REG - AstraZeneca PLC - AZN: Full-Year 2017 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 3
02/02/2018 07:06
- Part 3: For the preceding part double click ID:nRSB7444Db
in the following table:
Farxiga DECLARE SGLT2 inhibitor c.17,0001 patients with type-2 diabetes Time to first occurrence of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke Data anticipated H2 2018 (final analysis)
Farxiga DAPA-HF SGLT2 inhibitor c.4,500 patients with heart failure (HF) Time to first occurrence of CV death or hospitalisation for HF or an urgent HF visit FPCDQ1 2017
Data anticipated 2019
Farxiga DAPA-CKD SGLT2 inhibitor c.4,000 patients with CKD Time to first occurrence of ≥50% sustained decline in eGFR2 or reaching ESRD3 or CV death or renal death FPCDQ1 2017
Data anticipated 2020
Brilinta THEMIS P2Y12 receptor antagonist c.19,000 patients with type-2 diabetesand coronary artery diseasewithout a history ofMI or stroke Composite ofCV death, non-fatal MIand non-fatal stroke Data anticipated 2019
Epanova STRENGTH Omega-3 carboxylic acids c.13,000 patients with mixed dyslipidaemia Time to first occurrence of CV death, non-fatal MI or non-fatal stroke Data anticipated 2019
Epanova
STRENGTH
Omega-3 carboxylic acids
c.13,000 patients with mixed dyslipidaemia
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
Data anticipated 2019
1Includes c.10,000 patients who have had no prior index event and c.7,000 patients who have suffered an index event.
2Estimated Glomerular Filtration Rate.
3End-Stage Renal Disease.
RESPIRATORY
AstraZeneca's Respiratory focus is aimed at transforming the treatment of asthma and COPD through combination inhaled
therapies, biologics for the unmet medical needs of specific patient populations and an early pipeline focused on disease
modification.
The growing range of medicines includes up to four anticipated launches between 2017 and 2020; of these, Bevespi and
Fasenra are already benefitting patients. The capability in inhalation technology spans both pressurised, metered-dose
inhalers and dry-powder inhalers to serve patient needs, as well as the innovative Aerosphere Delivery Technology, a focus
of AstraZeneca's future-platform development for respiratory-disease combination therapies.
a) Symbicort (asthma)
During the period, the US FDA approved updates to the Symbicort labelling, including removal of the boxed warning for
Symbicort and other ICS/LABA medicines for serious asthma-related outcomes. The update followed a 2011 post-marketing
requirement from the US FDA, which required all manufacturers of LABA medicines to further evaluate their safety when used
in combination with ICS for the treatment of asthma. The agency analysed four clinical trials involving over 42,000
patients and the results did not show a significant increase in the risk of serious asthma-related events (hospitalisation,
intubations and death) with an ICS/LABA fixed-dose combination, compared with ICS alone.
b) Tudorza (COPD)
On 4 December 2017, AstraZeneca announced positive top-line results of the Phase IV ASCENT trial for Tudorza, a long-acting
muscarinic antagonist (LAMA), in patients with moderate to very severe COPD, with a history of CV disease and/or
significant CV risk factors.
The US FDA required data from the ASCENT trial as a post-marketing requirement to evaluate major adverse CV events for up
to three years with aclidinium bromide, the active ingredient in Tudorza. The trial included more than 3,600 patients from
Canada and the US and demonstrated a reduction in exacerbations and CV safety. A full analysis of the data is ongoing and
results will be presented at a forthcoming medical meeting. AstraZeneca intends to submit an sNDA for an expanded Tudorza
label.
c) Fasenra (benralizumab) (severe, uncontrolled asthma)
On 15 November 2017, the Company announced that the US FDA had approved Fasenra as a new medicine for patients with severe
asthma aged 12 years and older and with an eosinophilic phenotype.
On 10 January 2018, the EMA approved Fasenra as an add-on maintenance treatment in adult patients with severe,
inadequately-controlled eosinophilic asthma, despite high-dose inhaled corticosteroids plus LABA. The approvals were based
on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials SIROCCO and CALIMA, plus the
Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Regulatory decisions are anticipated in several other
jurisdictions in H1 2018.
On 19 January 2018, the Company announced that the Japanese Ministry of Health, Labour and Welfare had approved Fasenra as
an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations, despite treatment
with high-dose inhaled corticosteroid and other asthma controller(s).
