AMGN Amgen Inc.

247.72
-0.36  -0%
Previous Close 248.08
Open 248.69
52 Week Low 177.05
52 Week High 264.97
Market Cap $145,088,061,943
Shares 585,693,775
Float 584,293,341
Enterprise Value $167,891,061,943
Volume 6,042,470
Av. Daily Volume 2,551,092
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Upcoming Catalysts

Drug Stage Catalyst Date
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
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ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma
PDUFA
PDUFA
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Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
Phase 3
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Tezepelumab - NAVIGATOR
Asthma
Phase 3
Phase 3
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AMG 757
Small Cell Lung Cancer
Phase 1
Phase 1
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AMG 701
Multiple Myeloma
Phase 1
Phase 1
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AMG 160
Castration-resistant Prostate Cancer
Phase 1
Phase 1
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AMG 510
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)
Phase 1
Phase 1
Phase 1 data ASCO June 2, 2019. Overall response rate 70% (7/10) in high dose, 13/42 response across all cohorts.
AMG 890
Cardiovascular disease / Elevated Lipoprotein
Phase 2
Phase 2
Phase 2 trial has commenced - noted July 28, 2020.
AMG 594
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial is complete. Considering next steps.
Omecamtiv mecarbil METEORIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 enrollment to be completed early 2021.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
AMG 592
Systemic Lupus Erythematosus
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
AMG 592
Chronic Graft Versus Host Disease
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
AMG 510 CodeBreaK 200
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial is enrolling.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
AMG 510
Solid tumors
Phase 1
Phase 1
Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
AMG 570
Systemic Lupus Erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial is enrolling.
OTEZLA
Psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - May 6, 2020.
OTEZLA
Scalp Psoriasis
Approved
Approved
FDA approval announced April 2020.
ABP 710
REMICADE biosimilar - rheumatoid arthritis
Approved
Approved
FDA Approval announced December 6, 2019.
OTEZLA - PSA-006
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 - primary endpoint met.
OTEZLA
Behçet’s Disease
Approved
Approved
FDA Approval announced July 19, 2019.
BLINCYTO
Acute lymphoblastic leukemia (ALL) - pediatric
Phase 3
Phase 3
Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
Tezepelumab
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 trial is enrolling.
Nplate (Romiplostim)
Immune thrombocytopenia (ITP)
Approved
Approved
FDA Approval announced October 18, 2019.
ABP 980 (Kanjinti; trastuzumab-anns)
Herceptin biosimilar
CRL
CRL
FDA approval announced June 13, 2019.
EVENITY (Romosozumab)
Osteoporosis
Approved
Approved
FDA Approval announced April 9, 2019.
Nplate (Romiplostim)
Immune Thrombocytopenia (Pediatric)
Approved
Approved
FDA approval announced December 14, 2018.
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approval announced June 11, 2018.
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
Approved
Approved
Approval announced May 21, 2018.
Erenumab
Migraine
Approved
Approved
Approval announced May 17, 2018.
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approved January 17, 2018.
Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved
Approved February 7, 2017.
BLINCYTO
Ph+ R/R ALL
Approved
Approved
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
XGEVA
Multiple Myeloma
Approved
Approved
sBLA approval announced January 5, 2017.
Repatha
Cardiovascular disease
Approved
Approved
Approval announced December 1, 2017.
Corlanor
Chronic Heart Failure
Approved
Approved
Approved April 15, 2015.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
PDUFA
PDUFA
Approved September 14, 2017.
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
Approved
Approved
sBLA approval announced June 29, 2017.

Latest News

  1. THOUSAND OAKS, Calif., Sept. 20, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). Data from 59 patients with advanced non-small cell lung cancer reported in the NEJM manuscript were also featured today during an oral presentation at ESMO 2020.

    "CodeBreaK 100 is the largest Phase 1/2, and first-in-human, clinical study for a KRASG12C inhibitor," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Earlier this year at ASCO, we reported encouraging early…

    THOUSAND OAKS, Calif., Sept. 20, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). Data from 59 patients with advanced non-small cell lung cancer reported in the NEJM manuscript were also featured today during an oral presentation at ESMO 2020.

