AZN AstraZeneca PLC

56.58
+0.24  (+0%)
Previous Close 56.34
Open 57
52 Week Low 46.48
52 Week High 64.21
Market Cap $175,301,456,980
Shares 3,098,293,690
Float 3,096,480,746
Enterprise Value $200,267,740,736
Volume 5,813,755
Av. Daily Volume 5,321,592
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Upcoming Catalysts

Drug Stage Catalyst Date
IMFINZI (Durvalumab) - PACIFIC-2
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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AZD2816
COVID-19 vaccine (variant)
Phase 2/3
Phase 2/3
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PT027 (albuterol/budesonide)
Asthma
Phase 3
Phase 3
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Tezepelumab
Asthma
PDUFA priority review
PDUFA priority review
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IMFINZI (durvalumab)
Cervical cancer
Phase 3
Phase 3
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FARXIGA (Dapagliflozin) - (Deliver)
Chronic Heart Failure (CHF), preserved ejection fraction (HFpEF)
Phase 3
Phase 3
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IMFINZI (Durvalumab) - (PEARL)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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IMFINZI (Durvalumab) - ADRIATIC
Small cell lung cancer (SCLC) limited disease
Phase 3
Phase 3
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ALXN2040 add-on therapy
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 3
Phase 3
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ENHERTU (trastuzumab deruxtecan) - DESTINY-Breast02
Third line HER2+ breast cancer
Phase 3
Phase 3
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FASENRA (benralizumab) NATRON
Hyper-eosinophilic syndrome
Phase 3
Phase 3
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ENHERTU (trastuzumab deruxtecan) - DESTINY-Breast04
HER low breast cancer
Phase 3
Phase 3
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ULTOMIRIS (ravulizumab-cwvz)
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Phase 3
Phase 3
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FASENRA (benralizumab) - MESSINA
Eosinophilic Esophagitis
Phase 3
Phase 3
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IMFINZI (Durvalumab) - EMERALD-1
Locoregional Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Roxadustat (MATTERHORN)
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ORPATHYS (savolitinib) + TAGRISSO (osimertinib)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial first patient dosed November 22, 2021.
Durvalumab, Monalizumab, and Oleclumab - (COAST)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 trial met primary endpoint of confirmed ORR of 30% for durvalumab plus oleclumab, for durvalumab plus monalizumab 36%, for durvalumab alone 18%, September 17, 2021. Phase 3 trial planned.
AZD7442 (TACKLE)
COVID-19
Phase 3
Phase 3
Phase 3 trial met primary endpoint - October 11, 2021. Phase 3 separate treatment trial showed an 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset, noted November 18, 2021.
AZD7442 (PROVENT)
COVID-19
Phase 3
Phase 3
EUA application filed to FDA October 5, 2021. Phase 3 six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths, noted November 18, 2021.
Datopotamab Deruxtecan - (TROPION-Breast01)
HR Positive, HER2 Negative Breast Cancer
Phase 3
Phase 3
Phase 3 trial dosing initiated November 18, 2021.
AZD1222
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
IMFINZI (Durvalumab) +/- tremelimumab (DANUBE)
Bladder cancer
Phase 3
Phase 3
Phase 3 data released March 6, 2020 did not meet primary endpoint.
Selumetinib - ASTRA
Thyroid cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 26, 2018.
Savolitinib + IMFINZI (durvalumab)
Papillary renal cell carcinoma (PRCC)
Phase 3
Phase 3
Phase 3 first patient dosed October 28, 2021.
IMFINZI (Durvalumab) +/- tremelimumab (EAGLE)
Head & neck cancer
Phase 3
Phase 3
Phase 3 data released December 7, 2018 - primary endpoints not met.
IMFINZI (Durvalumab) TOPAZ-1
Biliary-tract cancer
Phase 3
Phase 3
Phase 3 interim analysis reported trial met primary endpoint of improvement in OS versus standard of care. The trial also met key secondary endpoints, noted October 25, 2021.
FASENRA (Benralizumab) - TERRANOVA
COPD
Phase 3
Phase 3
Phase 3 data released May 30, 2018. Primary endpoint not met.
IMFINZI (Durvalumab) +/- tremelimumab (NEPTUNE)
Lung cancer
Phase 3
Phase 3
Phase 3 data released August 21, 2019 did not meet primary endpoint.
IMFINZI (Durvalumab) +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3
Phase 3
Phase 3 data released July 27, 2017 - primary endpoint (PFS) not met. Overall survival data also did not meet primary endpoint - November 16, 2018.
TAGRISSO (Osimertinib) - FLAURA
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 final OS data released August 9, 2019. Endpoint met. Presentation at ESMO September 2019 noted OS of 38.6 months versus 31.8 months for comparator arm; PFS HR 0.48.
Tezepelumab
Eosinophilic esophagitis (EoE)
Phase 3
Phase 3
Phase 3 trial is planned.
AZD7442 (STORMCHASER)
COVID-19 (post-exposure prophylaxis)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 15, 2021.
ENHERTU (trastuzumab deruxtecan) - DESTINY-Lung01