During the period, the Phase III GRECO trial met its primary endpoint, showing that patients and caregivers could
self-administer Fasenra with an autoinjector. GRECO was a multicentre, open-label trial designed to assess the
functionality and reliability of a single use autoinjector of Fasenra, administered subcutaneously in an at-home setting
with monitoring of the autoinjector performance after use. The device performed as expected during the clinical trial.
d) Tralokinumab (asthma)
During the period, AstraZeneca decided to discontinue the development of tralokinumab, an investigational anti-IL-13 human
immunoglobulin-G4 monoclonal antibody, in severe, uncontrolled asthma. The decision followed the publication of results of
the Phase III programme, in which the primary endpoint of a significant reduction in the annual asthma exacerbation rate
was not met in the two pivotal trials, STRATOS 1 and STRATOS 2. In an OCS-sparing trial, TROPOS, tralokinumab did not
achieve a statistically-significant reduction in OCS use when added to the standard of care, in patients dependent on OCS.
e) PT010 (COPD)
On 26 January 2018, AstraZeneca announced the top-line results of the pivotal Phase III KRONOS trial for PT010, a potential
triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate) for the treatment of moderate to very severe
COPD. In the trial, PT010 significantly improved lung function compared to PT009 (budesonide/formoterol fumarate), Bevespi
(glycopyrronium/formoterol fumarate) and Symbicort Turbuhaler (budesonide/formoterol fumarate). AstraZeneca anticipates
presentation of the results at a forthcoming medical meeting and intends to make the first regulatory submission for PT010
in H2 2018.
During the period, the Phase III TELOS trial read out, which compared two doses of PT009 (budesonide/formoterol fumarate)
to its individual components, PT005 (formoterol fumarate) and PT008 (budesonide), and to Symbicort. The trial assessed lung
function in patients with moderate to very severe COPD to qualify PT009 as an active comparator in the PT010 clinical-trial
programme.
PT009, PT005 and PT008 were all delivered using Aerosphere Delivery Technology. All primary endpoints were met, with the
exception of the lung-function primary endpoint that compared low-dose PT009 to PT005. A full evaluation of the TELOS trial
results is ongoing, and the Company intends to present the results at a forthcoming medical meeting.
f) Tezepelumab (asthma)
In November 2017, the Company and its partner Amgen Inc. initiated the Phase III PATHFINDER programme for tezepelumab.
During the period, the first patient was enrolled in the first Phase III trial, NAVIGATOR. The decision to proceed with the
programme was based on the results from the Phase IIb PATHWAY trial in patients with severe, uncontrolled asthma. Results
from the trial were published in the New England Journal of Medicine and presented at the European Respiratory Society
International Congress in September 2017.
Development Pipeline 31 December 2017
________________________________________________________________________________________
AstraZeneca-sponsored or -directed trials
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional indications
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by
the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed
at this time.
Oncology
Calquence#(acalabrutinib) BTK inhibitor B-cell malignancy Q1 2015 Launched
savolitinib#SAVOIR MET inhibitor papillary renal cell carcinoma Q3 2017 2020 2020
selumetinib MEK inhibitor differentiated thyroid cancer Q3 2013 H2 2018(Orphan Drug Designation) H2 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 H1 2018(Orphan Drug Designation)
