Clinical trials appendix Full-Year and Q4 2016 Results update The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from https://clinicaltrials.gov/ to facilitate understanding of key aspects of ongoing clinical programmes and is correct to the best of the Company’s knowledge as of 31 December 2016, unless otherwise specified.

It includes estimated timelines with regards to trial completion and first external presentations of primary data. These estimates are subject to change as programmes recruit faster or slower than anticipated and many times are event driven.

Project postings on clinicaltrials.gov are updated on a continuous basis as projects progress. For the most up to date information on our clinical programmes please visit clinicaltrials.gov (https://clinicaltrials.gov/)

2 List of abbreviations

AE Adverse Event LCM Life-Cycle Management Q2W Quaque (every) Two Weeks AUC Area Under Curve LPCD Last Patient Commenced Dosing Q3W Quaque (every) Three Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q4W Quaque (every) Four Weeks CE Clinically Evaluable MDI Metered-Dose Inhaler Q8W Quaque (every) Eight Weeks CMAX Maximum Concentration Absorbed MITT Modified Intent To Treat QD Quaque Die (one time a day) cMITT Clinical-Modified Intent To Treat Microbiological-Modified Intent To SAD Single Ascending Dose mMITT Treat CNS Central Nervous System SC Sub Cutaneous MTD Maximum Tolerated Dose DLT Dose-Limiting Toxicity TID Ter In Die (three times a day) NME New Molecular Entity FDC Fixed-Dose Combination TOC Test Of Cure OLE Open Long-term Extension FEV Forced-Expiratory Volume XR Extended Release ORR Objective Response Rate FPD First Patient Dosed OS Overall Survival IM Intra Muscular PFS Progression-Free Survival IR Immediate Release PK Pharmacokinetics IV Intravenous

3 Table of contents slide

Early development - IMED Movement since Q3 2016 update Oncology

Q4 2016 New Molecular Entity (NME) Pipeline CVMD

Q4 2016 Lifecycle Management (LCM) Pipeline Respiratory

Other Approved medicines Oncology

CVMD Early development - MedImmune

Respiratory Oncology CVMD

Respiratory Late-stage pipeline Other Oncology CVMD

Respiratory

Other

4 Movement since Q3 2016 update

New to Phase I New to Phase II New to Pivotal Study New to Registration

NMEs NMEs NME’s AZD0284 AZD1419# benralizumab# [EU & US]1 Inhaled RORg psorisis TLR9 asthma IL-5R severe asthma AZD7594+abediterol# AZD1775# Inhaled SGRM+LABA asthma/COPD Wee1 solid tumours Additional indications AZD8601# AZD4076 durvalumab# [US]1 VEGF-A cardiovascular miR103/107 NASH PD-L1 2L bladder AZD8871# Tagrisso AURA3 [US & EU] 1 Additional indications MABA COPD EGFR T790M NSCLC >2L durva# or durva#+(treme or AZD9150#) PD-L1 or PD-L1+(CTLA-4 or STAT3) Additional indications durvalumab#+tremelimumab PD-L1+CTLA-4 HCC

Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration

NME NMEs Additional indications AZD81083 ATM AVI#3 durvalumab HAWK#¶4 NMDA suicidal ideation BL/BLI SBI solid tumours CXL#3 durvalumab#+tremelimumab CONDOR¶4 BLI/cephalosporin MRSA PD-L1+CTLA-4 2L SCCHN MEDI2070#3 durvalumab#+tremelimuab ALPS¶ IL-23 Crohns PD-L1+CTLA-4 1L metastatic pancreatic ductal MEDI7510 carcinoma sF+GLA-SE RSV prevention

¶ Registrational Phase II/III study # Partnered and/or in collaboration 1 Submission Accepted 2 Submitted 3 Divested 4 Completed 5 Q4 2016 New Molecular Entity (NME)1 Pipeline

Oncology Cardiovascular and metabolic disease Respiratory Other

1 Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area (See LCM chart for other parallel indications and oncology combination projects) # Partnered and/or in collaboration; ¶ Registrational P2/3 study Q4 2016 Lifecycle Management (LCM)1 Pipeline

Oncology Cardiovascular and metabolic disease Respiratory Other

1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study AstraZeneca

Approved medicines Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase III Platinum-sensitive recurrent 295 • Arm 1: Lynparza tablets 300mg BiD as maintenance therapy • PFS • FPD: Q3 2013 SOLO-2 (PSR) BRCAm ovarian cancer until progression • OS secondary endpoint • LPCD: Q4 2014 Partnered • Arm 2: placebo tablets BiD • Data readout: Q4 2016