Non-squamous non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Granted Breakthrough Therapy Designation, May 2020. Phase 2 trial met primary endpoint. Phase 2 data showed confirmed objective response rate (ORR) of 54.9%. One (1.1%) complete response (CR), 49 (53.8%) partial responses (PR) and 37% stable disease. A confirmed disease control rate (DCR) of 92.3% was seen. The median progression-free survival (PFS) was 8.2 months and the median overall survival (OS) was 17.8 months, September 18, 2021.
ULTOMIRIS (ravulizumab-cwvz)
Complement Mediated Thrombotic Microangiopathy (CM-TMA)
Phase 3
Phase 3
Phase 3 trial to be initiated 2Q 2021.
FARXIGA (Dapagliflozin)
COVID-19
Phase 3
Phase 3
Phase 3 trial did not achieve statistical significance for the primary endpoint - April 12, 2021.
ULTOMIRIS (ravulizumab-cwvz)
Generalized myasthenia gravis (gMG)
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - July 15, 2021.
IMFINZI (Durvalumab) + tremelimumab - (HIMALAYA)
Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
Phase 3 trial met primary endpoint of overall survival with a single priming dose every four weeks vs. sorafenib, noted October 15, 2021.
ENHERTU (trastuzumab deruxtecan) - DESTINY-Breast03
Second line HER2+ breast cancer
Phase 3
Phase 3
Phase 3 data trial met primary endpoint - August 9, 2021. Phase 3 data showed no statistically significant improvement in OS. The confirmed ORR more than doubled versus the T-DM1 arm (79.7% vs. 34.2%). Forty-two (16.1%) CR, and 166 (63.6%) PR were observed compared to 23 (8.7%) CR and 67 (25.5%) PR in patients treated with T-DM1, September 18, 2021. Breakthrough Therapy Designation granted October 4, 2021.
Nirsevimab (MELODY)
Respiratory syncytial virus
Phase 3
Phase 3
Phase 3 trial met primary endpoint - April 26, 2021.
LYNPARZA (olaparib) + cediranib
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 12, 2020.
FASENRA (Benralizumab) - OSTRO
Nasal polyps
Phase 3
Phase 3
Phase 3 trial met primary endpoints.
ALXN1840 (WTX101)
Wilson disease
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint August 26 2021.
ULTOMIRIS (ravulizumab-cwvz)
Hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)
Phase 3
Phase 3
Phase 3 trial initiated 4Q 2020.
SOLIRIS (eculizumab)
Neuromyelitis Optica Spectrum Disorder (NMOSD) - children
Phase 2/3
Phase 2/3
Phase 2/3 trial underway.
CALQUENCE (acalabrutinib) - (ELEVATE-RR)
Chronic Lymphocytic Leukemia (CLL)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 25, 2021. Phase 3 new formulation study showed durable efficacy and favorable tolerability vs. standards of care across multiple analyses, noted November 5, 2021.
Domvanalimab (AB154) and IMFINZI (Durvalumab) - PACIFIC-8
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial to commence 2H 2021.
ION449 (AZD8233)
Dyslipidaemia
Phase 2b
Phase 2b
Phase 2b trial initiation announced November 30, 2020. Phase 1 data reported that multiple doses of AZD8233 were generally safe, well tolerated, and reduced PCSK9 and LDL-C levels in a dose-dependent manner, noted November 13, 2021.
Tezepelumab (NAVIGATOR)
Asthma and comorbid nasal polyps
Phase 3
Phase 3
Phase 3 data showed an 86% reduction in the annualized asthma exacerbation rate (AAER) September 5, 2021.
Datopotamab Deruxtecan + KEYTRUDA (TROPION-Lung08)
Metastaic non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial planned.
LYNPARZA (olaparib) - PROpel
Castration-resistant prostate cancer -first line
Phase 3
Phase 3
Phase 3 trial met primary endpoint. Data demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus standard-of-care abiraterone, noted September 24, 2021.
IMFINZI (Durvalumab) + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)
Approved
Approved
FDA approval announced March 30, 2020. Phase 3 data showed sustained efficacy after a median follow up of more than three years, with a 29% reduction in the risk of death versus chemotherapy alone. Updated median OS was 12.9 months versus 10.5 for chemotherapy. 17.6% of patients treated with IMFINZI plus chemotherapy were alive at three years, versus 5.8% of patients treated with chemotherapy alone, September 18, 2021.
ENHERTU (trastuzumab deruxtecan)
Third line HER2+ breast cancer
Approved
Approved
FDA Approval announced December 20, 2019. Updated Phase 2 data showed an ORR of 62.0%, including one additional CR (7.1%). The median PFS was 19.4 months, September 18, 2021.
ENHERTU (trastuzumab deruxtecan) - DESTINY-Gastric01/02
Gastric cancer
Approved
Approved
FDA approval announced January 18, 2021. Phase 2 trial data showed confirmed overall response rate (ORR) of 38% as assessed by independent central review (ICR). Three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed in patients treated with ENHERTU, September 17, 2021.
IMFINZI (Durvalumab) - (PACIFIC)
Lung cancer
Approved
Approved
Approval announced February 19, 2018. Phase 3 median PFS of 16.9 months was observed, September 17, 2021.
IMFINZI (Durvalumab) + tremelimumab (POSEIDON)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 data showed statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy noted September 9, 2021.
ULTOMIRIS (ravulizumab-cwvz) - CHAMPION-ALS
Amyotrophic lateral sclerosis (ALS)
Phase 3
Phase 3
Phase 3 trial discontinued due to lack of efficacy - August 20, 2021.
ULTOMIRIS (ravulizumab-cwvz)
Paroxysmal Nocturnal Hemoglobinuria (PNH) - children
Approved
Approved
FDA approval announced June 7, 2021.
SOLIRIS (Eculizumab)
