AZN AstraZeneca PLC

48.91
-0.26  -1%
Previous Close 49.17
Open 49.84
52 Week Low 36.15
52 Week High 64.94
Market Cap $128,408,173,922
Shares 2,625,397,136
Float 2,625,397,136
Enterprise Value $144,227,712,548
Volume 12,831,669
Av. Daily Volume 13,257,557
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Upcoming Catalysts

Drug Stage Catalyst Date
Tezepelumab - NAVIGATOR
Asthma
Phase 3
Phase 3
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Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
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AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine
Phase 3
Phase 3
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Farxiga (Dapa-CKD)
Chronic Kidney Disease
PDUFA priority review
PDUFA priority review
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AZD7442 (STORMCHASER)
COVID-19 (post-exposure prophylaxis)
Phase 3
Phase 3
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Farxiga (Dapagliflozin)
COVID-19
Phase 3
Phase 3
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Imfinzi + tremelimumab (POSEIDON)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Imfinzi - PACIFIC-2
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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PT027
Asthma
Phase 3
Phase 3
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Imfinzi (PEARL)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Farxiga (Deliver)
Chronic Heart Failure (CHF), preserved ejection fraction (HFpEF)
Phase 3
Phase 3
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Lynparza - PROpel
Castration-resistant prostate cancer -first line
Phase 3
Phase 3
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Imfinzi + tremelimumab - HIMALAYA
Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Enhertu - Trastuzumab deruxtecan - DESTINY-Breast03
Second line HER2+ breast cancer
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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Enhertu - Trastuzumab deruxtecan DESTINY-Breast02
Third line HER2+ breast cancer
Phase 3
Phase 3
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Imfinzi - AEGEAN
Neoadjuvant Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Nirsevimab (MELODY)
Respiratory syncytial virus
Phase 3
Phase 3
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Roxadustat
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Imfinzi TOPAZ-1
Biliary-tract cancer
Phase 3
Phase 3
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Imfinzi DuO-O
Ovarian cancer
Phase 3
Phase 3
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Imfinzi (PACIFIC-5)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Fasenra MESSINA
Eosinophilic oesophagitis
Phase 3
Phase 3
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Fasenra MANDARA
Eosinophilic granulomatosis with polyangiitis
Phase 3
Phase 3
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Imfinzi CALLA
Cervical cancer
Phase 3
Phase 3
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Fasenra
Chronic obstructive pulmonary disease (COPD) and peripheral blood eosinophils
Phase 3
Phase 3
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Durvalumab (ADJUVANT)
Adjuvant Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Imfinzi
Non-muscle invasive bladder cancer
Phase 3
Phase 3
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Imfinzi
Locoregional Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Fasenra
Asthma
Phase 3
Phase 3
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Imfinzi
Muscle-invasive bladder cancer
Phase 3
Phase 3
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Durvalumab - EMERALD-1
Locoregional Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Durvalumab - ADRIATIC
Small cell lung cancer (SCLC) limited disease
Phase 3
Phase 3
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Fasenra
hypereosinophilic syndrome (HES)
Phase 3
Phase 3
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Brazikumab
Crohn's disease
Phase 3
Phase 3
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Brazikumab
Ulcerative colitis
Phase 2/3
Phase 2/3
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Imfinzi + tremelimumab (NILE)
Bladder cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ION449 (AZD8233)
Dyslipidaemia
Phase 2b
Phase 2b
Phase 2b trial initiation announced November 30, 2020.
Lynparza - 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.
Calquence (ELEVATE-RR)
Chronic Lymphocytic Leukemia (CLL)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 25, 2021.
Durvalumab +/- tremelimumab (KESTREL)
Head & neck cancer
Phase 3
Phase 3
Phase 3 trial did not meet the primary endpoint - February 5, 2021.
Trastuzumab deruxtecan - DESTINY-Gastric01
Gastric cancer
Approved
Approved
FDA approval announced January 18, 2021.
Tagrisso (ADAURA)
Non-small Cell Lung Carcinoma
Approved
Approved
FDA approval announced December 21, 2020.
Durvalumab +/- tremelimumab (NEPTUNE)
Lung cancer
Phase 3
Phase 3
Phase 3 data released August 21, 2019 did not meet primary endpoint.
MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
