REG - AstraZeneca PLC - 3rd Quarter Results <Origin Href="QuoteRef">AZN.L</Origin>

AstraZenecaAnnouncement

06/11/2014 08:42

RNS Number : 3116W
AstraZeneca PLC
06 November 2014
ASTRAZENECA DEVELOPMENT PIPELINE, 30 SEPTEMBER 2014
Phase III / Pivotal / Registration
NMEs and significant additional indications
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.
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
Brilinta/ Brilique1
ADP receptor antagonist
arterial thrombosis

Launched
Launched
Filed
Launched
Epanova#
omega-3 free fatty acids
hypertriglyceridaemia

Approved



Farxiga / Forxiga2
SGLT-2 inhibitor
Type 2 diabetes

Launched
Launched
Launched
Filed
Myalept 
leptin analogue
lipodystrophy

Launched
2015
N/A

roxadustat#
hypoxia- inducible factor inhibitor
anaemia in CKD / ESRD
Q3 2014
2018
N/A
N/A
2016
Oncology
AZD9291
EGFR tyrosine kinase inhibitor
advanced EGFRm T790M NSCLC
Q2 2014
2015
2015
2015
2017
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer 

Launched
Launched
Q4 2014
Filed
MEDI4736#
PACIFIC
anti-PD-L1 MAb
stage III NSCLC
Q2 2014
2017
2020
2020

MEDI4736#
ATLANTIC
anti-PD-L1 MAb
3rd line NSCLC
Q1 2014
2016
2017
2017

moxetumomab pasudotox#
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
2018
2018


Lynparza (olaparib)
PARP inhibitor
BRCAm PSR ovarian cancer

Filed 
Filed7#


Lynparza (olaparib)SOLO-1
PARP inhibitor
1st line BRCAm ovarian cancer
Q3 2013
2017
2017
2017
2018
Lynparza (olaparib) SOLO-2
PARP inhibitor
BRCAm PSR ovarian cancer
Q3 2013
2016
2016
2016
2016
Lynparza (olaparib) GOLD
PARP inhibitor
2nd line gastric cancer
Q3 2013


2017
2018
Lynparza (olaparib) OlympiA
PARP inhibitor
adjuvant breast cancer
Q2 2014
2020
2020
2020
2021
Lynparza (olaparib) OlympiAD
PARP inhibitor
metastatic breast cancer
Q2 2014
2016
2016
2016

selumetinib#
SELECT-1
MEK inhibitor
2nd line KRAS+ NSCLC
Q4 2013
2017
2017


selumetinib#
ASTRA
MEK inhibitor
differentiated thyroid cancer
Q3 2013
2017
2017


selumetinib#
SUMIT
MEK inhibitor
uveal melanoma
Q2 2014
2015
2015


tremelimumab
anti-CTLA-4 MAb
mesothelioma
Q2 2014
2016
2016
2016

Phase III / Pivotal / Registration (continued)
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
benralizumab#
CALIMA, SIROCCO, ZONDA
anti-IL-5R MAb
severe asthma
Q4 2013
2016
2016


benralizumab#
TERRANOVA, GALATHEA
anti-IL-5R MAb
COPD
Q3 20144
2018
2018


brodalumab#
AMAGINE-1,2,3
anti-IL-17R MAb
psoriasis
Q3 2012
++
++


brodalumab# AMVISION-1,2
anti-IL-17R MAb
psoriatic arthritis
Q1 2014
++
++


Lesinurad3
CLEAR 1,2
CRYSTAL
selective uric acid reabsorption inhibitor (SURI) 
chronic treatment of patients with gout
Q4 2011
Q4 2014
Q4 2014


PT003 GFF
LAMA / LABA
COPD
Q2 2013
2015
2016
2017
2017
PT001 GP
LAMA
COPD
Q2 2013
2016
2016
2017
2017
tralokinumab
STRATOS 1-2
TROPOS
anti-IL-13 MAb
severe asthma
Q3 2014
2018
2018
2018

Infection
 CAZ AVI#4 RECLAIM
 cephalosporin / beta lactamase inhibitor 
 serious infections
Q1 2012
N/A
2015

