AZN Astrazeneca PLC

53.8
+0.48  (+1%)
Previous Close 53.32
Open 53.63
52 Week Low 36.15
52 Week High 57.44
Market Cap $141,200,368,316
Shares 2,624,542,162
Float 2,624,542,162
Enterprise Value $154,351,588,077
Volume 4,591,334
Av. Daily Volume 5,153,310
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Upcoming Catalysts

Drug Stage Catalyst Date
AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine
Phase 1
Phase 1
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Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
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Imfinzi + tremelimumab - HIMALAYA
Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
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Tezepelumab - NAVIGATOR
Asthma
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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Fasenra OSTRO
Nasal polyps
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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Durvalumab +/- tremelimumab (KESTREL)
Head & neck cancer
Phase 3
Phase 3
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Trastuzumab deruxtecan DESTINY-Breast02
Third line HER2+ breast cancer
Phase 3
Phase 3
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Trastuzumab deruxtecan - DESTINY-Breast03
Second line HER2+ breast cancer
Phase 3
Phase 3
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Trastuzumab deruxtecan - DESTINY-Breast04
HER low breast cancer
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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Lynparza - PROpel
Castration-resistant prostate cancer -first line
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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PT027
Asthma
Phase 3
Phase 3
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Roxadustat
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Lynparza - OlympiA
HER2-negative breast 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 Plus Danvatirsen
Refractory head and neck cancer
Phase 1/2
Phase 1/2
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Imfinzi
Non-muscle invasive bladder cancer
Phase 3
Phase 3
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Imfinzi
Muscle-invasive bladder cancer
Phase 3
Phase 3
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Imfinzi CALLA
Cervical cancer
Phase 3
Phase 3
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Imfinzi + tremelimumab (NILE)
Bladder cancer
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 MANDARA
Eosinophilic granulomatosis with polyangiitis
Phase 3
Phase 3
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Imfinzi DuO-O
Ovarian cancer
Phase 3
Phase 3
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Imfinzi
Locoregional Hepatocellular carcinoma (HCC)
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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Fasenra
Chronic obstructive pulmonary disease (COPD) and peripheral blood eosinophils
Phase 3
Phase 3
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Fasenra
hypereosinophilic syndrome (HES)
Phase 3
Phase 3
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Fasenra MESSINA
Eosinophilic oesophagitis
Phase 3
Phase 3
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Imfinzi (PEARL)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Imfinzi TOPAZ-1
Biliary-tract cancer
Phase 3
Phase 3
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Fasenra
Asthma
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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Drug Pipeline

Drug Stage Notes
Brilinta (THEMIS)
Type 2 Diabetes / coronary artery disease (CAD)
Approved
Approved
FDA approval announced June 1, 2020.
Tagrisso (ADAURA)
Non-small Cell Lung Carcinoma
Phase 3
Phase 3
Phase 3 data released May 28, 2020 noted a reduction in the risk of disease recurrence or death by 83%.
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.
Farxiga (Dapa-CKD)
Chronic Kidney Disease
Phase 3
Phase 3
Phase 3 trial stopped early due to overwhelming efficacy.
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.
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.
Brazikumab
Ulcerative colitis
Phase 2/3
Phase 2/3
Phase 2/3 trial ongoing.
Brazikumab
Crohn's disease
Phase 3
Phase 3
Phase 3 ongoing.
Trastuzumab deruxtecan - DESTINY-Gastric01
Gastric cancer
Phase 2
Phase 2
Phase 2 data trial met primary endpoint.
Brilinta (THALES)
Acute ischaemic stroke
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 27, 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.
Fasenra
Hypereosinophilic Syndrome
Phase 2
Phase 2
Phase 2 trial met primary endpoint - noted April 4, 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.
Durvalumab +/- tremelimumab (NEPTUNE)
Lung cancer
Phase 3
Phase 3
Phase 3 data released August 21, 2019 did not 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 and Lerociclib (G1T38)
EGFR mutation-positive non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
Phase 1/2 poster at ESMO September 28, 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.
Breztri - (ETHOS)
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
Phase 3 data released August 28, 2019. Primary endpoint met.
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.
Acalabrutinib
Relapsed or Refractory Mantle Cell Lymphoma
Approved
Approved
Priority Review announced August 2, 2017. Approval announced October 31, 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).
Saxagliptin and dapagliflozin
Type-2 diabetes
Approved
Approved
Approval announced February 28, 2017.
Lynparza - SOLO 2
Second-line ovarian cancer
Approved
Approved
Approval announced August 17, 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.
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. Trial results published in New England Journal of Medicine

    Full results from the positive Phase III ETHOS trial showed AstraZeneca's triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

    Trial results published in New England Journal of Medicine

    Full results from the positive Phase III ETHOS trial showed AstraZeneca's triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

    Compared with glycopyrronium/formoterol fumarate, PT010 achieved a 24% reduction (p<0.001) in exacerbations. PT010 achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). The dual-combination therapies used as comparators in the trial represent recommended therapeutic classes for the treatment of COPD.