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
Approved
Approved
FDA Approval announced June 27, 2019.
ULTOMIRIS (ravulizumab-cwvz)
Paroxysmal nocturnal hemoglobinuria (PNH)
Approved
Approved
FDA approval announced December 21, 2018.
ULTOMIRIS (ravulizumab-cwvz)
atypical Hemolytic Uremic Syndrome (aHUS)
Approved
Approved
FDA Approval announced October 18, 2019.
ULTOMIRIS (ravulizumab-cwvz) subcutaneous
Paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - June 24, 2020. Regulatory filing due 3Q 2021.
SOLIRIS (Eculizumab)
Refractory generalized myasthenia gravis (gMG)
Approved
Approved
Approval announced October 23, 2017.
ANDEXXA (Andexanet alfa)
Factor Xa inhibitor reversal agent
Approved
Approved
Prior Approval Supplement (PAS) FDA Approval announced December 31, 2018.
BEVYXXA (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
Approved
FDA Approval noted June 23, 2017.
Roxadustat
Anaemia in Chronic Kidney Disease
CRL
CRL
CRL announced August 11, 2021.
CALQUENCE (acalabrutinib)
Relapsed/refractory chronic lymphocytic leukaemia
Phase 3
Phase 3
Phase 3 positive interim data released May 7, 2019. Trial to be stopped early.
CALQUENCE (acalabrutinib)
Chronic lymphocytic leukaemia
Approved
Approved
FDA Approval announced November 21, 2019.
SAPHNELO (Anifrolumab)
Lupus
Approved
Approved
FDA approval announced August 2, 2021.
BYDUREON BCise
Type 2 diabetes (Pediatric)
Approved
Approved
FDA approval announced July 23, 2021.
LYNPARZA (olaparib) - OlympiA
BRCAm adjuvant breast cancer
Phase 3
Phase 3
Phase 3 trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) versus placebo - February 17, 2021.
BREZTRI AEROSPHERE (budesonide/glycopyrrolate/formoterol fumarate)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
FDA approval announced July 24, 2020.
LOKELMA (sodium zirconium cyclosilicate)
Hyperkalaemia
Approved
Approved
Second CRL issued March 17, 2017. Approval announced May 18, 2018.
KOSELUGO (selumetinib)
Neurofibromatosis type 1 plexiform neurofibromas
Approved
Approved
FDA Approval announced April 13, 2020.
BRILINTA (ticagrelor) - (THEMIS)
Type 2 Diabetes / coronary artery disease (CAD)
Approved
Approved
FDA approval announced June 1, 2020.
BRILINTA (ticagrelor) - (THALES)
Acute ischaemic stroke
Approved
Approved
FDA approval announced November 6, 2020.
LUMOXITI (moxetumomab)
Cancer - leukaemia
Approved
Approved
FDA approval announced September 13, 2018.
FASLODEX (fulvestrant)
Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer
Approved
Approved
Expanded approval announced August 28, 2017.
IMFINZI (Durvalumab) +/- tremelimumab (KESTREL)
Head & neck cancer
Phase 3
Phase 3
Phase 3 trial did not meet the primary endpoint - February 5, 2021.
ONGLYZA (Saxagliptin) and FARXIGA (Dapagliflozin)
Type-2 diabetes
Approved
Approved
Approval announced February 28, 2017.
FARXIGA (Dapagliflozin)
Chronic Kidney Disease
Approved
Approved
FDA approval announced April 30, 2021.
FARXIGA (Dapagliflozin)
Heart failure in patients with type-2 diabetes
Approved
Approved
FDA Approval announced October 21, 2019.
FARXIGA (Dapagliflozin)
Heart failure
Approved
Approved
FDA Approval announced May 5, 2020.
FARXIGA (Dapagliflozin)
Type 1 diabetes
CRL
CRL
CRL issued for sNDA announced July 15, 2019.
TAGRISSO (Osimertinib) - (ADAURA)
Non-small Cell Lung Carcinoma
Approved
Approved
FDA approval announced December 21, 2020.
TAGRISSO (Osimertinib)
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Approved
Approved
Approval announced March 31, 2017.
FASENRA (benralizumab) - GALATHEA
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted May 11, 2018.
CALQUENCE (acalabrutinib)
Relapsed or Refractory Mantle Cell Lymphoma
Approved
Approved
Priority Review announced August 2, 2017. Approval announced October 31, 2017.
FASENRA (Benralizumab)
Severe, uncontrolled asthma
Approved
Approved
Approval announced November 14, 2017.
LYNPARZA (olaparib) + AVASTIN (bevacizumab) - PAOLA-1
First-line ovarian cancer
Approved
Approved
FDA Approval announced May 8, 2020.
LYNPARZA (olaparib) - SOLO 3
Third-line ovarian cancer
Phase 3
Phase 3
Phase 3 data met primary and secondary endpoints. ORR; 72.2% vs 51.4% for chemotherapy. PFS 13.4 months vs 9.2 months for chemo arm (HR 0.62).
LYNPARZA (olaparib)
Pancreatic cancer
Approved
Approved
FDA Approval announced December 30, 2019.
LYNPARZA (olaparib)
Second-line ovarian cancer
Approved
Approved
Approval announced August 17, 2017.
LYNPARZA (olaparib)
Castration-Resistant Prostate Cancer
Approved
Approved
FDA Approval announced May 19, 2020.
LYNPARZA (olaparib)
Breast cancer
Approved
Approved
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death). Approval announced January 12, 2018.
LYNPARZA (olaparib) - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
Approved
Approved
FDA Approval announced December 19, 2018.
MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
Phase 2 trial ongoing.
PT010
Chronic obstructive pulmonary disease (COPD)
CRL
CRL
CRL announced October 1, 2019.
Lanabecestat (AZD3293) - AMARANTH
Early Alzheimer's disease
Phase 3
Phase 3
Announced discontinuation of trial due to futility - June 12, 2018.
Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride)
Type 2 diabetes
Approved
Approved
FDA approval announced May 3, 2019.
Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - May 10, 2017.