Phase 2 trial ongoing.
Brilinta (THALES)
Acute ischaemic stroke
Approved
Approved
FDA approval announced November 6, 2020.
Fasenra OSTRO
Nasal polyps
Phase 3
Phase 3
Phase 3 trial met primary endpoints.
Durvalumab +/- tremelimumab (DANUBE)
Bladder cancer
Phase 3
Phase 3
Phase 3 data released March 6, 2020 did not meet primary endpoint.
Epanova
Hypertriglyceridaemia CVOT
Phase 3
Phase 3
Phase 3 trial to be discontinued due to low likelihood of demonstrating a benefit - January 13, 2020.
Breztri - (ETHOS)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
FDA approval announced July 24, 2020.
Brilinta (THEMIS)
Type 2 Diabetes / coronary artery disease (CAD)
Approved
Approved
FDA approval announced June 1, 2020.
Lynparza
Castration-Resistant Prostate Cancer
Approved
Approved
FDA Approval announced May 19, 2020.
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
Approved
Approved
FDA Approval announced May 8, 2020.
Farxiga (Dapa-HF)
Heart failure
Approved
Approved
FDA Approval announced May 5, 2020.
Selumetinib
Neurofibromatosis type 1 plexiform neurofibromas
Approved
Approved
FDA Approval announced April 13, 2020.
Imfinzi + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)
Approved
Approved
FDA approval announced March 30, 2020.
Lynparza + cediranib
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 12, 2020.
Lynparza (POLO)
Pancreatic cancer
Approved
Approved
FDA Approval announced December 30, 2019.
Enhertu (trastuzumab deruxtecan)
Third line HER2+ breast cancer
Approved
Approved
FDA Approval announced December 20, 2019.
Calquence
Chronic lymphocytic leukaemia
Approved
Approved
FDA Approval announced November 21, 2019.
Anifrolumab
Lupus
Phase 3
Phase 3
Phase 3 TULIP 1 data released August 31, 2018. Primary endpoint not met. TULIP 2 data released August 29, 2019 did meet primary endpoint.
Farxiga - DECLARE
Heart failure in patients with type-2 diabetes
Approved
Approved
FDA Approval announced October 21, 2019.
PT010
Chronic obstructive pulmonary disease (COPD)
CRL
CRL
CRL announced October 1, 2019.
Tagrisso - 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.
Calquence
Relapsed/refractory chronic lymphocytic leukaemia
Phase 3
Phase 3
Phase 3 positive interim data released May 7, 2019. Trial to be stopped early.
Selumetinib - ASTRA
Thyroid cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 26, 2018.
Farxiga (Depict)
Type 1 diabetes
CRL
CRL
CRL issued for sNDA announced July 15, 2019.
Durvalumab +/- tremelimumab (EAGLE)
Head & neck cancer
Phase 3
Phase 3
Phase 3 data released December 7, 2018 - primary endpoints not met.
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.
Lanabecestat (AZD3293) - AMARANTH
Early Alzheimer's disease
Phase 3
Phase 3
Announced discontinuation of trial due to futility - June 12, 2018.
Lynparza - 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).
Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride)
Type 2 diabetes
Approved
Approved
FDA approval announced May 3, 2019.
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
Approved
Approved
FDA Approval announced December 19, 2018.
Moxetumomab
Cancer - leukaemia
Approved
Approved
FDA approval announced September 13, 2018.
Durvalumab (PACIFIC)
Lung cancer
Approved
Approved
Approval announced February 19, 2018.
Benralizumab - TERRANOVA
COPD
Phase 3
Phase 3
Phase 3 data released May 30, 2018. Primary endpoint not met.
Lokelma (ZS-9)
Hyperkalaemia
Approved
Approved
Second CRL issued March 17, 2017. Approval announced May 18, 2018.
Fasenra (benralizumab) - GALATHEA
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted May 11, 2018.
Urothelial carcinoma - Bladder cancer
Bladder cancer
Approved
Approved
BLA acceptance announced December 9, 2017. PDUFA under priority review. Approval announced May 1, 2017.
Durvalumab +/- tremelimumab (ARCTIC)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 data released April 24, 2018 - primary endpoints not met.
Benralizumab
Severe, uncontrolled asthma
Approved
Approved
Approval announced November 14, 2017.
Bydureon
Type 2 Diabetes
Phase 3
Phase 3
Phase 3 Cardiovascular Outcome trial data released September 14, 2017 - primary efficacy objective of a superior reduction in MACE missed statistical significance (p=0.061).
Acalabrutinib
Relapsed or Refractory Mantle Cell Lymphoma
Approved
Approved
Priority Review announced August 2, 2017. Approval announced October 31, 2017.
Saxagliptin and dapagliflozin
Type-2 diabetes
Approved
Approved
Approval announced February 28, 2017.
Lynparza
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 - SOLO 2
Second-line ovarian cancer
Approved
Approved
Approval announced August 17, 2017.
Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - May 10, 2017.
Tagrisso
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Approved
Approved
Approval announced March 31, 2017.
Tralokinumab (STRATOS2)
Severe, uncontrolled asthma
Phase 3
Phase 3
Phase 3 data released November 1, 2017 - primary endpoint not met.
Faslodex (fulvestrant)
Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer
Approved
Approved
Expanded approval announced August 28, 2017.

