Slide 1: AstraZeneca LCM development programmes Q1 2014
AstraZeneca LCM development programmes Q1 2014
Slide 2: BRILINTA/BRILIQUE PARTHENON development programme
BRILINTA/BRILIQUE (ADP receptor antagonist) PARTHENON development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Patients with Phase III N= • ARM 1: Ticagrelor 90 mg BD • Composite of CV death, • FSI Q4 10 prior MI PEGASUS 21000 • ARM 2: Ticagrelor 60 mg BD non
Slide 3: Forxiga/Farxiga Type 2 Diabetes development programme
Forxiga/Farxiga (SGLT-2 inhibitor) Type 2 Diabetes development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Typ 2 diabetes Phase III/IV N= • ARM 1: Dapagliflozin 10 mg QD + standard • Time to first • FSI Q2 13 mellitus with DECLARE 17150 of care therapy event
Slide 4: Saxagliptin/Dapagliflozin FDC Type 2 Diabetes development programme
Saxagliptin/Dapagliflozin (DPP-4/SGLT-2 inhibitors) FDC Type 2 Diabetes development programme Patient Phase # of Design Primary Status* Population Study patients Endpoint Type 2 Diabetes Phase III N = 516 • ARM 1: Saxa 5 mg + Met XR • HbA1C reduction • FSI Q3 12 Mellitus • ARM 2: Dapa 10 mg + Met XR
Slide 5: BYDUREON/Exenatide Autoinjector Type 2 Diabetes development programme
BYDUREON/Exenatide (GLP-1 receptor antagonist) Autoinjector Type 2 Diabetes development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Type 2 Diabetes Phase III N = 375 • ARM 1: Byetta • Change in HbA1c • FSI Q1 13 DURATION- • ARM 2: Exenatide weekly suspension
Slide 6: IRESSA EGFR M+ NSCLC development programme
IRESSA (EGFR TKI) EGFR M+ NSCLC development programme Patient Phase # of Primary Design Status Population Study patients Endpoint EGFR M+ Phase III N = 289 • ARM 1: Gefitinib 250 mg QD + max 6 cycles of • Progression Free • FSI Q1 12 NSCLC who IMPRESS cisplatin and pemetrexed Survival • LSI Q4 13 ha
Slide 7: Faslodex Breast cancer development programme
Faslodex (oestrogen receptor antagonist) Breast cancer development programme Patient Phase # of Design Primary Status Population Study patients Endpoint st 1 line Phase III N = 605 • ARM 1: Faslodex 500 mg (+ oral placebo) • Progression Free • FSI Oct 2012 postmenopausal FALCON • ARM 2: Arimidex 1 m
Slide 8: AstraZeneca Late stage development programmes
AstraZeneca Late stage development programmes Q1 2014
Slide 9: Epanova Hypertriglyceridemia development programme
Epanova (prescription grade Omega-3 free fatty acid EPA+DHA) Hypertriglyceridemia development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Severe hyper- Phase III N = 104 • ARM 1: Epanova 2g QD • Change in serum • FSI Q4 13 triglyceridemia EVOLVE II • ARM 2:
Slide 10: Metreleptin Lipidystrophy development programme
Metreleptin (recombinant leptin analogue) Lipidystrophy development programme Patient Phase # of Design Primary Endpoints Status Population Study patients Lipodystrophy Phase III N = 72* • ARM 1: Metreleptin • Glycaemic control • Ongoing NIH /NIDDK • Triglycerides • Est. Completion date Q4 15 Open l
Slide 11: Benralizumab Asthma development programme
Benralizumab (anti-IL5Rα) Asthma development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Severe asthma, Phase III N = 1026 • ARM 1: 30 mg Q8wk • Rate of Asthma • FSI Q4 13 inadequately controlled CALIMA • ARM 2: 30 mg Q4wk Exacerbations • Est completion date
Slide 12: PT003 & PT001 COPD development programme
PT003 (LABA/LAMA) & PT001 (LAMA) COPD COPD development programme Patient Phase # of Design Primary Status Population Study patients G = Glycopyrronium, F = Formoterol fumarate Endpoint Moderate to Phase III N = 1751 • ARM 1: GF MDI (PT003) 14.4/9.6 μg • Change from baseline • FSI Q2 13 Very Severe P
