Development Pipeline as at 31 December 2013
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- Blaise Berry
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1 Line Extensions Cardiovascular Brilinta/ Brilique EUCLID Brilinta / Brilique PEGASUS-TIMI 54 Brilinta/ Brilique SOCRATES 1 Brilinta/ Brilique THEMIS Bydureon Dual Chamber Pen Bydureon EXSCEL Bydureon weekly suspension ADP ADP ADP ADP GLP-1 GLP-1 GLP-1 study in patients with PAD study in patients with prior MI study in patients with stroke or TIA study in patients with Type 2 diabetes and CAD but without previous history of MI or stroke Development Pipeline as at 31 December Q Q Q diabetes 2Q 2014 study 2Q diabetes 1Q Farxiga/Forxiga 2 DECLARE study 2Q Kombiglyze XR/ Komboglyze FDC 3 Onglyza SAVOR-TIMI 53 saxagliptin/ dapagliflozin FDC Xigduo DPP-4 / metformin FDC DPP-4 DPP-4 /SG LT2 FDC / metformin FDC diabetes Launched Launched study 2Q Q Q diabetes 2Q diabetes 4
2 Gastrointestinal Entocort Linaclotide # Nexium Neuroscience Diprivan # Oncology Caprelsa Faslodex Iressa glucocorticoid steroid GC-C peptide proton pump sedative and anaesthetic VEGFR/ EGFR tyrosine kinase with RET kinase activity oestrogen EGFR tyrosine kinase Crohn s disease/ulcer ative colitis irritable bowel syndrome with constipation (IBS-C) peptic ulcer bleeding conscious sedation differentiated thyroid 1 st line advanced breast treatment beyond progression Respiratory, Inflammation & Autoimmunity Breath inhaled Actuated Symbicort 6 steroid/ longacting β 2 Inhaler asthma / COPD Launched Launched 2015 N/A N/A N/A N/A Launched N/A Launched Launched 2H 2014 Launched 2Q Q Q Q 2011 # Partnered product 1 First subject dosed in January 2014 for SOCRATES 2 Farxiga US; Forxiga rest of world 3 Kombiglyze XR US; Komboglyze FDC EU 4 January nd CRL received from FDA in AZ response submitted to FDA in December 2012 and application remains under FDA review 6 Filing delayed pending evaluation of alternative device design
3 NMEs III/Registration Cardiovascular Brilinta /Brilique Epanova # Farxiga/ Forxiga 1 metreleptin Infection CAZ AVI (CAZ104) # CAZ AVI (CAZ104) # Zinforo (ceftaroline) # Neuroscience naloxegol (NKTR-118) # Oncology Caprelsa moxetumomab pasudotox # ADP omega-3 free fatty acids leptin analogue cephalosporin/ beta lactamase cephalosporin/ beta lactamase extended spectrum cephalosporin with affinity to penicillinbinding proteins oral peripherallyacting muopioid VEGFR / EGFR tyrosine kinase with RET kinase activity anti-cd22 recombinant immunotoxin Launched Launched Launched diabetes 2 Launched lipodystrophy 2015 N/A serious infections arterial thrombosis hypertriglyceridaemia hospitalacquired pneumonia/v entilatorassociated pneumonia pneumonia / skin infections opioidinduced constipation medullary thyroid hairy cell leukaemia 1Q 2012 N/A 4Q Q 2013 N/A N/A Launched N/A 1H 2014 Launched Launched 3Q Q PARP gbrcam PSR ovarian 1Q 2014 SOLO-1 SOLO-2 GOLD PARP PARP PARP 1 st line gbrcam ovarian gbrcam PSR ovarian 2 nd line gastric 3Q Q Q
4 selumetinib (AZD6244) MEK (ARRY ) # 2 nd line KRAS+ NSCLC Respiratory, Inflammation & Autoimmunity benralizumab # anti-il-5r severe asthma brodalumab # anti-il-17r lesinurad selective of URAT1 4Q Q psoriasis 3Q chronic management of hyperuricaem ia in patients with gout 4Q H H PT003 GFF LABA/LAMA COPD 2Q Farxiga US; Forxiga rest of world 2 January 2014
5 NMEs s I and II Cardiovascular AZD1722 # AZD4901 roxadustat (FG-4592) # NHE3 hormone modulator hypoxiainducible factor ESRD-Pi / CKD- with T2DM/ ESRD-Fluid Retention polycystic ovarian syndrome anaemia in CKD/endstage renal disease II 1Q 2013 II 2Q 2013 MEDI6012 LCAT ACS I 1Q 2012 Infection AZD5847 oxazolidinone anti-bacterial tuberculosis II 4Q 2012 CXL # ATM AVI AZD0914 MEDI-550 MEDI-559 (PRVV) MEDI4893 MEDI Neuroscience AZD3241 AZD5213 AZD3293 # AZD6423 beta lactamase / cephalosporin BL/BLI GyrAR pandemic influenza virus vaccine paediatric RSV vaccine staph alpha toxin YTE H7N9 vaccine myeloperoxidase (MPO) histamine-3 beta secretase NMDA MRSA II 4Q 2010 targeted serious bacterial infections serious bacterial infections pandemic influenza prophylaxis RSV prophylaxis hospitalacquired pneumonia / serious S. aureus infection avian influenza Parkinson s disease Tourette s syndrome/ neuropathic pain Alzheimer s disease suicidal ideation II N/A N/A 2016 I 4Q 2012 I 4Q 2013 I 2Q 2006 I 4Q 2008 I 1Q 2013 I 4Q 2013 II 2Q 2012 II 4Q 2013 I 4Q 2012 I 3Q In-licensed asset in late-development but the III AstraZeneca programme has yet to randomise its first patient 2 Vaccine in development through a CRADA with NIAID