• Primary endpoint met CVMD NCT01874353 Global trial

Phase III 1L maintenance BRCAm 391 • Arm 1: Lynparza tablets 300mg BiD maintenance therapy for 2 • PFS • FPD: Q3 2013 SOLO-1 ovarian cancer years or until disease progression • OS secondary endpoint • LPCD: Q1 2015 Partnered • Arm 2: placebo • Data anticipated: H2 2017

NCT01844986 Global trial

Phase III PSR gBRCAm ovarian cancer 411 • Arm 1: Lynparza 300mg BiD to progression • PFS • FPD: Q1 2015 SOLO-3 3L+ Line • Arm 2: Physician’s choice (single agent chemotherapy) • OS secondary endpoint Respiratory NCT02282020 Global trial

Phase I / II gBRCAm ovarian cancer 2L+ 133 • Arm 1: Lynparza tablets 300mg BID starting on week 1 day 1 / Primary endpoints • FPD: Q2 2016 MEDIOLA durvalumab IV 1.5g every 4 weeks starting on week 5 day 1. • DCR at 12 weeks gBRCAm HER2-negative • Dose until progression. • Safety and tolerability NCT02734004 breast cancer 1-3L

Global trial Secondary endpoints Other Small cell lung cancer 2L+ • DCR at 28 weeks • ORR, DoR, PFS, TDT, OS • PK Gastric cancer 2L+

PARP= Poly ADP Ribose Polymerase

9 Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to progression • PFS • FPD: Q2 2014 OlympiAD cancer • Arm 2: Physician’s choice: • Secondary endpoint: OS • LPCD: Q4 2015 capecitabine 2500mg/m2 x 14 q 21 • Data anticipated: H1 2017

NCT02000622 vinorelbine 30mg/m2 d 1, 8 q 21 CVMD eribulin 1.4mg/m2 d 1, 8 q 21 to progression

Global trial

Phase III BRCAm adjuvant breast 1,500 • Arm 1: Lynparza 30mg BiD • Invasive Disease Free Survival (IDFS) • FPD: Q2 2014 OlympiA cancer 12 month duration • Secondary endpoint: Distant Disease Partnered • Arm 2: Placebo 12 month duration Free Survival and OS

NCT02032823 Global trial partnership with BIG and NCI/NRG

Phase III Pancreas 145 • Arm 1: Lynparza tablets 300mg twice daily as maintenance • PFS • FPD: Q1 2015 Respiratory POLO gBRCA therapy until progression. • Secondary endpoint: OS • Arm 2: Placebo tablets BiD NCT02184195 Global trial

Phase II Metastatic castration resistant 142 • Arm 1: Lynparza 300mg BiD + abiraterone • Radiologic PFS • FPD: Q3 2014 prostate cancer • Arm 2: Placebo + abiraterone • LPCD: Q3 2015

NCT01972217 Other Global trial

PARP= Poly ADP Ribose Polymerase

10 Approved medicines Late-stage development Tagrisso Early development - IMED Early development - MedImmune (Highly-selective, irreversible EGFR TKI) Oncology Non-small cell lung cancer (NSCLC)

Trial Population Patients Design Endpoints Status CVMD Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso 80mg QD • PFS • FPD: Q3 2014 AURA3 TKI failure and primary • Arm 2: pemetrexed 500mg/m2 + carboplatin AUC5 or • OS and QoL as secondary endpoints • Data readout: Q3 2016 resistance mutation T790M pemetrexed 500mg/m2 + cisplatin 75mg/m2 (2:1 • Primary endpoint met NCT02151981 randomisation

Global trial Phase III Advanced EGFRm NSCLC 1L 674 • Arm 1: Tagrisso 80mg • PFS • FPD: Q1 2015 FLAURA • Arm 2: erlotinib 150mg or Iressa 250mg (dealers choice); 1:1 • OS and QoL as secondary endpoints • LPCD: Q4 2016 randomisation • Data anticipated: H2 2017 NCT02296125

Global trial Respiratory Phase III Adjuvant EGFRm NSCLC 700 • Arm 1: Tagrisso 80mg QD following complete tumour • DFS • FPD: Q4 2015 ADAURA resection, with or without chemotherapy • DFS Rate, OS, OS Rate, QoL • Data anticipated: 2022 • Arm 2: Placebo NCT02511106 Global trial Phase II Advanced EGFRm NSCLC TKI 171 • Tagrisso 80mg QD • ORR • FPD: Q3 2015

AURA17 failure and primary resistance • PFS and OS secondary endpoints • Data readout: Q2 2016 Other mutation T790M Asia Pacific regional trial NCT02442349