Latest News

  1. OlympiA Phase III trial of LYNPARZA in the adjuvant treatment of BRCA-mutated high-risk HER2-negative early breast cancer will be analyzed and reported early

    AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced the OlympiA Phase III trial for LYNPARZA® (olaparib) will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).

    Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for LYNPARZA versus placebo for patients with germline BRCA-mutated (gBRCA

    OlympiA Phase III trial of LYNPARZA in the adjuvant treatment of BRCA-mutated high-risk HER2-negative early breast cancer will be analyzed and reported early

    AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced the OlympiA Phase III trial for LYNPARZA® (olaparib) will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC).

    Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for LYNPARZA versus placebo for patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, and recommend primary analysis now take place.

    The OlympiA Phase III trial is a partnership between Breast International Group (BIG), NRG Oncology, the US National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and Merck.1 The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.

    An estimated 2.3 million women were diagnosed with breast cancer worldwide in 2020, and BRCA mutations are found in approximately 5% of breast cancer patients.2-10 Around 55-65% of women with a BRCA1 mutation and approximately 45% with a BRCA2 mutation will develop breast cancer before the age of 70.11

    Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor, Institute of Cancer Research and Kings College London, said: "We are delighted that our global academic and industry partnership has been able to help investigate a possible personalized treatment for women with hereditary breast cancer. The most common cause of hereditary breast cancer is an inherited mutation in the BRCA1 or BRCA2 genes which also may cause the disease to develop at a significantly earlier age than is usual. The OlympiA trial has allowed us to go beyond using genetic testing to identify patients who are at risk of this disease and explore the potential of LYNPARZA to prevent disease recurrence for these patients. We look forward to analyzing and presenting the full results of the trial at a forthcoming medical meeting."

    José Baselga, Executive Vice President, Oncology R&D, said: "Breast cancer remains one of the most common cancers globally and despite advances in treatment, many patients with high-risk disease will unfortunately develop a recurrence. We look forward to reviewing the results."

    Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck, said: "Analysis of the OlympiA trial, based upon the IDMC recommendation, could represent a potential step forward for patients with early-stage, high-risk primary breast cancer with a germline BRCA mutation."