    In a key secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate (unadjusted p=0.01).

    The results were published in the New England Journal of Medicine and simultaneously presented at the American Thoracic Society virtual Scientific Symposium, Clinical Trial Results in Pulmonary Medicine. AstraZeneca will continue to review these data with health authorities.

    Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and Lead Investigator of the ETHOS trial, said: "The Phase III ETHOS trial results are important and demonstrate the benefit of PT010 in reducing the rate of exacerbations in this progressive disease. The findings also show that reducing risk of all-cause mortality is achievable and could transform treatment goals in chronic obstructive pulmonary disease."

    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "Chronic obstructive pulmonary disease is the third leading cause of death worldwide and exacerbations can contribute to an increase in mortality in these patients. The results of the Phase III ETHOS trial support the strong clinical profile of PT010 in reducing exacerbation rates compared with dual-combination therapies. We are excited to have the data on all-cause mortality, which is a key consideration for COPD management."

    The safety and tolerability of PT010 were consistent with the known profiles of the dual comparators. In the trial, the most frequently reported adverse events were nasopharyngitis, COPD and upper respiratory tract infection. The incidence of confirmed pneumonia was 4.2% with PT010, 2.3% with glycopyrronium/formoterol fumarate and 4.5% with PT009.

    These results are based on PT010 at the standard dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg), an inhaled corticosteroid (ICS). In the trial, PT010 at half the dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with glycopyrronium/formoterol fumarate (14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg).

    PT010 is approved in Japan and China for patients with COPD. It is also under regulatory review in the US and EU.

    COPD

    COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people and is the third leading cause of death globally. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD. Even a single COPD exacerbation may be associated with a significant increase in the rate of decline in lung function, a significant deterioration in quality of life, and can significantly reduce life expectancy and increase the risk of mortality.

    ETHOS and the ATHENA clinical trial program

    ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.

    Glycopyrronium/formoterol fumarate is a fixed-dose dual bronchodilator in a pressurized metered-dose inhaler (pMDI), combining glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA). PT009 is a single inhaler, fixed-dose dual-combination therapy of budesonide, an ICS, and formoterol fumarate, a LABA. It was developed as a relevant comparator in clinical trials for PT010.

    ETHOS involved more than 8,500 patients who had experienced ≥1 moderate/severe exacerbation in the previous year and were receiving at least two inhaled maintenance treatments at entry into the trial.

    ETHOS is part of AstraZeneca's ATHENA Phase III clinical trial program for PT010, which included more than 15,500 patients globally across 11 trials. The results of the earlier pivotal Phase III KRONOS trial were published in Lancet Respiratory Medicine.

    ETHOS Primary and Key Secondary Endpoints

    ETHOS Primary Endpoints

    Endpoint

    Timepoint

    Comparison/results

    Rate of moderate

    or severe COPD

    exacerbations

     

    Over 52 weeks

     

    PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Significant (p<0.001)

    PT010 (320mcg budesonide dose) vs PT009

    Significant (p=0.003)

    PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Significant (p<0.001)

    PT010 (160mcg budesonide dose) vs PT009

    Significant (p=0.002)

    ETHOS Secondary Endpoints

    Endpoint

    Timepoint

    Comparison/results

    Time to first

    moderate or

    severe COPD

    exacerbation

    Over 52 weeks

    PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Significant (p=0.004)

    PT010 (320mcg budesonide dose) vs PT009

    Significant (p=0.006)

    PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Significant (p=0.001)

    PT010 (160mcg budesonide dose) vs PT009

    Significant (p=0.002)

    Rate of severe

    COPD

    exacerbations

    Over 52 weeks

    PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Not significant (p=0.09)

    PT010 (320mcg budesonide dose) vs PT009

    Significant (p=0.02)

    PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Not significant (p=0.22)