    "CodeBreaK 100 is the largest Phase 1/2, and first-in-human, clinical study for a KRASG12C inhibitor," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Earlier this year at ASCO, we reported encouraging early data in patients with advanced colorectal cancer and a number of other solid tumors. We're pleased to share these updated Phase 1 results, particularly in patients with advanced non-small cell lung cancer, and look forward to the Phase 2 readout in this heavily pretreated population later this year."

    Sotorasib demonstrated confirmed objective response rate (ORR) and disease control rates (DCR) of 35.3% and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1, 2020).

    Anticancer activity was seen across all dose levels in patients with NSCLC, with a confirmed ORR of 32.2% and DCR of 88.1%, and median duration of response of 10.9 months, with 10 of 19 responders still in response as of the data cutoff. Tumor shrinkage was observed in 71.2% of patients at the first week-6 assessment. Median progression-free survival (mPFS) in patients treated with sotorasib was 6.3 months.

    Safety and tolerability in patients with NSCLC were consistent with previously seen CodeBreaK 100 results. No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). The most common TRAEs were diarrhea (25.4%), alanine aminotransferase (ALT) increase (20.3%), aspartate aminotransferase (AST) increase (20.3%), fatigue (10.2%) and nausea (10.2%). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment.

    "These latest results show that sotorasib continues to demonstrate encouraging clinical benefit in heavily pretreated patients with KRAS G12C-mutant tumors," said lead author David S. Hong, M.D., Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, TX. "The results also establish a compelling trend in tumor shrinkage and median progression-free survival with a positive benefit-risk profile."

    The ESMO oral presentation included Phase 1 NSCLC results published in NEJM, as well as data on potential biomarkers of response to sotorasib that demonstrated clinical activity across a range of KRAS G12C mutant allele frequencies (MAFs), PD-L1 tissues expression levels, tumor mutational burden (TMB) plasma levels and tissue co-mutational profiles.

    "KRAS G12C is a driver of multiple solid tumor types and is particularly prevalent in non-small cell lung cancer," said Fabrice Barlesi, M.D., Ph.D., Professor of Medicine at Aix-Marseille University, Medical Director of Gustave Roussy Institute, Paris, France. "Despite this, there are currently no approved targeted therapy options for KRAS G12C and patients remain in need of additional treatment options, which makes these new findings particularly important."

    Amgen Webcast Investor Call

    Amgen will host two webcast calls for the investment community in conjunction with the ESMO Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, 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 investigators, will discuss Phase 1 data being presented on the Company's investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen's clinical development team, will discuss the Phase 1 data being presented on the Company's investigational half-life extended bispecific T-cell engager (BiTE®) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

    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 KRAS

    The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers.1,2 Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research.1 A specific mutation known as KRAS G12C, is a major driver of tumor growth, occurring broadly across solid tumor indications. In the U.S., about 13% of patients with non-small cell lung cancer harbor the KRAS G12C mutation.3,4 It is also found in approximately 3-5% of colorectal cancers and 1-2% of numerous other solid tumors, making this among the most broadly represented mutations across cancer patient subgroups.5,6,7,8,9. With the discovery of a unique surface groove in the KRASG12C protein, Amgen developed and advanced the first investigational KRASG12C inhibitor into the clinic and is exploring the potential of KRASG12C inhibition across multiple tumor types for patients who remain in dire need of treatment options.1,10

    About CodeBreaK

    The CodeBreaK clinical trial 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 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

    Amgen's single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a global Phase 3 randomized active-controlled confirmatory study comparing sotorasib to docetaxel in NSCLC (CodeBreaK 200) has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in 2021. Amgen is also currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101).

    Additional information about CodeBreaK clinical trials can be found at http://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.