immunotoxin
Imfinzi# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 H1 2018 H1 2018 H1 2018
ARCTIC
Imfinzi#+ tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q3 2015 H2 2018 H2 2018 H2 2018
Imfinzi#+ tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q4 2015 2019 2019 2019 2020
Imfinzi# + tremelimumab + chemotherapyPOSEIDON PD-L1 mAb + CTLA-4 mAb 1st-lineNSCLC Q2 2017 2019 2019 2019 2020
Imfinzi#+ tremelimumab + SoCCASPIAN PD-L1 mAb + CTLA-4 mAb + SoC 1st-line SCLC Q1 2017 2019 2019 2019
Imfinzi#+ tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line HNSCC Q4 2015 H2 2018 H2 2018 H2 2018
KESTREL
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line HNSCC Q4 2015 H2 2018 H2 2018 H2 2018
EAGLE
Imfinzi#+ tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder cancer Q4 2015 2019 2019 2019
Imfinzi# + tremelimumab HIMALAYA PD-L1 mAb + CTLA-4 mAb 1st-line hepatocellular carcinoma Q4 2017 2021 2021 2021 2021
Lynparza#¶+ cediranibCONCERTO PARP inhibitor + VEGF inhibitor recurrent platinum-resistant ovarian cancer Q1 2017 2019
CVMD
Epanova omega-3 carboxylic acids severe hypertriglycerid-aemia Approved 2020
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia - Accepted1 2019
roxadustat# OLYMPUS (US) ROCKIES (US) hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD / end-stage renal disease Q3 2014 H2 2018 Accepted2
Respiratory
Bevespi (PT003) LABA/LAMA COPD Launched Accepted H2 2018 H2 2018
Fasenra# (benralizumab#)CALIMA SIROCCO ZONDABISEBORAGREGALE IL-5R mAb severe, uncontrolled asthma Launched Approved Approved 2021
PT010 LABA/LAMA/ ICS COPD Q3 2015 2019 2019 H2 2018 H2 2018
tezepelumabNAVIGATORSOURCE TSLP mAb severe, uncontrolled asthma Q1 2018 2021 2021 2021
Other
anifrolumab# TULIP Type I IFN receptor mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
lanabecestat#AMARANTH + extension, DAYBREAK-ALZ beta-secretase inhibitor Alzheimer's disease Q2 2016 2020(Fast Track) 2020 2020
2019
2019
lanabecestat#AMARANTH + extension, DAYBREAK-ALZ
beta-secretase inhibitor
Alzheimer's disease
Q2 2016
2020(Fast Track)
2020
2020
# Collaboration
¶ Registrational Phase IItrial
1 CHMP positive opinion received
2 Fibrogen completed rolling regulatory submission in China
Phases I and II
NMEs and significant additional indications
Oncology
Imfinzi# PD-L1 mAb solid tumours II Q3 2014
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb biliary tract, osophageal II Q4 2013
Imfinzi# + tremelimumab + chemo PD-L1 mAb + CTLA-4 mAb 1st-line pancreatic ductal adenocarcinoma, osophageal and SCLC I Q2 2016
Imfinzi# + AZD5069 PD-L1 mAb + CXCR2 antagonist pancreatic ductal adenocarcinoma II Q2 2017
Imfinzi# + AZD5069 or Imfinzi# + AZD9150# PD-L1 mAb + CXCR2 antagonist or PD-L1 mAb + STAT3 inhibitor HNSCC II Q3 2015
Imfinzi# + dabrafenib + trametinib PD-L1 mAb + BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
Imfinzi# + AZD1775# PD-L1 mAb + Wee1 inhibitor solid tumours I Q4 2015
Imfinzi# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours II Q3 2016
Imfinzi# or Imfinzi# + (tremelimumab or AZD9150#) PD-L1 mAb or PD-L1 mAb + (CTLA-4 mAb or STAT3 inhibitor) diffuse large B-cell lymphoma I Q3 2016
Imfinzi#+ Iressa PD-L1 mAb + EGFR inhibitor NSCLC I Q2 2014
Imfinzi#+ MEDI0562# PD-L1 mAb + humanised OX40 agonist solid tumours I Q2 2016
Imfinzi# + MEDI9197# PD-L1 mAb + TLR 7/8 agonist solid tumours I Q2 2017
Imfinzi# + oleclumab (MEDI9447) PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
Imfinzi# + monalizumab PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
Imfinzi#+ selumetinib PD-L1 mAb + MEK inhibitor solid tumours I Q4 2015
Imfinzi# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