    PT010 (160mcg budesonide dose) vs PT009

    Not significant (p=0.06)

    Time to death (all-

    cause mortality)

    Over 52 weeks

    PT010 (320mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Nominally Significant (unadjusted p=0.01)

    PT010 (320mcg budesonide dose) vs PT009

    Not significant (p=0.34)

    PT010 (160mcg budesonide dose) vs glycopyrronium/formoterol fumarate

    Not significant (p=0.27)

    PT010 (160mcg budesonide dose) vs PT009

    Not significant (p=0.59)

    PT010

    PT010 (budesonide/glycopyrronium/formoterol fumarate) is a single-inhaler, fixed dose triple-combination of budesonide, an ICS, with glycopyrronium, a LAMA, and formoterol fumarate, a LABA.

    Under the terms of the agreement to acquire Pearl Therapeutics Inc., AstraZeneca anticipates making a $150m milestone payment upon US regulatory approval of PT010 for COPD. This payment would be the final development and regulatory milestone under that agreement.

    AstraZeneca in Respiratory & Immunology

    Respiratory & Immunology is one of AstraZeneca's three therapy areas and is a key growth driver for the Company.

    AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company's early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

    With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company's growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca's ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

    AstraZeneca

    AstraZeneca (NYSE:AZN) 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 and 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 www.astrazeneca-us.com and follow the Company on Twitter @AstraZenecaUS.

    US-40366 Last Updated 6/20

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  2. SUZHOU, China and ROCKVILLE, Md., June 21, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and senescence diseases, today announced a clinical collaboration with Acerta Pharma, the hematology research and development center of excellence of AstraZeneca (NYSE:AZN). Under the terms of the collaboration, Ascentage will sponsor a clinical trial to study the combination of Ascentage Pharma's APG-2575, a selective Bcl-2 inhibitor, and Acerta's CALQUENCE® (acalabrutinib), a Bruton's Tyrosine Kinase (BTK) inhibitor, evaluating the efficacy and safety of this combination therapy in patients with relapsed/refractory (r/r) chronic…

    SUZHOU, China and ROCKVILLE, Md., June 21, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and senescence diseases, today announced a clinical collaboration with Acerta Pharma, the hematology research and development center of excellence of AstraZeneca (NYSE:AZN). Under the terms of the collaboration, Ascentage will sponsor a clinical trial to study the combination of Ascentage Pharma's APG-2575, a selective Bcl-2 inhibitor, and Acerta's CALQUENCE® (acalabrutinib), a Bruton's Tyrosine Kinase (BTK) inhibitor, evaluating the efficacy and safety of this combination therapy in patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

    This global, multicenter, open-label Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with CALQUENCE® in patients with r/r CLL/SLL. The study has already initiated in US with the dosing of first patient, and planned to expand in Europe, and Australia.



    CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms and constitutes the most common form of adult leukemia in North America and Europe, accounting for about 30% of all new leukemia cases. Despite significant initial responses to current first-line treatments, many patients with CLL need ongoing treatment to maintain these responses, and relapse often portends a poor prognosis. Recent studies in CLL showed that combining a BTK inhibitor with another Bcl-2 inhibitor can deepen responses and even shorten cyclic treatment, enabling patients to achieve complete remission and therefore discontinue treatment.1,2 These findings have provided a compelling rationale for exploring APG-2575 in combination with BTK inhibitors.

    "We are delighted to enter this collaboration with Acerta. APG-2575 is a key drug candidate in our development pipeline targeting apoptosis, with great potential in the treatment of hematologic malignancies. Collaborating with Acerta helps to accelerate our global clinical development program for APG-2575," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Combination therapy is becoming more important in cancer treatment, and the rationale of a Bcl-2 inhibitor combined with a BTK inhibitor is sound. We hope that APG-2575 combined with CALQUENCE® will show synergistic effects in the treatment of CLL/SLL, offering additional treatment options for patients with otherwise limited treatment options around the world."

    References

    1. Jain N, Keating M, Thompson P, et al. Ibrutinib and venetoclax for first-line treatment of CLL. N Engl J Med 2019;380:2095-2103.

    2. Wiestner A. Ibrutinib and venetoclax — doubling down on CLL. N Engl J Med 2019;380:2169-2171.

    About APG-2575

    APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat a variety of hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Since March 2020, the company has received approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, and is advancing clinical development of APG-2575 for a variety of hematologic malignancy indications.