Slide 13: Brodalumab Inflammatory diseases development programme
Brodalumab (anti-IL-17RA) Inflammatory diseases development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Moderate to severe Phase III N = 661 • ARM 1: 210 mg brodalumab • PASI at wk 12 • FSI Q3 12 plaque psoriasis AMAGINE-1 • ARM 2: 140 mg brodalumab • Static
Slide 14: Lesinurad Gout development programme
Lesinurad (URAT1 inhibitor) Gout development programme Patient Population Phase # of Design Primary endpoint Status Study patients Gout with Phase III N = 600 • Arm 1: Placebo • Proportion of subjects with an • FSI Q1 12 Inadequate CLEAR 1 • Arm 2: lesinurad 200 mg QD sUA level that is < 6.0 mg/dL •
Slide 15: Olaparib Ovarian and gastric cancer development programme
Olaparib (PARP inhibitor) Ovarian and gastric cancer development programme Patient Phase # of Design Primary Status Population Study patients Endpoint PSR gBRCAm Phase III N = 264 • ARM 1: olaparib tablet 300 mg BD • Progression Free • FSI Q3 13 ovarian cancer SOLO-2 maintenance therapy until progre
Slide 16: Selumetinib Solid tumours development programme
Selumetinib (AZD6244, ARRY142886) (MEK-inhibitor) Solid tumours development programme Patient Phase # of Design Primary Status Population Study patients Endpoint nd 2 Line KRASm Phase III N = 634 • ARM 1: Selumetinib 75mg BD + docetaxel • Progression Free • FSI Q4 13 NSCLC SELECT-1 75 mg/m2 intraven
Slide 17: CAZ-AVI Serious infections development programme
CAZ-AVI (BLI/cephalosporin SBI) Serious infections development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Hospitalised Phase III N = 523 • ARM 1: CAZ-AVI (2000/500mg) plus • Co primary of: • FSI Q1 12 patients with RECLAIM-1 Metronidazole (i) clinical respo
Slide 18: CAZ-AVI Serious infections development programme
CAZ-AVI (BLI/cephalosporin SBI) Serious infections development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Patients with Phase III N = 400 • ARM 1: CAZ-AVI (2000/500mg) plus • Patients with clinical • FSI Q113 complicated urinary REPRISE Metronidazole cure a
Slide 19: AstraZeneca Early development programmes
AstraZeneca Early development programmes Q1 2014
Slide 20: AZD1722 ESRD & CKD development programme
AZD1722 (NHE3 inhibitor) ESRD & CKD development programme Patient Phase # of Design Primary Status Population Study patients Endpoint ESRD on Phase IIa N = 70 • ARM 1: AZD1722, starting dose 45 mg • Reduction in mean • FSI Q1 13 hemodialysis BD, down titration based on tolerability weekly interdialy
Slide 21: AZD5069 Asthma development programme
AZD5069 (CXCR2) Asthma development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Adult patients Phase IIb N = 640 • Arm 1: ICS/LABA + AZD5069 45mg • Placebo adjusted • FSI Q4 12 with NIMBUS • Arm 2: ICS/LABA + AZD5069 15mg effect of AZD5069 on • Est completion
Slide 22: PT010 COPD development programme
PT010 (LABA/LAMA/ICS) COPD development programme Patient Phase # of Design Primary Status Population Study patients (B= Budesonide, G = Glycopyrronium, Endpoint F = Formoterol fumarate) Healthy Phase I N = 84 • ARM 1: BGF MDI 320/14.4/9.6 μg • Overall safety • FSI Q4 13 volunteers • ARM 2: BGF MDI 1
Slide 23: RDEA3170 Gout development program
RDEA3170 (URAT1) Gout development program Patient Phase # of Design Primary endpoint Status Population Study patients Subjects with Phase II N = 160 • Arm A: Placebo • Efficacy at Week 12 • FSI Q3 13 Gout • Arm B: RDEA3170 5 mg QD • LSI Q4 13 NCT01927198 • Arm C: RDEA3170 10 mg QD • Estimated comple
