

    Infections

    • In GPA/MPA Study 1, 62% vs 47% (rituximab-treated vs cyclophosphamide-treated, respectively) of patients experienced an infection by Month 6. The most common infections in the rituximab group were upper respiratory tract infections, urinary tract infections, and herpes zoster. The incidence of serious infections was 11% vs 10% (rituximab-treated vs cyclophosphamide-treated, respectively), with rates of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection was pneumonia.

    Hypogammaglobulinemia

    • Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit of normal) has been observed in patients with GPA and MPA treated with rituximab in GPA/MPA Study 1. At 6 months, in the rituximab group, 27%, 58%, and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG, and IgM levels, respectively, compared to 25%, 50%, and 46% in the cyclophosphamide group.

    Immunogenicity

    • A total of 23/99 (23%) rituximab-treated adult patients with GPA or MPA tested positive for anti-rituximab antibodies by 18 months in GPA/MPA Study 1. The clinical relevance of anti-rituximab antibody formation in rituximab-treated adult patients is unclear.

    Treatment of Patients with GPA/MPA Who Have Achieved Disease Control with Induction Treatment (GPA/MPA Study 2)

    • In GPA/MPA Study 2, the safety profile was consistent with the known safety profile of rituximab in immunologic indications.

    Infusion-Related Reactions (IRR)

    • In GPA/MPA Study 2, 7/57 (12%) patients in the non-US-licensed approved rituximab arm reported infusion-related reactions. The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (<4%). One patient had two serious IRRs; two IRRs led to a dose modification; and no IRRs were severe, fatal, or led to withdrawal from the study.

    Infections

    • In GPA/MPA Study 2, 30/57 (53%) patients in the non-US-licensed approved rituximab arm and 33/58 (57%) in the azathioprine arm reported infections. The incidence of all-grade infections was similar between the arms. The incidence of serious infections was similar in both arms (12%). The most commonly reported serious infection in the group was mild or moderate bronchitis.

    Attention Healthcare Provider: Provide Medication Guide to patient prior to RIABNITM infusion and advise patients to read guide.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatchYou may also report side effects to Amgen at 1-800-772-6436. 

    Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

    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 will 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 Oncology

    Amgen 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.

    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.

    Rituxan® is a registered trademark of Biogen.

    Truxima® is a registered trademark of Celltrion Inc.

    Ruxience® is a trademark of Pfizer Inc.

    CONTACT: Amgen, Thousand Oaks 

    Kelley Davenport, 202-585-9637 (media)

    Trish Rowland, 805-447-5631 (media) 

    Arvind Sood, 805-447-1060 (investors) 

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

     

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  14. THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen Inc. (NASDAQ:AMGN) today announced its intention to transfer the securities exchange listing for its 1.250% Senior Notes due 2022 and 2.00% Senior Notes due 2026 (the "Debt Securities") from the New York Stock Exchange to the Nasdaq Bond Exchange ("Nasdaq"), effective December 28, 2020, after market close. The Debt Securities are expected to begin trading as Nasdaq-listed Debt Securities on December 29, 2020. 

    The respective trading symbols and CUSIP numbers of the Debt Securities are as follows:

    Series of Debt Securities


    Trading Symbol


    CUSIP

     

    1.250% Senior Notes Due 2022


     

    AMGN22


     

    031162 CA6






    2.00% Senior Notes Due 2026


    AMGN26


    031162 CB4

    Amgen is transferring the listing of the Debt…

    THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen Inc. (NASDAQ:AMGN) today announced its intention to transfer the securities exchange listing for its 1.250% Senior Notes due 2022 and 2.00% Senior Notes due 2026 (the "Debt Securities") from the New York Stock Exchange to the Nasdaq Bond Exchange ("Nasdaq"), effective December 28, 2020, after market close. The Debt Securities are expected to begin trading as Nasdaq-listed Debt Securities on December 29, 2020. 

    The respective trading symbols and CUSIP numbers of the Debt Securities are as follows:

    Series of Debt Securities



    Trading Symbol



    CUSIP

     

    1.250% Senior Notes Due 2022



     

    AMGN22



     

    031162 CA6











    2.00% Senior Notes Due 2026



    AMGN26



    031162 CB4

    Amgen is transferring the listing of the Debt Securities to Nasdaq to consolidate its equity and debt listing relationships under one exchange.

    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 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. 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. 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 

    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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  15. THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.76 per share dividend for the first quarter of 2021. The dividend will be paid on March 8, 2021, to all stockholders of record as of the close of business on February 15, 2021. This represents a 10% increase from that paid in each of the previous four quarters.

    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…

    THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.76 per share dividend for the first quarter of 2021. The dividend will be paid on March 8, 2021, to all stockholders of record as of the close of business on February 15, 2021. This represents a 10% increase from that paid in each of the previous four quarters.

    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 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. 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. 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 

    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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    SOURCE Amgen

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  16. THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy. 

    "Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation. In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need…

    THOUSAND OAKS, Calif., Dec. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy. 

    "Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation. In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This submission, along with these other important regulatory achievements, underscore Amgen's commitment to bringing this potential treatment option to patients as quickly as possible."

    The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.1 

    The submission is supported by positive Phase 2 results in patients with locally advanced or metastatic NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.2 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.

    About Sotorasib

    Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.3 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

    Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced NSCLC harboring the KRAS G12C mutation with a once daily oral formulation.  Promising responses have also been observed in multiple other solid tumors.

    KRAS G12C is the most common KRAS mutation in NSCLC.4,5  In the U.S., about 13% of patients with NSCLC harbor the KRAS G12C mutation.6 There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRASG12C targeted therapies approved.7

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's investigational 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 KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 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-mutated 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, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

    For information, please visit www.codebreaktrials.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.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. 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. 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 U.S. Food and Drug Administration. Real Time Oncology Review https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program . Accessed November 20, 2020.

    2 Amgen Data on File. 2020.

    3 Kim D, et al. Cell. 2020;183 :850-859.

    4 Pakkala S, et al. JCI Insight. 2018;3:e120858. 

    5 Arbour KC, et al. Clin Cancer Res. 2018;24:334-340. 

    6 Amgen, Data on File. 2020.

    7 Aggarwal S, et al. Presented at: The European Society for Medical Oncology; September 2020; Virtual Congress. Poster 1339P.

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

     

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  17. THOUSAND OAKS, Calif., Dec. 8, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.

    "For more than 40 years, scientists have been trying to target KRAS. Today's news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies," said Bonnie J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer…

    THOUSAND OAKS, Calif., Dec. 8, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.

    "For more than 40 years, scientists have been trying to target KRAS. Today's news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies," said Bonnie J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer. "We are pleased that the FDA and Amgen recognize the unmet need for these patients and are working to make new treatment options available as quickly as possible."

    KRAS G12C is the most common KRAS mutation in NSCLC.1,2  In the U.S., about 13% of patients with NSCLC adenocarcinoma harbor the KRAS G12C mutation3 and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.4  Unmet need remains high and options are limited for NSCLC patients with the KRAS G12C mutation that have failed first-line treatment. The outcomes with current therapies are suboptimal with response rates of approximately 9-18% and a median progression-free survival of approximately 4 months for second-line NSCLC.5,6,7  

    Amgen has taken on one of the toughest challenges of the last 40 years in cancer research8 by developing sotorasib. Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across 4 continents. In just over two years, the sotorasib clinical program has also established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

    "Breakthrough Therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it."

    A Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.9 The Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.10

    The designation and RTOR are supported by positive Phase 2 results in patients with advanced NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.11 

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's investigational 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 KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 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, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

    For information, please visit www.codebreaktrials.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.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. 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. 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 Pakkala S, et al. JCI Insight. 2018;3:e120858. 

    2 Arbour KC, et al. Clin Cancer Res. 2018;24:334-340. 

    3 Amgen, Data on File. 2020.

    4 American Cancer Society, Cancer Facts and Figures. 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed November 23, 2020.

    5 Herbst RS, et al. Lancet. 2016;387-1540-1550. 

    6 Aggarwal S, et al. Poster presentation at ESMO Virtual Congress 2020, Sep. 19-21, 2020. Poster 1339P.

    7 Hayashi H, et al. Clin Lung Cancer. 2013;14:261-266.

    8 Kim D, et al. Cell. 2020. doi:10.1016/j.cell.2020.09.044.

    9 U.S. Food and Drug Administration. Breakthrough Therapy. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy. Accessed November 10, 2020.