Latest News

  1. Tempus, a leader in artificial intelligence and precision medicine, today announced a multi-year, strategic collaboration with AstraZeneca (NASDAQ:AZN) in which the two companies will work together to gather insights, discover novel drug targets, and aim to develop therapeutics for the broader oncology community. By combining the capabilities of a technology company with those of a biopharmaceutical company, the two companies hope to advance drug discovery and development, to more quickly deliver innovation to patients.

    The strategic collaboration aims to optimize Tempus' AI-enabled platform and vast repository of multimodal data to advance novel therapeutic programs in oncology on a global scale. Under the terms of the agreement, AstraZeneca…

    Tempus, a leader in artificial intelligence and precision medicine, today announced a multi-year, strategic collaboration with AstraZeneca (NASDAQ:AZN) in which the two companies will work together to gather insights, discover novel drug targets, and aim to develop therapeutics for the broader oncology community. By combining the capabilities of a technology company with those of a biopharmaceutical company, the two companies hope to advance drug discovery and development, to more quickly deliver innovation to patients.

    The strategic collaboration aims to optimize Tempus' AI-enabled platform and vast repository of multimodal data to advance novel therapeutic programs in oncology on a global scale. Under the terms of the agreement, AstraZeneca will leverage Tempus' de-identified data and analytical tools across a broad range of capabilities. This collaboration combines Tempus' AI and machine learning capabilities for identifying novel insights with AstraZeneca's deep expertise in R&D to ultimately develop new therapeutic options for patients.

    "Artificial intelligence has the potential to advance precision medicine in ways that seemed unimaginable just a few short years ago," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working with AstraZeneca to apply AI-enabled solutions to advance its robust therapeutic pipeline in an effort to help patients live longer and healthier lives."

    "Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. "We are very pleased to collaborate with Tempus to enhance our data-driven R&D strategy and glean critical insights that will deepen our understanding of complex tumor biology, enhance access to predictive preclinical models, and increase the probability of clinical success across our diverse pipeline."

    About Tempus

    Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world's largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

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  2. NEW YORK, Nov. 19, 2021 /PRNewswire/ -- Deutsche Bank today announced that the presentations from the November 16th and 17th  Depositary Receipts Virtual Investor Conference ("dbVIC") are now available for on-demand viewing. The event featured presentations from international companies with American Depositary Receipt (ADR) programs in the US.

    Representatives from participating companies based in Australia, China, Germany, France and the UK presented their equity stories and answered audience questions. The presentations are targeted to all types of investors as well as analysts interested in non-US companies.

    To log in, please use the following link: www.adr.db.com/dbvic 

    The company presentations will be available 24/7 for 90…

    NEW YORK, Nov. 19, 2021 /PRNewswire/ -- Deutsche Bank today announced that the presentations from the November 16th and 17th  Depositary Receipts Virtual Investor Conference ("dbVIC") are now available for on-demand viewing. The event featured presentations from international companies with American Depositary Receipt (ADR) programs in the US.

    Representatives from participating companies based in Australia, China, Germany, France and the UK presented their equity stories and answered audience questions. The presentations are targeted to all types of investors as well as analysts interested in non-US companies.

