Astrazeneca Plc · LSE:AZN

Astrazeneca — Q2 2015 Earnings Presentation

103 slides from Astrazeneca's earnings presentation, Jun 30, 2015

1. Slide 1: Clinical Trials Appendix Q2 2015 Results Update

   Clinical Trials Appendix Q2 2015 Results Update The following information about AstraZeneca clinical studies in Phases I-IV has been created with selected information from clinicaltrials.gov to facilitate understanding of key aspects of our clinical programmes and is correct to the best of our knowl

2. Slide 2: List of abbreviations

   List of abbreviations AEs Adverse Events LCM Lifecycle Management Q3W Every Three Weeks ASA Acetylsalicylic Acid LPD Last Patient Dosed Q4W Every Four Weeks BiD Twice Daily MAD Multiple Ascending Dose Study Q8W Every Eight Weeks CE Clinically Evaluable MDI Metered Dose Inhaler QD Once Daily cMITT Cl

3. Slide 3: Movement since Q1 2015 update

   Movement since Q1 2015 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs anifrolumab#1 CAZ AVI# IFNαR SLE serious infections PT0101 AZD9291 [US, EU] LABA/LAMA/ICS COPD EGFR EGFRm T790M NSCLC 2L+ Additional indications Additional indications Additional indicatio

4. Slide 4: Q2 New Molecular Entity (NME) Pipeline

   Q2 New Molecular Entity (NME)† Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal † Includes significant fixed dose combination projects, and parallel indications that are in a separate therapeutic area (See LCM chart for other parallel indications and oncology combination projects

5. Slide 5: Q2 Lifecycle Management (LCM) Pipeline

   Q2 Lifecycle Management (LCM)† Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal Oncology Combinations Phase I Phase II Phase III 12 Projects 1 Project 2 Projects AZD9291+durvalumab durvalumab (MEDI4636)#+tremelimumab Oncology Large Combinations molecule durvalumab (MEDI4636)# +tr

6. Slide 6: 2015-2016: 14-16 NME & LCM submissions

   2015-2016: 14-16 NME & LCM submissions MEDI4736 + tremelimumab 2L SCCHN Faslodex MEDI4736 1L metastatic breast 2L SCCHN cancer LCM Lynparza Brilinta submission stroke BRCAm metastatic breast cancer opportunities Lynparza  saxa/dapa FDC brodalumab* BRCAm PSR type 2 diabetes psoriatic arthritis ovari

7. Slide 7: Immuno-oncology Major trials I

   Immuno-oncology Major trials I Tumour type Line of therapy Treme Combo Durva Combo OX40 Combo (CTLA-4 mAb) durva + treme (PD-L1 mAb) durva + OX40 treme + OX40 Mesothelioma Second line DETERMINE Phase II NSCLC Adjuvant ADJUVANT Phase III Stage III un- PACIFIC resectable Phase III First line MYSTIC MY

8. Slide 8: Immuno-oncology Major trials II

   Immuno-oncology Major trials II Tumour type Line of therapy Treme Combo Durva Combo OX40 Combo (CTLA-4 mAb) durva + treme (PD-L1 mAb) durva + OX40 treme + OX40 SCCHN Second line EAGLE EAGLE Phase III Phase III PD-L1- CONDOR CONDOR CONDOR Phase II Phase II HAWK PD-L1+ Phase II Gastric Second/third li

9. Slide 9: Lifecycle management (new uses of existing medicines)

   AstraZeneca Lifecycle management (new uses of existing medicines)

10. Slide 10: Symbicort (ICS/LABA) Mild asthma

    Lifecycle management Late-stage development Early development – IMED Symbicort (ICS/LABA) Early development - MedImmune Mild asthma Patient population Study phase Number of patients Design Endpoints Status Patients in need of GINA step Phase III N = 3,750 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as