tremelimumab + MEDI0562# CTLA-4 mAb + humanised OX40 agonist solid tumours I Q2 2016
Imfinzi# + azacitidine PD-L1 mAb + azacitidine myelodysplastic syndrome I Q2 2016
Imfinzi#+ MEDI0457# PD-L1 mAb + DNA HPV vaccine HNSCC II Q4 2017
Imfinzi + RT (platform)CLOVER PD-L1 mAb + RT locally-advanced HNSCC, NSCLC, SCLC I Q1 2018
Lynparza#+ AZD6738 PARP inhibitor + ATR inhibitor gastric cancer II Q3 2016
Lynparza# + AZD1775# PARP inhibitor + Wee1 inhibitor solid tumours I Q3 2015
Lynparza# + ImfinziMEDIOLA PARP inhibitor + PD-L1 mAb solid tumours II Q2 2016
Tagrisso + (selumetinib# or savolitinib#)TATTON EGFR inhibitor + (MEK inhibitor or MET inhibitor) advanced EGFRm NSCLC II Q2 2016
Tagrisso BLOOM EGFR inhibitor CNS metastases in advanced EGFRm NSCLC II Q4 2015
AZD1775#+ chemotherapy Wee1 inhibitor + chemotherapy ovarian cancer II Q1 2015
AZD1775# Wee1 inhibitor solid tumours I Q3 2015
vistusertib mTOR inhibitor solid tumours II Q1 2013
AZD5363# AKT inhibitor breast cancer II Q1 2014
AZD4547 FGFR inhibitor solid tumours II Q4 2011
AZD0156 ATM inhibitor solid tumours I Q4 2015
AZD1390 ATM inhibitor healthy volunteer trial I Q4 2017
AZD2811# Aurora B inhibitor solid tumours I Q4 2015
AZD4573 CDK9 inhibitor haematological malignancies I Q4 2017
AZD4635 A2aR inhibitor solid tumours I Q2 2016
AZD4785 KRAS inhibitor solid tumours I Q2 2017
AZD5153 BRD4 inhibitor solid tumours I Q3 2017
AZD5991 MCL1 inhibitor haematological malignancies I Q3 2017
Calquence + vistusertib B-cell malignancy + mTor inhibitor haematological malignancies I Q3 2017
AZD6738 ATR inhibitor solid tumours I Q4 2013
AZD8186 PI3k inhibitor solid tumours I Q2 2013
AZD9496 selective oestrogen receptor degrader oestrogen receptor +ve breast cancer I Q4 2014
MEDI-565# CEA BiTE mAb solid tumours I Q1 2011
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI1873 GITR agonist fusion protein solid tumours I Q4 2015
MEDI3726# PSMA antibody drug conjugate prostate cancer I Q1 2017
MEDI4276 HER2 bi-specific antibody drug conjugate solid tumours I Q4 2015
MEDI5083 immune activator solid tumours I Q1 2017
MEDI7247 antibody drug conjugate haematological malignancies I Q2 2017
MEDI9197# TLR 7/8 agonist solid tumours I Q4 2015
oleclumab (MEDI9447) CD73 mAb solid tumours I Q3 2015
CVMD
verinurad URAT1 inhibitor CKD II Q2 2017
MEDI0382 GLP-1 /glucagon dual agonist type-2 diabetes / obesity II Q3 2016
MEDI6012 LCAT CV disease II Q4 2015
AZD4831 myeloperoxidase HF with a preserved ejection fraction I Q3 2016
AZD5718 FLAP coronary artery disease II Q4 2017
AZD8601# VEGF-A CV disease I Q1 2017
MEDI5884# cholesterol modulation CV disease II Q4 2017
Respiratory
abediterol# LABA asthma / COPD II Q4 2007
tezepelumab# TSLP mAb atopic dermatitis II Q2 2015
AZD1419# inhaled TLR9 agonist asthma II Q4 2016
AZD7594 inhaled SGRM asthma / COPD II Q3 2015
AZD8871# MABA COPD II Q1 2017
PT010 LABA/LAMA/ICS asthma II Q2 2014
AZD5634 inhaled ENaC cystic fibrosis I Q1 2016
AZD7594 + abediterol# inhaled SGRM + LABA asthma / COPD I Q4 2016
AZD7986# DPP1 COPD II Q4 2017
AZD9567 oral SGRM rheumatoid arthritis / respiratory I Q4 2015
AZD1402# Inhaled IL-4Ra asthma I Q4 2017
MEDI3506 IL-33 mAb COPD I Q2 2017
Other
anifrolumab# Type 1 IFN receptor mAb lupus nephritis II Q4 2015
anifrolumab# Type 1 IFN receptor mAb systemic lupus erythematosus (subcutaneous) II Q1 2017
inebilizumab# CD19 mAb neuromyelitis optica II(Orphan drug US, EU) Q1 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
MEDI3902 Psl/PcrV bispecific mAb prevention of nosocomial Pseudomonas aeruginosa pneumonia II(Fast Track, US) Q2 2016
suvratoxumab (MEDI4893) mAb binding to S. aureus toxin prevention of nosocomial Staphylococcus aureuspneumonia II(Fast Track, US) Q4 2014