    To log in, please use the following link: www.adr.db.com/dbvic 

    The company presentations will be available 24/7 for 90 days. Investors, advisors and analysts may download shareholder materials from the "virtual trade booth" for the next three weeks.

    The following companies participated in the conference:

    In addition to specializing in administering cross-border equity structures such as American and Global Depositary Receipts, Deutsche Bank provides corporates, financial institutions, hedge funds and supranational agencies around the world with trustee, agency, escrow and related services. The Bank offers a broad range of services for diverse products, from complex securitizations and project finance to syndicated loans, debt exchanges and restructurings.

    Deutsche Bank provides commercial and investment banking, retail banking, transaction banking and asset and wealth management products and services to corporations, governments, institutional investors, small and medium-sized businesses, and private individuals. Deutsche Bank is Germany's leading bank, with a strong position in Europe and a significant presence in the Americas and Asia Pacific.

    Deutsche Bank is sponsoring the Deutsche Bank Depositary Receipt Investor Conference solely for informational purposes. Deutsche Bank does not prepare, review, approve or edit any presentations, statements, documents or other information or materials, whether in written, electronic or verbal form, provided by any company participating in such conference, and disclaims any responsibility for the accuracy or adequacy of any such information or materials. Deutsche Bank is not promoting, endorsing or recommending any company participating in the conference.

    The Depositary Receipts have been registered pursuant to the US Securities Act of 1933 (the "Act"). The investment or investment service which is the subject of this notice is not available to retail clients as defined by the UK Financial Conduct Authority. This notice has been approved and/or communicated by Deutsche Bank AG New York. The services described in this notice are provided by Deutsche Bank Trust Company Americas (Deutsche Bank) or by its subsidiaries and/or affiliates in accordance with appropriate local registration and regulation. Deutsche Bank is providing the attached notice strictly for information purposes and makes no claims or statement, nor does it warrant or in any way represent, as to the accuracy or completeness of the details contained herein or therein. This announcement appears as a matter of record only. Neither this announcement nor the information contained herein constitutes an offer or solicitation by Deutsche Bank or any other issuer or entity for the purchase or sale of any securities nor does it constitute a solicitation to any person in any jurisdiction where solicitation would be unlawful. No part of this notice may be copied or reproduced in any way without the prior written consent of Deutsche Bank. Past results are not an indication of future performance. Copyright© November 2021 Deutsche Bank AG. All rights reserved.

    Cision View original content:https://www.prnewswire.com/news-releases/deutsche-banks-depositary-receipts-virtual-investor-conference-presentations-now-available-for-on-demand-viewing-301429119.html

    SOURCE dbVIC - Deutsche Bank Depositary Receipts Virtual Investor Conference

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  3. Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the first patient was dosed in the global TROPION-Breast01 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy.

    Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 70% of all breast cancers are considered HR positive…

    Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the first patient was dosed in the global TROPION-Breast01 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy.

    Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 70% of all breast cancers are considered HR positive, HER2 negative.2 For patients with HR positive, HER2 negative metastatic breast cancer that progresses on or is not suitable for hormone therapy-based regimens, current standard of care is single-agent chemotherapy, which demonstrates diminishing efficacy with each subsequent line of treatment.3

    "There are no TROP2 directed therapies currently approved for HR positive, HER2 negative breast cancer and we are encouraged by the emerging clinical profile of datopotamab deruxtecan in patients with breast cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer."

    "Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy. In this setting, the unmet need is high, and new therapeutic approaches are necessary to delay disease progression and extend survival," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy."

    About TROPION-Breast01

    TROPION-Breast01 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6 mg/kg) compared with investigator's choice of chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in patients with inoperable or metastatic HR positive, HER2 negative breast cancer (per ASCO/CAP guidelines, on local laboratory results) who have progressed on or were not suitable for endocrine therapy and previously treated with one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting.

    The dual primary endpoints of TROPION-Breast01 are progression-free survival (PFS) assessed by blinded independent central review and overall survival. Secondary endpoints include PFS assessed by investigator, objective response rate, duration of response, disease control rate, and patient reported outcomes, as well as safety and pharmacokinetics.

    TROPION-Breast01 will enroll approximately 700 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

    About HR Positive, HER2 Negative Breast Cancer

    Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 5% to 10% of women diagnosed with breast cancer have metastatic disease at diagnosis, and up to 30% of women with early-stage breast cancer will develop metastatic disease.4

    Approximately 70% of all breast cancers are considered HR positive, HER2 negative, meaning tumors test positive for estrogen and/or progesterone hormone receptors and negative for HER2.2 Current standard of care treatment for patients with HR positive, HER2 negative metastatic breast cancer that progresses on hormone therapy-based regimens is sequential single-agent chemotherapy. However, response rates are low with PFS ranging from 4 to 6.3 months with second-line chemotherapy, and 2.4 to 5.5 months with third-line chemotherapy.5,6,7,8 Data in subsequent lines of treatment show decreasing median PFS and OS with each further line of chemotherapy. There remains a need to improve outcomes including survival for patients living with advanced HR positive, HER2 negative breast cancer.9

    About TROP2

    TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein overexpressed in several types of solid tumors, including breast cancer.10 TROP2 expression has been detected in a wide range of breast cancer subtypes, including the HR positive, HER2 negative subtype.11,12 High TROP2 expression is an unfavorable prognostic factor for overall survival in all types of breast cancer.13 There are currently no TROP2 directed therapies approved for treatment of HR positive, HER2 negative breast cancer.