11. Slide 11: Eklira/Tudorza (LAMA) COPD

    Lifecycle management Late-stage development Early development – IMED Eklira/Tudorza (LAMA) Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Patient population Study phase Number of patients Design Endpoints Status Patients with COPD Phase IV N = 224 • Arm 1: aclidinium brom

12. Slide 12: Duaklir (LAMA/LABA) COPD

    Lifecycle management Late-stage development Early development – IMED Duaklir (LAMA/LABA) Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Patient population Study phase Number of patients Design Endpoints Status Patients with moderate to Phase IV N = 268 • Arm 1: aclidinium

13. Slide 13: Brilinta/Brilique Cardiovascular

    Lifecycle management Late-stage development Early development – IMED Brilinta/Brilique (ADP receptor antagonist) Early development - MedImmune Cardiovascular Patient population Study phase Number of patients Design Endpoints Status Patients with prior MI Phase III N = 21,000 • Arm 1: Ticagrelor 90 m

14. Slide 14: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Early development – IMED Epanova (omega-3 carboxylic acids) Early development - MedImmune Hypertriglyceridaemia Patient population Study phase Number of patients Design Endpoints Status Severe hyper-triglyceridaemia Phase III N = 162 • Arm 1: Epanova 2g QD

15. Slide 15: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Early development – IMED Epanova (omega-3 carboxylic acids) Early development - MedImmune Hypertriglyceridaemia Patient population Study phase Number of patients Design Endpoints Status Type 2 DiM Phase II N = 80 • Arm 1: Epanova 4g QD • Reduction in liver

16. Slide 16: Onglyza (DPP-IV inhibitor) Type 2 Diabetes

    Lifecycle management Late-stage development Early development – IMED Onglyza (DPP-IV inhibitor) Early development - MedImmune Type 2 Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes mellitus Phase III N = 444 • Arm 1: Onglyza 5 mg QD +insulin or Ongl

17. Slide 17: Farxiga/Forxiga (SGLT-2 inhibitor) Diabetes

    Lifecycle management Late-stage development Early development – IMED Farxiga/Forxiga (SGLT-2 inhibitor) Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes Phase III/IV N = 17,150 • Arm 1: Forxiga 10 mg QD + standard of car

18. Slide 18: Farxiga/Forxiga (SGLT-2 inhibitor) Diabetes

    Lifecycle management Late-stage development Early development – IMED Farxiga/Forxiga (SGLT-2 inhibitor) Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 1 diabetes mellitus Phase III N = 768 • Arm 1: Forxiga 5 mg QD 52 weeks + insu

19. Slide 19: Saxagliptin/dapagliflozin Diabetes

    Lifecycle management Late-stage development Early development – IMED Saxagliptin/dapagliflozin (DPP-4/SGLT-2 inhibitors) Early development - MedImmune Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes mellitus Phase III N = 280 • Arm 1: Saxa 5mg + Dap

20. Slide 20: Bydureon (GLP-1 receptor agonist) Type 2 Diabetes

    Lifecycle management Late-stage development Early development – IMED Bydureon (GLP-1 receptor agonist) Early development - MedImmune Type 2 Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes Phase III N = 375 • Arm 1: Bydureon BiD SC (autoinjector) • C

21. Slide 21: Bydureon (GLP-1 receptor agonist) Type 2 Diabetes

    Lifecycle management Late-stage development Early development – IMED Bydureon (GLP-1 receptor agonist) Early development - MedImmune Type 2 Diabetes Patient population Study phase Number of patients Design Endpoints Status Type 2 diabetes Phase IV N = 14,000 • Arm 1: Bydureon once weekly 2mg SC • Ti

22. Slide 22: Faslodex Breast cancer - metastatic

    Lifecycle management Late-stage development Early development – IMED Faslodex (oestrogen receptor antagonist) Early development - MedImmune Breast cancer - metastatic Patient population Study phase Number of patients Design Endpoints Status Postmenopausal women with Phase III N ~450 • Arm 1: Faslode