    10 U.S. Food and Drug Administration. Real Time Oncology Review https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program . Accessed November 20, 2020. 

    11 Hong DS, et al. N Engl J Med. 2020; 383:1207-1217.

     

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  18. THOUSAND OAKS, Calif., Dec. 7, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced a partnership with Karamo Brown, Emmy-nominated host from Netflix's hit show "Queer Eye," to support and empower people living with migraine. Karamo, who is known for helping people open up about themselves, is discussing his own struggles with migraine for the first time to help spread knowledge and acceptance. The Know Migraine Mission is a national effort by the companies behind Aimovig® (erenumab-aooe) to challenge public misconceptions, start new conversations and make the world a more migraine-friendly place. As part of the initiative, Karamo, who is not an Aimovig® patient but has dealt with migraine for years, will share his thoughts with people personally…

    THOUSAND OAKS, Calif., Dec. 7, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced a partnership with Karamo Brown, Emmy-nominated host from Netflix's hit show "Queer Eye," to support and empower people living with migraine. Karamo, who is known for helping people open up about themselves, is discussing his own struggles with migraine for the first time to help spread knowledge and acceptance. The Know Migraine Mission is a national effort by the companies behind Aimovig® (erenumab-aooe) to challenge public misconceptions, start new conversations and make the world a more migraine-friendly place. As part of the initiative, Karamo, who is not an Aimovig® patient but has dealt with migraine for years, will share his thoughts with people personally affected by migraine along with their friends, families and coworkers to help increase understanding of the disease.

    "We've all been feeling the stress of this year, and it's compounded if you live with migraine like me. However, some people don't realize how challenging this disease can be, which is why I'm excited to lend my voice to the Know Migraine Mission," said Karamo. "For people with migraine, talking about it can help make a real difference in their lives. Those conversations are important, even though they might look different today – so, whether it's a social-distanced lunch date with a friend or a video call with a doctor, it's important to take control where possible."

    Migraine is a complex neurological disease that impacts millions of people in the U.S.2-5 Despite its prevalence and severity, migraine is often misunderstood and dismissed as being "just a headache."6 Research shows people may often feel stigmatized for missing time with friends, family and co-workers because of their migraine.2,6

    Karamo has struggled with migraine since he was in high school. The disease has impacted many parts of his life, including his ability to spend time with his two sons and other family and friends. As part of this partnership, Karamo is answering questions and sharing his thoughts with others who are living with this disease. On KnowMigraineMission.com and social media, including the Aimovig Facebook and Instagram pages, Karamo will address how others can start new conversations to help reduce the stigma around migraine.6

    Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the first Food and Drug Administration (FDA)-approved treatment indicated to prevent migraine in adults by targeting the calcitonin gene-related peptide (CGRP) receptor.7 Clinical study results have established the efficacy and safety profile of Aimovig across a spectrum of people living with both episodic and chronic migraine.8,9

    "Aimovig is proven to reduce monthly migraine days and for some, can cut the number of monthly migraine days in half or more, allowing patients to be there more in their everyday lives," said Darryl Sleep, M.D., senior vice president, Global Medical, and chief medical officer at Amgen. "But while treatment has evolved, progress still needs to be made to change the conversation around migraine and better support people living with this debilitating disease. Through the Know Migraine Mission, we want to educate the broader community about the impact of migraine and empower people to speak up about their disease and seek treatment options that may be appropriate for them."

    To learn more about Karamo's story and for additional information and resources, visit www.KnowMigraineMission.com and follow Aimovig on Facebook and Instagram.

    About the Know Migraine Mission

    The Know Migraine Mission is a national effort by Amgen and Novartis to challenge public misconceptions, start new conversations and make the world a more migraine-friendly place. The way migraine can be treated has changed,7 but the way people with migraine are treated still has a long way to go. Amgen and Novartis believe the more vocal and visible people with migraine are, the more others will recognize the debilitating effects of this disease.5

    About Aimovig® (erenumab-aooe) 

    Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.7,11 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.9,10 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.7,12 More than 3,000 patients participated in registrational trials of Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.8,9,10,13,14

    Aimovig is also being evaluated through CATALYST, a comprehensive evidence generation program initiated by Amgen and Novartis that includes over 7,500 patients across ongoing clinical trials and a robust assessment of real-world evidence. Spanning over 39 countries globally, CATALYST clinical trials will explore the role of Aimovig in comparative studies, assessing impact on novel migraine outcomes, understanding predictive biomarkers and investigating Aimovig's use in additional study populations. To date, more than 480,000 patients worldwide have been prescribed Aimovig for the preventive treatment of migraine in adults.15 

    AIMOVIG INDICATION

    Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

    IMPORTANT SAFETY INFORMATION

    Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

    Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy. 

    Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

    Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

    Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.

    Monitor patients treated with Aimovig® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig® is warranted if evaluation fails to establish an alternative etiology.

    Adverse Reactions: The most common adverse reactions in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.

    Please see Aimovig® full Prescribing Information.

    About Migraine

    People with frequent migraine attacks may lose more than half their life to migraine.16,17 One attack could last up to three days.16 They endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.5,6 The 2017 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.18 Migraine is associated with personal and societal burdens of pain, disability and financial cost, and it remains under-recognized and under-treated.2,19

    About Amgen and Novartis Neuroscience Collaboration

    In August 2015, Amgen entered into a global collaboration with Novartis to develop and commercialize pioneering treatments in the field of migraine. The collaboration focuses on investigational Amgen drugs in the migraine field, including Aimovig (approved by the FDA in May 2018 for the preventive treatment of migraine in adults).7 In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine programs, Amgen retains exclusive commercialization rights in the U.S. (other than for Aimovig as described above) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. At the center of the Amgen and Novartis neuroscience collaboration is the shared mission to fight migraine and the stereotypes and misperceptions surrounding this debilitating disease.

    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 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.

    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. 

    References

    1. Al-Hashel and Ismail. Impact of coronavirus disease 2019 (COVID-19) pandemic on patients with migraine: a web-based survey study. The Journal of Headache and Pain. (2020) 21:115.
    2. Lipton R, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5)343-349.
    3. US Census Bureau. Age and Sex 2014-2018 American Community Survey 5-Year Estimate. https://data.census.gov/cedsci/table?q=united% 20states&tid=ACSDP5Y2018.DP05&hidePreview=true. Accessed October 21, 2020.
    4. Buse DC, Manack AN, Fanning KM, et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012;52(10):1456-1470.
    5. Russo AF. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
    6. Rutberg S, Ohrling K. Migraine – more than a headache: Women's experiences of living with migraine. Disabil Rehabil. 2012;34(4):329-336.
    7. Aimovig® (erenumab-aooe) prescribing information, Amgen, April 2020.
    8. Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and long-term safety of erenumab inpatients with episodic migraine: results of a 5-year, open-label extension study. Presented at The 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
    9. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434. doi:10.1016/S1474-4422(17)30083-2.
    10. Olesen J, Diener HS, Husstedt I, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004;350(11):1104-1110.
    11. Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. doi:10.1016/S1474-4422(16)00019-3.
    12. Data on File. Amgen. May 2019.
    13. Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained Efficacy and Safety of Erenumab in Episodic Migraine Patients Failing 2–4 Prior Preventive Treatments: 2-year Interim Results of the LIBERTY Open-Label Extension Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
    14. Wang S-J, Roxas Jr, A, Saravia B, et al. Efficacy and Safety of Erenumab in Patients with Episodic Migraine from the EMPOWER Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
    15. Data on File. Novartis. October 2020.
    16. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
    17. Lipton R, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001;41(7):1-211.
    18. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789-1858.
    19. Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355-363.

    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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  19. THOUSAND OAKS, Calif., Dec. 5, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients with relapsed/refractory multiple myeloma (R/R MM). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation on Dec. 5 at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition.

    "The emerging data from the BiTE platform in hematological malignancies are encouraging. Previously, Amgen provided important evidence for BCMA-directed BiTE molecules as a…

    THOUSAND OAKS, Calif., Dec. 5, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first presentation of clinical safety and efficacy data from the Phase 1 study of AMG 701 in heavily pre-treated patients with relapsed/refractory multiple myeloma (R/R MM). AMG 701 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) immuno-oncology therapy targeting B-cell maturation antigen (BCMA). The data will be presented during a live oral presentation on Dec. 5 at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition.

