31st Jan 2013 07:00
Development Pipeline as at
31 December 2012
Line Extensions
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
| US | EU | Japan | China | |||||
| Cardiovascular | ||||||||
Axanum | proton pump inhibitor + low dose aspirin FDC | low dose aspirin associated peptic ulcer in high risk CV patients | III | Withdrawn | Launched | 2016 | ||
Brilinta/ BriliqueEUCLID | ADP receptor antagonist | outcomes study in patients with PAD | III | 4Q 2012 | 2016 | 2016 | 2016 | 2017 |
Brilinta/Brilique PEGASUS-TIMI 54 | ADP receptor antagonist | outcomes study in patients with prior MI | III | 4Q 2010 | 2015 | 2015 | 2015 | 2017 |
Bydureon EXSCEL# | GLP-1 receptor agonist | outcomes study | III | 2Q 2010 | 2018 | |||
Bydureon Dual Chamber Pen# | GLP-1 receptor agonist | diabetes | III | 3Q 2013 | ||||
Forxiga(dapagliflozin)/ metformin FDC# | SGLT2 inhibitor + metformin FDC | diabetes | III | 3Q 2007 | Filed | |||
Forxiga (dapagliflozin)# | SGLT2 inhibitor | diabetes - add on to DPP-4 | III | 1Q 2010 | Filed | |||
Forxiga (dapagliflozin)# | SGLT2 inhibitor | diabetes - add on to insulin and add-on to metformin long-term data | III | 2Q 2008 | Filed | |||
Forxiga (dapagliflozin)# | SGLT2 inhibitor | diabetes - in patients with high CV risk - Study 18 and 19 long-term data | III | 1Q 2010 | 1H 2014 | |||
Forxiga (dapagliflozin)# | SGLT2 inhibitor | diabetes - triple therapy (dapa+met+ SU) | III | 1Q 2011 | 1Q 2013 | |||
Kombiglyze XR/ Komboglyze FDC#* | DPP-4 inhibitor + metformin FDC | diabetes | III | Launched | Launched | 1H 2014 | ||
SaxaDapa FDC# | DPP-4 inhibitor / SGLT2 inhibitor | diabetes | III | 2Q 2012 | 2015 | 2015 | ||
OnglyzaSAVOR-TIMI 53# | DPP-4 inhibitor | outcomes study | III | 2Q 2010 | 4Q 2013 | 4Q 2013 | 2H 2014 | |
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | ||||
| US | EU | Japan | China | ||||||
Gastrointestinal | |||||||||
Entocort | glucocorticoid steroid | Crohn's disease / ulcerative colitis | III | Launched | Launched | 2015 | |||
Nexium | proton pump inhibitor | peptic ulcer bleeding | III | Filed** | Launched | N/A | Launched | ||
Neuroscience | |||||||||
Diprivan# | sedative and anaesthetic | conscious sedation | III | Launched | 1H 2014 | Launched | |||
Oncology | |||||||||
Faslodex | oestrogen receptor antagonist | 1st line advanced breast cancer | III | 4Q 2012 | 2016 | 2016 | 2016 | 2016 | |
Iressa | EGFR tyrosine kinase inhibitor | treatment beyond progression | III | 1Q 2012 | 2015 | 2015 | 2015 | ||
Respiratory & Inflammation | |||||||||
Symbicort*** | inhaled steroid/ long-acting β2 agonist | Breath Actuated Inhaler asthma / COPD | III | 4Q 2011 | 1H 2014 | ||||
#Partnered product
*Kombiglyze XR US; Komboglyze FDC EU
**2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012
***Excludes Symbicort pMDI post marketing LABA safety study
NCEs
Phase III/Registration
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||||
| US | EU | Japan | China | |||||||
| Cardiovascular | ||||||||||
Brilinta/Brilique | ADP receptor antagonist | arterial thrombosis | III | Launched | Launched | 2Q 2013 | Approved | |||
Forxiga (dapagliflozin)# | SGLT2 inhibitor | diabetes | III | Filed* | Launched | 1Q 2013 | 1Q 2013 | |||
metreleptin# | leptin analogue | lipodystrophy | III | 2Q 2013 | N/A | |||||
Infection | ||||||||||
CAZ AVI# (CAZ104) | beta lactamase inhibitor/ cephalosporin | serious infections | III | 1Q 2012 | N/A | 2H 2014 | 2H 2014 | 2016 | ||
Q-LAIVFlu Vaccination** | live, attenuated, intranasal influenza virus vaccine (quadrivalent) | seasonal influenza | III | Approved | Filed | |||||
Zinforo# (ceftaroline)
| extended spectrum cephalosporin with affinity to penicillin- binding proteins | pneumonia / skin infections | III | N/A | Launched | 1H 2014 | ||||
Neuroscience | ||||||||||
naloxegol (NKTR-118)# | oral peripherally-acting mu-opioid receptor antagonist | opioid-induced constipation | III | 2Q 2011 | 3Q 2013 | 3Q 2013 | ||||