Phase II Advanced EGFRm NSCLC TKI 210 • Tagrisso 80mg QD • ORR • FPD: Q2 2014 AURA2 failure and primary resistance • PFS and OS secondary endpoints mutation T790M Global trial NCT02094261

Phase I/II Advanced EGFRm NSCLC TKI 605 • Dose escalation trial • Safety and tolerability • FPD: Q1 2013 AURA failure + /- primary resistance • Ph II Extension cohort (T790M only) Tagrisso 80mg QD • ORR mutation T790M • PFS and OS secondary endpoints NCT01802632 Global trial

11 Approved medicines Late-stage development Tagrisso Early development - IMED Early development - MedImmune (Highly-selective, irreversible EGFR TKI) Oncology Non-small cell lung cancer (NSCLC)

Trial Population Patients Design Endpoints Status CVMD Phase Ib Advanced EGFRm NSCLC TKI ~90 • Arm 1: Tagrisso + durvalumab • Safety, Tolerability, Pharmacokinetics • FPD: Q3 2014 TATTON failure • Arm 2: Tagrisso + savolitinib and Preliminary Anti-tumour Activity • Enrolment to durvalumab combination • Arm 3: Tagrisso + selumetinib arms will not restart NCT02143466 Global trial Phase I EGFRm NSCLC, CNS 47 • MAD • Safety and tolerability • FPD: Q4 2014 BLOOM disease • Expansion in leptomeningeal metastasis (LM) and brain • Preliminary anti-tumour activity • Data anticipated: H1 2017 metastasis (BM) patients at RP2D with AZD3759 NCT02228369 • Expansion in LM patients at 160mg with Tagrisso including cohort with T790M NSCLC Respiratory Global trial – four countries Other

12 Approved medicines Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Oncology

Trial Population Patients Design Endpoints (primary) Status

Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BiD • Composite of cardiovascular (CV) death, • FPD: Q1 2014 THEMIS and coronary artery disease • Arm 2: Placebo BiD non-fatal MI and non-fatal stroke • LPCD: Q2 2016 without a previous history of on a background of Acetylsalicylic Acid if not contra indicated or • Data anticipated: 2018

NCT01991795 myocardial infarction (MI) or not tolerated CVMD stroke Global trial – 42 countries

Phase III (BE) Japanese healthy subjects 36 Single dose, Cross-Over • Bioequivalence (BE) of Brilinta OD tablet • FPD: Q2 2015 • Arm 1 Brilinta (oral dispersible) OD tablet 90mg + 150mL of vs Brilinta IR tablet • LPCD: Q3 2015 NCT02436577 water • Data readout: Q4 2015 • Arm 2 Brilinta OD tablet 90mg without water • Arm 3 Brilinta Immediate Release (IR) tablet 90mg + 200mL of water

Local trial – one country

Phase III (BE) Caucasian healthy subjects 36 Single dose, Cross-Over • BA/BE of Brilinta dispersible tablet vs • FPD: Q2 2015 Respiratory • Arm 1 Brilinta OD tablet 90mg +200ml of water Brilinta immediate release tablet • LPCD: Q3 2015 NCT02400333 • Arm 2 Brilinta OD tablet 90mg without water • Data readout: Q4 2015 • Arm 3 Brilinta OD tablet 90mg (suspended in water) via nasogastric tube • Arm 4 Brilinta IR tablet 90mg + 200mL of water

Local trial – one country Other Phase II Patients with sickle cell 90 • Arm 1: Brilinta 10mg BiD • Number of days with pain due to Sickle • FPD: Q3 2015 HESTIA2 disease • Arm 2: Brilinta 45mg BiD Cell Disease • LPCD: H2 2016 • Arm 3: Placebo BiD • Data readout: H2 2016 NCT02482298 Global trial – eight countries

13 Approved medicines Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Oncology

Trial Population Patients Design Endpoints Status

Phase IV Japanese patients with type-2 266 • Arm 1: Farxiga 5mg • Change from baseline in Haemoglobin • FPD: Q2 2014 diabetes with inadequate • Arm 2: Placebo A1C (HbA1c) at week 16 • LPCD: Q4 2015 NCT02157298 glycemic control on insulin • 1 year LT data • Data readout: Q2 2016

Japan trial CVMD

Phase III/IV Type-2 diabetes 17,276 • Arm 1: Farxiga 10mg QD + standard of care therapy QD • Time to first event included in the • FPD: Q2 2013 DECLARE with high risk for CV event • Arm 2: Placebo + standard of care therapy for type-2 Diabetes composite endpoint of CV death, MI or • LPCD: 2019 ischemic stroke • Data anticipated: 2019 NCT01730534 Global trial – 33 countries