    "The emerging data from the BiTE platform in hematological malignancies are encouraging. Previously, Amgen provided important evidence for BCMA-directed BiTE molecules as a therapeutic approach in multiple myeloma. AMG 701 continues to show the potential of that strategy in patients who are heavily pre-treated," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

    "These data are the latest in a series that reinforce both the potential versatility of the BiTE platform and Amgen's commitment to developing innovative medicines for novel targets in difficult-to-treat cancers," Reese continued. "This year alone, Amgen has presented proof-of-concept data for four BiTE® molecules in hematological malignancies and solid tumors, and we are proud to end the year with these data in multiple myeloma at ASH."

    This interim analysis of the Phase 1 dose escalation study evaluated AMG 701 in 85 R/R MM patients who had received at least three prior lines of therapy, and a median of six lines. The response rate was 36% at doses of 3-18 mg with responses lasting up to 26 months in one patient. Six of seven patients, who were tested for minimal residual disease (MRD), were MRD-negative. In the most recent evaluable cohort, there was an 83% ORR, with 4/5 responders being triple refractory.

    "Despite advances in the treatment of multiple myeloma, there remains an unmet need for patients with this difficult-to-treat disease who have relapsed or refractory disease following current standard therapies," said Professor Simon J. Harrison, director of the Centre of Excellence in Cellular Immunotherapy, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Australia. "These first-in-human data show that AMG 701, a half-life extended BiTE therapy targeting BCMA, has encouraging signs of activity as a single agent in this heavily pre-treated patient population."

    The most common hematological adverse events (AEs) were anemia (42%), neutropenia (25%) and thrombocytopenia (21%). The most common non-hematological AEs were cytokine release syndrome (CRS, 65%), diarrhea (31%) and hypophosphatemia (31%). CRS was mostly grade 1 (27%) or 2 (28%) based on Lee Blood 2014 criteria. All Grade 3 CRS events (9%) were reversible with mitigation procedures outlined in the study protocol, with a median duration of two days.

    Learn more about Amgen's development of innovative medicines for novel targets in difficult-to-treat tumors at AmgenOncology.com/medical, and follow Amgen Oncology on Twitter and LinkedIn.

    About BiTE® Technology

    BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage 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 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 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 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 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 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 November 9, 2020.

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

     

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  20. Enhanced agreement to transform cancer care, improve outcomes by accelerating development and access to life-changing medicines

    McKesson and Amgen (NASDAQ:AMGN), one of the world's leading biotechnology companies, have signed a strategic agreement to help improve cancer care in community oncology settings. Today, 1 in 5 cancer patients receives an Amgen medicine, whileMcKesson reaches 20% of U.S. cancer patients. This multi-year agreement bridges the power and reach of the two companies and will focus on reducing gaps in care by optimizing access to innovative precision medicine and immuno-oncology in the community setting.

    Access to the latest innovations in cancer care is still very dependent on demographics, socioeconomic status, and where…

    Enhanced agreement to transform cancer care, improve outcomes by accelerating development and access to life-changing medicines

    McKesson and Amgen (NASDAQ:AMGN), one of the world's leading biotechnology companies, have signed a strategic agreement to help improve cancer care in community oncology settings. Today, 1 in 5 cancer patients receives an Amgen medicine, while McKesson reaches 20% of U.S. cancer patients. This multi-year agreement bridges the power and reach of the two companies and will focus on reducing gaps in care by optimizing access to innovative precision medicine and immuno-oncology in the community setting.

    Access to the latest innovations in cancer care is still very dependent on demographics, socioeconomic status, and where in the U.S. patients receive their care. Currently, the majority of new patients are first seen in the community setting,1 making community oncology practices increasingly critical to improved patient care. Community oncology providers also typically treat a more diverse patient population, providing the greatest opportunity to impact cancer care across dimensions, including rural populations.

    "Community oncology practices in the United States are the backbone of oncology care for the vast majority of patients. The COVID-19 pandemic further heightens the need to help strengthen that network as it has become imperative that people be treated closer to home," said Darryl Sleep, M.D., senior vice president, Global Medical and chief medical officer, Amgen. "At Amgen, we believe that cancer patients and those who treat them deserve to have access to the latest innovations in care no matter where they live or practice. Together with McKesson, our ultimate goal is to help community oncologists and their teams have rapid access to the latest innovations and insights to provide the best care possible where patients need it most."

    Kirk Kaminsky, president of U.S. Pharmaceutical, McKesson, shared, "The combined commitment of our organizations to optimize patient outcomes will change the future of cancer care. We look forward to working with Amgen and oncology providers to navigate the inherent complexity in cancer and make novel insights actionable and accessible at the exact point of need."

    This partnership will be led by OntadaTM, McKesson's new oncology technology and insights business. Ontada is focused on helping life sciences companies like Amgen improve patient outcomes for cancer care, from early clinical development to drug commercialization and post-launch activation of insights, as well as empowering oncology providers at the point of need to deliver more-informed, more-effective, more-efficient care to their patients. Through real-world data gathered with Ontada's proprietary technology for community oncology practices, such as those that are part of The US Oncology Network, Ontada has the real-world knowledge to help push cancer care forward.

    "I have been an oncologist for 30 years, and we have never seen so much innovation, yet so many challenges, as we do today," said Michael Seiden, MD, PhD, president, The US Oncology Network. "Being able to contribute to such robust thought leadership and work with stakeholders like Ontada and Amgen allow us to really move the needle and enhance cancer care for the patients we serve in the community setting."

    Amgen and Ontada will launch various programs over the course of the partnership and build on projects that have already begun, such as those focusing on reducing gaps in molecular testing and understanding treatment patterns in the community setting. For example, Amgen and McKesson recently conducted real-world research to better understand patterns of molecular testing in advanced/metastatic non-small cell lung cancer with community oncologists with plans to publish the findings in early 2021. Through the strategic partnership, McKesson and Amgen hope to:

    • Elevate awareness on molecular testing in order to optimize care in patients that benefit from targeted therapy;
    • Uncover insights on unmet need and treatment outcomes by enriching data and insight capabilities;
    • Leverage real-world evidence to better understand and optimize the deployment of biosimilars to offer providers and their patients greater choice of therapies relative to value;
    • Co-develop new approaches to deliver immuno-oncology therapies in the community setting; and
    • Optimize therapy sequencing to improve patient outcomes including supportive care.

    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.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. 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.

    About Ontada

    Ontada is an oncology technology and insights business dedicated to transforming the fight against cancer. Part of McKesson Corporation, Ontada was founded on the core belief that precise insights – delivered exactly at the point of need – can save more patients' lives. We connect the full patient journey by combining technologies used by The US Oncology Network and other community oncology providers with real-world data and research relied on by all top 15 global life sciences companies. Our work helps accelerate innovation and power the future of cancer care. For more information, visit ontada.com or follow @OntadaOncology.

    About The US Oncology Network

    Every day, The US Oncology Network (The Network) helps more than 1,380 independent physicians deliver value-based, integrated care to patients — close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides practices with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Corporation. This collaboration allows the providers in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. The Network is committed to the success of independent practices, everywhere.

    About McKesson Corporation

    McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful — all for the better health of patients. McKesson has been named a "Most Admired Company" in the healthcare wholesaler category by FORTUNE, a "Best Place to Work" by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.com.

    _____________________________________

    1 Community Oncology Alliance

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  21. THOUSAND OAKS, Calif., Dec. 3, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community on Tuesday, Dec. 8, at 4:00 p.m. ET following the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of the clinical development team, will participate to discuss our oncology and hematology programs with a focus on Amgen's innovative BiTE® platform including the first clinical data for AMG 701 and analyses from a BLINCYTO® (blinatumomab) Phase 3 pediatric study.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media…

    THOUSAND OAKS, Calif., Dec. 3, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community on Tuesday, Dec. 8, at 4:00 p.m. ET following the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of the clinical development team, will participate to discuss our oncology and hematology programs with a focus on Amgen's innovative BiTE® platform including the first clinical data for AMG 701 and analyses from a BLINCYTO® (blinatumomab) Phase 3 pediatric study.

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

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

    About Amgen 

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

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

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

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-to-webcast-investor-call-at-ash-2020-301186063.html

    SOURCE Amgen

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  22. 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. 

     

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  23. 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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  24. 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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  25. 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) 

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  26. 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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  27. THOUSAND OAKS, Calif., Nov. 10, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 4th Annual Virtual IO Summit at 3:30 p.m. ET on Friday, November 13, 2020. David M. Reese, M.D., executive vice president of Research and Development 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…

    THOUSAND OAKS, Calif., Nov. 10, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 4th Annual Virtual IO Summit at 3:30 p.m. ET on Friday, November 13, 2020. David M. Reese, M.D., executive vice president of Research and Development 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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  28. THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma.