23. Slide 23: Caprelsa Thyroid cancer - metastatic

    Lifecycle management Late-stage development Early development – IMED Caprelsa (kinase inhibitor) Early development - MedImmune Thyroid cancer - metastatic Patient population Study phase Number of patients Design Endpoints Status Differentiated thyroid cancer Phase III N = 227 • Arm 1: Vandetanib 300

24. Slide 24: Lynparza (PARP inhibitor) Ovarian cancer and other solid tumours

    Lifecycle management Late-stage development Early development – IMED Lynparza (PARP inhibitor) Early development - MedImmune Ovarian cancer and other solid tumours Patient population Study phase Number of patients Design Endpoints Status PSR BRCAm ovarian cancer Phase III N = 264 • Arm 1: Lynparza t

25. Slide 25: Lynparza (PARP inhibitor) Solid tumours

    Lifecycle management Late-stage development Early development – IMED Lynparza (PARP inhibitor) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status BRCAm metastatic breast Phase III N = 310 • Arm 1: Lynparza 300 mg BiD, continuous to p

26. Slide 26: Nexium, Entocort, Linaclotide Gastrointestinal

    Lifecycle management Late-stage development Early development – IMED Nexium, Entocort, Linaclotide Early development - MedImmune Gastrointestinal Compound Patient population Study phase Number of patients Design Endpoints Status Nexium Refractory RE Phase III N = 280 • Arm 1: Nexium 20 mg BiD • Heal

27. Slide 27: Late-stage development

    AstraZeneca Late-stage development

28. Slide 28: Lesinurad (SURI, URAT 1 inhibitor) Gout

    Lifecycle management Late-stage development Early development – IMED Lesinurad (SURI, URAT 1 inhibitor) Early development - MedImmune Gout Patient population Study phase Number of patients Design Endpoints Status Gout with inadequate Phase III N = 600 • Arm 1: Placebo • Proportion of subjects with a

29. Slide 29: Brodalumab (IL-17R mAb) Psoriasis & psoriatic arthritis

    Lifecycle management Late-stage development Early development – IMED Brodalumab (IL-17R mAb) Early development - MedImmune Psoriasis & psoriatic arthritis Patient population Study phase Number of patients Design Endpoints Status Moderate to severe plaque Phase III N = 661 • Arm 1: 210 mg brodalumab

30. Slide 30: PT003 (LABA/LAMA) COPD

    Lifecycle management Late-stage development Early development – IMED PT003 (LABA/LAMA) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe COPD Phase III N = 2,103 Treatment (24-week Treatment Period) • Change from base

31. Slide 31: PT003 (LABA/LAMA) COPD

    Lifecycle management Late-stage development Early development – IMED PT003 (LABA/LAMA) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Moderate to severe COPD Phase IIIb N = 150 Treatment ( 5- to 6- week Treatment Period) Percentage of dev

32. Slide 32: PT003 (LABA/LAMA) COPD

    Lifecycle management Late-stage development Early development – IMED PT003 (LABA/LAMA) Early development - MedImmune COPD Patient population Study phase Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Moderate to severe COPD Phase IIIb N = 40 Treatments ( 8-w

33. Slide 33: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development Early development – IMED PT010 (LABA/LAMA/ICS) Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Moderate to severe COPD Phase II N = 180 • Arm 1: BFF MDI 320/9.6 μg BiD • Forced expirator

34. Slide 34: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development Early development – IMED PT010 (LABA/LAMA/ICS) Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe COPD Phase III N = 10,000 Treatments ( 1-year Treatment Period) • R

35. Slide 35: PT010 (LABA/LAMA/ICS) COPD & Asthma

    Lifecycle management Late-stage development Early development – IMED PT010 (LABA/LAMA/ICS) Early development - MedImmune COPD & Asthma Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe COPD Phase III N = 320 Treatments (28-Week Treatment Period) • Chan

36. Slide 36: Benralizumab (IL-5R mAb) Asthma

    Lifecycle management Late-stage development Early development – IMED Benralizumab (IL-5R mAb) Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Severe asthma, inadequately Phase III N = 1026 HD + ~200 • Arm 1: 30 mg Q8w SC • Annual asthma