Phase III Asian patients with type-2 273 • Arm 1: Farxiga 10mg QD for 24 weeks + background Insulin • Change from baseline in HbA1c at week • FPD: Q1 2014 diabetes with inadequate • Arm 2: Placebo QD for 24 weeks + background Insulin 24 • LPCD: Q1 2016

NCT02096705 glycemic control on insulin • Data Readout: Q2 2016 Respiratory Asia trial – three countries Partnered

Phase III Patients with type-2 diabetes 302 • Arm 1: Farxiga 10mg QD for 24 weeks • Change from baseline in HbA1c at week • FPD: Q2 2015 DERIVE and moderate renal • Arm 2: Placebo 10mg QD for 24 weeks 24 • Data anticipated: H2 2017 impairment NCT02413398 Global trial – five countries Other Phase III Type-1 diabetes 768 • Arm 1: Farxiga 5mg QD 52 weeks + insulin Primary: • FPD: Q4 2014 DEPICT 1 • Arm 2: Farxiga 10mg QD 52 weeks + insulin • Adjusted Mean Change From Baseline • LPCD Q2 2016 • Arm 3: Placebo QD 52 weeks + insulin in Haemoglobin A1C (HbA1c) at • Data anticipated: H1 2017 NCT02268214 week 24 Global trial – 17 countries Partnered

Phase III Type-1 diabetes 768 • Arm 1: Farxiga 5mg QD 52 weeks + insulin Primary: • FPD: Q3 2015 DEPICT 2 • Arm 2: Farxiga 10mg QD 52 weeks + insulin • Adjusted Mean Change From Baseline • Data anticipated: 2018 • Arm 3: Placebo QD 52 weeks + insulin in Haemoglobin A1C (HbA1c) at NCT02460978 week 24 Global trial – 14 countries Partnered

14 Approved medicines Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Oncology

Trial Population Patients Design Endpoints Status

Phase III Type-2 diabetes 444 • Arm 1: Onglyza 5mg QD + insulin with or without metformin Primary: • FPD: Q3 2014 • Arm 2: Placebo QD + insulin with or without metformin • Change from baseline in HbA1C at • LPCD: Q3 2015 NCT02104804 24 weeks • Data readout: Q2 2016

Trial in China CVMD Secondary: • Change from baseline at 24 weeks in 120-minute postprandial plasma glucose (PPG) in response to a meal tolerance

Phase III Type-2 diabetes 639 • Arm 1: Onglyza 5mg + Met Primary: • FPD: Q1 2015 (500mg with titration) • The change in HbA1c from baseline to • LPCD: Q1 2016 NCT02273050 • Arm 2: Onglyza 5mg + Placebo week 24 (prior to rescue) • Data readout: Q4 2016 • Arm 3: Met (500mg with titration) + Placebo Secondary: Trial in China • The proportion of subjects achieving a

therapeutic glycaemic response at week Respiratory 24 (prior to rescue) defined as HbA1c <7.0% Other

15 Approved medicines Late-stage development Qtern (saxagliptin/dapagliflozin) (DPP-4/SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Oncology

Trial Population Patients Design Endpoints Status

Phase III Type-2 diabetes 420 • Arm 1: Saxagliptin 5mg + dapagliflozin 10mg + Met IR/XR Primary: • FPD: Q1 2015 • Arm 2: Sitagliptin 100mg + Met IR/XR • Mean change from baseline in HbA1C at • LPCD: Q3 2015 NCT02284893 week 24 • Data readout: Q3 2016

Global trial – six countries Secondary: CVMD • The proportion of subjects achieving a therapeutic glycemic response at week 24 defined as HbA1C<7% • Mean change in total body weight at week 24

Phase III Type-2 diabetes 440 • Arm 1: Saxagliptin 5mg + dapagliflozin 10mg + Met IR/XR Primary: • FPD: Q3 2015 • Arm 2: Glimeperide 1-6mg + Met IR/XR • Mean change from baseline in HbA1c at • LPCD: Q3 2016 NCT02419612 week 52 • Data anticipated: H2 2017 Global trial – 10 countries Secondary: • Mean change from baseline in total body

weight at week 52 Respiratory • The proportion of subjects achieving a therapeutic glycemic response at week 52 defined as HbA1c<7.0%