prezalumab# (MEDI5872#) B7RP1 mAb primary Sjögren's syndrome II Q3 2015
MEDI8852 influenza A mAb influenza A treatment II(Fast Track, US) Q4 2015
MEDI8897# RSV mAb-YTE passive RSV prophylaxis II(Fast Track, US) Q1 2015
AZD0284 RORg psoriasis / respiratory I Q4 2016
MEDI0700# BAFF/B7RP1 bispecific mAb systemic lupus erythematosus I Q1 2016
MEDI1814# amyloid beta mAb Alzheimer's disease I Q2 2014
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI7352 NGF/TNF bi-specific mAb osteoarthritis pain I Q1 2016
MEDI7734 ILT7 mAb myositis I Q3 2016
MEDI9314 IL-4R mAb atopic dermatitis I Q1 2016
Q3 2016
MEDI9314
IL-4R mAb
atopic dermatitis
I
Q1 2016
# Collaboration
Significant Lifecycle Management
Oncology
Calquence#(acalabrutinib) BTK inhibitor 1st-line chronic lymphocytic leukaemia Q3 2015 2020(Orphan Drug Designation) 2020(Orphan designation)
Calquence#(acalabrutinib) BTK inhibitor relapsed/refractory chronic lymphocytic leukaemia, high risk Q4 2015 2019(Orphan Drug Designation) 2019(Orphan designation)
Calquence#(acalabrutinib) BTK inhibitor 1st-line mantle cell lymphoma Q1 2017 2023
FaslodexFALCON oestrogen receptor antagonist 1st-line hormone receptor +ve advanced breast cancer Approved Approved Approved Approved
Imfinzi#PACIFIC PD-L1 mAb locally-advanced (Stage III), NSCLC Q2 2014 Accepted(Breakthrough Therapy Designation & Priority Review) Accepted Accepted
Imfinzi#PEARL (China) PD-L1 mAb 1st-lineNSCLC Q1 2017 2020
Lynparza# OlympiAD PARP inhibitor gBRCA metastatic breast cancer Q2 2014 Approved(Priority Review) H1 2018 Accepted(Orphan drug designation, Priority Review) H2 2018
Lynparza# PARP inhibitor 2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy Q3 2013 Approved(Priority Review) Accepted Approved(Orphan drug designation) Accepted
SOLO-2
Lynparza# PARP inhibitor 1st-line BRCAm ovarian cancer Q3 2013 H2 2018 H2 2018 H2 2018 2019
SOLO-1
Lynparza# PARP inhibitor gBRCA PSR ovarian cancer Q1 2015 H2 2018
SOLO-3
Lynparza# PARP inhibitor pancreatic cancer Q1 2015 2019 2019
POLO
Lynparza#PROfound PARP inhibitor prostate cancer Q1 2017 2020(Breakthrough Therapy Designation) 2020 2020 2020
Lynparza#OlympiA PARP inhibitor gBRCA adjuvant breast cancer Q2 2014 2020 2020 2020
Tagrisso FLAURA EGFR inhibitor 1st-line advanced EGFRm NSCLC Q1 2015 Accepted(Breakthrough Therapy designation) Accepted Accepted H2 2018
Tagrisso ADAURA EGFR inhibitor adjuvant EGFRm NSCLC Q4 2015 2022 2022 2022 2022
CVMD
Brilinta1THALES P2Y12 receptor antagonist acute ischaemic stroke or transient ischaemic attack Q1 2018 2020 2020 2020 2020
Brilinta1THEMIS P2Y12 receptor antagonist CV outcomes trial in patients with type-2 diabetes and coronary artery disease without a previous history ofMI or stroke Q1 2014 2019 2019 2019 2020
Brilinta1HESTIA P2Y12 receptor antagonist prevention of vaso-occlusive crises in paediatric patients with sickle cell disease Q1 2014 2021 2021
Farxiga2 SGLT2 inhibitor CV outcomes trial in patients with type-2 diabetes Q2 2013 2019 2019
DECLARE-
TIMI 58
Farxiga2 SGLT2 inhibitor type-1 diabetes Q4 2014 H2 2018 H1 2018 H2 2018
Farxiga2 SGLT2 inhibitor worsening HF or CV death in patients with chronic HF Q1 2017 2020 2020 2020 2020
Farxiga2 SGLT2 inhibitor renal outcomes and CVmortality in patients with CKD Q1 2017 2021 2021 N/A 2021
Xigduo XR/Xigduo3 SGLT2 inhibitor/ metformin FDC type-2 diabetes Launched Launched 2020
Qtern DPP-4 inhibitor / SGLT2 inhibitor FDC type-2 diabetes Launched Launched
Bydureon GLP-1 receptor agonist type-2 diabetes Q1 2013 Launched Accepted
BCise / Bydureon autoinjector4
Bydureon EXSCEL GLP-1 receptor agonist type-2 diabetes outcomes trial Q2 2010 H1 2018 H1 2018 H2 2018
saxagliptin/dapagliflozin/metformin DPP-4 inhibitor / SGLT2 inhibitor type-2 diabetes Q2 2017 H1 2018 H1 2018