37. Slide 37: Benralizumab (IL-5R mAb) Asthma

    Lifecycle management Late-stage development Early development – IMED Benralizumab (IL-5R mAb) Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Asthmatic with FEV1 (50-90% Phase III N = 200 • Arm 1: 30 mg Q4w SC • Pulmonary function (FEV1

38. Slide 38: Benralizumab (IL-5R mAb) COPD

    Lifecycle management Late-stage development Early development – IMED Benralizumab (IL-5R mAb) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Moderate to very severe Phase III N = 2,088 • Arm 1: 10 mg Q8w SC • Rate of COPD exacerbation •

39. Slide 39: Tralokinumab (IL-13 mAb) Asthma

    Lifecycle management Late-stage development Early development – IMED Tralokinumab (IL-13 mAb) Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Adults with uncontrolled Phase III N = 1,140 Cohort 1: Primary: • FPD: Q3 14 severe asthma STRA

40. Slide 40: Anifrolumab Systemic Lupus Erythematosus (SLE)

    Lifecycle management Late-stage development Early development – IMED Anifrolumab (type I IFN receptor mAb) Early development - MedImmune Systemic Lupus Erythrmatosus (SLE) Patient population Study phase Number of patients Design Endpoints Status Moderate to severe Systemic Phase III N = 450 • Arm 1:

41. Slide 41: Roxadustat (HIF-PHI) Chronic Kidney Disease

    Lifecycle management Late-stage development Early development – IMED Roxadustat (HIF-PHI) Early development - MedImmune Chronic Kidney Disease (CKD) Patient population Study phase Number of patients Design Endpoints Status Anaemia in Chronic Kidney Phase III ANDES N = 450 • Arm 1: 300 mg IV MEDI-546

42. Slide 42: AZD9291 Non-small cell lung cancer

    Lifecycle management Late-stage development Early development – IMED AZD9291 (Highly selective, irreversible EGFR TKI) Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Advanced EGFRm NSCLC TKI Phase III N = 410

43. Slide 43: Selumetinib (AZD6244) Solid tumours

    Lifecycle management Late-stage development Early development – IMED Selumetinib (AZD6244) (MEK-inhibitor) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status 2L KRASm positive NSCLC Phase III N = 634 • Arm 1: Selumetinib 75mg BiD + d

44. Slide 44: Durvalumab (MEDI4736) Non-small cell lung cancer

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Unresectable Stage III NSCLC Phase III N = 702 • Arm 1: ME

45. Slide 45: Durvalumab (MEDI4736) Non-small cell lung cancer

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status Adjuvant NSCLC patients Phase III N = 1,100 • Arm 1: MEDI4

46. Slide 46: Durvalumab SCCHN and other solid tumours

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune SCCHN and other solid tumours Patient population Study phase Number of patients Design Endpoints Status SCCHN Phase II N = 112 • Single-arm: MEDI4736 IVQ2W • ORR • FPD

47. Slide 47: Tremelimumab (CTLA-4 mAb) Mesothelioma

    Lifecycle management Late-stage development Early development – IMED Tremelimumab (CTLA-4 mAb) Early development - MedImmune Mesothelioma Patient population Study phase Number of patients Design Endpoints Status Patients with unresectable Phase II N = 564 • Arm 1: Tremelimumab IV • Overall survival

48. Slide 48: Durvalumab + Tremelimumab Solid tumours

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune + Tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status Stage IIIB-IV 3L NSCLC Phase III N = 900 Substudy A

49. Slide 49: Durvalumab + Tremelimumab Solid tumours

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune + Tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status Patients with with metastatic Phase II N = 174 • Ar

50. Slide 50: Cediranib (VEGF) Ovarian cancer

    Lifecycle management Late-stage development Early development – IMED Cediranib (VEGF) Early development - MedImmune Ovarian cancer Patient population Study phase Number of patients Design Endpoints Status Patients with platinum- Phase III N = 486 • Arm 1: Placebo • Progression Free Survival • FPD: Q