Phase III Type-2 diabetes 598 • Arm 1: Saxagliptin 5mg + dapagliflozin 10mg + Met IR/XR with Primary: • FPD: Q4 2015 or without SU • Mean change from baseline in HbA1C at • LPCD: Q4 2016 NCT02551874 • Arm 2: Insulin glargine + Met IR/XR with or without SU week 24 • Data anticipated: H2 2017 Secondary: Global trial – 12 countries • Mean change in total body weight at Other week 24 • The proportion of subjects with confirmed hypoglycemia at week 24

Phase III Type-2 diabetes 900 • Arm 1: Saxagliptin 5mg + dapagliflozin 5mg + Met IR/XR Primary: • FPD: Q1 2016 • Arm 2: Dapagliflozin 5mg + placebo + Met IR/XR • Mean change from baseline in HbA1C at • LPCD: HQ4 2016 NCT02681094 • Arm 3: Saxagliptin 5mg + placebo + Met IR/XR week 24 • Data anticipated: H2 2017 Secondary: • The proportion of subjects achieving a Global trial – six countries therapeutic glycemic respons at week 24 defined as HbA1C<7% • Mean change in fasting plasma glucose at 24 weeks

16 Approved medicines Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 diabetes Oncology

Trial Population Patients Design Endpoints Status Phase IV Type-2 diabetes 14,743 • Arm 1: Bydureon once weekly 2mg SC • Time to first confirmed CV event in the • FPD: Q2 2010 EXSCEL • Arm 2: Placebo primary composite CV endpoint (CV • LPCD: 2H 2017 death, non-fatal MI, non-fatal stroke) • Data anticipated: 2018 NCT01144338 On a background of SoC medication, different degree of CV risk CVMD

Partnered Global trial

Phase III Type-2 diabetes 375 • Arm 1: Bydureon BiD SC (autoinjector) • Change in HbA1c from baseline at • FPD: Q1 2013 DURATION-NEO 1 • Arm 2: Bydureon weekly suspension SC (autoinjector) 28 weeks • LPCD: • Data readout: Q3 2014 NCT01652716 On a background of diet & exercise alone or with stable regimen • Primary endpoint met of oral antidiabetics Partnered US only

Phase III Type-2 diabetes 360 • Arm 1: Sitagliptin • Change in HbA1c from baseline at • FPD: Q1 2013

DURATION-NEO 2 • Arm 2: Bydureon weekly suspension SC (autoinjector) 28 weeks • LPCD: Respiratory • Arm 3: Placebo • Data readout : Q3 2014 NCT01652729 • Primary endpoint met On a background of diet & exercise alone or with stable regimen Partnered of oral antidiabetics

US only

Phase III Type-2 diabetes 440 • Arm 1: Bydureon once weekly 2mg SC + Titrated Basal Insulin • Change in HbA1c from baseline at • FPD: Q3 2014 DURATION 7 • Arm 2: Placebo + Titrated Basal Insulin 28 weeks • LPCD: Q3 2016 Other • Data readout: Q4 2016 NCT02229383 Double-blind 1:1 randomisation. Background therapy with or • Primary endpoint met without Metformin

Global trial

Phase III Type-2 diabetes 660 • Arm 1: Bydureon once weekly 2mg SC • Change in HbA1c from baseline at • FPD: Q3 2014 DURATION 8 • Arm 2: Dapagliflozin 10mg 28 weeks • LPCD: 2H 2017 • Arm 3: Bydureon once weekly 2mg SC + dapagliflozin 10mg • Data readout: Q3 2016 - 28-week data NCT02229396 • Data anticipated: Double-blind 1:1:1 randomisation. Background therapy with H1 2017 - 52-week data Metformin 1500mg/day up to 2 months prior to screening 2018 - 104-week data

Global trial

17 Approved medicines Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Oncology

Trial Population Patients Design Endpoints Status Phase III Japanese patients with 375 • Epanova 2g and 4g vs. Placebo (after meal) daily for 52 weeks • Safety in Japanese patients • FPD: Q2 2015 hypertriglyceridemia • % change in triglycerides • LPCD: Q1 2016 NCT02463071 Global trial – one country • Data anticipated: H1 2017 CVMD

Phase III Severe hyper-triglyceridaemia 162 • Arm 1: Epanova 2g QD • Change in serum triglycerides over • FPD: Q4 2013 EVOLVE II • Arm 2: Placebo (olive oil) 12 weeks • LPCD: Q4 2014 • Data readout: Q4 2015 NCT02009865 Global trial – seven countries