Slide 24: AZD9291 NSCLC development programme
AZD9291 (3rd Generation EGFR TKI) NSCLC development programme Patient Population Phase # of Design Primary Status Study patients Endpoint Advanced NSCLC Phase I N ~ 200 • Dose escalation study • Safety and tolerability • FSI Q1 13 TKI failure with AURA • Cohort expansion • Est completion Q4 14 activ
Slide 25: AZD1775 Solid tumours development programme
AZD1775 (WEE-1) Solid tumours development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Adult Patients Phase I N = 200 • Dose escalation study monotherapy & • Tolerability, PK/PD • FSI Q2 08 with Advanced combination with either gemcitabine or • ORR • LSI Q3 1
Slide 26: AZD4547 Solid tumours development programme
AZD4547 (FGFR) Solid tumours development programme Patient Phase # of Design Primary Status population Study patients Endpoint Advanced solid Phase I N = 149 • Part A: AZD4547 monotherapy in ascending multiple • Part A: MTD and Parts A,B, C1 tumours who doses (c. 50 patients) recommended dose for •
Slide 27: AZD6094 (volitinib) Oncology development programme
AZD6094 (volitinib) (cMET) Oncology development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Advanced Phase I N ~ 40 • Dose escalation study • Safety and tolerability • FSI Q1 12 Cancer (All • LSI Q1 14 comers) NCT01773018 Conducted in Australia • Est complet
Slide 28: AZD9150 Oncology development programme
AZD9150 (STAT3) Oncology development programme Patient Phase # of Design Primary Status Population Study patients Endpoint HCC Phase I N = 80 • Dose-escalation and dose-expansion study • Safety and tolerability • FSI Q2 13 . • Est completion Q4 14 NCT01839604 Study conducted in Japan, Korea, Taiwan
Slide 29: AZD3293 Alzheimer's Disease development programme
AZD3293 (BACE) Alzheimer’s Disease development programme Patient Phase # of Design Endpoints Status Population Study Patients Healthy Phase I N = 72 • Active ARMS: AZD3293 single doses, • AEs, labs, vital signs, • Poster presentation Clinical Trial Volunteers ascending doses ranging from 1mg to a EC
Slide 30: AZD3293 Alzheimer's Disease development programme
AZD3293 (BACE) Alzheimer’s Disease development programme Patient Phase # of Design Status Population Study patients Endpoints Healthy Phase I N = 16 • ARMS 1 and 2: Single AZD3293 • AEs, labs, vital signs, ECGs • FSI Q1 14. Volunteers doses in two separate tablet • PK • LSO Q1 14. NCT02039180 formul
Slide 31: ATM-AVI Serious infections development programme
ATM-AVI (Aztreonam-Avibactam β- lactamase) Serious infections development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Healthy Phase I • Randomised, double-blind, 3-part study in • Safety/tolerability • FSI Q4 12 volunteers healthy young and elderly volunteer
Slide 32: MedImmune Early development programmes
MedImmune Early development programmes Q1 2014
Slide 33: Sifalimumab/MEDI-545 SLE development programme
Sifalimumab/MEDI-545 (anti-interferon α mAb) SLE development programme Patient Phase Study # of Design Primary endpoint Status Population patients Moderate- Phase ll N= 431 • Arm 1: 200 mg IV MEDI-545 q2wks for 4 wks • Proportion of subjects • FSI Q2 11 severe then monthly for 44 wks achieving a res
Slide 34: MEDI-546 SLE development programme
MEDI-546 (anti-type I IFN receptor mAb) SLE development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Moderate- Phase ll N = 300 • ARM 1: 300 mg IV MEDI-546 q4wks for 48 weeks • Response in SLE • FSI Q1 12 severe SLE • ARM 2: 1000 mg IV MEDI-546 q4wks for 48 w