51. Slide 51: CAZ-AVI Infections

    Lifecycle management Late-stage development Early development – IMED CAZ-AVI (BLI/cephalosporin SBI) Early development - MedImmune Infections Patient population Study phase Number of patients Design Endpoints Status Hospitalised patients with Phase III N = 493 • Arm 1: CAZ-AVI 2000/500mg plus Metron

52. Slide 52: CAZ-AVI Infections

    Lifecycle management Late-stage development Early development – IMED CAZ-AVI (BLI/cephalosporin SBI) Early development - MedImmune Infections Patient population Study phase Number of patients Design Endpoints Status Patients with complicated Phase III N = 345 • Arm 1: CAZ-AVI 2000/500mg plus Metroni

53. Slide 53: AZD3293 (BACE inhibitor) Alzheimer's disease

    Lifecycle management Late-stage development Early development – IMED AZD3293 (BACE inhibitor) Early development - MedImmune Alzheimer’s disease Patient population Study phase Number of patients Design Endpoints Status Alzheimer’s disease patients Phase II/III N = 2,202 • Arm 1: AZD3293 20 mg once da

54. Slide 54: Early development

    AstraZeneca Early development

55. Slide 55: AZD2115 (MABA) COPD

    Lifecycle management Late-stage development Early development – IMED AZD2115 (MABA) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status COPD Phase IIa N = 39 • Arm 1: AZD2115, 25 μg (iNeb) • Peak and trough FEV1 • FPD: Q1 12 MISTRAL • Arm 2: A

56. Slide 56: AZD7624 (p38 inhibitor) COPD

    Lifecycle management Late-stage development Early development – IMED AZD7624 (p38 inhibitor) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Healthy subjects Phase I N = 48 SAD • Safety and tolerability following inhaled • FPD: Q1 13 • Fiv

57. Slide 57: AZD7986 (DPP1 inhibitor) COPD

    Lifecycle management Late-stage development Early development – IMED AZD7986 (DPP1 inhibitor) Early development - MedImmune COPD Patient population Study phase Number of patients Design Endpoints Status Healthy subjects and COPD Phase I N = up to 152 Part 1 (SAD) • Safety and tolerability and PK fol

58. Slide 58: AZD7594 (inhaled SGRM) Asthma/COPD

    Lifecycle management Late-stage development Early development – IMED AZD7594 (inhaled SGRM) Early development - MedImmune Asthma/COPD Patient population Study phase Number of patients Design Endpoints Status Patients with mild to moderate Phase II N = 48 Sequence 1 • Forced expiratory volume in one

59. Slide 59: RDEA3170 (SURI, URAT 1 inhibitor) Gout

    Lifecycle management Late-stage development Early development – IMED RDEA3170 (SURI, URAT 1 inhibitor) Early development - MedImmune Gout Patient population Study phase Number of patients Design Endpoints Status Monotherapy study in Phase II N = 160 • Arm A: Placebo • Efficacy and Safety at Week 24

60. Slide 60: Savolitinib (AZD6094) Papillary renal cell and other cancers

    Lifecycle management Late-stage development Early development – IMED Savolitinib (AZD6094) (MET) Early development - MedImmune Papillary renal cell and other cancers Patient population Study phase Number of patients Design Endpoints Status Papillary renal cell cancer Phase II N = 90 • Single arm stu

61. Slide 61: AZD1775 (WEE-1) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD1775 (WEE-1) Early development - MedImmune Solid tumours, ovarian cancer and non-small cell lung cancer Patient population Study phase Number of patients Design Endpoints Status p53 mutant advanced solid Phase II N = 132 • Monot

62. Slide 62: AZD2014 (TORC 1/2) Breast cancer

    Lifecycle management Late-stage development Early development – IMED AZD2014 (TORC 1/2) Early development - MedImmune Breast cancer Patient population Study phase Number of patients Design Endpoints Status 2nd line ER+ metastatic breast Phase II N = 300 • Arm 1: Fulvestrant • Progression Free Surviv