    The NAVIGATOR trial met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful reduction compared to placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population. SoC was medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or…

    THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma.

    The NAVIGATOR trial met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful reduction compared to placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population. SoC was medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).

    In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.  Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microliter.

    The significant exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microliter support the U.S. Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. 2018 for patients with severe asthma, without an eosinophilic phenotype.

    Tezepelumab was very well tolerated in patients with severe asthma.  Preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups.  Results from the NAVIGATOR trial will be presented at an upcoming medical meeting.

    Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.1,2 NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma by targeting TSLP.

    "We are absolutely thrilled with the topline results of the NAVIGATOR study in this broad population of patients with severe asthma, regardless of eosinophil count," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Tezepelumab represents a potential new class of biologics that could enable us to treat severe asthma at the top of the inflammatory cascade, addressing a high unmet need among the millions of patients living with severe asthma throughout the world. Tezepelumab has the potential to revolutionize care with efficacy demonstrated even in patients with a low eosinophil count."

    Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR trial said: "Due to the complex nature of severe asthma, many patients continue to face debilitating asthma despite receiving standard of care inhaled medicines and currently approved biologics. Today's ground-breaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype."

    Amgen and AstraZeneca Collaboration

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

    About Tezepelumab

    Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.1,2,3

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.2,3 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.2,3 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.2,3

    NAVIGATOR and the PATHFINDER clinical trial program

    Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE.4,5 The program includes additional planned mechanistic and long-term safety trials.

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. The trial population included approximately equal proportions of patients with high (≥ 300 cells/µL) and low (< 300 cells/µL) blood eosinophil counts. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients received their prescribed controller medications without change throughout the trial.4

    The primary efficacy endpoint was the annualized asthma exacerbation rate during the 52-week treatment period. Key secondary endpoints included the effect of tezepelumab on lung function, asthma control and health-related quality of life.4

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy. The primary endpoint is the categorized % reduction from baseline in the daily OCS dose while not losing asthma control.5

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long term safety and efficacy.5

    About Severe Asthma 

    Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide.6,7 Approximately 10% of asthma patients have severe asthma.6,7 Yet, many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.6-8 Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.6-8 Patients with severe asthma account for twice as many asthma-related hospitalizations.9,10 There is also a significant socio-economic burden, with these patients accounting for 50% of asthma-related costs.11

    Multiple inflammatory pathways are involved in the pathogenesis of asthma.12,13,14 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.14 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).4,15 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.15

    Amgen Inflammation

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

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

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

    About Amgen 

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

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

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

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration 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 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631 (media) 

    Arvind Sood, 805-447-1060 (investors) 

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

    2 Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23;380(21):2082]. N Engl J Med. 2017; 377 (10): 936-946.

    3 Roseti S, Corren J, Parnes JR, et al. Efficacy and safety of tezepelumab in adults with severe asthma: A randomized phase 2 study. European Respiratory Journal 2017; 50: OA3189.

    4 Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: September 2020].

    5 Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: September 2020].

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

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

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

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

    10 World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available from: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: September 2020]

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

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

    13 Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. EMJ Allergy Immunol. 2018; 3: 60-9.

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

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

     

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  29. THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from its cardiovascular (CV) portfolio will be presented at the American Heart Association (AHA) Scientific Sessions 2020: A Virtual Experience, Nov. 13-17, 2020.

    Amgen will present new analyses that provide further evidence of the benefits of intensive lipid-lowering to reduce CV events with Repatha® (evolocumab); new data from the GOULD registry, a real-world study with more than 5,000 adults to better understand cholesterol treatment patterns in patients with established cardiovascular disease (CVD); and new first-in-human data for olpasiran (formerly AMG 890), a novel small interfering RNA (siRNA) being developed for patients with CVD with…

    THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from its cardiovascular (CV) portfolio will be presented at the American Heart Association (AHA) Scientific Sessions 2020: A Virtual Experience, Nov. 13-17, 2020.

    Amgen will present new analyses that provide further evidence of the benefits of intensive lipid-lowering to reduce CV events with Repatha® (evolocumab); new data from the GOULD registry, a real-world study with more than 5,000 adults to better understand cholesterol treatment patterns in patients with established cardiovascular disease (CVD); and new first-in-human data for olpasiran (formerly AMG 890), a novel small interfering RNA (siRNA) being developed for patients with CVD with elevated lipoprotein(a) (Lp(a)), a risk factor for CV events. Primary results from GALACTIC-HF, the Phase 3 outcomes trial of omecamtiv mecarbil, an investigational cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF), will also be presented in a late-breaking clinical trial session. Amgen announced in October that GALACTIC-HF met its primary composite endpoint and did not meet its secondary endpoint of reduction in CV death.

    The new Repatha data contribute to Amgen's PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations) program of clinical and real-world evidence studies investigating the impact of Repatha on CVD and examining the use of lipid-lowering therapies across multiple patient populations. To date, the PROFICIO program consists of 50 clinical trials including more than 43,000 patients worldwide with eight real-world evidence studies.

    "We are committed to serving patients with cardiovascular disease, and these data add further evidence to our PROFICIO program, which supports more intensive and sustained lipid management to achieve guideline recommended LDL-C levels," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We also look forward to sharing our first data for olpasiran, a novel siRNA, designed to target lipoprotein(a), an independent, heritable risk factor for heart attacks or other cardiovascular events."

    Notable data being presented at the meeting include new analyses from the FOURIER trial evaluating Repatha in reducing the risk of major coronary events for atherosclerotic cardiovascular disease (ASCVD) patients on statin therapy, with a history of percutaneous coronary intervention, and a new meta-analysis across 48 randomized clinical trials evaluating the efficacy of lipid-lowering therapies, including Repatha, in reducing low-density lipoprotein cholesterol (LDL-C) levels.

    Results from GALACTIC-HF, one of the largest heart failure trials ever conducted will be presented at a live, virtual, embargoed AHA News Briefing on Thursday, Nov. 12, 2020 from 1:30-2:30 p.m. CT. Heart failure affects more than 64 million worldwide,1 and despite advances in treatment and care over the last decade, hospitalization and mortality rates remain high.

    A list of Amgen-sponsored abstracts at AHA Scientific Session 2020: A Virtual Experience can be found below and the full program planner is available online:

    GALACTIC-HF Primary Results

    • Omecamtiv Mecarbil in Chronic Heart Failure with Reduced Ejection Fraction: the Global Approach to Lowering Adverse Cardiac Outcomes through Improving Contractility in Heart Failure (GALACTIC-HF) Trial

      Late Breaking Oral Presentation, Friday, Nov. 13, 2020 10:35-10:45 a.m. CT

    The following virtual on-demand presentations will be available online from Friday, Nov. 13, 2020 9:00 a.m. to Tuesday, Nov. 17, 2020 8:30 p.m. CT:

    Heart Failure Data

    • Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and a Worsening Heart Failure Event (Abstract P427)
    • Down-Titration of Renin-Angiotensin System Inhibitors After Hospitalization for Heart Failure with Reduced Ejection Fraction (Abstract P628)
    • Enabling Advanced Real-World Evidence in Heart Failure: A Pilot Study Defining Preferred Approaches to Electronic Health Record Data Use (Abstract P970)
    • Thirty Day Episode of Care Spending Following Heart Failure Hospitalization Among Medicare Beneficiaries With Heart Failure (Abstract P975)

    Repatha Data

    • A Contemporary Assessment of Lipid Lowering Therapies and Low-Density Lipoprotein Cholesterol in Peripheral Artery Disease (Abstract P54)
    • A Novel Genetic Risk Score Predicts Ischemic Stroke in Patients with Cardiometabolic Disease (Abstract 165)
    • Cardiovascular Outcomes in Patients with Established Atherosclerosis and LDLR Loss of Function: Results from the FOURIER Trial (Abstract MP352)
    • Effects Of Evolocumab In Patients With Prior Percutaneous Coronary Intervention: An Analysis From The FOURIER Trial (Abstract P2137)
    • Efficacy of Lowering Low-Density Lipoprotein Cholesterol in Elderly Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (Abstract P389)
    • Evolocumab Inhibits the Acute Rise in Lipoprotein(a) in Patients With Non-ST Elevation Myocardial Infarction (NSTEMI)- Results From the EVACS Study (Abstract P392)
    • Incorporation of High-Sensitivity Troponin along with the AHA/ACC Cholesterol Guidelines for Improved Risk Stratification and Targeted PCSK9 Inhibition in Atherosclerotic Cardiovascular Disease (Abstract MP512)
    • Reduction with Evolocumab in Complex Coronary Disease Requiring Revascularization: Insights from the FOURIER Trial (Abstract P394)
    • Relative Efficacy of Alirocumab, Bempedoic Acid, Evolocumab, Ezetimibe and Inclisiran Added to Statins for Reduction of Low-Density Lipoprotein Cholesterol - A Network Meta-Analysis of Randomized Clinical Trials (Abstract MP460)
    • Relationship Between Baseline Low-Density Lipoprotein Cholesterol and Percent Low-Density Lipoprotein Cholesterol Reduction with Evolocumab in the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Patients with Elevated Risk) Trial (Abstract MP461)