Phase III Patients with hypertri- 13,000 • Arm 1: Epanova 4g QD + statin • Composite of MACE • FPD: Q4 2014 STRENGTH (CVOT) glyceridaemia and high • Arm 2: Placebo (corn oil) + statin • Data anticipated: 2019 cardiovascular disease risk NCT02104817 Global trial – 22 countries Respiratory

Phase II Overweight patients with 75 • Epanova 4g vs. Placebo vs. Fenofibrate 200mg daily for 12 • Reduction in liver fat content (%) at the • FPD: Q3 2015 EFFECT I hypertriglyceridemia weeks end of 12 weeks compared to placebo • LPCD: Q2 2016 • Reduction in liver fat content (%) at the • Data readout: Q4 2016 NCT02354976 Global trial – one country end of 12 weeks compared to fenofibrate Other

Phase II Type-2 diabetes 80 • Arm 1: Epanova 4g QD • Reduction in liver fat content (%) at the • FPD: Q1 2015 EFFECT II Liver fat >5.5% • Arm 2: Placebo (olive oil) end of 12 weeks • LPCD: Q4 2015 • Arm 3: Epanova 4g + dapaglifozin 10mg QD • Data readout: Q2 2016 NCT02279407 • Arm 4: Dapaglifozin 10mg

Local trial – one country

Phase I Pancreatic Exocrine 66 • Arm 1: Epanova 4g single dose • Presence of Pancreatic Exocrine • FPD: Q1 2015 PRECISE Insufficiency (PEI) in patients • Arm 2: Omacor 4g single dose Insufficiency (PEI), Pharmacokinetics of • LPCD: Q4 2015 with type-2 diabetes Epanova and Omacor following a single • Data readout: Q2 2016 NCT02370537 Global trial – six countries in Europe oral dose in patients with different degrees of PEI

18 Approved medicines Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 40 Part A • Arm 1: D1400147 4g • Rate and extent of absorption of omega- • FPD: Q1 2015 42 Part B • Arm 2: D14000136 4g 3-carboxylic acids following single-dose • LPCD: Q3 2015 NCT02359045 • Arm 3: D14000137 4g oral administration of test formulations A, • Data readout: Q2 2016

• Arm 4: Epanova 4g B and C and reference formulation CVMD (Epanova®) under fed and fasted Local trial – one country condition, by assessment of AUC, AUC(0-72) and Cmax

Phase I Healthy male subjects 42 • Epanova 4g X 3 separate occasions (fasting, before meal, and • Effect of food timing (fasting, before • FPD: Q1 2015 after meal) meal, and after meal) on • LPCD: Q2 2015 NCT02372344 pharmacokinetics (AUC, Cmax, • Data readout: Q4 2015 Local trial – one country AUC0-72)

Phase I Healthy male Japanese and 18 • Arm 1: (Japanese): Epanova 2g vs. Placebo QD • PK of single and multiple doses in • FPD: Q3 2014 Caucasian subjects • Arm 2: (Japanese): Epanova 4g vs Placebo QD healthy male Japanese subjects • LPCD: Q4 2014 NCT02209766 • Arm 3: (Caucasian): Epanova 4g vs Placebo • Safety/tolerability profile • Data readout: Q3 2015 Respiratory

Local trial – one country

Phase I Patients with a history of 16 • Arm 1: Epanova 4g →omega-3-acid ethyl esters capusles 4g • Plasma concentration vs. time curve • FPD: Q3 2014 pancreatitis QD (AUC0-τ) • LPCD: Q2 2015 NCT02189252 • Arm 2: omega-3-acid ethyl esters capusles 4g →Epanova 4 g [Time Frame: 0 to 24 hours • Data readout: Q4 2015 QD (AUC0-24)] • Arm 3: Epanova 2g →omega-3-acid ethyl esters capusles 4g Other QD • Arm 4: omega-3-acid ethyl esters capusles 4g →Epanova 2g QD

Global trial – two countries

19 Approved medicines Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Oncology

Trial Population Patients Design Endpoints Status

Phase III Patients in need of GINA 3,850 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as needed' + Placebo • Well-controlled asthma weeks • FPD: Q4 2014 SYGMA1 step-2 treatment Pulmicort Turbuhaler 200μg bid • Time to first severe asthma exacerbation • LPCD: Q3 2016 • Arm 2: Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4mg • Time to first moderate or severe asthma • Data anticipated: H2 2017

NCT02149199 Turbuhaler 'as needed' exacerbation CVMD • Arm 3: terbutaline Turbuhaler 0.4mg 'as needed' + placebo • Average change from baseline in Pulmicort 200μg Turbuhaler bid pre-dose FEV1