6 NMEs s I and II (continued) Oncology AZD1775 # Wee-1 ovarian II 4Q 2012 AZD2014 TOR kinase solid tumours II 1Q 2013 AZD4547 FGFR tyrosine kinase solid tumours II 4Q 2011 MEDI-551 # anti-cd19 haematological malignancies II 1Q 2012 MEDI-573 # anti-igf MBC II 4Q 2011 PARP breast II 1Q 2012 selumetinib (AZD6244) (ARRY ) # MEK various s II 4Q 2008 tremelimumab anti-ctla4 mesothelioma II 2Q 2013 AZD1208 PIM kinase haematological malignancies I 1Q 2012 AZD5363 # AKT solid tumours I 4Q 2010 AZD6738 ATR CLL/ head & neck I 4Q 2013 AZD8186 AZD9150 # AZD9291 MEDI-565 # MEDI0639 # MEDI0680 (AMP-514) MEDI3617 # MEDI4736 # MEDI4736 # + tremelimumab MEDI4736 # + dabrafenib + trametinib 3 MEDI6469 # moxetumomab pasudotox # volitinib # (AZD6094) PI3 kinase beta STAT3 epidermal growth factor anti-cea BiTE anti-dll-4 solid tumours I 2Q 2013 haematological malignancies I 1Q 2012 solid tumours I 1Q 2013 solid tumours I 1Q 2011 solid tumours I 2Q 2012 anti-pd-1 solid tumours I 4Q 2013 anti-ang-2 anti-pd-l1 anti-pd-l1 + anti- CTLA4 anti-pd-l1 + BRAF + MEK murine anti- OX40 anti-cd22 recombinant immunotoxin solid tumours I 4Q 2010 solid tumours I 3Q 2012 solid tumours I 4Q 2013 melanoma I 1Q 2014 solid tumours I 1Q 2006 pall I 3Q 2008 MET solid tumours I 1Q MedImmune-sponsored study in collaboration with GlaxoSmithKline. First patient dosed in January 2014
7 NMEs s I and II (continued) Respiratory, Inflammation & Autoimmunity AZD2115 # MABA COPD II 2Q 2012 AZD5069 CXCR2 asthma II 4Q 2010 benralizumab # brodalumab # mavrilimumab # MEDI-546 # MEDI2070 # MEDI7183 # MEDI8968 # RDEA3170 sifalimumab # tralokinumab anti-il-5r anti-il-17r anti-gm- CSFR anti-ifnalphar anti-il-23 anti-a4b7 anti-il-1r selective of URAT1 anti-ifnalpha anti-il-13 COPD II 4Q 2010 asthma / psoriatic arthritis rheumatoid arthritis II 2Q 2013 II 1Q 2010 SLE II 1Q 2012 Crohn s disease II 1Q 2013 Crohn s disease / ulcerative colitis II 4Q 2012 COPD, HS II 4Q 2011 chronic management of hyperuricaemia in patients with gout II 3Q 2013 SLE II 3Q 2008 asthma / IPF II 1Q 2008 AZD1419 TLR9 asthma I 3Q 2013 AZD4721 CXCR2 COPD I 3Q 2013 AZD7624 ip38i COPD I 1Q 2013 AZD8848 # inhaled TLR7 asthma I 2Q 2012 MEDI-551 # MEDI5872 # MEDI9929 # PT010 anti-cd19 anti-b7rp1 anti-tslp LAMA/LABA/ ICS multiple sclerosis I 3Q 2012 SLE I 4Q 2008 asthma I 4Q 2008 COPD I 4Q 2013
8 Development Pipeline - Discontinued Projects between 1 January 2013 and 31 December 2013 Infection NME/Line Extension Compound Reason for Discontinuation NME MEDI-557 Safety/Efficacy Area Under RSV prevention in high risk adults (COPD/CHF/other) Neuroscience NME/Line Extension Compound Reason for Area Under Discontinuation NME AZD1446 Safety/Efficacy Alzheimer s disease NME AZD3480 ## Safety/Efficacy Alzheimer s disease NME AZD5213 Hypothesis risk Alzheimer s disease NME AZD6765 Safety/Efficacy major depressive disorder NME MEDI5117 Safety/Efficacy OA pain Oncology NME/Line Extension Compound Reason for Area Under Discontinuation NME AZD8330 # (ARRY ) Safety/Efficacy solid tumours NME fostamatinib ## Safety/Efficacy haematological malignancies NME MEDI-575 ## Safety/Efficacy NSCLC Respiratory, Inflammation & Autoimmunity NME/Line Extension Compound Reason for Area Under Discontinuation NME AZD5423 # Safety/Efficacy COPD NME AZD7594 # Safety/Efficacy COPD NME fostamatinib ## Safety/Efficacy rheumatoid arthritis NME MEDI4212 Safety/Efficacy asthma NME MEDI7814 Economic COPD LCM tralokinumab Safety/Efficacy UC Completed Projects Launch Status Cardiovascular Forxiga (dapagliflozin) Forxiga (dapagliflozin) diabetes add on to DPP-4 diabetes add on to metformin longterm data Forxiga (dapagliflozin) 1 diabetes in patients with high CV risk study 18 and 19 long-term data Forxiga (dapagliflozin) diabetes triple therapy (dapa+met+ SU) Infection Q-LAIV Flu Vaccination live, attenuated, intranasal influenza virus vaccine (quadrivalent) seasonal influenza 1 Studies 18/19 complete. No filing planned from this data Comments
9 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 III and beyond.
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