    About Datopotamab Deruxtecan (Dato-DXd)

    Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker.14

    A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), HR positive/HER2 negative breast cancer, small cell lung cancer (SCLC), urothelial, gastric and esophageal cancer. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

    About the Daiichi Sankyo and AstraZeneca Collaboration

    Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

    About Daiichi Sankyo in Oncology

    The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

    About Daiichi Sankyo

    Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: www.daiichisankyo.com.


    References:

    1 Sung H, et al. CA Cancer J Clin. 2021; 10.3322/caac.21660.

    2 Howlander et al. JNCI J Natl Cancer Inst. 2014; 106(5).

    3 NCCN Treatment Guidelines for Breast Cancer. Version 8.2021s.

    4 Davie A, et al. BMC Cancer. 2020 (20):855.

    5 Cazzaniga ME, et al. Breast. 2019;48:7-16.

    6 Cortes J, et al. Lancet 2011;377:914-923.

    7 Yuan P, et al. Eur J Cancer. 2019;112:57-65.

    8 Park IH, et al. Clin Breast Cancer. 2015;15:e55-62.

    9 Davie A et al. BMC Cancer. (2020) 20:855.

    10 Goldenberg D, et al. Oncotarget. 2018;9(48): 28989-29006.

    11 Ambrogi F, et al. PLoS One. 2014;9(5):e96993.

    12 Vidula N, et al. Journal of Clinical Oncology. 2017; 35:15_suppl, 1075-1075.

    13 Cardoso F et al. Ann Oncol. 2020 (12); 1623-1649.

    14 Okajima D. et al. Mol Cancer Ther. August 19, 2021.

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  4. Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442

    Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset

    New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

    In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

    About 2% of the global population is considered at increased…

    Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442

    Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset

    New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

    In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

    About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.1 This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.2-6

    The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants. More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.

    There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442 at either the primary or six-month analyses. In the placebo arm, there were two additional cases of severe COVID-19 at the six-month assessment, for a total of five cases of severe COVID-19 and two COVID-related deaths.

    An exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.

    A total of 90% of participants enrolled in TACKLE were from populations at high risk of progression to severe COVID-19 if they became infected, including those with co-morbidities.

    In both PROVENT and TACKLE, AZD7442 was generally well tolerated. No new safety issues were identified in the six-month analysis of PROVENT.

    Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and AZD7442 principal investigator, said: "These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives. Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination."

    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with one dose. These new data add to the growing body of evidence supporting AZD7442's potential to make a significant difference in the prevention and treatment of COVID-19. We are progressing regulatory filings around the world and look forward to providing an important new option against SARS-CoV-2 as quickly as possible."

    Full results from PROVENT and TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

    On October 5, 2021, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorization for AZD7442 for prophylaxis of COVID-19.

    AstraZeneca has agreed to supply the US Government with 700,000 doses of AZD7442 if granted an Emergency Use Authorization by the FDA and has agreements to supply to other countries.

    Notes

    PROVENT

    PROVENT is a Phase III, randomized, double-blind, placebo-controlled, multi-center trial assessing the safety and efficacy of a single IM 300mg dose of AZD7442 compared to placebo for the prevention of COVID-19 in participants who did not have who did not have SARS-CoV-2 infection at baseline. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium. 5,197 participants were randomized in a 2:1 ratio to receive a single IM dose of either 300mg of AZD7442 (n = 3,460) or saline placebo (n = 1,737), administered in two separate, sequential IM injections.

    The primary analysis reported on August 20, 2021 was based on 5,172 participants, with data cut-off May 9, 2021. The primary efficacy endpoint was the first case of any SARS-CoV-2 RT-PCR positive symptomatic illness occurring post dose prior to day 183. The six-month assessment was based on 4,991 participants, with a data cut-off of August 29, 2021. Subjects will continue to be followed for 15 months. Participants who chose to leave the PROVENT trial at any point to get vaccinated were excluded from the primary and six-month efficacy analyses.

    Participants were adults 18 years-old and over who would benefit from prevention with the LAAB, defined as having increased risk for inadequate response to active immunization (predicted poor responders to vaccines or intolerant of vaccine) or having increased risk for SARS-CoV-2 infection, including those whose locations or circumstances put them at appreciable risk of exposure to the SARS-CoV-2 virus. Participants at the time of screening were unvaccinated and had a negative point-of-care SARS-CoV-2 serology test.

    Approximately 43% of participants were 60 years and over. In addition, more than 75% had baseline co-morbidities and other characteristics that are associated with an increased risk for severe COVID-19 should they become infected, including those with immunosuppressive disease or taking immunosuppressive medications, diabetes, severe obesity or cardiac disease, chronic obstructive pulmonary disease, chronic kidney and chronic liver disease.