2016
 CAZ AVI#4 REPROVE
 cephalosporin / beta lactamase inhibitor
 hospital-acquired pneumonia / ventilator- associated pneumonia
Q2 2013
N/A
2017
2018
Zinforo#
extended spectrum cephalosporin with affinity to penicillin-binding proteins 
pneumonia / skin infections

N/A
Launched
N/A
Filed
Neuroscience
Movantik/Moventig5#
oral peripherally- acting mu-opioid receptor antagonist
opioid-induced constipation

Approved
Filed6


# Partnered product.
 Registrational Phase II / III study.
++ Filing is the responsibility of the partner.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Regulatory approval no longer being sought in China. This market will be served by RDEA3170.
4 No current plan to launch CAZ AVI in Japan.
5 Movantik in the US; Moventig in EU.
6 Positive opinion received.
7 Positive opinion announced on 24 October 2014.
Phases I and II
NMEs and significant additional indications
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
tenapanor (AZD1722)#
NHE3 inhibitor
ESRD-Pi / CKD with T2DM1
II
Q1 2013




AZD4901
hormone modulator
polycystic ovarian syndrome
II
Q2 2013




AZD1979
melanin- concentrating hormone (MCH) receptor
obesity
I
Q2 2014




MEDI6012
LCAT
ACS
I
Q1 2012




MEDI8111 
Rh-factor II
trauma / bleeding
I
Q1 2014




Oncology
AZD1775#
WEE-1 inhibitor
ovarian cancer
II
Q4 2012




AZD2014
mTOR serine / threonine kinase inhibitor
solid tumours
II
Q1 2013




AZD4547
FGFR tyrosine kinase inhibitor
solid tumours
II
Q4 2011




MEDI-551#
anti-CD19 MAb
CLL / DLBCL
II
Q1 2012




MEDI-573#
anti-IGF MAb
metastatic breast cancer
II
Q2 2012




Lynparza (olaparib)
PARP inhibitor
prostate cancer
II
Q3 2014




selumetinib#
MEK inhibitor
2nd line KRAS- NSCLC
II
Q1 2013




AZD5363#
AKT kinase inhibitor
breast cancer
II
Q1 2014




MEDI4736#
anti-PD-L1 MAb
solid tumours
II
Q3 2014




moxetumomab
pasudotox#
anti-CD22 recombinant immunotoxin
pALL
II
Q3 2014




volitinib#
MET tyrosine kinase inhibitor
papillary renal cell carcinoma
II
Q2 2014




AZD5312#
androgen receptor inhibitor
solid tumours
I
Q2 2014




AZD6738
ATR serine / threonine kinase inhibitor
solid tumours
I
Q4 2013




AZD8186
PI3 kinase beta inhibitor
solid tumours
I
Q2 2013




AZD9150#
STAT3 inhibitor
haematological malignancies
I
Q1 2012




AZD9291 + (MEDI4736# or selumetinib# or volitinib#)
EGFR tyrosine kinase inhibitor + (anti-PD-L1 or MEK inhibitor or MET tyrosine kinase inhibitor)
advanced EGFRm NSCLC
I
Q3 2014




Phases I and II (continued)
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Oncology (continued)
MEDI4736# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab) TATTON
anti-PD-L1 MAb
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or anti- CTLA-4 MAb)
NSCLC
I
Q3 2014




MEDI-565#
anti-CEA BiTE MAb
solid tumours
I
Q1 2011




MEDI0639#
anti-DLL-4 MAb
solid tumours
I
Q2 2012




MEDI0680 
anti-PD-1 MAb
solid tumours
I
Q4 2013




MEDI3617#
anti-ANG-2 MAb
solid tumours
I
Q4 2010




MEDI4736#
anti-PD-L1 MAb
various cancers
I
Q3 2014




MEDI4736# + MEDI0680
anti-PD-L1 MAb + anti-PD- 1 MAb
solid tumours
I
Q2 2014




MEDI4736# + MEDI6469
anti-PD-L1 MAb + murine OX40 agonist
solid tumours
I
Q3 2014