    In its communication, the IDMC did not raise any new safety concerns. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival.

    In the US, LYNPARZA is approved for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. LYNPARZA is not currently approved for the adjuvant treatment of gBRCAm high-risk HER2-negative early breast cancer.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    There are no contraindications for LYNPARZA.

    WARNINGS AND PRECAUTIONS

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The duration of therapy in patients who developed secondary MDS/AML varied from <6 months to >2 years. All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy, and some also had a history of more than one primary malignancy or of bone marrow dysplasia.

    Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

    If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

    Pneumonitis: Occurred in <1% of patients exposed to LYNPARZA, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

    Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

    Females

    Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

    Males

    Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

    Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

    ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%), and stomatitis (11%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

    ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

    Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab compared to a ≥5% frequency for placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%) and headache (14%).

    In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%) and decrease in platelets (35%).

    ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

    Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%) and dyspepsia (20%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

    ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer after 3 or more lines of chemotherapy (pooled from 6 studies) were: fatigue/asthenia (66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia (22%), decreased appetite (22%), and arthralgia/musculoskeletal pain (21%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for advanced gBRCAm ovarian cancer (pooled from 6 studies) were: decrease in hemoglobin (90%), mean corpuscular volume elevation (57%), decrease in lymphocytes (56%), increase in serum creatinine (30%), decrease in platelets (30%), and decrease in absolute neutrophil count (25%).

    ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

    Most common adverse reactions (Grades 1-4) in ≥20% of patients in OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

    ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

    ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

    Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

    DRUG INTERACTIONS

    Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

    CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

    CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

    USE IN SPECIFIC POPULATIONS

    Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

    Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

    Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

    Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

    INDICATIONS

    LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

    First-Line Maintenance BRCAm Advanced Ovarian Cancer

    For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab

    In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

    • a deleterious or suspected deleterious BRCA mutation, and/or
    • genomic instability

    Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    Maintenance Recurrent Ovarian Cancer

    For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

    Advanced gBRCAm Ovarian Cancer

    For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    gBRCAm, HER2-Negative Metastatic Breast Cancer

    For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

    For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

    For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

    Please click here for complete Prescribing Information, including Patient Information (Medication Guide).

    Early breast cancer

    Breast cancer is the most common cancer among women worldwide and an estimated 90% of all breast cancer is diagnosed at an early stage.12,13 Breast cancer is one of the most biologically diverse tumor types with various factors fuelling its development and progression.14 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease.15

    BRCA1 and BRCA2

    BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including LYNPARZA.16-19

    OlympiA

    OlympiA is a Phase III, double-blind, parallel group, placebo-controlled, multicenter trial testing the efficacy and safety of LYNPARZA tablets versus placebo as adjuvant treatment in patients with gBRCAm high-risk HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial is iDFS defined as time from randomization to date of first treatment failure that is loco-regional or distant recurrence or new cancer or death from any cause.1

    NRG Oncology

    NRG Oncology is a network group funded by the NCI, a part of the National Institutes of Health. All of the NCI funded network groups participated in the trial. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement.

    NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project, the Radiation Therapy Oncology Group, and the Gynecologic Oncology Group, with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research.

    BIG

    The Breast International Group (BIG) is an international not-for-profit organization for academic breast cancer research groups from around the world, based in Brussels, Belgium.

    Founded by leading European opinions leaders in 1999, the organization aims to address fragmentation in European breast cancer research and now represents a network of over 55 like-minded research groups affiliated with specialized hospitals, research centers and leading experts across approximately 70 countries on six continents.

    BIG's research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG's purely academic breast cancer trials and research programs.

    FSTRF

    Frontier Science & Technology Research Foundation (FSTRF) is a non-profit, research organization which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful high-quality clinical trials. The OlympiA trial involved research staff in the US and in the Affiliate office in Scotland.

    FSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centers around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.

    Through its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.