    About Ascentage Pharma

    Ascentage Pharma (6855.HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and senesce diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.

    Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 30 Phase I/II clinical trials in the US, Australia, and China. The company's core drug candidate HQP1351 was recently granted orphan drug and fast-track designations by the US Food and Drug Administration (FDA), and a New Drug Application for HQP1351 has been submitted in China.

    Forward-Looking Statements

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ascentage-pharma-enters-clinical-collaboration-to-evaluate-the-combination-of-bcl-2-and-btk-inhibitors-301080771.html

    SOURCE Ascentage Pharma

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  3. Exploratory analysis from FARXIGA DAPA-HF Phase III trial will provide insights on the onset of type 2 diabetes in heart failure patients

    Sub-analyses from the DECLARE Phase III trial to highlight FARXIGA's effect on fast renal decline

    AstraZeneca will present new data from the landmark Phase III DAPA-HF and DECLARE-TIMI 58 trials at the upcoming 80th American Diabetes Association (ADA) Virtual Scientific Sessions, June 12 – 16 2020. The data are among 23 accepted abstracts, including four oral presentations, covering trials that showcase the depth and breadth of potential cardio, renal and metabolic benefits for patients across AstraZeneca's portfolio.

    Highlights include:

    • An oral presentation of data from the DAPA-HF trial showing the…

    Exploratory analysis from FARXIGA DAPA-HF Phase III trial will provide insights on the onset of type 2 diabetes in heart failure patients

    Sub-analyses from the DECLARE Phase III trial to highlight FARXIGA's effect on fast renal decline

    AstraZeneca will present new data from the landmark Phase III DAPA-HF and DECLARE-TIMI 58 trials at the upcoming 80th American Diabetes Association (ADA) Virtual Scientific Sessions, June 12 – 16 2020. The data are among 23 accepted abstracts, including four oral presentations, covering trials that showcase the depth and breadth of potential cardio, renal and metabolic benefits for patients across AstraZeneca's portfolio.

    Highlights include:

    • An oral presentation of data from the DAPA-HF trial showing the effect of FARXIGA® (dapagliflozin) on the incidence of new onset of type 2 diabetes (T2D) in patients with heart failure and reduced ejection fraction (HFrEF) (Abstract #271-OR)1
    • New sub analyses from the DECLARE-TIMI 58 trial, presented orally, providing insights on FARXIGA's effect on fast kidney function decline in T2D patients with established or increased risk for cardiovascular disease (Abstract #303-OR)2
    • An analysis of the DAPA-HF trial examining if background T2D therapy impacts the benefits of FARXIGA in heart failure (HF) (Abstract #1112-P)3
    • A new analysis of the global observational DISCOVER real world evidence study, presented orally, reporting health-related quality of life factors in patients with T2D initiating a second-line glucose-lowering therapy (Abstract #40-OR)4
    • An oral presentation of new Phase II data on investigational cotadutide, a dual receptor agonist with balanced GLP-1 and glucagon activity, showing positive effect on blood glucose levels and changes in liver fat and glycogen stores in patients with T2D (Abstract #354-OR)5
    • BRILINTA® (ticagrelor) data on duration of T2D, baseline HbA1c levels as well as the impact of blood sugar-lowering background therapies on outcomes in T2D patients with coronary artery disease (THEMIS diabetes subgroup) (Abstract #403-P)6

    Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: "An overwhelming majority of people with type 2 diabetes also have at least one other cardiovascular, renal or metabolic disease. The breadth and depth of data we are presenting at ADA 2020 demonstrates our commitment to developing treatment options for patients living with diabetes that go beyond glycemic control to also protect the heart, liver and kidneys."

    In addition to its robust clinical data, AstraZeneca will also present results from a global survey of more than 1,600 physicians in 18 countries examining primary care approaches and clinical inertia in the treatment of patients with T2D.

    Key abstracts and other notable abstracts to be presented at ADA:

    Lead author

     

    Abstract title

     

    Presentation details

    Cotadutide

    Robertson, D.

     

    Cotadutide (MEDI0382), a Dual Receptor Agonist With Glucagon-like Peptide-1 and Glucagon Activity, Modulates Hepatic Glycogen and Fat Content

     

    Oral Presentation

    Monday, June 15

    5:30 – 5:45

    #354-OR

    Robertson, D.