MEDI4736# + dabrafenib + trametinib2
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor
melanoma
I
Q1 2014




MEDI4736# + Iressa
anti-PD-L1 MAb + EGFR tyrosine kinase inhibitor
NSCLC
I
Q2 2014




MEDI4736# + tremelimumab
anti-PD-L1 MAb + anti- CTLA-4 MAb
solid tumors
I
Q4 2013




MEDI-551# + rituximab3
anti-CD19 MAb + anti-CD20 MAb
haematological malignancies
I
Q2 2014




MEDI6383
OX40 agonist
solid tumours
I
Q3 2014




MEDI6469#
murine OX40 agonist
solid tumours
I
Q1 2006




Respiratory, Inflammation and Autoimmunity
AZD2115#
MABA
COPD
II
Q2 2012




AZD9412#
inhaled interferon 
asthma / COPD
II
Q1 2010




anifrolumab#
anti-IFN- alphaR MAb
SLE
II
Q1 2012




brodalumab#
anti-IL-17R MAb
asthma
II
Q2 2013




mavrilimumab#
anti-GM-CSFR MAb
rheumatoid arthritis
II
Q1 2010




MEDI2070#
anti-IL-23 MAb
Crohn's disease
II
Q1 2013




MEDI7183#
anti-a4b7 MAb
Crohn's disease / ulcerative colitis
II
Q4 2012




MEDI9929#
anti-TSLP MAb
asthma
II
Q2 2014




PT010
LAMA / LABA / ICS
COPD
II
Q2 2014




RDEA3170
selective uric acid reabsorption inhibitor (SURI)
chronic management of hyperuricaemia in patients with gout
II
Q3 2013




sifalimumab#
anti-IFN-alpha MAb
SLE
II
Q3 2008




tralokinumab
anti-IL-13 MAb
IPF
II
Q4 2012




Phases I and II (continued)
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity (continued)
AZD1419#
TLR9 agonist
asthma
I
Q3 2013




AZD7594
inhaled SGRM
asthma / COPD
I
Q3 20124




AZD7624
inhaled P38 inhibitor
COPD
I
Q1 2013




MEDI-551#
anti-CD19 MAb
multiple sclerosis
I
Q3 2012




MEDI4920
anti-CD40L- Tn3 fusion protein
primary Sjgren's syndrome
I
Q2 2014




MEDI5872#
anti-B7RP1 MAb
SLE
I
Q4 2008




Infection
AZD5847
oxazolidinone anti-bacterial inhibitor
tuberculosis
II
Q4 2012




CXL#
beta lactamase inhibitor / cephalosporin
MRSA
II
Q4 2010




ATM AVI
monobactam / beta lactamase inhibitor
targeted serious bacterial infections
I
Q4 2012




AZD0914
GyrAR
serious bacterial infections
I
Q4 2013




MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
Q2 2006




MEDI-559 
paediatric RSV vaccine
RSV prophylaxis
I
Q4 2008




MEDI4893
MAb binding to S. aureus toxin
hospital-acquired pneumonia / serious S. aureus infection
I
Q1 2013




MEDI3902
anti-Psl/PcrV
pseudomonas
I
Q3 2014




MEDI7510
RSV sF+GLA- SE
prevention of RSV disease in older adults
I
Q2 2014




MEDI8897#
anti-RSV MAb- YTE
passive RSV prophylaxis
I
Q2 2014




Neuroscience
AZD3241
myeloperoxidase inhibitor
multiple system atrophy5
II
Q2 2012




AZD5213
histamine-3 receptor antagonist
Tourette's syndrome / neuropathic pain
II
Q4 2013