    Real-World Treatment Patterns

    • Two-year Results of the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry of Patients with Atherosclerotic Cardiovascular Disease (ASCVD) (Abstract P2255)
    • Underuse of Combination Pharmacotherapy for Management of Dyslipidemia versus Diabetes and Hypertension Among Patients with Atherosclerotic Cardiovascular Disease (ASCVD): Insights from the Getting to an Improved Understanding of Low-density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Registry (Abstract MP459)

    Olpasiran (AMG 890) Data

    • Safety, Tolerability and Efficacy of Single-Dose AMG 890, a Novel siRNA Targeting Lp(a), in Healthy Subjects and Subjects with Elevated Lp(a) (Abstract P2338)

    About the Repatha CV Outcomes (FOURIER) Study

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

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

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

    GOULD Study Design

    Getting to an ImprOved Understanding of Low-Density Lipoprotein and Dyslipidemia Management (GOULD) Registry is a multicenter, observational registry of ASCVD patients, to describe LDL-C treatment patterns in the U.S. and track them over time. This registry and subsequent analysis sought to better understand the adaptability of lipid management guidelines for patients with ASCVD.

    From December 2016 to April 2018, interactive phone surveys with the lead physicians from each of the 120 U.S. centers participating in the registry (1 physician from each center) and patients (N=5,006) were conducted. Patients with ASCVD receiving any pharmacological lipid-lowering therapy were eligible for enrollment in 1 of 3 cohorts: 1) currently receiving a PCSK9i antibody, 2) no PCSK9i and LDL-C 70-99 mg/dL, and 3) no PCSK9i and LDL-C ≥ 100 mg/dL. Patients underwent a 1-year retrospective chart review, followed by chart reviews and interviews every 6 months for 2 years.

    GALACTIC-HF: Trial Design 

    GALACTIC-HF,2 (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), one of the largest Phase 3 global CV outcomes studies in heart failure ever conducted, enrolled 8,256 patients in 35 countries with HFrEF, New York Heart Association (NYHA) class II-IV, left ventricular ejection fraction (LVEF) ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization or emergency department visit for heart failure within a year. Patients were randomized to either oral placebo or a starting dose of 25 mg omecamtiv mecarbil twice daily (maintenance dose of 50 mg, 37.5 mg, or 25 mg twice daily) guided by pharmacokinetic-guided dose selection. A blood test, the QMS Omecamtiv Mecarbil Immunoassay (the OM Test) was used to measure plasma levels of omecamtiv mecarbil in each patient in order to guide selection of the appropriate maintenance dose.

    The primary composite endpoint of this double-blind, placebo-controlled, event-driven trial was time to CV death or first heart failure event (heart failure hospitalization and other urgent treatment for heart failure). Secondary endpoints were: time to CV death, patient reported outcomes (measured by Kansas City Cardiomyopathy Questionnaire [KCCQ] Total Symptom Score [TSS]), time to first heart failure hospitalization and time to all-cause death.

    About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program

    Omecamtiv mecarbil is an investigational selective cardiac myosin activator, the first of a novel class of myotropes3 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.4,5,6 Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction.

    Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.

    About Heart Failure 

    Heart failure is a grievous condition that affects more than 64 million people worldwide1 about half of whom have reduced left ventricular function.7,8 It is the leading cause of hospitalization and readmission in people age 65 and older.9,10 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.11 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.12,13 

    About Olpasiran

    Olpasiran (formerly known as AMG 890) is a small interfering RNA (siRNA) that targets lipoprotein(a), also known as Lp(a). It is being investigated for the treatment of ASCVD.

    About Amgen in the Cardiovascular Therapeutic Area

    Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.14 Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as elevated lipids, including high cholesterol and Lp(a), and heart failure.

    About Amgen 

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

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

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

    About Repatha® (evolocumab)

    Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.15

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

    Important U.S. Product Information

    Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated:

    • to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
    • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
    • as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

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

    Important U.S. Safety Information

    Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.

    Allergic reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

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

    From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising.

    Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

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

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

    Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.

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

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

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration 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 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.

    CONTACT: Amgen, Thousand Oaks 

    Trish Rowland, 805-447-5631 (media)

    Jessica Akopyan, 447-447-0974 (media) 

    Arvind Sood, 805-447-1060 (investors) 

    References

    1 James SL, et al. Lancet. 2018;392:1789-1858.

    2 Teerlink JR, et al. JACC Heart Fail. 2020;8(4):329-340.

    3 Psotka MA, et al. JACC. 2019;73:2345-53.

    4 Planelles-Herrero VJ, et al. Nat Commun. 2017;8:190.

    5 Shen YT, et al. Circ Heart Fail. 2010;3:522-27.

    6 Malik FI, et al. Science. 2011;331(6023):1439-43.

    7 Yancy CW, et al. Circulation. 2013;128:e240-e327.

    8 Ponikowski  P, et al. Eur Heart J. 2016;37:2129–2200.

    9 Roger VL. Circulation Research. 2013;113:646-659.

    10 Kilgore M, et al. Risk Manag Healthc Policy. 2017;10:63-70.

    11 Jhund PS, et al. Circulation. 2009;119:515-523.

    12 Benjamin EJ, et al. Circulation. 2018;137:e67-e492.

    13 Rogers VL, et al. JAMA. 2004;292:344-350.

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

    15 Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.

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

     

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  30. THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer (SCLC). AMG 757 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) molecule targeting delta-like ligand 3 (DLL3). The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's (SITC) 35th Annual Meeting being held virtually.

    "These AMG 757 proof of concept data in small cell lung cancer and the recently presented AMG 160 data in prostate cancer…

    THOUSAND OAKS, Calif., Nov. 9, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer (SCLC). AMG 757 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) molecule targeting delta-like ligand 3 (DLL3). The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's (SITC) 35th Annual Meeting being held virtually.

    "These AMG 757 proof of concept data in small cell lung cancer and the recently presented AMG 160 data in prostate cancer provide encouraging evidence of the BiTE platform's clinical activity in solid tumors," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "AMG 757 is a half-life extended BiTE immuno-oncology molecule targeting DLL3, which is an attractive target due to its differential expression in small cell lung cancer. Small cell lung cancer is a large unmet medical need globally, and yet treatment options have not advanced significantly in decades."

    This interim analysis of the Phase 1 dose escalation study evaluated 40 patients with relapsed/refractory SCLC at a dose of up to 10 mg every two weeks. In this study, AMG 757 demonstrated an acceptable safety profile and showed preliminary evidence of anti-tumor activity. Among 38 patients with evaluable disease, 16% (6) had confirmed partial response, 29% (11) had stable disease, and 3% (1) had unconfirmed partial response. Five of the six responses are on-going with a median follow-up of 8.8 months. The maximum tolerated dose for AMG 757 has not been reached and dosing optimization is ongoing.

    Cytokine release syndrome (CRS) was the most common treatment-related adverse event (AE) reported in 43% (17) of patients. All CRS events were grade 1 (30%) or 2 (13%), typically occurred in cycle 1, and did not recur in subsequent cycles. All CRS events were reversible, manageable, and did not lead to treatment interuptions or discontinations.

    "Small cell lung cancer is an aggressive cancer resulting in poor prognosis for patients. Current platinum-based chemotherapy and immunotherapy options have limited benefit in patients with small cell lung cancer, leaving patients in need of novel therapeutic options," said Hossein Borghaei, DO, MS, chief of thoracic medical oncology at Fox Chase Cancer Center. "These early data of AMG 757 are encouraging for a BiTE immuno-oncology molecule that targets DLL3 in small cell lung cancer."