    LYNPARZA

    LYNPARZA (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of PARP-dependent tumor types with defects and dependencies in the DDR pathway.

    LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has been used to treat over 40,000 patients worldwide. LYNPARZA has the broadest and most advanced clinical trial development program of any PARP inhibitor, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types. LYNPARZA is the foundation of AstraZeneca's industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

    The AstraZeneca and Merck strategic oncology collaboration

    In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world's first PARP inhibitor, and selumetinib, a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

    AstraZeneca in breast cancer

    Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

    AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines fulvestrant and goserelin and the next-generation selective estrogen receptor degrader (SERD) and potential new medicine camizestrant (AZD9833). PARP inhibitor, LYNPARZA is a targeted treatment option for patients with germline BRCA-mutated HER2-negative metastatic breast cancer. AstraZeneca with Merck continue to research LYNPARZA in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state.

    Building on the first approval of fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody-drug conjugate (ADC), in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab in combination with other oncology medicines, including LYNPARZA and fam-trastuzumab deruxtecan-nxki, assessing the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

    AstraZeneca in oncology

    AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

    By harnessing the power of six scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

    AstraZeneca

    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca-us.com and follow the Company on Twitter @AstraZenecaUS.

    References

    1. ClinicalTrials.gov. Olaparib as Adjuvant Treatment in Patients with Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA). Available at https://clinicaltrials.gov/ct2/show/NCT02032823. Accessed February 2021.

    2. GLOBOCAN. Breast Cancer. Available at https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf. Accessed February 2021.

    3. Gomes M.C, et al. Prevalence of BRCA1 and BRCA2 Mutations in Breast Cancer Patients from Brazil. Breast Cancer Res Treat. 2007 Jul;103(3):349-53.

    4. Hernandez J.E, et al. Prevalence of BRCA1 and BRCA2 Mutations in Unselected Breast Cancer Patients from Medellín, Colombia. Hered Cancer in Clin Pract. 2014;12:11.

    5. Bu R, et al. Identification of Novel BRCA Founder Mutations in Middle Eastern Breast Cancer Patients Using Capture and Sanger Sequencing Analysis. Int J Cancer. 2016;139:1091-1097.

    6. Abugattas J, et al. Prevalence of BRCA1 and BRCA2 Mutations in Unselected Breast Cancer Patients From Peru. Clin Genet. 2015 October;88(4):371-375.

    7. Kast K, et al. Prevalence of BRCA1/2 Germline Mutations in 21,401 Families with Breast and Ovarian Cancer. J Med Genet. 2016;53:465-471.

    8. Winter C, et al. Targeted Sequencing of BRCA1 and BRCA2 Across a Large Unselected Breast Cancer Cohort Suggests That One-third of Mutations Are Somatic. Ann Oncol. 2016;27:1532-1538.

    9. Hoberg-Vetti H, et al. BRCA1/2 Testing in Newly Diagnosed Breast and Ovarian Cancer Patients Without Prior Genetic Counselling: the DNA-BONus Study. Eur J HumGenetic. 2016;24:881-888.

    10. Kim R, et al. Incidence of germline BRCA1- and BRCA2-mutated Breast Cancer in the US. SABCS. 2017;poster P5-08-28.

    11. National Breast Cancer Foundation. BRCA: The Breast Cancer Gene. Available at https://www.nationalbreastcancer.org/what-is-brca. Accessed February 2021.

    12. SEER. SEER Cancer Statistics Review, 1975-2013. Available at http://seer.cancer.gov/csr/1975_2013/. Accessed February 2021.

    13. Bertozzi S, et al. Biomarkers in Breast Cancer. Intechopen. 2018.

    14. Yersal O, and Barutca S. Biological Subtypes of Breast Cancer: Prognostic and therapeutic implications. World J Clin Oncol. 2014;5(3):412-424.

