4 PIPELINE UPDATE - ASTRAZENECA DEVELOPMENT PIPELINE,
30 JUNE 2014
NMEs
Phase III / Pivotal / Registration
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 |
diabetes |
|
Launched |
Launched |
Launched |
Filed |
Myalept |
leptin analogue |
lipodystrophy |
|
Launched |
2015 |
N/A |
|
roxadustat# |
hypoxia-inducible factor inhibitor |
anaemia in CKD / ESRD |
Q3 20143 |
2018 |
N/A |
N/A |
2016 |
Oncology |
AZD9291¶ |
EGFR tyrosine kinase inhibitor |
advanced T790M+ NSCLC |
Q2 2014 |
2015 |
2015 |
2015 |
2017 |
Caprelsa |
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity |
medullary thyroid cancer |
|
Launched |
Launched |
Q3 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 |
|
|
olaparib |
PARP inhibitor |
BRCAm PSR ovarian cancer |
|
Filed |
Filed |
|
|
olaparib SOLO-1 |
PARP inhibitor |
1st line BRCAm ovarian cancer |
Q3 2013 |
2017 |
2017 |
2017 |
2018 |
olaparib SOLO-2 |
PARP inhibitor |
BRCAm PSR ovarian cancer |
Q3 2013 |
2016 |
2016 |
2016 |
2016 |
olaparib GOLD |
PARP inhibitor |
2nd line gastric cancer |
Q3 2013 |
|
|
2017 |
2018 |
olaparib OlympiA |
PARP Inhibitor |
adjuvant breast cancer |
Q2 2014 |
2020 |
2020 |
2020 |
2021 |
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 |
2017 |
2017 |
2017 |
|
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, ZONDIA |
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 |
++ |
++ |
|
|
lesinurad |
selective uric acid reabsorption inhibitor (URAT1) |
chronic treatment of patients with gout |
Q4 2011 |
Q4 2014 |
Q4 2014 |
|
n/a5 |
PT003 GFF |
LAMA / LABA |
COPD |
Q2 2013 |
2015 |
2016 |
|
|
PT001 GP |
LAMA |
COPD |
Q2 2013 |
2015 |
2016 |
|
|
Infection |
CAZ AVI# RECLAIM |
cephalosporin / beta lactamase inhibitor |
serious infections |
Q1 2012 |
N/A |
Q4 2014 |
2015 |
2016 |
CAZ AVI# REPROVE |
cephalosporin / beta lactamase inhibitor |
hospital-acquired pneumonia / ventilator-associated pneumonia |
Q2 2013 |
N/A |
2017 |
2017 |
2018 |
Zinforo# |
extended spectrum cephalosporin with affinity to penicillin-binding proteins |
pneumonia / skin infections |
|
N/A |
Launched |
N/A |
Filed |
Neuroscience |
Movantik# |
oral peripherally-acting mu-opioid receptor antagonist |
opioid-induced constipation |
|
Filed |
Filed |
|
|
# 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 First patient enrolled in June and dosed in July 2014.
4 First patient dosed in July 2014.
5 Regulatory approval no longer being sought in China. This market will be served by RDEA3170.
NMEs
Phases I and II
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 |
arterial thrombosis |
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 |
|
|
|
|
selumetinib# |
MEK inhibitor |
2nd line KRAS- NSCLC |
II |
Q1 2013 |
|
|
|
|
AZD5363# |
AKT kinase inhibitor |
breast cancer |
II |
Q1 2014 |
|
|
|
|
volitinib# |
MET tyrosine kinase inhibitor |
papillary renal cell carcinoma |
II |
Q2 2014 |
|
|
|
|
AZD1208 |
PIM kinase inhibitor |
haematological malignancies |
I |
Q1 2012 |
|
|
|
|
AZD5312# |
androgen receptor inhibitor |
prostate cancer |
I |
Q2 2014 |
|
|
|
|
AZD6738 |
ATR serine / threonine kinase inhibitor |
CLL / head & neck |
I |
Q4 2013 |
|
|
|
|
AZD8186 |
PI3 kinase beta inhibitor |
solid tumours |
I |
Q2 2013 |
|
|
|
|
AZD9150# |
STAT3 inhibitor |
haematological malignancies |
I |
Q1 2012 |
|
|
|
|
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# + tremelimumab |
anti-PD-L1 MAb + anti-CTLA-4 MAb |
solid tumors |
I |
Q4 2013 |
|
|
|
|
MEDI4736# + dabrafenib + trametinib2 |