Global trial – 19 countries

Phase III Patients in need of GINA 4,214 • Arm 1: Symbicort Turbuhaler 160/4.5μg 'as needed' + Placebo • Annual severe asthma exacerbation rate • FPD: Q1 2015 SYGMA2 step-2 treatment Pulmicort Turbuhaler 200μg bid • Time to first severe asthma exacerbation • LPCD: Q3 2016 • Arm 2: Pulmicort 200μg Turbuhaler bid + terbutaline 0.4mg • Average change from baseline in pre- • Data anticipated: H2 2017 NCT02224157 Turbuhaler 'as needed' dose FEV1 • Time to trial specific asthma related Global trial – 25 countries discontinuation ICS= Inhaled corticosteroids Respiratory LABA= Long Acting Beta Agonist GINA - Global Initiative for Asthma guidelines Other

20 Approved medicines Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase IV Patients with COPD 224 • Arm 1: Aclidinium bromide 400μg • Change from baseline in overall E-RS • FPD: Q1 2015 • Arm 2: Placebo to aclidinium bromide 400μg Total score (i.e. score over the whole 8 • LPCD: Q3 2015 NCT02375724 weeks study period) • Data readout: Q1 2016

Global trial – five countries • Change from baseline in overall E-RS CVMD Partnered Cough and Sputum domain score. • Change from baseline in the LCQ Total score at Week 8. Average change from baseline in pre-dose FEV1

Phase IV Patients with moderate to very 4,000 • Arm 1: Aclidinium bromide 400μg • Time to first Major Adverse • FPD: Q3 2013 ASCENT severe COPD • Arm 2: Placebo to aclidinium bromide 400μg Cardiovascular Event (MACE). Up to 36 • LPCD: Q3 2016 Months • Data anticipated: 2018 NCT01966107 Global trial – two countries • Rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment.

• Rate of hospitalisations due to COPD Respiratory exacerbation per patient per year during the first year of treatment • Time to first Major Adverse Cardiovascular Event (MACE) or other serious cardiovascular events of interest. Up to 36 Months

Phase IV Patients with stable moderate 30 • Arm 1: aclidinium bromide 400μg • Change from baseline in normalised • FPD: Q2 2014

and severe COPD • Arm 2: Placebo to Aclidinium bromide 400μg forced expiratory volume in one second • LPCD: Q1 2015 Other NCT02153489 (FEV1). Week 3. FEV1 over the 24-hour • Data readout: Q4 2015 Local trial – one country period (AUC0-24) will be measured Partnered following morning administration • Adverse events. Week 5. A follow up telephone call will be made 14 days after the last study drug administration (for completed patients) or premature discontinuation visit (when applicable) to record adverse events.

LAMA= Long Acting Muscarinic Agonist

21 Approved medicines Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase IIb Patients with moderate COPD 120 • Arm 1: Aclidinium/formoterol FDC 400/12 μg • Change from baseline in normalised • FPD: Q3 2016 ACHIEVE • Arm 2: Placebo to aclidinium/formoterol FDC 400/12 μg FEV1 AUC over the 12h period • LPCD: Q3 2016 immediately after morning study drug • Data anticipated: H1 2017

NCT02796651 Global trial – one Country administration, AUC0-12/12h at Day 7 CVMD on treatment. • Change from baseline in FEV1 AUC0- 6/6h at day one and day seven on treatment. • Change from baseline in morning pre- dose FEV1 at day seven on treatment.

Phase III Patients with stable COPD 1,500 • Arm 1: Aclidinium bromide 400μg/Formoterol Fumarate 12 μg • Change from baseline in 1-hour morning • FPD: Q3 2016 AMPLIFY • Arm 2: Aclidinium bromide 400μg post-dose dose FEV1 of AB/FF • LPCD: Q4 2016 • Arm 3: Formoterol fumarate 12μg 400/12μg compared to AB 400μg at • Data anticipated: H2 2017 NCT02796677 • Arm 4: Tiotropium 18μg week 24.

• Change from baseline in morning Respiratory predose (trough) FEV1 of AB/FF 400/12μg compared to FF 12μg at week Global trial – 13 Countries 24. • Change from baseline in morning predose (trough) FEV1 at week 24 • comparing AB 400μg versus TIO 18μg.