    15. Rivenbark A, et al. Molecular and Cellular Heterogeneity in Breast Cancer: Challenges for Personalized Medicine. Am J Pathol. 2013;183(4):1113-1124.

    16. Roy R, et al. BRCA1 and BRCA2: Different Roles in a Common Pathway of Genome Protection. Nat Rev Cancer. 12(1):68-78.

    17. Wu J, et al. The Role of BRCA1 in DNA Damage Response. Protein Cell. 2010;1(2):117-123.

    18. Gorodetska I, et al. BRCA Genes: The Role in Genome Stability, Cancer Stemness and Therapy Resistance. J Cancer. 2019;10(9):2109-2127.

    19. Li H, et al. PARP Inhibitor Resistance: The Underlying Mechanisms and Clinical Implications. Mol Cancer. 2020;19:107.

    US-50210 | 2/21

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  2. MOUNTAIN VIEW, Calif., Feb. 16, 2021 /PRNewswire/ -- AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, today announced a new collaboration with AstraZeneca (NASDAQ:AZN), a global science-led biopharmaceutical company, to research new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. The collaboration will translate AliveCor's potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions.

    The cross-industry collaboration expands the research and development of AliveCor's Kardia-K AI platform, which received "Breakthrough Device Designation" status from the FDA to screen for elevated levels of blood potassium. Kardia-K is being built using AliveCor's proprietary deep neural network, and analyzes electrocardiograms (ECGs) to measure a patient's potassium levels without requiring any blood from the patient. AliveCor's neural network was trained in collaboration with Mayo Clinic using more than 1.5 million ECGs and was validated on approximately 62,000 ECGs. The research was published in JAMA Cardiology in April 2019.

    "By collaborating across industries, AliveCor is leading the way in the development of non- invasive, more accessible medical solutions for patients and health organizations worldwide," said Aman Bhatti, Head of BioPharma Relationships at AliveCor. "Our collaboration with AstraZeneca exemplifies how pharmaceutical and digital health companies can work together to drive the future of medicine."

    For the nearly 30 million U.S. adults with chronic kidney disease, the one-day likelihood of a fatality is 3 to 13 times higher if potassium is elevated. The current standard practice for measuring potassium levels is a blood test, which is invasive, inconvenient, and poses safety risks for patients during the pandemic. A remote, easy-to-use potassium test could help track for increased potassium levels in those patients, as well as the 500,000 Americans with end stage kidney disease and on dialysis, where high potassium may contribute to up to 40% of fatalities.

    The collaboration seeks to improve the delivery of life-changing medicines that are fueling growth in the industry and providing value to patients and society. Its initiative accelerates AliveCor's work with key players in the BioPharma industry and demonstrates diverse interest in AliveCor's technology, from clinical research organizations to health systems to pharmaceutical companies' digital therapeutic programs.

    About AliveCor

    AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world. KardiaMobile provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Heart Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the early detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor's enterprise platform allows third party providers to manage their patients' and customers' heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alivecor-announces-collaboration-with-astrazeneca-to-develop-non-invasive-potassium-monitoring-solutions-301228042.html

    SOURCE AliveCor

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  3. Following the European Medicines Agency (EMA) approval, millions of AstraZeneca vaccines began shipping on 5 February as part of the initial 17m doses that are due to be delivered over the next weeks, with more planned in March.

    AstraZeneca and IDT Biologika are exploring options to accelerate output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021 in order to help support Europe's immediate vaccination needs during the pandemic.

    AstraZeneca and IDT Biologika also intend to strengthen Europe's vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Details of the agreement are to be finalised. Both companies plan to invest in capacity expansion at IDT…

    Following the European Medicines Agency (EMA) approval, millions of AstraZeneca vaccines began shipping on 5 February as part of the initial 17m doses that are due to be delivered over the next weeks, with more planned in March.

    AstraZeneca and IDT Biologika are exploring options to accelerate output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021 in order to help support Europe's immediate vaccination needs during the pandemic.