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor |
melanoma |
I |
Q1 2014 |
|
|
|
|
MEDI4736# + Iressa |
anti-PD-L1 MAb + EGFR inhibitor |
NSCLC |
I |
Q2 2014 |
|
|
|
|
MEDI4736# + MEDI0680 |
anti-PD-L1 MAb + anti-PD-1 MAb |
solid tumours |
I |
Q2 2014 |
|
|
|
|
MEDI-551# + rituximab3 |
anti-CD19 MAb + anti-CD20 MAb |
haematological malignancies |
I |
Q2 2014 |
|
|
|
|
NMEs
Phases I and II (continued)
Compound |
Mechanism |
Area Under Investigation |
Phase |
Date Commenced Phase |
Estimated Filing |
US |
EU |
Japan |
China |
Oncology (continued) |
MEDI6469# |
murine anti-OX40 MAb |
solid tumours |
I |
Q1 2006 |
|
|
|
|
moxetumomab
pasudotox# |
anti-CD22 recombinant immunotoxin |
pALL |
I |
Q3 2008 |
|
|
|
|
tremelimumab + Iressa |
anti-CTLA-4 MAb + EGFR inhibitor |
NSCLC |
I |
Q2 2014 |
|
|
|
|
Respiratory, Inflammation and Autoimmunity |
AZD2115# |
MABA |
COPD |
II |
Q2 2012 |
|
|
|
|
AZD9412# (SNG001) |
inhaled interferon β |
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 (URAT1) |
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 |
asthma / IPF |
II |
Q1 2008 |
|
|
|
|
AZD1419# |
TLR9 agonist |
asthma |
I |
Q3 2013 |
|
|
|
|
AZD7594 |
inhaled SGRM |
asthma / COPD |
I |
Q3 20124 |
|
|
|
|
AZD7624 |
inhaled P38 inhibitor |
COPD |
I |
Q1 2013 |
|
|
|
|
AZD8848# |
inhaled TLR7 agonist |
asthma |
I |
Q2 2012 |
|
|
|
|
MEDI-551# |
anti-CD19 MAb |
multiple sclerosis |
I |
Q3 2012 |
|
|
|
|
MEDI4920 |
anti-CD40L MAb |
primary Sjögren'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 |
|
|
|
|
NMEs
Phases I and II (continued)
Compound |
Mechanism |
Area Under Investigation |
Phase |
Date Commenced Phase |
Estimated Filing |
US |
EU |
Japan |
China |
Infection (continued) |
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 |
|
|
|
|
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 |
2016 |
2016 |
2017 |
2017 |
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 |
diabetes |
|
Approved |
Filed |
Filed |
|
Bydureon EXSCEL |
GLP-1 receptor agonist |
outcomes study |
Q2 2010 |
2018 |
2018 |
2018 |
|
Bydureon weekly
suspension |
GLP-1 receptor agonist |
diabetes |
Q1 2013 |
2015 |
2015 |
|
|
Farxiga / Forxiga2
DECLARE-
TIMI 58 |
SGLT-2 inhibitor |
outcomes study |
Q2 2013 |
2020 |
2020 |
|
|
Kombiglyze XR FDC / Komboglyze FDC3 |
DPP-4 inhibitor / metformin FDC |
diabetes |
|
Launched |
Launched |
|
Filed |
Onglyza SAVOR-TIMI 53 |
DPP-4 inhibitor |
outcomes study |
Q2 2010 |
Filed |
Filed |
|
2015 |
saxagliptin / dapagliflozin FDC |
DPP-4 inhibitor / SGLT-2 inhibitor FDC |
diabetes |
Q2 2012 |
2015 |
2015 |
|
|
Xigduo XR FDC / Xigduo FDC4 |
SGLT-2 inhibitor / metformin FDC |
diabetes |
|
Filed |
Launched |
|
|
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 advanced breast cancer |
Q4 2012 |
2016 |
2016 |
2016 |
2016 |
Iressa IMPRESS |
EGFR tyrosine kinase inhibitor |
treatment beyond progression |
Q1 2012 |
|
2015 |
2015 |
2015 |
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 |
peptic ulcer bleeding |
|
Launched |
Launched |
N/A |
Launched |
# 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.
Terminations (discontinued projects between 1 April and 30 June 2014)
NME / Line Extension |
Compound |
Reason for Discontinuation |
Area Under Investigation |
NME |
AZD47211 |
Safety / efficacy |
COPD |
NME |
AZD50691 |
Safety / efficacy |
asthma |
NME |
MEDI8968# |
Safety / efficacy |
COPD / HS |
NME |
MEDI9287 |
economic |
avian influenza |
# Partnered product.
1 Termination decision made July 2014.