    Additional Data Presentations

    Data on IMLYGIC® (talimogene laherparepvec) will be featured during an oral presentation.  Data on AMG 404, AMG 160, and AMG 509 will be presented as poster presentations. More information can be found on the SITC website here.

    About BiTE® Technology 

    BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's 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 IMLYGIC® (talimogene laherparepvec)

    IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.

    IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.

    The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.

    INDICATION & LIMITATIONS OF USE

    IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

    Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.

    IMPORTANT SAFETY INFORMATION

    Contraindications

    • Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
    • Do not administer IMLYGIC® to pregnant patients.

    Warnings and Precautions

    • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
    • Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
    • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
    • Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC®-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
    • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
    • IMLYGIC® is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
    • Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC® treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
    • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (e.g., previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
    • Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC®. Consider the risks and benefits of IMLYGIC® before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
    • Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
    • Obstructive Airway Disorder: Obstructive airway disorder has been reported following IMLYGIC® treatment. Use caution when injecting lesions close to major airways.

    Adverse Reactions

    • The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.

    The most common Grade 3 or higher adverse reaction was cellulitis. Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.

    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 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 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.

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (media)

    Jessica Akopyan, 805-447-0974 (media)

    Arvind Sood, 805-447-1060 (investors) 

    References

    1. Saunders LR, et al. Sci Transl Med 2015;7:302ral36.

     

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

     

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  31. THOUSAND OAKS, Calif., Nov. 4, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 29th Annual Credit Suisse Virtual Healthcare Conference at 4:15 p.m. ET on Monday, Nov. 9, 2020, in Scottsdale, Ariz. Murdo Gordon, executive vice president of Global Commercial Operations at Amgen and Peter H. Griffith, executive vice president and chief financial officer, 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…

    THOUSAND OAKS, Calif., Nov. 4, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 29th Annual Credit Suisse Virtual Healthcare Conference at 4:15 p.m. ET on Monday, Nov. 9, 2020, in Scottsdale, Ariz. Murdo Gordon, executive vice president of Global Commercial Operations at Amgen and Peter H. Griffith, executive vice president and chief financial officer, 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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  32. THOUSAND OAKS, Calif., Oct. 28, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2020.

    Key results include:

    • Total revenues increased 12% to $6.4 billion in comparison to the third quarter of 2019 driven by higher volume growth, partially offset by lower net selling prices and the effects of the COVID-19 pandemic.
      • Product sales increased 12% globally, driven by 18% volume growth across a number of our newer products, including Otezla® (apremilast), MVASI® (bevacizumab-awwb), KANJINTI® (trastuzumab-anns), and Repatha® (evolocumab), partially offset by declines in select products from the impact of COVID-19, and biosimilar and generic competition.
    • GAAP earnings per share (EPS) increased 5% to…

    THOUSAND OAKS, Calif., Oct. 28, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2020.

    Key results include:

    • Total revenues increased 12% to $6.4 billion in comparison to the third quarter of 2019 driven by higher volume growth, partially offset by lower net selling prices and the effects of the COVID-19 pandemic.
      • Product sales increased 12% globally, driven by 18% volume growth across a number of our newer products, including Otezla® (apremilast), MVASI® (bevacizumab-awwb), KANJINTI® (trastuzumab-anns), and Repatha® (evolocumab), partially offset by declines in select products from the impact of COVID-19, and biosimilar and generic competition.
    • GAAP earnings per share (EPS) increased 5% to $3.43 primarily driven by increased revenues and lower weighted-average shares outstanding, partially offset by the amortization of costs associated with our November 2019 acquisition of Otezla.
      • GAAP operating income decreased 1% to $2.5 billion and GAAP operating margin decreased 5.1 percentage points to 40.2%, primarily driven by the amortization of intangible assets from our Otezla acquisition.
    • Non-GAAP EPS increased 19% to $4.37 driven by increased revenues.
      • Non-GAAP operating income increased 14% to $3.2 billion and non-GAAP operating margin increased 1.0 percentage point to 52.1%.
    • The Company generated $3.2 billion of free cash flow in the third quarter versus $3.2 billion in the third quarter of 2019.
    • 2020 total revenues guidance narrowed to $25.1-$25.5 billion; EPS guidance revised to $11.53-$11.93 on a GAAP basis and revised to $15.80-$16.15 on a non-GAAP basis.

    "Amgen continues to deliver strong, volume-driven growth in a challenging environment, while also advancing new medicines in our pipeline," said Robert A. Bradway, chairman and chief executive officer.

    $Millions, except EPS, dividends paid per share and percentages

    Q3 '20



    Q3 '19



    YOY Δ

    Total Revenues

    $

    6,423



    $

    5,737



    12%

    GAAP Operating Income

    $

    2,453



    $

    2,476



    (1%)

    GAAP Net Income

    $

    2,021



    $

    1,968



    3%

    GAAP EPS

    $

    3.43



    $

    3.27



    5%

    Non-GAAP Operating Income

    $

    3,183



    $

    2,793



    14%

    Non-GAAP Net Income

    $

    2,572



    $

    2,201



    17%

    Non-GAAP EPS

    $

    4.37



    $

    3.66



    19%

    Dividends Paid Per Share

    $

    1.60



    $

    1.45



    10%

    References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.

    Product Sales Performance

    • Total product sales increased 12% versus the third quarter of 2019 driven by 18% volume growth, partially offset by declines in net selling prices.
    • COVID-19 update: During the third quarter, physician-patient interactions and prescribing volumes continued to increase, but remained modestly below pre-COVID-19 levels on a portfolio basis. While prescription trends were more consistent throughout the third quarter versus the second quarter, we continue to expect quarter-to-quarter variability due to the pandemic.
    • Prolia® (denosumab) sales increased 11% year-over-year driven by 10% volume growth as patients returned for treatment in the quarter, with rates of osteoporosis diagnoses in the U.S. recovering to ~70% of pre-COVID-19 levels. Our efforts remain focused on assisting patients with continuity of care to improve product access from the initial stages of the pandemic. Prior to the pandemic, the first and third quarters of each year had lower sales than the second and fourth quarters. Given the impact of the pandemic in the second quarter of 2020 and 6-month dosing regimen of Prolia, we expect year-over-year growth rates in the fourth quarter to be lower than pre-COVID-19 growth trends.  
    • EVENITY® (romosozumab-aqqg) generated $59 million of sales in the third quarter of 2020. U.S. sales increased 35% quarter-over-quarter driven by 30% volume growth. Japan sales declined quarter-over-quarter driven by an inventory drawdown by our partner Astellas following large purchases during the first half of 2020, as well as an unfavorable change to estimated sales deductions.
    • Repatha sales increased 22% year-over-year driven by 60% volume growth, partially offset by lower net selling price and unfavorable changes to estimated sales deductions. Despite a modest disruption in access in the third quarter, Repatha remains the global segment leader in the proprotein convertase subtilisin/kexin type 9 (PCSK9) class. Repatha's year-over-year net selling price declined as a result of additional contracting to improve Medicare Part D patient access and affordability. At the end of the third quarter, more than 60% of Medicare patients had access to affordable, fixed co-pays of $50 or less.
    • Aimovig® (erenumab-aooe) sales increased 59% year-over-year driven by 36% volume growth and the effect of unfavorable changes to estimated sales deductions in the prior year. Net selling price declined minimally year-over-year. Aimovig remains the segment leader within the preventive calcitonin gene-related peptide (CGRP) class with 46% share of total prescriptions (TRx) and 38% share of new-to-brand prescriptions (NBRx) in the quarter. With five-year efficacy and safety data, Aimovig is well positioned for the preventive segment which impacts more than 4 million individuals in the U.S.
    • Parsabiv® (etelcalcetide) sales increased 17% year-over-year driven by 24% volume growth, partially offset by lower net selling price. The final rule from the Centers for Medicare & Medicaid Services (CMS) to include calcimimetics in the end stage renal disease (ESRD) bundled payment system is expected in November 2020, with implementation projected for January 2021. In anticipation of this change, we believe U.S. sales were negatively impacted late in the third quarter and we expect this trend to continue in the fourth quarter.
    • Otezla generated $538 million of sales in the third quarter of 2020. U.S. Otezla TRx volume growth remained strong with an 11% year-over-year increase, and NBRx volumes continued to recover from the impacts of COVID-19. Net selling price was flat year-over-year in the U.S. Third quarter year-over-year Otezla sales* were negatively impacted by lower inventory levels and unfavorable changes to estimated sales deductions. Otezla continues to lead in biologic-naïve patient share in moderate-to-severe psoriasis.
    • Enbrel® (etanercept) sales decreased 3% year-over-year driven by lower volumes, partially offset by favorable changes to estimated sales deductions. Enbrel continued to lose share in the third quarter, and that dynamic was compounded with lower growth of the rheumatology segment due to COVID-19. Net selling price was flat year-over-year. 
    • AMGEVITA (adalimumab) increased 31% year-over-year driven by 49% volume growth, partially offset by lower net selling price. AMGEVITA continues to be the most prescribed adalimumab biosimilar in Europe.
    • KYPROLIS® (carfilzomib) sales decreased 2% year-over-year driven by volume declines, as fewer new patients began treatment due to COVID-19. Early indications point to a strong launch of the new once-weekly KYPROLIS and DARZALEX® (daratumumab) combination regimen that was approved by the U.S. Food and Drug Administration (FDA) in August.
    • XGEVA® (denosumab) sales increased 1% year-over-year. Sales increased 11% quarter-over-quarter, reflecting a recovery in the number of patients returning to treatment.
    • Vectibix® (panitumumab) sales declined 2% year-over-year driven by volume declines.
    • Nplate® (romiplostim) sales increased 9% year-over-year driven by volume growth.
    • BLINCYTO® (blinatumomab) sales increased 5% year-over-year driven by volume growth as we continued to see broader adoption in the community hospital setting.
    • MVASI generated $231 million of sales in the third quarter of 2020, with 44% exit share of the bevacizumab segment in the U.S. Sales increased 34% quarter-over-quarter driven by 36% volume growth, partially offset by a decline in net selling price. Going forward, we expect the launch of additional competing biosimilars in the U.S.
    • KANJINTI generated $167 million of sales in the third quarter of 2020, with 34% exit share of the trastuzumab segment in the U.S. Sales increased 36% quarter-over-quarter driven by 11% volume growth and favorable changes to estimated sales deductions. Moving forward, we expect volume growth will be offset by a decline in net selling price due to increased competition. 
    • Neulasta® (pegfilgrastim) sales decreased 22% year-over-year driven by declines in volumes and net selling price due to increased biosimilar competition, partially offset by favorable changes to estimated sales deductions. Within the long-acting granulocyte colony-stimulating factor (G-CSF) segment, Neulasta Onpro® continues to be the preferred choice for physicians and patients, with volume share of 55% in the quarter. CMS's most recently published average selling price for Neulasta in the U.S. declined 19% year-over-year and declined 6% quarter-over-quarter. Going forward, we expect the pricing and volume trends to continue.
    • NEUPOGEN® (filgrastim) sales increased 20% year-over-year driven by favorable changes to estimated sales deductions, partially offset by 19% volume decline due to competition.
    • EPOGEN® (epoetin alfa) sales decreased 31% year-over-year driven by volume declines as well as lower net selling price resulting from our existing contractual commitment with DaVita.
    • Aranesp® (darbepoetin alfa) sales decreased 15% year-over-year driven by lower net selling price and volume declines due to competition.
    • Sensipar/Mimpara® (cinacalcet) sales decreased 64% year-over-year driven by declines in volume and net selling price due to generic competition.