    AstraZeneca and IDT Biologika also intend to strengthen Europe's vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Details of the agreement are to be finalised. Both companies plan to invest in capacity expansion at IDT Biologika's production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca's COVID-19 vaccine. The new assets are estimated to be operational by the end of 2022.

    The investment could also allow for the manufacture of other vaccines sharing a similar manufacturing process, greatly expanding Europe's domestic vaccine production capability. IDT Biologika will have among the largest vaccine manufacturing capacities of its kind in Europe and play an important part in ensuring Europe's future vaccine supply independence.

    Jürgen Betzing, Chief Executive Officer, IDT Biologika, said: “We are proud that AstraZeneca has chosen us as a strategic partner for the manufacturing of their vaccines. The agreement underscores our expertise in the production of demanding vector-based vaccines and our ability to provide a one-stop solution, from creating drug substance, through to “fill and finish” and secondary packaging. I would like to thank the German Ministry of Health for their support in making this cooperation happen, which marks a great day for Germany and Europe.”

    Pascal Soriot, Chief Executive Officer, said: “This agreement will greatly help Europe build an independent vaccine manufacturing capability that will allow it to meet the challenges of the current pandemic and create strategic supply capacity for the future. We are delighted to be investing with our partner IDT Biologika in the future health, security and wellbeing of millions of citizens across Europe. I would like to thank the German Federal Government and the European Commission for their support in our efforts.”

    On 29 January, COVID-19 Vaccine AstraZeneca was granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. The vaccine's flexible dosing regimen allows an interval of up to three months between first and second dose, allowing public health authorities to rapidly deploy the vaccine to large numbers of people.

    COVID-19 Vaccine AstraZeneca, formerly AZD1222
    COVID-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

    In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.

    COVID-19 Vaccine AstraZeneca has already been granted a conditional marketing authorisation or emergency use in over 50 countries, spanning four continents including in the EU, a number of Latin American countries, India, Morocco and the UK.

    AstraZeneca
    AstraZeneca (NASDAQ:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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. Please visit astrazeneca.com 

    — WebWireID270231 —


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  4. The KESTREL Phase III trial for AstraZeneca's Imfinzi (durvalumab) did not meet the primary endpoint of improving overall survival (OS) versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the 1st-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumours expressed high levels of PD-L1. Also, the combination of Imfinzi plus tremelimumab did not indicate an OS benefit in 'all-comer' patients, a secondary endpoint.

    Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis. While we are disappointed by these results, insights from the KESTREL…

    The KESTREL Phase III trial for AstraZeneca's Imfinzi (durvalumab) did not meet the primary endpoint of improving overall survival (OS) versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the 1st-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumours expressed high levels of PD-L1. Also, the combination of Imfinzi plus tremelimumab did not indicate an OS benefit in 'all-comer' patients, a secondary endpoint.

    Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis. While we are disappointed by these results, insights from the KESTREL Phase III trial will advance our understanding and application of immunotherapy across our clinical development programme. We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit.”

    The safety and tolerability profiles for Imfinzi as a monotherapy and in combination with tremelimumab were consistent with previous trials. The data will be shared in due course.

    HNSCC
    Nearly 750,000 patients were diagnosed with head and neck cancer around the world in 2020.1 Two thirds of these patients are diagnosed in advanced stages, and more than half of those treated eventually relapse.2,3 Median survival for a patient with an uncurable or metastatic relapse remains under one year.More than 90% of all head and neck cancers start in the squamous cells that line the mouth, nose and throat and are called head and neck squamous cell carcinomas.4

    KESTREL
    The KESTREL Phase III trial was a randomised, open-label, multi-centre, global trial in the 1st-line treatment of recurrent or metastatic HNSCC. The trial tested Imfinzi or Imfinzi plus a second immunotherapy, tremelimumab, versus the EXTREME treatment regimen (cetuximab with cisplatin or carboplatin plus 5-fluorouracil), a standard of care treatment. High PD-L1 was defined as either 50% or more tumour cells or 25% or more tumour-infiltrating immune cells expressing PD-L1.