    AstraZeneca is progressing with filings around the globe for potential emergency use authorization or conditional approval of AZD7442 in both prophylaxis and treatment.

    TACKLE

    TACKLE is a Phase III, randomized, double-blind, placebo-controlled, multi-center trial assessing the safety and efficacy of a single 600mg IM dose of AZD7442 compared to placebo for the outpatient treatment of COVID-19. 903 participants were randomized (1:1) to receive either AZD7442 (n = 452) or saline placebo (n = 451), administered in two separate, sequential IM injections. The primary analysis was reported on October 11, 2021.

    Participants were adults 18 years-old and over who were non-hospitalized with mild-to-moderate COVID-19 and symptomatic for seven days or less. Participants had a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal, or nasal swab or saliva) collected no more than three days prior to day one.

    The primary efficacy endpoint was the composite of either severe COVID-19 or death from any cause through day 29. Subjects will continue to be followed for 15 months.

    Approximately 13% of participants were 65 years and over. In addition, 90% had baseline co-morbidities and other characteristics that put them at high risk of progression to severe COVID-19, including cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease or immunosuppression.

    AZD7442

    AZD7442 is a combination of two LAABs - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein7 and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration8-10; data from the Phase III PROVENT trial show protection lasting at least six months, with the Phase I trial showing high neutralizing antibody titers for at least nine months.11 The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.12

    AZD7442 is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Health's ACTIV-3 trial and in an additional collaborator hospitalization treatment trial.

    AZD7442 is being developed with support from the US Government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

    In preclinical experiments, data show the LAABs were able to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.13 Additional in vitro findings demonstrate AZD7442 neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.14

    Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

    About AstraZeneca

    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

    References

    1. Oliver, S MD. Data and clinical considerations for additional doses in immunocompromised people. ACIP Meeting July 22, 2021. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf. [Last accessed: November 2021].
    2. Centers for Disease Control and Prevention. Altered immunocompetence. General best practice guideline for immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. [Online]. Available at: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html. [Last accessed: November 2021].
    3. Boyarsky BJ, et al. Immunogenicity of a single dose of SARS-CoV-2 messenger RNA vaccine in solid organ transplant recipients. JAMA 2021; 325 (17):1784-1786.
    4. Rabinowich L, et al. Low immunogenicity to SARS-CoV-2 vaccination among liver transplant recipients, Journal of Hepatology (2021), doi: https://doi.org/10.1016/j.jhep.2021.04.020.
    5. Deepak P, et al. Glucocorticoids and B cell depleting agents substantially impair immunogenicity of mRNA vaccines to SARS-CoV-2. medRxiv [Preprint]. 2021 Apr 9:2021.04.05.21254656. doi: 10.1101/2021.04.05.21254656. PMID: 33851176; PMCID: PMC8043473.
    6. Simon D, et al. SARS-CoV-2 vaccination responses in untreated, conventionally treated and anticytokine-treated patients with immune-mediated inflammatory diseases. Ann Rheum Dis. 2021 May 6: annrheumdis-2021-220461. doi: 10.1136/annrheumdis-2021-220461. Epub ahead of print. PMID: 33958324.
    7. Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101/2021.01.27.428529.
    8. Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013; 57 (12): 6147-53.
    9. Griffin MP, et al. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Antimicrob Agents Chemother. 2017; 61(3): e01714-16.
    10. Domachowske JB, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion F-targeting monoclonal antibody administered as a single dose to healthy preterm infants. Pediatr Infect Dis J. 2018; 37(9): 886-892.
    11. Loo Y-M, et al. AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans. medRxiv. Cold Spring Harbor Laboratory Press; 2021 [preprint] Available from: https://www.medrxiv.org/content/10.1101/2021.08.30.21262666v1.
    12. van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548.
    13. Zost SJ, et al. Potently neutralizing and protective human antibodies against SARS-CoV 2. Nature. 2020; 584: 443–449.
    14. ACTIV. National Center for Advancing Translational Sciences OpenData Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: https://opendata.ncats.nih.gov/variant/activity [Last accessed: November 2021].

     

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  5. AstraZeneca has been granted Fast Track Designation in the United States (US) for the development of LOKELMA® (sodium zirconium cyclosilicate) to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia (HK). The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need. This is being investigated in the ongoing Phase III DIALIZE-Outcomes trial.

    HK is a prevalent condition in patients with chronic kidney disease (CKD) and heart failure (HF), affecting 24% to 48% of patients with moderate to advanced (stage 3-4) CKD and/or HF, and it remains a burden once patients are on chronic hemodialysis…

    AstraZeneca has been granted Fast Track Designation in the United States (US) for the development of LOKELMA® (sodium zirconium cyclosilicate) to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia (HK). The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need. This is being investigated in the ongoing Phase III DIALIZE-Outcomes trial.