AZD3293#
beta-secretase inhibitor
Alzheimer's disease
I
Q4 2012




AZD6423
NMDA antagonist
suicidal ideation
I
Q3 2013




MEDI1814
anti-amyloid beta MAb
Alzheimer's disease
I
Q2 2014




# Partnered product.
1 Fluid retention indication for tenapanor terminated in Q2.
2 MedImmune-sponsored study in collaboration with GSK.
3 MedImmune-sponsored study in collaboration with Genentech.
4 Original programme terminated in 2013. Programme now reinitiated.
5 Multiple system atrophy is now the lead indication for this molecule.
Line Extensions
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
Brilinta / Brilique1 EUCLID
ADP receptor antagonist
outcomes study in patients with peripheral artery disease
Q4 2012
2017
2017
2017
2018 
Brilinta / Brilique1
PEGASUS-
TIMI 54
ADP receptor antagonist
outcomes study in patients with prior myocardial infarction
Q4 2010
2015
2015
2015
2017
Brilinta / Brilique1 SOCRATES
ADP receptor antagonist
outcomes study in patients with stroke or TIA
Q1 2014
2016
2016
2016
2017
Brilinta / Brilique1 THEMIS
ADP receptor antagonist
outcomes study in patients with type 2 diabetes and CAD, but without a previous history of MI or stroke
Q1 2014
2017
2017
2018
2018
Bydureon Dual
Chamber Pen
GLP-1 receptor agonist
type 2 diabetes

Launched
Approved
Filed

Bydureon EXSCEL
GLP-1 receptor agonist
type 2 diabetes outcomes study 
Q2 2010
2018
2018
2018

Bydureon weekly
suspension
GLP-1 receptor agonist
type 2 diabetes
Q1 2013
2015
2015


Farxiga / Forxiga2
DECLARE-
TIMI 58
SGLT-2 inhibitor
type 2 diabetes outcomes study
Q2 2013
2020
2020


KombiglyzeXR FDC / Komboglyze FDC3
DPP-4 inhibitor / metformin FDC
type 2 diabetes

Launched
Launched

Filed
Onglyza SAVOR- TIMI 53
DPP-4 inhibitor
type 2 diabetes outcomes study
Q2 2010
Filed
Launched

2015
saxagliptin / dapagliflozin FDC 
DPP-4 inhibitor / SGLT-2 inhibitor FDC
type 2 diabetes
Q2 2012
2015
2015


XigduoXR FDC / Xigduo FDC4
SGLT-2 inhibitor / metformin FDC
type 2 diabetes 

Filed
Approved6


Oncology
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
differentiated thyroid cancer
Q2 2013
2016
2016
2016

Faslodex
FALCON 
oestrogen receptor antagonist
1st line hormone receptor +ve advanced breast cancer
Q4 2012
2016
2016
2016
2016
Respiratory, Inflammation and Autoimmunity 
Symbicort5
ICS / LABA
Breath Actuated Inhaler asthma / COPD





Line Extensions (continued)
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Neuroscience
Diprivan#
sedative and anaesthetic
conscious sedation

N/A
Launched
Q4 2014
Launched
Gastrointestinal
Entocort
glucocorticoid steroid
Crohn's disease / ulcerative colitis

Launched
Launched
2015
N/A
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)

N/A
N/A
N/A
2015
Nexium
proton pump inhibitor
refractory reflux esophagitis

N/A
N/A
Q4 2014 
N/A
Nexium
proton pump inhibitor
stress ulcer prophylaxis

N/A
N/A
N/A
2017
Nexium 
proton pump inhibitor
paediatrics

Launched
Launched
2016
TBD
# Partnered product.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Kombiglyze XR in the US; Komboglyze FDC in the EU.
4 Xigduo XR FDC in the US; Xigduo FDC in the EU.
5 Development of a new BAI device is ongoing.
6 Approval announced on 30 October 2014.
Completed projects
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Nexium
proton pump inhibitor
peptic ulcer bleeding

Launched
Launched
N/A
Launched
Terminations (discontinued projects between 1 July and 30 September 2014)1
NME / Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD1208
Safety / efficacy
haematological malignancies
NME
AZD8848#
Safety / efficacy
asthma
LCM
Iressa IMPRESS
Safety / efficacy
treatment beyond progression
# Partnered product.
1 tremelimumab+Iressa removed from table Q3 2014. Project is not terminated but is an investigator-sponsored study and, therefore, does not meet the requirement for inclusion in this table.

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