    The trial was conducted in more than 200 centres across 23 countries, including centres in the US, Europe, South America and Asia. The primary endpoint was OS in patients with high PD-L1 expression in the Imfinzi monotherapy arm. OS in 'all-comer' patients treated with the combination of Imfinzi plus tremelimumab was being tested as a key secondary endpoint.

    Imfinzi
    Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

    Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in the EU, US, Japan, China and many other countries, based on the PACIFIC Phase III trial. Additionally, it is approved in the EU, US, Japan and many other countries for the treatment of extensive-stage small cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Imfinzi&#8239;is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.

    As part of a broad development programme, Imfinzi is being tested as a monotherapy and in combination with other anti-cancer treatments for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma (HCC), biliary tract cancer, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.

    Tremelimumab
    Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer and HCC.

    AstraZeneca in immunotherapy
    Immunotherapy is a therapeutic approach designed to stimulate the body's immune system to attack tumours. The Company's Immuno-Oncology (IO) portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

    The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and small, targeted molecules from across AstraZeneca's oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

    In head and neck cancer, the Company is also testing monalizumab, a first-in-class humanised anti-NKG2A antibody, in combination with cetuximab in the INTERLINK-1 Phase III trial in patients with recurrent or metastatic HNSCC previously treated with IO and chemotherapy. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

    AstraZeneca in oncology
    AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

    By harnessing the power of six scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

    AstraZeneca
    AstraZeneca (NASDAQ:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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. Please visit astrazeneca.com 

    1. World Health Organization. World GLOBOCAN 2020. Available at https://gco.iarc.fr/today/home. Accessed January 2021.

    2. Heriou A, et al. Multiple Cancers of the Head and Neck. MAEDICA – a Journal of Clinical Medicine 2013;8(1):80-852.

    3. Rothschild U, et al. Immunotherapy in head and neck cancer – scientific rationale, current treatment options and future directions. Swiss Med Wkly. 2018;148:w14625.

    4. Palka K, et al. Update in Molecular Diagnostic Tests in Head and Neck Cancer. Semin Oncol. 2008 June;35(3):198-210.

     

    — WebWireID270057 —


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  5. AstraZeneca has agreed, subject to certain limited exceptions, to divest its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc (Nasdaq: HZNP).

    AstraZeneca is anticipating to receive cash proceeds and profit of c.$760-$780m upon closing for the sale of the holding, which will be recorded in Reported and Core Other Operating Income and Expense in the Company's financial statements. The divestment is expected to complete by the end of the first quarter of 2021.

    The divestment does not impact the Company's financial guidance for 2020. Guidance for 2021 is anticipated to be issued with full-year 2020 results on 11 February 2021.

    Viela
    Viela (NASDAQ:VIE), headquartered in Gaithersburg…

    AstraZeneca has agreed, subject to certain limited exceptions, to divest its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc (Nasdaq: HZNP).

    AstraZeneca is anticipating to receive cash proceeds and profit of c.$760-$780m upon closing for the sale of the holding, which will be recorded in Reported and Core Other Operating Income and Expense in the Company's financial statements. The divestment is expected to complete by the end of the first quarter of 2021.

    The divestment does not impact the Company's financial guidance for 2020. Guidance for 2021 is anticipated to be issued with full-year 2020 results on 11 February 2021.

    Viela
    Viela (NASDAQ:VIE), headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialisation of novel treatments for autoimmune and severe inflammatory diseases. Viela was founded in 2018 as a spinout from AstraZeneca, with clinical and pre-clinical projects from AstraZeneca's inflammation and autoimmunity pipeline.

    AstraZeneca
    AstraZeneca (NASDAQ:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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. Please visit astrazeneca.com 

    — WebWireID269806 —


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