63. Slide 63: AZD3759 Lung cancer with metastases

    Lifecycle management Late-stage development Early development – IMED AZD3759 (EGFRm BBB) Early development - MedImmune Lung cancer with lung and/or brain metastases Patient population Study phase Number of patients Design Endpoints Status EGFRm+ NSCLC Phase I N = 47 • MAD • Safety and tolerability •

64. Slide 64: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD4547 (FGFR) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Stage IIIB-IV NSCLC patients Phase II/III Lung N = 318 (AZD4547 5-Arm study based on biomarker exp

65. Slide 65: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD4547 (FGFR) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced cancer who have Phase I N = 94 • Part A: Ascending oral doses of AZD4547 to define maximu

66. Slide 66: AZD9496 (SERD) Breast cancer

    Lifecycle management Late-stage development Early development – IMED AZD9496 (SERD) Early development - MedImmune Breast cancer Patient population Study phase Number of patients Design Endpoints Status ER+ Breast Cancer Phase I N ~150 • This is a Phase I open label multicentre study of AZD9496 • Pri

67. Slide 67: AZD5312 (ISIS-AR) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD5312 (ISIS-AR) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced solid tumours with Phase I N = 90 Part A: Dose escalation • Part A: MTD and Recommende

68. Slide 68: AZD5363 (AKT) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD5363 (AKT) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status ER+ breast cancer receiving Phase IIb N = 100 • Arm 1: AZD5363 + paclitaxel • Progression Free surv

69. Slide 69: AZD8835 (PI3Kα/δ inhibitor) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD8835 (PI3Kα/δ inhibitor) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Women with estrogen receptor Phase I N = 100 Part A: AZD8835 single agent dose escala

70. Slide 70: AZD6738 (ATR) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD6738 (ATR) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Solid tumours Phase I N = 117 • MAD • Safety and tolerability • FPD: Q4 14 • Efficacy • Est. comple

71. Slide 71: AZD8186 (PI3Kb/d) Solid tumours

    Lifecycle management Late-stage development Early development – IMED AZD8186 (PI3Kb/d) Early development - MedImmune Solid tumours Patient population Study phase Number of patients Design Endpoints Status Advanced Phase I N = 96 • Part A: AZD8186 monotherapy in ascending intermittent doses in • Part

72. Slide 72: AZD9150 (STAT3) Haematological malignancies

    Lifecycle management Late-stage development Early development – IMED AZD9150 (STAT3) Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status DLBLC Phase I/II* N = 55 • Dose-escalation and dose-expansion study • Safety and to

73. Slide 73: ATM-AVI Infections

    Lifecycle management Late-stage development Early development – IMED ATM-AVI Early development - MedImmune Infections Compound Patient population Study phase Number of patients Design Endpoints Status ATM-AVI Healthy volunteers Phase I • Randomised, double-blind, 3-part study in • Safety/tolerabilit

74. Slide 74: AZD5213 Neuroscience

    Lifecycle management Late-stage development Early development – IMED AZD5213 (Histamine H3 receptor inverse agonist) Early development - MedImmune Neuroscience Patient population Study phase Number of patients Design Endpoints Status Tourette’s Disorder Phase IIa N = 18 • Part 1: • Improvement in To

75. Slide 75: AZD8108 (NMDA) Phase I programme

    Lifecycle management Late-stage development Early development – IMED AZD8108 (NMDA) Early development - MedImmune Phase I clinical development programme Patient population Study phase Number of patients Design Endpoints Status Healthy volunteers Phase I N = 40 • Randomized, double-blind, placebo-con

76. Slide 76: AZD4901 (NK3 Receptor Antagonist) Phase II programme

    Lifecycle management Late-stage development Early development – IMED AZD4901 (NK3 Receptor Antagonist) Early development - MedImmune Phase II clinical development programme Patient population Study phase Number of patients Design Endpoints Status Polycystic ovary syndrome Phase IIa N = 56 • Arm 1: A