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (media)

    Jessica Akopyan, 805-447-0974 (media)

    Arvind Sood, 805-447-1060 (investors)

    References

    1 Cox AD, et al. Nat Rev Drug Discov. 2014;13:828-851.

    2 Fernandez-Medarde A, et al. Genes Cancer. 2011;2:344-358.

    3 Biernacka A, et al. Cancer Genet. 2016;209:195-198.

    4 Stephen AG, et al. Cancer Cell. 2014;25:272-281.

    5 Neumann J, et al. Pathol Res Pract. 2009;205:858-862.

    6 Jones RP, et al. Br J Cancer. 2017;116:923-929.

    7 Wiesweg M, et al. Oncogene. 2019;38:2953-2966.

    8 Canon J, et al. Nature. 2019;575:217-223.

    9 Zhou L, et al. Med Oncol. 2016;33:32.

    10 Ryan MB, et al. Nat Rev Clin Oncol. 2018;15:709-720.

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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/clinical-data-from-full-phase-1-cohort-of-investigational-sotorasib-published-in-new-england-journal-of-medicine-301134338.html

    SOURCE Amgen

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  2. INDIANAPOLIS and THOUSAND OAKS, Calif., Sept. 17, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the world should one or more of Lilly's antibody therapies prove successful in clinical testing and receive regulatory approval.

    "Based on our initial clinical studies…

    INDIANAPOLIS and THOUSAND OAKS, Calif., Sept. 17, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly's potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the world should one or more of Lilly's antibody therapies prove successful in clinical testing and receive regulatory approval.

    "Based on our initial clinical studies, we believe that virus neutralizing antibodies, including LY-CoV-555, could play an important role in the fight against COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "Increasing the manufacturing capacity for our neutralizing antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able to produce many millions of doses even next year."

    "We are impressed with Lilly's data, in particular the reduction in hospitalizations, and are enthusiastic about the potential for these neutralizing antibodies as a therapeutic for COVID-19," said David M. Reese, M.D., executive vice president of research and development at Amgen. Esteban Santos, executive vice president of Operations at Amgen, added "we are proud to partner with Lilly and leverage our deep technical expertise in antibody development and, in particular, our strong capabilities in the scale up and manufacturing of complex biologics. This is yet another example of the ways our industry is closely collaborating to combat this devastating disease and help patients around the world access new therapies."

    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 Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/news. C-LLY

    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.

    Lilly Forward Looking Statements

    This press release contains forward-looking statements about the supply and use of Lilly antibodies to treat or prevent COVID-19 and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly antibodies will prove to be safe and effective to treat or prevent COVID-19, that any Lilly antibody will receive regulatory approval, or that we can provide an adequate supply of Lilly antibodies. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

    Refer to:

    Mark Taylor; ; (317) 276-5795 (Media)



    Kevin Hern; ; (317) 277-1838 (Investors)



    Trish Rowland; ; (805) 447-5631 (Media)



    Arvind Sood; ; (805) 447-1060 (Investors)

     

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  3. THOUSAND OAKS, Calif., Sept. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host two webcast calls for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2020 Virtual Congress. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT,  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 investigators, will discuss Phase 1 data being presented on the Company's investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen's clinical development team, will discuss the Phase 1 data being presented on the Company's investigational…

    THOUSAND OAKS, Calif., Sept. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host two webcast calls for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2020 Virtual Congress. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT,  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 investigators, will discuss Phase 1 data being presented on the Company's investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen's clinical development team, will discuss the Phase 1 data being presented on the Company's investigational half-life extended bispecific T-cell engager (BiTE®) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

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

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

    About 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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  4. THOUSAND OAKS, Calif., Sept. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020.

    Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations. Data from the study of sotorasib, Amgen's investigational KRASG12C inhibitor, will showcase Phase 1 clinical results on durability of clinical benefit in patients with non-small cell lung cancer (NSCLC). Additionally, data from Amgen's bispecific T cell engager (BiTE®) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational…

    THOUSAND OAKS, Calif., Sept. 16, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020.

    Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations. Data from the study of sotorasib, Amgen's investigational KRASG12C inhibitor, will showcase Phase 1 clinical results on durability of clinical benefit in patients with non-small cell lung cancer (NSCLC). Additionally, data from Amgen's bispecific T cell engager (BiTE®) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). Abstracts will be released on Saturday, Sept. 19, and will be followed by oral presentations (sotorasib, Sunday Sept. 20 and AMG 160, Monday Sept. 21) that will highlight more recent data.

    "During ESMO, we will highlight our pioneering work in two key areas of oncology research – KRAS inhibition and BiTE therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Clinicians will be presenting updated data from the first and largest Phase 1 human clinical study of an investigational KRASG12C inhibitor, sotorasib -- now the first KRASG12C inhibitor to advance to a Phase 3 study. In addition, early and encouraging data from our BiTE platform in the solid tumor setting will be presented. Our data at ESMO underscore our unique approach to harnessing the human biology of cancer to alter the course of cancer care for patients who need it most."

    Learn more about Amgen's development of innovative medicines for novel targets in difficult-to-treat solid tumors at AmgenOncology.com.

    Key Clinical Abstracts and Presentation Times (Pipeline):

    • Durability of Clinical Benefit and Biomarkers in Patients (pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Treated With AMG 510 (sotorasib)*

      Presentation #1257O, Proffered Paper Session, Sunday, Sept. 20, 2020, from 2:25 p.m.2:37 p.m. CEST / 5:25 a.m.5:37 a.m. PDT
    • Results From a Phase 1 Study of AMG 160, a Half-Life Extended (HLE), PSMA-Targeted, Bispecific T Cell Engager (BiTE®) Immune Therapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

      Presentation #609O, Proffered Paper Session, Monday, Sept. 21, 2020, from 2:25 p.m.2:37 p.m. CEST / 5:25 a.m.5:37 a.m. PDT

    Amgen Webcast Investor Call

    Amgen will host two webcast calls for the investment community in conjunction with the ESMO Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, 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 investigators, will discuss Phase 1 data being presented on the Company's investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen's clinical development team, will discuss the Phase 1 data being presented on the Company's investigational half-life extended bispecific T-cell engager (BiTE®) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

    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.

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

    About CodeBreaK

    The CodeBreaK clinical trial program for Amgen's investigational drug sotorasib is designed to treat patients with multiple KRAS G12C-mutant solid tumors 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 were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

    Amgen's single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a Phase 3 trial comparing sotorasib with docetaxel in NSCLC has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in early 2021.

    Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). In addition, a randomized global Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been initiated. Additional information about CodeBreaK clinical trials can be found at http://www.codebreaktrials.com.

    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 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, 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)

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  5. SAN FRANCISCO, Sept. 15, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and MBC BioLabs today announced that BigHat Biosciences and Trilo Therapeutics have each been awarded an Amgen Golden Ticket to MBC BioLabs. The companies will receive priority admission or renewal for one year of lab bench space with access to core facilities at the MBC BioLabs life sciences incubator, including access to Amgen's scientific experts and business leaders to help advance their scientific programs. Amgen is a proud sponsor of MBC BioLabs, assisting high-potential and innovative early-stage life science and biotech companies accelerating development of new therapies to improve human health.

    The 2020 Amgen Golden Ticket winners were chosen by a team of scientific leaders…

    SAN FRANCISCO, Sept. 15, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and MBC BioLabs today announced that BigHat Biosciences and Trilo Therapeutics have each been awarded an Amgen Golden Ticket to MBC BioLabs. The companies will receive priority admission or renewal for one year of lab bench space with access to core facilities at the MBC BioLabs life sciences incubator, including access to Amgen's scientific experts and business leaders to help advance their scientific programs. Amgen is a proud sponsor of MBC BioLabs, assisting high-potential and innovative early-stage life science and biotech companies accelerating development of new therapies to improve human health.

    The 2020 Amgen Golden Ticket winners were chosen by a team of scientific leaders who evaluated the strength and novelty of their scientific rationale, subject matter expertise, and business plan viability.

