Development Pipeline as at 30 June 2013
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- Caroline Watts
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1 Line Extensions Cardiovascular Axanum*** Brilinta/ Brilique EUCLID Brilinta / Brilique PEGASUS- TIMI 54 Bydureon EXSCEL # Bydureon Dual Chamber Pen # (dapagliflozin)/ metformin FDC # (dapagliflozin) DECLARE # Kombiglyze XR/ Komboglyze FDC # * SaxaDapa FDC # proton pump + low dose aspirin FDC ADP ADP GLP-1 agonist GLP-1 agonist + metformin FDC DPP-4 + metformin FDC DPP-4 / Onglyza SAVOR-TIMI 53 # DPP-4 low dose aspirin associated peptic ulcer in high risk CV patients study in PAD study in prior MI study Development Pipeline as at 30 June 2013 III Withdrawn Launched III 4Q III 4Q III 2Q diabetes III 3Q Q 2013 diabetes III 3Q Q 2013 Filed diabetes add on to DPP-4 diabetes add on to insulin and add-on to metformin long-term data diabetes in high CV risk - Study 18 and 19 long-term data diabetes triple therapy (dapa+met+ SU) study III 1Q 2010 Filed III 2Q 2008 Filed III 1Q H 2014 III 1Q Q 2013 III 2Q diabetes III Launched Launched 1H 2014 diabetes III 2Q study III 2Q Q Q H 2014
2 Gastrointestinal Entocort Nexium Neuroscience Diprivan # Oncology Faslodex Iressa glucocorticoid steroid proton pump sedative and anaesthetic oestrogen EGFR tyrosine kinase Crohn s disease / ulcerative colitis peptic ulcer bleeding conscious sedation 1 st line advanced breast cancer treatment beyond progression Respiratory, Inflammation & Autoimmunity Breath inhaled Actuated steroid/ longacting β 2 Symbicort Inhaler asthma / agonist COPD III Launched Launched 2015 N/A III Filed** Launched N/A Launched III Launched 2H 2014 Launched III 4Q III 1Q III 4Q H 2014 *Kombiglyze XR US; Komboglyze FDC EU **2 nd CRL received from FDA in AZ response submitted to FDA in December 2012 ***Commercial support now withdrawn, no Japan launch expected
3 NCEs III/Registration Cardiovascular Brilinta/ Brilique Epanova # metreleptin # Infection CAZ AVI # (CAZ104) Q-LAIV Flu Vaccination** Zinforo (ceftaroline) # Neuroscience naloxegol (NKTR-118) # Oncology Caprelsa moxetumomab pasudotox # ADP omega-3 free fatty acids leptin analogue beta lactamase / cephalosporin live, attenuated, intranasal influenza virus vaccine quadrivalent extended spectrum cephalosporin with affinity to penicillinbinding proteins oral peripherallyacting muopioid VEGFR / EGFR tyrosine kinase with RET kinase activity anti-cd22 recombinant immunotoxin arterial thrombosis hypertriglyceridaemia III Launched Launched Filed Launched III Filed diabetes III Filed* Launched Filed Filed lipodystrophy III Filed 1H 2014 N/A intra abdominal infections (ciai) & urinary tract infections (cuti); hospital acquired pneumonia (HAP) & ventilator associated pneumonia (VAP) *** seasonal influenza pneumonia / skin infections opioid-induced constipation medullary thyroid cancer hairy cell leukaemia III 1Q 2012 N/A 2H III Approved Filed III N/A Launched 1H 2014 III 2Q Q Q 2013 III Launched Launched 2015 Filed III 2Q
4 Respiratory, Inflammation & Autoimmunity brodalumab # anti-il-17r psoriasis III 3Q PT003 GFF LABA/LAMA COPD III 2Q selective uric chronic acid treatment of lesinurad reabsorption gout (SURI) *CRL received in January 2012, re-submission 3Q 2013 **sbla in US, MAA in EU ***HAP/VAP is a follow up filing, EU filing expected in 2017 III 4Q H H