Oncology | ||||||||||
Caprelsa
| VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity | medullary thyroid cancer | III | Launched | Launched | 2015 | Filed | |||
Respiratory & Inflammation | ||||||||||
brodalumab# | anti-IL-17R MAb | psoriasis | III | 3Q 2012 | 2015 | 2015 | ||||
fostamatinib# | spleen tyrosine kinase (SYK) inhibitor | rheumatoid arthritis | III | 3Q 2010 | 4Q 2013 | 4Q 2013 | ||||
lesinurad | selective inhibitor of URAT1 | chronic management of hyperuricaemia in patients with gout | III | 4Q 2011 | 1H 2014 | 1H 2014 | 2017 | 2017 | ||
#Partnered product
*CRL received in January 2012
**sBLA in US, MAA in EU
NCEs
Phases I and II
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
| US | EU | Japan | China | |||||
Cardiovascular | ||||||||
AZD1722# | NHE3 inhibitor | end stage renal disease / chronic kidney disorder | I | 4Q 2010 | ||||
Gastrointestinal | ||||||||
tralokinumab | anti-IL-13 MAb | ulcerative colitis | II | 2Q 2012 | ||||
Infection | ||||||||
AZD5847 | oxazolidinone anti-bacterial inhibitor | tuberculosis | II | 4Q 2012 | ||||
CXL# | beta lactamase inhibitor/ cephalosporin | MRSA | II | 4Q 2010 | ||||
ATM AVI | BL/BLI | targeted serious bacterial infections | I | 4Q 2012 | ||||
MEDI-550 | pandemic influenza virus vaccine | pandemic influenza prophylaxis | I | 2Q 2006 | ||||
MEDI-557 | anti-RSV MAb - extended half-life | RSV prevention in high risk adults (COPD/CHF/other) | I | 3Q 2007 | ||||
MEDI-559 | paediatric RSV vaccine | RSV prophylaxis | I | 4Q 2008 | ||||
Neuroscience | ||||||||
AZD3241 | myeloper-oxidase (MPO) inhibitor | Parkinson's disease | II | 2Q 2012 | ||||
AZD3480# | alpha4/beta2 neuronal nicotinic receptor agonist | Alzheimer's disease | II | 3Q 2007 | ||||
AZD5213 | histamine-3 receptor antagonist | Alzheimer's disease | II | 2Q 2012 | ||||
AZD6765 | NMDA receptor antagonist | major depressive disorder | II | 3Q 2007 | ||||
AZD1446# | alpha4/beta2 neuronal nicotinic receptor agonist | Alzheimer's disease | I | 4Q 2008 | ||||
AZD3293# | beta secretase | Alzheimer's disease | I | 4Q 2012 | ||||
MEDI5117 | anti-IL-6 MAb | rheumatoid arthritis | I | 2Q 2012 | ||||
#Partnered product
NCEs
Phases I and II (continued)
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
| US | EU | Japan | China | |||||
Oncology | ||||||||
AZD4547 | FGFR tyrosine kinase inhibitor | solid tumours | II | 4Q 2011 | ||||
fostamatinib# | spleen tyrosine kinase (SYK) inhibitor | haematological malignancies | II | 1Q 2012 | ||||
MEDI-551# | anti-CD19 MAb | haematological malignancies | II | 1Q 2012 | ||||
MEDI-573# | anti-IGF MAb | MBC | II | 4Q 2011 | ||||
MEDI-575# | anti-PDGFR-alpha MAb | NSCLC | II | 2Q 2011 | ||||
olaparib | PARP inhibitor | gBRCAm ovarian cancer, gBRCAm breast cancer, gastric cancer | II | 1Q 2012 | ||||
selumetinib# (AZD6244)(ARRY-142886) | MEK inhibitor | solid tumours | II | 4Q 2006 | ||||
tremelimumab | anti-CTLA4 MAb | solid tumours | II | 3Q 2004 | ||||
AZD1208 | PIM kinase inhibitor | haematological malignancies | I | 1Q 2012 | ||||
AZD2014 | TOR kinase inhibitor | solid tumours | I | 1Q 2010 | ||||
AZD5363# | AKT inhibitor | solid tumours | I | 4Q 2010 | ||||
AZD8330# (ARRY 424704) | MEK inhibitor | solid tumours | I | 1Q 2007 | ||||
AZD9150 | STAT3 inhibitor | haematological malignancies | I | 1Q 2012 | ||||
MEDI0639# | anti-DLL-4 MAb | solid tumours | I | 2Q 2012 | ||||
MEDI3617# | anti-ANG-2 MAb | solid tumours | I | 4Q 2010 | ||||
MEDI4736# | anti-PD-L1 MAb | solid tumours | I | 3Q 2012 | ||||
MEDI-565# | anti-CEA BiTE | solid tumours | I | 1Q 2011 | ||||
MEDI6469# | murine anti-OX40 MAb | solid tumours | I | 1Q 2006 | ||||
moxetumomab pasudotox#
| anti-CD22 recombinant immunotoxin | haematological malignancies | I | 2Q 2007 | ||||
volitinib# | MET inhibitor | solid tumours | I | 1Q 2012 | ||||