    *Third quarter 2019 Sales information derived from Celgene Corporation's reporting for that period.

    Product Sales Detail by Product and Geographic Region

    $Millions, except percentages

    Q3 '20



    Q3 '19



    YOY Δ



    US



    ROW



    TOTAL



    TOTAL



    TOTAL

    Prolia®

    $

    478





    $

    223





    $

    701





    $

    630





    11%

    EVENITY®

    54





    5





    59





    59





    Repatha®

    92





    113





    205





    168





    22%

    Aimovig®

    105









    105





    66





    59%

    Parsabiv®

    156





    27





    183





    157





    17%

    Otezla®

    439





    99





    538









    NM

    Enbrel®

    1,289





    36





    1,325





    1,366





    (3%)

    AMGEVITA™





    80





    80





    61





    31%

    KYPROLIS®

    173





    87





    260





    266





    (2%)

    XGEVA®

    363





    118





    481





    476





    1%

    Vectibix®

    90





    103





    193





    196





    (2%)

    Nplate®

    118





    94





    212





    195





    9%

    BLINCYTO®

    54





    35





    89





    85





    5%

    MVASI®

    185





    46





    231





    43





    *

    KANJINTI®

    149





    18





    167





    69





    *

    Neulasta®

    484





    71





    555





    711





    (22%)

    NEUPOGEN®

    44





    21





    65





    54





    20%

    EPOGEN®

    149









    149





    215





    (31%)

    Aranesp®

    158





    226





    384





    452





    (15%)

    Sensipar®/Mimpara®

    7





    32





    39





    109





    (64%)

    Other**

    31





    52





    83





    85





    (2%)

    Total product sales

    $

    4,618





    $

    1,486





    $

    6,104





    $

    5,463





    12%





















    NM = not meaningful









    * Change in excess of 100%





    ** Other includes GENSENTA, IMLYGIC®, Corlanor®, Bergamo and AVSOLA®

    Operating Expense, Operating Margin and Tax Rate Analysis

    On a GAAP basis:

    • Total Operating Expenses increased 22%. Cost of Sales margin increased 6.6 percentage points driven by amortization expense related to the Otezla acquisition. Research & Development (R&D) expenses increased 6% driven by higher spend in support of our late-stage development programs, primarily sotorasib, our biosimilar programs and Otezla, partially offset by recoveries from our collaboration with BeiGene. Selling, General & Administrative (SG&A) expenses increased 10% primarily due to Otezla commercial related expenses.
    • Operating Margin decreased 5.1 percentage points to 40.2% primarily driven by the amortization of intangible assets from our Otezla acquisition.
    • Tax Rate decreased 5.2 percentage points primarily driven by favorable items in the quarter, including effective settlement of certain federal income tax matters and adjustments to prior year tax liabilities, partially offset by changes in jurisdictional mix of earnings.

    On a non-GAAP basis:

    • Total Operating Expenses increased 10%. Cost of Sales margin increased 0.4 percentage points primarily driven by an increase in royalties, partially offset by favorable product mix. R&D expenses increased 6% driven by higher spend in support of our late-stage development programs, primarily sotorasib, our biosimilar programs and Otezla, partially offset by recoveries from our collaboration with BeiGene. SG&A expenses increased 10% primarily due to Otezla commercial related expenses.
    • Operating Margin increased 1.0 percentage point to 52.1%.
    • Tax Rate decreased 1.7 percentage points primarily driven by favorable items in the quarter, including adjustments to prior year tax liabilities, partially offset by changes in jurisdictional mix of earnings.

    $Millions, except percentages



    GAAP



    Non-GAAP





    Q3 '20



    Q3 '19



    YOY Δ



    Q3 '20



    Q3 '19



    YOY Δ

    Cost of Sales



    $

    1,561





    $

    1,036





    51%



    $

    874





    $

    760





    15%

    % of product sales





    25.6%







    19.0%





    6.6 pts





    14.3%







    13.9%





    0.4 pts

    Research & Development



    $

    1,062





    $

    1,001





    6%



    $

    1,037





    $

    977





    6%

    % of product sales





    17.4%







    18.3%





    (0.9) pts





    17.0%







    17.9%





    (0.9) pts

    Selling, General & Administrative



    $

    1,346





    $

    1,223





    10%



    $

    1,329





    $

    1,207





    10%

    % of product sales





    22.1%







    22.4%





    (0.3) pts





    21.8%







    22.1%





    (0.3) pts

    Other



    $

    1





    $

    1







    $





    $





    —%

    Total Operating Expenses



    $

    3,970





    $

    3,261





    22%



    $

    3,240





    $

    2,944





    10%



























    Operating Margin

























    operating income as % of product sales



    40.2%





    45.3%





    (5.1) pts



    52.1%





    51.1%





    1.0 pts



























    Tax Rate



    8.4%





    13.6%





    (5.2) pts



    13.5%





    15.2%





    (1.7) pts



























    pts: percentage points







    Cash Flow and Balance Sheet

    • The Company generated $3.2 billion of free cash flow in the third quarter of 2020 versus $3.2 billion in the third quarter of 2019.
    • The Company's third quarter 2020 dividend of $1.60 per share was declared on July 23, 2020, and was paid on September 8, 2020 to all stockholders of record as of August 17, 2020, representing a 10% increase from 2019.
    • During the third quarter, the Company repurchased 3.0 million shares of common stock at a total cost of $752 million. At the end of the third quarter, the Company had $4.2 billion remaining under its stock repurchase authorization.
    • Cash and investments totaled $12.4 billion and debt outstanding totaled $34.3 billion at the end of Q3 2020.