5 NCEs s I and II Cardiovascular AZD1722 # MEDI6012 (ACP-501) Infection AZD5847 CXL # ATM AVI MEDI4893 MEDI-550 PRVV (MEDI-559) Neuroscience AZD3241 AZD5213 AZD6765 AZD3293 # NHE3 end stage renal disease / chronic kidney disorder II 1Q 2013 LCAT ACS I 1Q 2012 oxazolidinone anti-bacterial beta lactamase / cephalosporin BL/BLI staph alpha toxin YTE pandemic influenza virus vaccine live attenuated paediatric RSV vaccine myeloperoxidase (MPO) histamine-3 NMDA beta secretase tuberculosis II 4Q 2012 MRSA II 4Q 2010 targeted serious bacterial infections hospitalacquired pneumonia / serious S. aureus infection pandemic influenza prophylaxis RSV prophylaxis Parkinson s disease neuropathic pain * major depressive disorder Alzheimer s disease I 4Q 2012 I 1Q 2013 I 2Q 2006 I 4Q 2008 II 2Q 2012 II II 3Q 2007 I 4Q 2012 *Terminated in Alzheimer s Disease neuropathic pain study due to start 3Q 2013
6 NCEs s I and II (continued) Oncology AZD4547 FGFR tyrosine kinase anti-cd19 solid tumours II 4Q 2011 MEDI-551 # haematological malignancies II 1Q 2012 MEDI-573 # anti-igf MBC II 4Q 2011 gbrcam ovarian olaparib PARP cancer, gbrcam II 1Q 2012 breast cancer, gastric cancer selumetinib # (AZD6244) (ARRY ) MEK solid tumours II 4Q 2006 tremelimumab anti-ctla4 solid tumours II 3Q 2004 AZD1208 PIM kinase haematological malignancies I 1Q 2012 AZD2014 TOR kinase solid tumours I 1Q 2010 AZD5363 # AKT solid tumours I 4Q 2010 AZD8186 PI3 kinase beta solid tumours I 2Q 2013 AZD9150 # STAT3 haematological malignancies I 1Q 2012 epidermal AZD9291 growth factor solid tumours I 1Q 2013 MEDI0639 # anti-dll-4 solid tumours I 2Q 2012 MEDI3617 # anti-ang-2 solid tumours I 4Q 2010 MEDI4736 # anti-pd-l1 solid tumours I 3Q 2012 MEDI-565 # anti-cea BiTE solid tumours I 1Q 2011 MEDI6469 # murine anti- OX40 solid tumours I 1Q 2006 volitinib # MET solid tumours I 1Q 2012
7 NCEs s I and II (continued) Respiratory, Inflammation & Autoimmunity AZD2115 # MABA COPD II 2Q 2012 AZD5069 CXCR2 asthma II 4Q 2010 AZD5423 # benralizumab # mavrilimumab # MEDI2070 # MEDI-546 # MEDI7183 # MEDI8968 # sifalimumab # tralokinumab inhaled SGRM anti-il-5r anti-gm- CSFR anti-il-23 anti-ifnalphar anti-a4b7 anti-il-1r anti-ifnalpha anti-il-13 COPD II 4Q 2010 asthma / COPD II 4Q 2008 rheumatoid arthritis II 1Q 2010 Crohn s disease II 1Q 2013 SLE II 1Q 2012 Crohn s disease / ulcerative colitis II 4Q 2012 COPD, HS II 4Q 2011 SLE II 3Q 2008 asthma / IPF / UC II 1Q 2008 AZD8848 # inhaled TLR7 asthma I 2Q 2012 AZD7594 # inhaled SGRM COPD I 4Q 2012 AZD7624 ip38i COPD I 1Q 2013 MEDI-551 # MEDI5872 # MEDI9929 # RDEA3170 anti-cd19 anti-b7rp1 anti-tslp selective uric acid reabsorption (SURI) multiple sclerosis I 3Q 2012 SLE I 4Q 2008 asthma I 4Q 2008 chronic treatment of gout I 3Q 2011
8 Development Pipeline - Discontinued Projects between 1 January 2013 and 30 June 2013 Infection NCE/Line Extension Compound Reason for Discontinuation NCE MEDI-557 safety / efficacy Area Under RSV prevention in high risk adults (COPD/CHF/other) Neuroscience NCE/Line Extension Compound Reason for Area Under Discontinuation NCE AZD1446 safety / efficacy Alzheimer s disease NCE AZD3480 # safety / efficacy Alzheimer s disease NCE MEDI5117 safety / efficacy rheumatoid arthritis Oncology NCE/Line Extension Compound Reason for Area Under Discontinuation NCE AZD8330 # (ARRY ) safety / efficacy solid tumours NCE fostamatinib # safety / efficacy haematological malignancies NCE MEDI-575 # safety / efficacy NSCLC Respiratory, Inflammation & Autoimmunity NCE/Line Extension Compound Reason for Area Under Discontinuation NCE fostamatinib # safety / efficacy rheumatoid arthritis NCE MEDI7814 economic COPD NCE MEDI4212 safety / efficacy asthma 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 III and beyond.
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