    HK is a prevalent condition in patients with chronic kidney disease (CKD) and heart failure (HF), affecting 24% to 48% of patients with moderate to advanced (stage 3-4) CKD and/or HF, and it remains a burden once patients are on chronic hemodialysis. In patients with end-stage renal disease (ESRD) receiving chronic hemodialysis, HK has been associated with an increased risk of all-cause and CV mortality, and hospitalizations.

    The Food and Drug Administration's (FDA) Fast Track program is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.

    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: "The DIALIZE-Outcomes trial is the first ever cardiovascular outcomes trial with a potassium binder in hemodialysis and has the potential to transform standard of care for these patients. The FDA decision demonstrates the importance of this trial, which will offer important information on LOKELMA's ability to reduce potentially deadly cardiovascular complications associated with hyperkalemia for patients on chronic hemodialysis."

    The DIALIZE-Outcomes trial is part of the CRYSTALIZE evidence program, which is comprised of over 50 clinical and real-world evidence studies researching the potential benefit of LOKELMA in the management of HK across the cardiorenal spectrum. The DIALIZE-Outcomes trial is currently underway with results expected in 2024.

    LOKELMA is a highly selective, oral potassium-removing agent currently approved in the US, EU, Canada, Hong Kong, China, Russia, Japan and other countries for the treatment of HK. In 2020, the FDA and the European Commission (EC) approved label updates in the US and EU, respectively, to include a dosing regimen specifically to treat HK in patients with ESRD on chronic hemodialysis.

    IMPORTANT SAFETY INFORMATION FOR LOKELMA® (sodium zirconium cyclosilicate)

    WARNINGS AND PRECAUTIONS:

    • Gastrointestinal Adverse Events in Patients with Motility Disorders: Avoid LOKELMA® in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders. LOKELMA® has not been studied in patients with these conditions and it may be ineffective and may worsen gastrointestinal conditions
    • Edema: Each 5-g dose of LOKELMA® contains approximately 400 mg of sodium, but the extent of absorption by the patient is unknown. In clinical trials of LOKELMA® in patients who were not on dialysis, edema was observed and was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily. Monitor for signs of edema, particularly in patients who should restrict their sodium intake or are prone to fluid overload (eg, heart failure or renal disease). Advise patients to adjust dietary sodium, if appropriate. Increase the dose of diuretics as needed



      In a clinical trial of LOKELMA® in patients on chronic hemodialysis in which most patients were treated with doses of 5 g to 10 g once daily on non-dialysis days, there was no difference in the mean change from baseline in interdialytic weight gain (a measure of fluid retention) between the LOKELMA® and placebo groups
    • Hypokalemia in Patients on Hemodialysis: Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia on LOKELMA® (eg, illnesses associated with decreased oral intake, diarrhea). Consider adjusting LOKELMA® dose based on potassium levels in these settings
    • Diagnostic Tests: LOKELMA® has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures

    ADVERSE REACTIONS: The most common adverse reaction in non-dialysis patients with LOKELMA was mild to moderate edema. In placebo-controlled trials up to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of non-dialysis patients treated with 5 g, 10 g, and 15 g of LOKELMA once daily, respectively vs 2.4% of non-dialysis patients receiving placebo.

    DRUG INTERACTIONS: LOKELMA® can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least 2 hours before or 2 hours after LOKELMA. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.

    INDICATION AND LIMITATION OF USE

    LOKELMA® is indicated for the treatment of hyperkalemia in adults.

    LOKELMA® should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

    PLEASE READ FULL PRESCRIBING INFORMATION.

    Notes

    Hyperkalemia

    Hyperkalemia is characterized by high levels of potassium in the blood, generally defined as greater than 5.0 meq/L. Many people living with chronic kidney disease (CKD) have hyperkalemia despite being on hemodialysis and often experience fluctuations in their potassium levels. More than 500,000 patients in the US are living with dialysis-dependent ESRD, and in Europe approximately 300,000 patients with ESRD are undergoing hemodialysis. Despite adequate hemodialysis, up to 25% of patients have serum potassium >5.5 meq/L. Patients with high variability in potassium levels between dialysis sessions are at significant risk of arrhythmias, which can lead to cardiac arrest. Worldwide, there are an estimated 850 million and 64 million people living with CKD and HF respectively with hyperkalemia occurring in an estimated 24% to 48% of patients with moderate to advanced (stage 3-4) CKD and/or HF.

    DIALIZE-Outcomes

    DIALIZE-Outcomes is a Phase III randomized, double-blind, placebo-controlled, multicenter study evaluating the effect of LOKELMA on arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia. The study consists of a 4-week dose-titration period followed by patient visits every 3 months over an average of 2 years. This is an international study involving approximately 300 sites across the US, Canada, Russia, Europe, Asia, and South America.

    LOKELMA

    LOKELMA® (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine. It is administered orally, is odorless, tasteless and stable at room temperature. LOKELMA is indicated for the treatment of hyperkalemia in adults including patients on chronic hemodialysis.

    AstraZeneca in CVRM

    Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca's three disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

    About AstraZeneca

    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

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