Slide 35: Mavrilimumab RA development programme
Mavrilimumab (CAM-3001) (anti-GMCSF mAb) RA development programme Patient Phase # of Design Primary Status Population Study patients Endpoint RA patients*with Phase II N = 280 • ARM 1: Mavrilimumab 30 mg • DAS28 response at wk12 • FSI Q3 12 an inadequate EARTH • ARM 2: Mavrilimumab 100 mg • ACR 20 a
Slide 36: Tralokinumab Asthma & IPF development programme
Tralokinumab (anti-IL-13 mAb) Asthma & IPF development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Adults with Phase IIb N = 452 Cohort 1: • Asthma exacerbation • FSI Q4 11 Uncontrolled • ARM 1: Tralokinumab high dose rate at week 52 • Est completion Q4 13 S
Slide 37: MEDI-551 NMO/MS development programme
MEDI-551 (anti-CD19 mAb) NMO/MS development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Multiple sclerosis Phase I N = 28 • Single ascending dose study • Safety, PK • Study is recruiting • Expected to complete recruitment NCT01585766 Q1 14 • Est. Completion
Slide 38: MEDI-551 Hematological tumors development programme
MEDI-551 (anti-CD19 mAb) Hematological tumors development programme Patient Phase # of Design Primary Status* Population Study patients Endpoint Adults with relapsed Phase II N = 180 • ARM 1: MEDI-551 (dose-level • Evaluation of the Overall • FSI Q1 12 or refractory B-cell 1) and Bendamustine Respon
Slide 39: MEDI-573 Breast Cancer development programme
MEDI-573 (anti-IGF Ligand) Breast Cancer development programme Patient Population Phase # of Design Primary endpoint Status* Study patients Patients with HR+ Phase I/II N = 187 • ARM 1: MEDI-573 and • Progression Free Survival • FSI Q2 11 st HER2-, 1 line, Aromatase Inhibitor among all patients. • E
Slide 40: MEDI4736 Solid tumours development programme
MEDI4736 (anti-PD-L1 mAb) Solid tumours development programme Patient Phase # of Design Primary Status Population Study patients Endpoint NSCLC, SCCHN Phase I N = 220 • Dose Escalation: 5 cohorts at Q2W • Safety • FSI Q3 12 HCC, and 1 cohort at Q3W • Optimal biologic dose • LSI Q4 14 pancreas, NCT01
Slide 41: MEDI4736 + tremelimumab Solid tumours development programme
MEDI4736 (anti-PD-L1) + tremelimumab (anti-CTLA-4) Solid tumours development programme Patient Phase # of Design Primary Status Population Study patients Endpoint NSCLC Phase I N = 156 • Dose Escalation: minimum 5 cohorts • Safety • FSI Q4 13 (Immunotx naïve exploring various treme Q4w and • Optimal
Slide 42: MEDI4736 + dabrafenib/trametinib Melanoma development programme
MEDI4736 (anti-PD-L1 mAb) + dabrafenib/trametinib Melanoma development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Metastatic or Phase I/II N = 69 Dose Escalation: • Safety • FSI Q1 14 unresectable • Cohort A – dabrafenib 150mg BD/ • Optimal biologic dose fo
Slide 43: IMT-C portfolio Oncology development programme
IMT-C portfolio Oncology development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Patients with Phase II N = 180 • ARM 1: Tremelimumab • Overall survival • FSI Q2 13 unresectable • ARM 2: Placebo (OS) • LSI Q2 14 Treme- pleural or NCT01843374 • Est. completio
Slide 44: MEDI3617 Solid Tumors development programme
MEDI3617 (anti-Ang2 mAb) Solid Tumors development programme Patient Phase # of Design Primary Status Population Study patients Endpoint Solid tumors Phase I N = 24-42 • MEDI3617 Dose escalation study Safety and tolerability Complete and ovarian cancer NCT01248949 N = 12-24 • MEDI3617 + bevacizumab d
Slide 45: Confidentiality Notice
Confidentiality Notice This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or dis