77. Slide 77: AZD3241 (MPO) Multiple System Atrophy

    Lifecycle management Late-stage development Early development – IMED AZD3241 (MPO) Early development - MedImmune Multiple System Atrophy Patient population Study phase Number of patients Design Endpoints Status Healthy Subjects Phase I N = 46 • Active ArmS: SAD • AEs, labs, vital signs, ECGs • Study

78. Slide 78: MedImmune Early development

    MedImmune Early development

79. Slide 79: Tralokinumab Idiopathic Pulmonary Fibrosis

    Lifecycle management Late-stage development Early development – IMED Tralokinumab (IL-13 mAb) Early development - MedImmune Idiopathic Pulmonary Fibrosis (IPF) Patient population Study phase Number of patients Design Endpoints Status Adults with Idiopathic Phase II N = 176 • Arm 1: Tralokinumab high

80. Slide 80: Tralokinumab Atopic dermatitis

    Lifecycle management Late-stage development Early development – IMED Tralokinumab (IL-13 mAb) Early development - MedImmune Atopic dermatitis Patient population Study phase Number of patients Design Endpoints Status Adults with atopic dermatitis Phase II N = 184 • Arm 1: Tralokinumab dose 45mg SC •

81. Slide 81: MEDI7836 (IL-13 mAb) Asthma

    Lifecycle management Late-stage development Early development – IMED MEDI7836 (IL-13 mAb) Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Healthy volunteers Phase I N = 32 • Arm 1: 30 mg MEDI7836 (n = 6) or placebo (n = 2) as a single •

82. Slide 82: MEDI9929 (TSLP mAb) Asthma

    Lifecycle management Late-stage development Early development – IMED MEDI9929 (TSLP mAb) Early development - MedImmune Asthma Patient population Study phase Number of patients Design Endpoints Status Adult subjects with Phase II N = 552 • Arm 1: Placebo • Reduction in the annualized asthma • FPD: Q2

83. Slide 83: MEDI5872 (B7RP-1 mAb) SLE

    Lifecycle management Late-stage development Early development – IMED MEDI5872 (B7RP-1 mAb) Early development - MedImmune Systemic Lupus Erythematosus (SLE) Patient population Study phase Number of patients Design Endpoints Status SLE and lupus related Phase I N = 40 Dose escalation study: • Safety a

84. Slide 84: Mavrilimumab (GMCSF mAb) Rheumatoid arthritis

    Lifecycle management Late-stage development Early development – IMED Mavrilimumab (GMCSF mAb) Early development - MedImmune Rheumatoid arthritis (RA) Patient population Study phase Number of patients Design Endpoints Status RA patients who have failed 1 Phase II N = 138 • Arm 1: Mavrilimumab SC • AC

85. Slide 85: Other biologics Autoimmunity

    Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Autoimmunity Compound Patient population Study phase Number of patients Design Endpoints Status Anti-CD19 mAb Adults with Phase II/III N = 212 (est.) • Arm 1: MEDI-551500mg IV • Primary

86. Slide 86: Other biologics Cardiovascular & metabolic disease

    Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Cardiovascular & metabolic disease Compound Patient population Study phase Number of patients Design Endpoints Status rhLCAT Adults with stable Phase I N = 16 • SAD IV • Safety • Comple

87. Slide 87: Durvalumab + Iressa Non-small cell lung cancer

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) Patient population Study phase Number of patients Design Endpoints Status NSCLC Phase I N = 36 Escalation phase

88. Slide 88: Other biologics Immuno-oncology

    Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Immuno-oncology Compound Patient population Study phase Number of patients Design Endpoints Status PD-L1 Solid tumours Phase I/II N = 907 • Dose Escalation: 5 cohorts at Q2W and 1 • Saf