#Partnered product
NCEs
Phases I and II (continued)
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | |||
| US | EU | Japan | China | |||||
Respiratory & Inflammation | ||||||||
AZD2115# | MABA | COPD | II | 2Q 2012 | ||||
AZD5069 | CXCR2 | asthma | II | 4Q 2010 | ||||
AZD5423# | inhaled SGRM | COPD | II | 4Q 2010 | ||||
benralizumab# | anti-IL-5R MAb | asthma / COPD | II | 4Q 2008 | ||||
mavrilimumab# | anti-GM-CSFR MAb | rheumatoid arthritis | II | 1Q 2010 | ||||
MEDI-546# | anti-IFN-alphaR MAb | SLE | II | 1Q 2012 | ||||
MEDI7183# | anti-a4b7 MAb | Crohn's disease / ulcerative colitis | II | 4Q 2012 | ||||
MEDI8968# | anti-IL-1R MAb | COPD | II | 4Q 2011 | ||||
sifalimumab# | anti-IFN-alpha MAb | SLE | II | 3Q 2008 | ||||
tralokinumab | anti-IL-13 MAb | asthma / IPF | II | 1Q 2008 | ||||
AZD8848# | inhaled TLR7 | asthma | I | 2Q 2012 | ||||
AZD7594# | inhaled SGRM | COPD | I | 4Q 2012 | ||||
MEDI2070# | anti-IL-23 MAb | Crohn's disease | I | 2Q 2010 | ||||
MEDI4212 | anti-IgE MAb | asthma | I | 1Q 2012 | ||||
MEDI-551# | anti-CD19 MAb | multiple sclerosis | I | 3Q 2012 | ||||
MEDI5872# | anti-B7RP1 MAb | SLE | I | 4Q 2008 | ||||
MEDI7814 | anti-C5/C5a MAb | COPD | I | 1Q 2012 | ||||
MEDI9929# | anti-TSLP MAb | asthma | I | 4Q 2008 | ||||
RDEA3170 | selective inhibitor of URAT1 | chronic management of hyperuricaemia in patients with gout | I | 3Q 2011 | ||||
#Partnered product
Completed Projects
Compound | Mechanism | Area Under Investigation | Phase | Date Commenced Phase | Estimated Filing | ||||
| US | EU | Japan | China | ||||||
Cardiovascular | |||||||||
Crestor# | statin | outcomes in subjects with elevated CRP | Launched | Launched | Launched | ||||
Gastrointestinal | |||||||||
Nexium | proton pump inhibitor | GERD | Launched | Launched | Launched | Launched | |||
Infection | |||||||||
FluMist/Fluenz | live, attenuated, intranasal influenza virus vaccine | influenza | Launched | Launched | |||||
Neuroscience | |||||||||
EMLA | local anaesthetic | topical anaesthesia | Launched | Launched | |||||
Oncology | |||||||||
Iressa | EGFR tyrosine kinase inhibitor | 1st line EGFR mut+ NSCLC | Launched | Launched | Launched | ||||
Faslodex | oestrogen receptor agonist | High dose (500mg) 2nd line advanced breast cancer | Launched | Launched | Launched | ||||
Ranmark# (denosumab) | anti-RANKL MAb | Bone disorders stemming from bone metastasis | Launched | ||||||
Respiratory & Inflammation | |||||||||
Oxis | long-acting β2 agonist | COPD | Launched | Launched | Launched | ||||
Symbicort | inhaled steroid/ long-acting β2 agonist | COPD | Launched | Launched | Launched | Launched | |||
Symbicort | inhaled steroid/long acting β2 agonist | SMART | Launched | Launched | Launched | ||||
Development Pipeline - Discontinued Projects between 30 June 2012 and 31 December 2012
Cardiovascular
NCE/Line Extension | Compound | Reason for Discontinuation | Area Under Investigation |
NCE | AZD2820 | Safety/Efficacy | obesity |
NCE | AZD4017 | Safety/Efficacy | glaucoma |
Infection
NCE/Line Extension | Compound | Reason for Discontinuation | Area Under Investigation |
NCE | AZD9773 | Safety/Efficacy | severe sepsis |
Oncology
NCE/Line Extension | Compound | Reason for Discontinuation | Area Under Investigation |
NCE | AZD1480 | Safety/Efficacy | solid tumours |
NCE | AZD3514 | Safety/Efficacy | prostate cancer |
NCE | AZD8931 | Safety/Efficacy | breast cancer chemo. combi./solid tumours |
NCE | selumetinib (AZD6244) (ARRY-142886)/MK2206# | Study completed | solid tumours |
Respiratory & Inflammation
NCE/Line Extension | Compound | Reason for Discontinuation | Area Under Investigation |
NCE | AZD8683 | Safety/Efficacy | COPD |
NCE | MEDI-570 | Safety/Efficacy | SLE |
Comments
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.
Submission dates shown for assets in Phase III and beyond.
Related Shares:
Astrazeneca