     

    Cotadutide (MEDI0382), A Dual Receptor Agonist With Glucagon-like Peptide-1 And Glucagon Activity, Is Well-tolerated (<600 μG) With Robust Effects On Blood Glucose In Patients With T2DM

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #951-P

    Laker, R.C.

     

    Cotadutide, a GLP-1/Gcg Receptor Co-agonist Improves Insulin Sensitivity and Restores Normal Insulin Secretory Capacity in DIO Mice

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1800-P

    FARXIGA

    Inzucchi, SE.

     

    Effect of Dapagliflozin on the Incidence Of Diabetes: A Prespecified Exploratory Analysis From DAPA-HF

     

    Oral Presentation

    Monday, June 15

    8:00 – 8:15

    #271-OR

    Raz, I.

     

    Effect of Dapagliflozin on Risk for Fast Decline in eGFR: Analyses from the DECLARE-TIMI 58 Trial

     

    Oral Presentation

    Monday, June 15

    2:30 – 2:45

    #303-OR

    Cahn, A.

     

    Cardiorenal Outcomes with Dapagliflozin by Baseline Glucose Lowering Agents Analyses from DECLARE-TIMI 58

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1101-P

    Ang, L.

     

    Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients with Type 2 Diabetes

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #554-P

    Ono, S.

     

    Effects of Long-term Dapagliflozin Treatment on Hemorheology (D-PATH Study)

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1106-P

    Docherty, KF.

     

    Does Background T2D Therapy Modify the Benefits of Dapagliflozin in Heart Failure? Analysis of the DAPA-HF Trial

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1112-P

    Sato, D.

     

    Dapagliflozin Suppresses Adipose Fatty Acid Accumulation in Rats Fed on High-Fat Diet but not on Normal Chow

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1946-P

    Faerch, K.

     

    Changes in Plasma Levels of Liver Enzymes in Response to Dapagliflozin, Metformin or Exercise in People with Prediabetes: The PRE-D Trial

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #845-P

    Clemmensen, KKB.

     

    Effects Of Dapagliflozin, Metformin Or Exercise On Plasma Glucagon Concentrations in Individuals With Prediabetes: The PRE-D Trial

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #844-P

    Kabir, M.

     

    Dapagliflozin Promotes Adipose Beiging and Lipolysis and Reduces Adipocyte Size in the Obese Prediabetic Dog

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1711-P

    Brunton, S.

     

    Approaches to and Inertia in Cardiovascular and Renal Risk Management of Type 2 Diabetes Patients in Primary Care: Global Quantitative Survey Results

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1188-P

    DISCOVER

    Bonnet, F.

     

    HbA1c < 7.0% 6 Months after Initiation of Second-Line Therapy in Patients with Uncontrolled Type 2 Diabetes is Associated with Good Glycemic Control at 3 Years: The DISCOVER Study

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1598-P

    Nicolucci, A.

     

    Quality of Life in People with Type 2 Diabetes Following Initiation of Second-Line Therapy: DISCOVER

     

    Oral Presentation

    Friday, June 12

    6:00 – 6:15

    #40-OR

    Khunti, K.

     

    Effects of Second-Line Metformin Combination Therapies on Weight, HbA1c, and Risk of Hypoglycemia over 3 Years: The DISCOVER Study

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1590-P

    BYDUREON

    Clegg, LE.

     

    Once-Weekly Exenatide Effects on eGFR Slope and UACR as a Function of Baseline UACR: An EXSCEL Trial Post Hoc Analysis

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #958-P

    BRILINTA

    Leiter, LA.

     

    Impact of Diabetes-Related Factors And Background Antihyperglycemic Therapy On The Efficacy And Safety Of Ticagrelor Added To Aspirin: Insights From The THEMIS Trial

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #403-P

    Early Research & Development

    Mather, K.

     

    A Direct AMPK Activator Reduces Liver Steatosis in a Mouse Model of NASH

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #1820-P

    Cheng, W.

     

    Synergetic and Distinct Roles in the Control of Food Intake and Energy Balance for Subpopulations of NTS Neurons

     

    Late-Breaking Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #196-LB

    Gray, SM.

     

    Discrepancy between Single-Cell RNA Sequencing and Protein Expression Assessments of GLP-1Rr Heterogeneity in Beta Cells

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #2113-P

    Gray, SM.

