REG - AstraZeneca PLC - AstraZeneca Pipeline <Origin Href="QuoteRef">AZN.L</Origin>
06/09/2014 22:42
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RNS Number : 8347N
AstraZeneca PLC
31 July 2014
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# anti-PD-L1 MAb 3rd line NSCLC Q1 2014 2016 2017 2017
ATLANTIC¶
moxetumomab pasudotox# anti-CD22 recombinant hairy cell leukaemia Q2 2013 2018 2018
immunotoxin
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# MEK inhibitor 2nd line KRAS+ NSCLC Q4 2013 2017 2017
SELECT-1
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2017 2017
ASTRA
selumetinib# MEK inhibitor uveal melanoma Q2 2014 2015 2015
SUMIT
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 anti-CD22 recombinant immunotoxin pALL I Q3 2008
pasudotox#
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 ADP receptor antagonist outcomes study in patients with prior myocardial infarction Q4 2010 2015 2015 2015 2017
PEGASUS-
TIMI 54
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 GLP-1 receptor agonist diabetes Approved Filed Filed
Chamber Pen
Bydureon EXSCEL GLP-1 receptor agonist outcomes study Q2 2010 2018 2018 2018
Bydureon weekly GLP-1 receptor agonist diabetes Q1 2013 2015 2015
suspension
Farxiga / Forxiga2 SGLT-2 inhibitor outcomes study Q2 2013 2020 2020
DECLARE-
TIMI 58
KombiglyzeXR 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
XigduoXR 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
FaslodexFALCON oestrogen receptor antagonist 1st line advanced breast cancer Q4 2012 2016 2016 2016 2016
IressaIMPRESS 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 N/A N/A N/A 2015
(IBS-C)
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.
This information is provided by RNS
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