    $Billions, except shares



    Q3 '20



    Q3 '19



    YOY Δ

    Operating Cash Flow



    $

    3.4





    $

    3.4





    $

    0.0



    Capital Expenditures



    0.1





    0.2





    0.0



    Free Cash Flow



    3.2





    3.2





    0.0



    Dividends Paid



    0.9





    0.9





    0.1



    Share Repurchases



    0.8





    1.2





    (0.4)



    Average Diluted Shares (millions)



    589





    602





    (13)





















    9/30/20



    12/31/19



    YTD Δ

    Cash and Investments



    $

    12.4





    $

    8.9





    $

    3.5



    Debt Outstanding



    34.3





    29.9





    4.4

















    Note: Numbers may not add due to rounding













    2020 Guidance

    For the full year 2020, the Company now expects:

    • Total revenues in the range of $25.1 billion to $25.5 billion.
      • Previously, the Company expected total revenues in the range of $25.0 billion to $25.6 billion.
    • On a GAAP basis, EPS in the range of $11.53 to $11.93 and a tax rate in the range of 9.5% to 10.5%.
      • Previously, the Company expected GAAP EPS in the range of $10.73 to $11.43 and a tax rate in the range of 10.5% to 11.5%.
    • On a non-GAAP basis, EPS in the range of $15.80 to $16.15 and a tax rate in the range of 13.0% to 14.0%.
      • Previously, the Company expected non-GAAP EPS in the range of $15.10 to $15.75 and a tax rate in the range of 13.5% to 14.5%.
    • Capital expenditures to be approximately $600 million
    • Quarterly dividend maintained at $1.60 per share.
    • Share repurchases at the lower end of our previous guidance of $3 billion to $5 billion.

    Third Quarter Product and Pipeline Update

    The Company provided the following updates on selected product and pipeline programs:

    Sotorasib

    • The Company discussed the previously announced Phase 1 data and positive topline results from the Phase 2 monotherapy study of sotorasib in patients with advanced non-small cell lung cancer (NSCLC).
    • Data from the Phase 2 monotherapy study in advanced colorectal cancer patients are expected in H1 2021.
    • A Phase 3 study comparing sotorasib to docetaxel is enrolling patients with advanced NSCLC.
    • 7 Phase 1b combination cohorts are now enrolling patients.

    Bispecific Programs

    • The Company expects initial data from Phase 1 dose escalation studies of the following half-life extended (HLE) BiTE® constructs in Q4 2020:
      • AMG 701 targeting BCMA (B-cell maturation antigen) for relapsed or refractory multiple myeloma
      • AMG 757 targeting DLL3 (delta-like ligand 3) for relapsed or refractory small cell lung cancer, to be presented at the Society for Immunotherapy of Cancer Annual Meeting, November 9-14, 2020
    • Phase 1 development of the HLE BiTE® construct, AMG 562, targeting CD19 for non-Hodgkin's lymphoma has been stopped due to portfolio prioritization.

    BLINCYTO

    • The Company discussed encouraging results recently published in the New England Journal of Medicine from an independent clinical study of an investigational regimen of dasatinib induction therapy followed by blinatumomab consolidation therapy in adults with Philadelphia chromosome positive acute lymphoblastic leukemia.

    Tezepelumab

    • Data are expected in Q4 from the pivotal Phase 3 NAVIGATOR study evaluating tezepelumab in adults and adolescents with severe, uncontrolled asthma.
    • Data are expected in Q4 from the Phase 3 SOURCE study evaluating tezepelumab for the reduction of oral corticosteroid use in adults with oral corticosteroid dependent asthma.

    Efavaleukin alfa (AMG 592)

    • In October, the Company announced that the planned Phase 2 study of efavaleukin alfa in patients with Systemic Lupus Erythematosus was selected for participation in the FDA's Complex Innovative Trial Designs (CID) Pilot Program. The CID Pilot Program aims to facilitate and advance the use of novel clinical trial designs that support the development and regulatory review of new therapeutics. The FDA considers several eligibility factors when selecting qualifying programs, including the level of innovation of the trial design, and the therapeutic need.

    ABP 654 (biosimilar ustekinumab)

    • The Company has advanced ABP 654, a biosimilar candidate to STELARA® (ustekinumab), into Phase 3 development.

    KYPROLIS

    • In August, the FDA approved the expansion of the KYPROLIS U.S. prescribing information to include its use in combination with DARZALEX® plus dexamethasone in two dosing regimens—once weekly and twice weekly—for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.

    MCL-1 Inhibitor Program

    • Phase 1 studies of MCL-1 inhibitors AMG 176 and AMG 397 are reinitiating enrollment of patients with hematologic malignancies.

    Nplate

    • The FDA has granted priority review for Nplate for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome, with a Prescription Drug User Fee Act target action date of January 28, 2021. Research was conducted in collaboration with and support from both the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

    ABP 798 (biosimilar rituximab)

    • The FDA Biosimilar User Fee Act target action date for the Biologics License Application for ABP 798, a biosimilar candidate to RITUXAN® (rituximab), is December 19, 2020.

    Omecamtiv mecarbil 

    • The Company discussed the topline results from the Phase 3 GALACTIC-HF trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction.

    Olpasiran (AMG 890)

    • The FDA granted Fast Track designation for olpasiran, a lipoprotein(a) small interfering RNA currently in Phase 2 development for the treatment of atherosclerotic cardiovascular disease.

    Otezla

    • Otezla is being investigated as a potential immunomodulatory treatment in patients hospitalized with SARS-CoV-2 infections in multiple COVID-19 platform trials.

    Aimovig

    • In September, a marketing authorization application was filed with the Japan Pharmaceuticals and Medical Devices Agency for Aimovig for the prevention of migraine.
    • In October, results from the five-year, open-label treatment period of a Phase 2 study in episodic migraine prevention showed Aimovig helped patients achieve sustained reductions in monthly migraine days and in use of acute migraine-specific medication. The safety profile was consistent with what was observed in the double-blind treatment phase of the study, with no increases in adverse event rates over five years of exposure.

    COVID-19 Therapeutics

    • In September, the Company announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Eli Lilly's potential COVID-19 therapies.

    DARZALEX and STELARA are registered trademarks of Janssen Pharmaceutica NV

    Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

    Tezepelumab is being developed in collaboration with AstraZeneca

    RITUXAN is a registered trademark of Biogen Inc.

    Non-GAAP Financial Measures

    In this news release, management has presented its operating results for the third quarters of 2020 and 2019, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2020 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the third quarters of 2020 and 2019. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

    The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

    The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

    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. 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 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. 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. 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)

    Arvind Sood, 805-447-1060 (investors)





    Amgen Inc.

    Consolidated Statements of Income - GAAP

    (In millions, except per-share data)

    (Unaudited)





    Three months ended

    September 30,



    Nine months ended

    September 30,



    2020



    2019



    2020



    2019

    Revenues:















    Product sales

    $

    6,104





    $

    5,463





    $

    17,906





    $

    16,323



    Other revenues

    319





    274





    884





    842



    Total revenues

    6,423





    5,737





    18,790





    17,165



















    Operating expenses:















    Cost of sales

    1,561





    1,036





    4,562





    3,103



    Research and development

    1,062





    1,001





    2,978





    2,804



    Selling, general and administrative

    1,346





    1,223





    3,957





    3,637



    Other

    1





    1





    162





    (5)



    Total operating expenses

    3,970





    3,261





    11,659





    9,539



















    Operating income

    2,453





    2,476





    7,131





    7,626



















    Interest expense, net

    302





    313





    944





    988



    Interest and other income, net

    55





    114





    69





    517



















    Income before income taxes

    2,206





    2,277





    6,256





    7,155



















    Provision for income taxes

    185





    309





    607





    1,016



















    Net income

    $

    2,021





    $

    1,968





    $

    5,649





    $

    6,139



















    Earnings per share:















    Basic

    $

    3.45





    $

    3.29





    $

    9.61





    $

    10.08



    Diluted

    $

    3.43





    $

    3.27





    $

    9.54





    $

    10.01



















    Weighted-average shares used in calculation of earnings per share:















    Basic

    585





    599





    588





    609



    Diluted

    589





    602





    592