     

    Quantification of GLP-1R Trafficking in Primary Beta Cells in Response to Different Ligands

     

    Poster Presentation

    Saturday, June 13

    10:00 – 11:00

    #2114-P

    INDICATIONS AND LIMITATIONS OF USE for FARXIGA® (dapagliflozin)

    FARXIGA is indicated:

    • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
    • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
    • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction

    FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

    IMPORTANT SAFETY INFORMATION for FARXIGA® (dapagliflozin) 5 mg and 10 mg tablets

    Contraindications

    • Prior serious hypersensitivity reaction to FARXIGA
    • Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) being treated for glycemic control without established CV disease or multiple CV risk factors
    • Patients on dialysis

    Warnings and Precautions

    • Volume Depletion: FARXIGA can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating FARXIGA in these patients, assess volume status and renal function. After initiating therapy, monitor for signs and symptoms of hypotension and renal function
    • Ketoacidosis in Diabetes Mellitus has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
    • Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections (UTIs) and serious UTIs have been reported with FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
    • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
    • Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Rare but serious, life-threatening cases have been reported in patients with diabetes mellitus receiving SGLT2 inhibitors including FARXIGA. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue FARXIGA
    • Genital Mycotic Infections: FARXIGA increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately

    Adverse Reactions

    In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

    Use in Specific Populations

    • Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters
    • Lactation: FARXIGA is not recommended when breastfeeding

    DOSING

    • To improve glycemic control in patients with T2D, the recommended starting dose of FARXIGA is 5 mg orally once daily, taken in the morning. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily
    • To reduce the risk of hospitalization for heart failure in patients with T2D and established CV disease or multiple CV risk factors, the recommended dose of FARXIGA is 10 mg orally once daily
    • To reduce the risk of CV death and hospitalization for heart failure in patients with HFrEF, the recommended dose of FARXIGA is 10 mg orally once daily

    Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.

    INDICATIONS

    BRILINTA is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.

    BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.

    DOSING

    In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily.

    In patients with CAD but no prior stroke or MI, administer 60 mg twice daily.

    Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

    IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

    WARNINGS:

    A. BLEEDING RISK

    • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
    • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
    • Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery
    • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

    B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

    • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided

    CONTRAINDICATIONS

    • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product.

    WARNINGS AND PRECAUTIONS

    • Dyspnea was reported more frequently with BRILINTA than in patients treated with control agents. Dyspnea from BRILINTA is often self-limiting
    • Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible
    • Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the post-marketing setting. Clinical trials excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias
    • Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients
    • In patients with Heparin Induced Thrombocytopenia (HIT): False negative results for HIT-related platelet functional tests, including the heparin-induced platelet aggregation (HIPA) assay, have been reported with BRILINTA. BRILINTA is not expected to impact PF4 antibody testing for HIT

    ADVERSE REACTIONS

    • The most common adverse reactions (>5%) associated with the use of BRILINTA included bleeding and dyspnea

    DRUG INTERACTIONS

    • Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor
    • As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor. Consider use of a parenteral anti-platelet in ACS patients requiring co-administration
    • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events
    • Monitor digoxin levels with initiation of, or change in, BRILINTA therapy

    SPECIAL POPULATIONS

    • Lactation: Breastfeeding not recommended

    Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

    INDICATION AND LIMITATIONS OF USE

    BYDUREON BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

    • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
    • Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis
    • Use with prandial insulin has not been studied
    • Do not coadminister with other exenatide-containing products
    • Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis

    IMPORTANT SAFETY INFORMATION

    WARNING: RISK OF THYROID C-CELL TUMORS

    • Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined
    • BYDUREON BCise is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON BCise

    CONTRAINDICATIONS

    • Personal or family history of MTC, patients with MEN 2
    • Prior serious hypersensitivity reactions to exenatide or product components
    • History of drug-induced, immune-mediated thrombocytopenia from exenatide products

    WARNINGS AND PRECAUTIONS

    • Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis
    • Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON BCise
    • Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m2
    • Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)
    • Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy
    • Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice
    • Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide. Serious bleeding, which may be fatal, has been reported. Discontinue promptly if suspected and avoid re-exposure to exenatide
    • Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported
    • Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

    ADVERSE REACTIONS

    Most common (≥5%) in clinical trials: injection-site nodule (10.5%), nausea (8.2%).

    DRUG INTERACTIONS

    • Oral Medications BYDUREON BCise slows gastric emptying and may reduce the rate of absorption of orally administered drugs
    • Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON BCise

    PREGNANCY

    Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON, and BYDUREON BCise.

    AstraZeneca in CV, Renal & Metabolism (CVMD)

    CV, renal and metabolism together form one of AstraZeneca's main therapy areas and 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 to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMD 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, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. 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.