    "Amgen addresses important scientific questions to advance care and improve the lives of patients with serious diseases, including oncology, inflammation and cardiometabolic diseases, among others," said Flavius Martin, vice president of Oncology, Inflammation and Site Head at Amgen South San Francisco. "BigHat Biosciences and Trilo Therapeutics are working on promising early-stage innovation that address serious illnesses such as cancer, autoimmune diseases, infectious diseases, and others, which is why funding these companies and providing them the necessary lab space to move their science forward is so important. We are happy to support their scientific efforts as they tackle complex research challenges that potentially address critical unmet medical needs for patients. Congratulations to both companies and their scientific entrepreneurs."

    BigHat Biosciences:

    BigHat Biosciences is an early-stage Bay Area startup reimagining antibody discovery and engineering to create better antibodies faster and undertake novel designs far beyond what's possible today. BigHat designs antibodies using an agile, multi-objective, and data-driven platform that integrates a high-speed wet lab with AI and machine learning.

    "We are grateful to receive Amgen's Golden Ticket Award," said Mark DePristo, chief executive officer of BigHat Biosciences. "Amgen's support for our facility at MBC BioLabs' and access to their biologics R&D group will help accelerate our mission to radically improve antibody design using the latest techniques in machine learning and synthetic biology."

    Trilo Therapeutics: 

    Trilo Therapeutics is focused on the discovery of novel inhibitors of protein-protein interactions for therapeutic purposes. Our Trilomer® platform of peptidomimetic binders allows for the targeted inhibition of disease-causing proteins, for the treatment of cancer, autoimmune diseases, infectious diseases, and others. In a revolution of therapeutic approaches, Trilomer® peptidomimetic binders combine the cell permeability and degradation resistance of small molecules with the large surface area of antibodies, allowing them to target both intracellular and extracellular targets. Due to their fully synthetic modular building blocks, affinity optimization and structure-activity relationships (SAR) can be performed much more rapidly than either traditional medicinal chemistry or targeted mutagenesis of biologics. Our Degradomer® class of targeted protein degraders expands on the Trilomer® concept, allowing highly specific degradation of disease-causing proteins.

    "We are very excited to have won Amgen's Golden Ticket," said Keith Wilson, chief executive officer, Trilo Therapeutics. "Amgen's interest in our approach provides important additional validation for our work to develop novel therapeutics to currently undruggable targets. We look forward to interacting with Amgen's scientific and therapeutic experts to help move Trilomer® therapies into the clinic. MBC BioLabs' facilities and support will be instrumental in fostering Trilo's rapid research progression."

    "Amgen continues to be a steadfast and integral partner in supporting entrepreneurial scientists at MBC BioLabs. Now with their fifth round of Golden Ticket awards, Amgen has helped propel 10 promising companies forward," said Doug Crawford, General Manager at MBC BioLabs. "When Amgen first partnered with us in 2015, MBC BioLabs was a single site in San Francisco hosting 40 companies. With their support and the support of our other partners, we have now grown MBC BioLabs to three sites serving over 90 companies. By the end of the year that number will swell to over 100. We and the companies we host are deeply appreciative of Amgen's commitment and leadership in early innovation."

    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, please visit us at www.amgen.com or follow us on Facebook, Twitter, LinkedIn, and YouTube.

    About MBC BioLabs

    MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single bench and providing entrepreneurial scientists with access to millions of dollars of equipment, we allow companies to be fast, focused, and frugal. We now have three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos. Each site has a complete molecular biology core facility that allows companies to do experiments on day one, not year one. We have partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide our entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Our labs have truly enabled awesome: since our opening in 2013 we have helped launch and grow 194 companies. These companies have brought 53 programs to the clinic, produced 13 approved diagnostics, and raised over $4.5 billion. For more information, visit www.MBCBioLabs.com.

    CONTACT:

    Amgen

    Jessica Akopyan

    805-447-0974

    MBC BioLabs

    Linda Eng

    415-348-8287

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