89. Slide 89: Durvalumab + Tafinlar/Mekinist Melanoma

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) + Tafinlar Early development - MedImmune (dabrafenib)/ Mekinist (trametinib) Melanoma Patient population Study phase Number of patients Design Endpoints Status Metastatic or unresectable Phase I/II

90. Slide 90: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Early development – IMED Durvalumab (MEDI4736) (PD-L1 mAb) Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Patient population Study phase Number of patients Design Endpoints Status NSCLC Phase Ib N = 301 • Dose Escalation: minimum 5

91. Slide 91: MEDI6469 + combinations Advanced malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI6469 (murine OX40 mAb) + combinations Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I/II N = 212 Dose-escalation phase

92. Slide 92: MEDI0562 (OX40 agonist) Advanced malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI0562 (OX40 agonist) Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 50 Dose-escalation phase • Safety • FPD: Q1 15

93. Slide 93: MEDI6383 + Durvalumab Advanced malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI6383 (OX40 agonist) + Durvalumab Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 212 Dose-esc

94. Slide 94: MEDI0680 + MEDI4736 Advanced malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI0680 (PD-1 mAb) + MEDI4736 (PD-L1 mAb) Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 150 Dose-escalation phase •

95. Slide 95: MEDI0562 (OX40 agonist) Advanced malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI0562 (OX40 agonist) Early development - MedImmune Advanced malignancies Patient population Study phase Number of patients Design Endpoints Status Advanced malignancies Phase I N = 50 Dose-escalation phase • Safety • FPD: Q1 15

96. Slide 96: MEDI-551 (CD19 mAb) Haematological malignancies

    Lifecycle management Late-stage development Early development – IMED MEDI-551 (CD19 mAb) Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status Adults with relapsed or Phase II N = 180 • Arm 1: MEDI-551 IV (dose-level 1) an

97. Slide 97: Moxetumomab Pasudotox Haematological malignancies

    Lifecycle management Late-stage development Early development – IMED Moxetumomab Pasudotox (CD22 mAb) Early development - MedImmune Haematological malignancies Patient population Study phase Number of patients Design Endpoints Status Adults with relapsed or Phase III N = 77 • Multicentre, single-arm

98. Slide 98: Other biologics Solid tumours

    Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Solid tumours Compound Patient population Study phase Number of patients Design Endpoints Status Anti-IGF ligand Patients with HR+ Phase I/II N = 176 • Arm 1: MEDI-573 IV and Aromatase

99. Slide 99: Other biologics Solid tumours

    Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Solid tumours Compound Patient population Study phase Number of patients Design Endpoints Status Anti-CEA BiTE Adults with Phase I N = 51 max • Dose-escalation (3+3), IV • MTD and safet

100. Slide 100: Other biologics Infections

     Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Infections Compound Patient population Study phase Number of patients Design Endpoints Status Anti-Staph AT Intubated ICU Phase II N = 462 • Placebo-controlled, single-dose, dose- • Eff

101. Slide 101: Vaccine biologics Influenza vaccines

     Lifecycle management Late-stage development Early development – IMED Vaccine biologics Early development - MedImmune Influenza vaccines Compound Patient population Study phase Number of patients Design Endpoints Status MEDI3250 Children 2 to 6 years Phase III N = 100 • Open-label • Safety and tolera

102. Slide 102: MEDI1814 (amyloid beta mAb) Alzheimer's disease

     Lifecycle management Late-stage development Early development – IMED MEDI1814 (amyloid beta mAb) Early development - MedImmune Alzheimer’s disease Patient population Study phase Number of patients Design Endpoints Status Alzheimer’s disease & healthy Phase I N = 121 • SAD & MAD • Safety, tolerabilit

103. Slide 103: Other biologics Gastrointestinal

     Lifecycle management Late-stage development Early development – IMED Other biologics Early development - MedImmune Gastrointestinal Compound Patient population Study phase Number of patients Design Endpoints Status Anti-α4β7 mAb Moderate to severe Phase II N = 359 • Arm 1: MEDI7183 dose level 1, SC

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