    View Full Article Hide Full Article
  4. Accent to receive a $55M USD upfront payment and is eligible for up to approximately $1.1B USD in total additional milestones, plus tiered royalties, under co-development and co-commercialization arrangement

    Accent Therapeutics and AstraZeneca (NYSE:AZN) will collaborate to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer. The collaboration combines Accent's expertise as a leader in the biology, target identification and drug discovery of RMP-targeting therapies with AstraZeneca's industry leading expertise in oncology.

    Inhibition of RMPs is a new approach for addressing RNA pathobiology by targeting proteins that control many aspects of RNA biology. This…

    Accent to receive a $55M USD upfront payment and is eligible for up to approximately $1.1B USD in total additional milestones, plus tiered royalties, under co-development and co-commercialization arrangement

    Accent Therapeutics and AstraZeneca (NYSE:AZN) will collaborate to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer. The collaboration combines Accent's expertise as a leader in the biology, target identification and drug discovery of RMP-targeting therapies with AstraZeneca's industry leading expertise in oncology.

    Inhibition of RMPs is a new approach for addressing RNA pathobiology by targeting proteins that control many aspects of RNA biology. This class of targets represents a vast field of potentially important targets for cancer and other diseases.

    José Baselga, Executive Vice President, Oncology R&D, AstraZeneca said: "The promise of RMP inhibition is a compelling area of exploration for AstraZeneca. With this collaboration, we will seek to identify novel targets and unlock the full potential of our medicines. We believe that the Accent team's expertise in RNA-modifying protein biology and drug discovery complements AstraZeneca's extensive research and development portfolio."

    Shakti Narayan, Chief Executive Officer, Accent Therapeutics said: "This collaboration leverages both AstraZeneca's vast cancer expertise and resources and Accent's rich pipeline of RMP therapeutic programs to bring new and potentially life-changing medicines to patients. This collaborative effort will enable us to rapidly advance and achieve the rich therapeutic potential of these exciting programs."

    Under the terms of the collaboration agreement, Accent will be responsible for research and development activities for a nominated preclinical program through to the end of Phase I clinical trials. Following completion of Phase I, AstraZeneca will lead development and commercialization activities for the nominated program, with Accent having the option to jointly develop and commercialize with AstraZeneca in the US. AstraZeneca will also have the exclusive option to license worldwide rights to two further preclinical discovery programs, for which Accent will conduct certain preclinical activities.

    Accent will receive an upfront payment of $55 million and, in the event that Accent elects to jointly develop the nominated program, is eligible to receive up to $1.1 billion in additional success-based payments across all programs in the form of option fees and milestone payments, as well as tiered royalties on net sales ranging from mid-single digit to low-double digits. In the event Accent opts into co-developing and co-commercializing the nominated program, profits and losses will be split in the US.

    About Accent Therapeutics

    Accent Therapeutics is a biopharmaceutical company developing oncology-focused, small molecule therapies in the emerging field of RNA modification. This field of biology encompasses post-transcriptional chemical modifications of RNA that provide cells with a unique mechanism for regulating proteins critical for cellular growth and differentiation. By targeting cancer-linked RNA-modifying proteins (RMPs) with precision therapies, the Company aims to translate extraordinary science into life-changing therapies for patients. For more information, please visit www.accenttx.com.

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  5. New BRILINTA indication expands treatment to high-risk coronary patients without a history of stroke or heart attack

    AstraZeneca's BRILINTA® (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease.

    The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus BRILINTA 60mg versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke…

    New BRILINTA indication expands treatment to high-risk coronary patients without a history of stroke or heart attack

    AstraZeneca's BRILINTA® (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease.

    The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus BRILINTA 60mg versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke. The primary composite endpoint was driven by a reduction in heart attack and stroke.

    This is the first regulatory approval for aspirin plus BRILINTA dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke.

    Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, and Professor of Medicine at Harvard Medical School, Boston, US said: "Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people. The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients."

    Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at Université de Paris, said: "THEMIS for ticagrelor was a large, multi-national trial of more than 19,000 patients with coronary artery disease and type 2 diabetes. Around one third of patients with coronary artery disease have type 2 diabetes, putting them at higher risk of heart attack or stroke, than patients without diabetes. Today's approval brings new hope to patients at risk of experiencing a first heart attack or stroke."

    Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: "Today's approval of BRILINTA is important news for patients with coronary artery disease who will now have a new therapy option to reduce the risk of a first heart attack or stroke. This new indication is a further testament to the overwhelming science supporting BRILINTA in the management of patients with coronary artery disease at high risk for cardiovascular events."

    The THEMIS trial demonstrated the relative risk reduction of the composite endpoint of heart attack, stroke and CV death by 10% (absolute risk reduction; 0.8%, 7.7% vs 8.5%) with aspirin plus long-term BRILINTA compared to aspirin alone in patients who had CAD and T2D without a history of heart attack or stroke. While this indication is not limited to this setting, the efficacy of BRILINTA was established in a population with T2D in the THEMIS trial. The safety profile for BRILINTA was consistent with the known profile of the medicine with an increased risk of bleeding events observed.

    The data from the THEMIS trial and the THEMIS-PCI sub-analysis were published in The New England Journal of Medicine and The Lancet respectively.

    Regulatory submissions to expand the approved indication for BRILINTA based on the THEMIS trial are also under regulatory review in the EU, Japan and China.

    AstraZeneca also recently announced the high-level results from the Phase III THALES trial that showed aspirin plus BRILINTA 90mg reduced the risk of the composite of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack, compared to aspirin alone.

    BRILINTA is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack.

    BRILINTA is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

    INDICATIONS

    BRILINTA is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.

    BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.

    DOSING

    In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily.

    In patients with CAD but no prior stroke or MI, administer 60 mg twice daily.

    Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

    IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

    WARNINGS:

    A. BLEEDING RISK

    • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
    • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
    • Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery
    • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

    B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

    • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided

    CONTRAINDICATIONS

    • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product.

    WARNINGS AND PRECAUTIONS

    • Dyspnea was reported more frequently with BRILINTA than in patients treated with control agents. Dyspnea from BRILINTA is often self-limiting
    • Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible
    • Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the post-marketing setting. Clinical trials excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias
    • Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients
    • In patients with Heparin Induced Thrombocytopenia (HIT): False negative results for HIT-related platelet functional tests, including the heparin-induced platelet aggregation (HIPA) assay, have been reported with BRILINTA. BRILINTA is not expected to impact PF4 antibody testing for HIT

    ADVERSE REACTIONS

    • The most common adverse reactions (>5%) associated with the use of BRILINTA included bleeding and dyspnea

    DRUG INTERACTIONS

    • Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor
    • As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor. Consider use of a parenteral anti-platelet in ACS patients requiring co-administration
    • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events
    • Monitor digoxin levels with initiation of, or change in, BRILINTA therapy

    SPECIAL POPULATIONS

    • Lactation: Breastfeeding not recommended

    Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

    CAD and T2D

    CAD is the most common type of heart disease. Ischemic heart disease is the leading cause of healthy life years lost due to disability in men and the second cause in women worldwide. The disease burden of atherosclerosis is significantly higher in patients with CAD and T2D than in CAD patients without T2D.

    THEMIS

    THEMIS is an AstraZeneca-sponsored, multi-national, randomized, double-blinded Phase III trial in patients with CAD and T2D with no prior heart attack or stroke. More than 19,000 patients were randomized across 42 countries in Europe, Asia, Africa, North and South America. THEMIS was designed to test the hypothesis that aspirin daily plus BRILINTA 60mg twice daily would reduce MACE (major adverse cardiac events), compared with aspirin alone. CAD was defined as a history of percutaneous coronary intervention (PCI), coronary artery bypass surgery, or at least a 50% narrowing of a coronary artery. Additionally, THEMIS-PCI is a clinically meaningful and prespecified sub-analysis of patients (11,154 which is 58% of total patients) who had previously undergone percutaneous coronary intervention (PCI).

    BRILINTA

    BRILINTA (ticagrelor) is an oral, reversibly binding, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. BRILINTA, together with aspirin, has been shown to significantly reduce the risk of major adverse cardiovascular events (myocardial infarction [MI], stroke or CV death) in patients with acute coronary syndrome (ACS) or a history of MI.

    AstraZeneca in CV, Renal & Metabolism (CVMD)

    CV, renal and metabolism together form one of AstraZeneca's main therapy areas and 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 to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMD 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, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. 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.

    Disclosure

    Brigham and Women's Hospital received research funding for Dr Bhatt's role as co-Chair of THEMIS and THEMIS-PCI.

    US-40170 Last Updated 6/20

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