EpanovaSTRENGTH omega-3 carboxylic acids CV outcomes trial in statin-treated patients at high CV risk, with persistent hypertriglyceridae-mia plus low HDL-cholesterol Q4 2014 2020 2020 2020 2020
Respiratory
Fasenra# (benralizumab#)TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 H2 2018 H2 2018 2019
SymbicortSYGMA ICS/LABA as-needed use in mild asthma Q4 2014 2018 2019
Duaklir Genuair# LAMA/LABA COPD H1 2018 Launched 2019
Other
Nexium proton-pump inhibitor stress ulcer prophylaxis Accepted
Nexium proton-pump inhibitor paediatrics Launched Launched Approved
linaclotide# GC-C receptor peptide agonist irritable bowel syndrome with constipation Accepted
(IBS-C)
Launched
Launched
Approved
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)
Accepted
# Collaboration
1 Brilinta in the US and Japan; Brilique in ROW
2 Farxiga in the US; Forxiga in ROW
3 Xigduo XR in the US; Xigduo in the EU
4 Bydureon BCise in the US, Bydureon autoinjector in the EU
Terminations (discontinued projects: 1 October to 31 December 2017)
NME / Line Extension Compound Reason for Discontinuation Area Under Investigation
NME AZD9898# safety / efficacy asthma
NME MEDI-573 safety / efficacy metastatic breast cancer
NME tralokinumabSTRATOS 1,2TROPSMESOS safety / efficacy severe, uncontrolled asthma
# Collaboration
Completed Projects/Divestitures (1 October to 31 December 2017)
Compound Mechanism Area Under Investigation Completed/Divested Estimated Regulatory Submission Acceptance
US EU Japan China
MEDI0680 PD-1 mAb solid tumours completed - - - -
Kombiglyze XR/Komboglyze1 DPP-4 inhibitor / metformin FDC type-2 diabetes Launched Launched Launched
1 Kombiglyze XR in the US; Komboglyze in ROW
Condensed Consolidated Statement of Comprehensive Income
Product Sales 20,152 21,319
Externalisation Revenue 2,313 1,683
Total Revenue 22,465 23,002
Cost of sales (4,318) (4,126)
Gross profit 18,147 18,876
Distribution costs (310) (326)
Research and development expense (5,757) (5,890)
Selling, general and administrative costs (10,233) (9,413)
Other operating income and expense 1,830 1,655
Operating profit 3,677 4,902
Finance income 113 67
Finance expense (1,508) (1,384)
Share of after tax losses in associates and joint ventures (55) (33)
Profit before tax 2,227 3,552
Taxation 641 (146)
Profit for the period 2,868 3,406
Other comprehensive income/(loss)
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (242) (575)
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss (9) -
Tax on items that will not be reclassified to profit or loss 16 136
(235) (439)
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 536 (1,050)
Foreign exchange arising on designating borrowings in net investment hedges 505 (591)
Fair value movements on cash flow hedges 311 (115)
Fair value movements on cash flow hedges transferred to profit or loss (315) 195
Fair value movements on derivatives designated in net investment hedges (48) (4)
Amortisation of loss on cash flow hedge 1 1
Net available for sale (losses)/gains taken to equity (83) 139
Tax on items that may be reclassified subsequently to profit or loss (33) 86
874 (1,339)
Other comprehensive income/(loss) for the period, net of tax
- More to follow, for following part double click ID:nRSB7444DdRecent news on AstraZeneca
See all newsRCS - LHH - LHH, EZRA's AI Leadership Transformation Program
AnnouncementREG - AstraZeneca PLC - Baxdrostat met primary endpoint in Bax24 Ph3 trial
AnnouncementREG - AstraZeneca PLC - Datroway improved OS and PFS in TROPION-Breast02
AnnouncementREG - AstraZeneca PLC - Total Voting Rights
AnnouncementREG - AstraZeneca PLC - Enhertu improved IDFS in early BC in DB-05
Announcement