Phase III Patients with stable COPD 1,060 • Arm 1: Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg • Change from baseline in 1-hour morning • FPD: Q1 2017 AVANT • Arm 2: Aclidinium bromide 400 μg post-dose dose FEV1 of Aclidinium • Data anticipated: H2 2018 Other • Arm 3: Formoterol fumarate 12 μg bromide 400 µg/Formoterol fumarate 12 CTs.gov Identifier: • Arm 4: Tiotropium 18 μg µg compared to Aclidinium bromide at TBD Week 24. • Change from baseline in morning pre- dose (trough) FEV1 of Aclidinium Global Study – 5 Countries bromide 400 µg/Formoterol fumarate 12 µg compared to Formoterol fumarate at Week 24. • Change from baseline in trough FEV1 of Aclidinium bromide 400 µg compared to placebo at Week 24.

LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist

22 Approved medicines Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase IV Patients with moderate COPD 268 • Arm 1: Aclidinium/formoterol FDC 400/12 μg • Change from baseline in trough • FPD: Q2 2015 ACTIVATE • Arm 2: Placebo to aclidinium/formoterol FDC 400/12 μg Functional Residual capacity (FRC) after • LPD: Q2 2016 4 weeks of treatment • Data readout: Q3 2016

NCT02424344 Global Study – 5 Countries • Change from baseline in Endurance CVMD Time (ET) during constant work rate Partnered cycle ergometry to symptom limitation at 75% of Wmax after 8 weeks of treatment • Percentage of inactive patients (<6000 steps per day) after 8 weeks on treatment Respiratory Other

LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist

23 Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase III Moderate to very severe 2,103 Treatment (24-week Treatment Period) • Change from baseline in morning pre- • FPD: Q2 2013 PINNACLE 1 COPD • Arm 1: GFF MDI (Bevespi Aerosphere) 14.4/9.6μg BiD dose trough FEV1 • LPCD: Q3 2014 • Arm 2: GP MDI (PT001) 14.4μg BiD • Data readout: Q1 2015

NCT01854645 • Arm 3: FF MDI (PT005) 9.6μg BiD CVMD • Arm 4: Open-label tiotropium bromide inhalation powder 18μg QD • Arm 5: Placebo MDI BiD Multicentre, randomised, double-blind, parallel-group, chronic dosing, placebo- and active- controlled

US, Australia, New Zealand

Phase III Moderate to very severe 1,615 Treatment (24-week Treatment Period) • Change from baseline in morning pre- • FPD: Q3 2013 PINNACLE 2 COPD • Arm 1: GFF MDI (Bevespi Aerosphere) 14.4/9.6μg BiD dose trough FEV1 • LPCD: Q3 2014 • Arm 2: GP MDI (PT001) 14.4μg BiD • ToData readout: Q2 2015

NCT01854658 • Arm 3: FF MDI (PT005) 9.6μg BiD Respiratory • Arm 4: Placebo MDI BiD Multicentre, randomised, double-blind, parallel group, chronic dosing and placebo-controlled

US

Phase III Moderate to very severe 893 Treatment (28-week Treatment Period) • Overall safety, tolerability and efficacy • FPD: Q4 2013 PINNACLE 3 COPD • Arm 1: GFF MDI (Bevespi Aerosphere) 14.4/9.6μg BiD • LPCD: Q3 2014

• Arm 2: GP MDI (PT001) 14.4μg BiD • Data readout: Q2 2015 Other NCT01970878 • Arm 3: FF MDI (PT005) 9.6μg BiD • Arm 4: Open-label tiotropium bromide inhalation powder QD Multi-centre, randomised, double-blind, parallel-group and active- controlled

US, Australia, New Zealand LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist GFF= Glycopyrronium and formoterol

24 Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase IIIb Moderate to severe COPD 150 Treatment (5- to 6- week Treatment Period) • Percentage of devices where number of • FPD: Q4 2014 • GFF 14.4/9.6µg actuations as counted at the end of the • LPCD: Q4 2014 • Placebo MDI BID trial using dose indicator reading is • Data readout: Q1 2015

NCT02268396 Open-label and multiple-centre consistent (± 20 actuations) with number CVMD of actuations reported by subject US

Phase IIIb Moderate to severe COPD 40 Treatments (8-week Treatment Period) • FEV1 AUC0-24 on Day 29 • FPD: Q1 2015 • GFF MDI 14.4/9.6µg BID • LPCD: Q1 2015 NCT02347085 • Placebo MDI BID • Data readout: Q3 2015 Randomised, 2-period, 2-treatment Double-blind, Multi-centre and Cross-over

US

Phase IIIb Moderate to severe COPD 80 Treatments ( 12-week Treatment Period) • FEV1 AUC0-24 on Day 29 • FPD: Q1 2015 • GFF MDI 14.4/9.6µg BID • LPCD: Q2 2015 Respiratory • Placebo • Data readout: Q3 2015 NCT02347072 • Spiriva Respimat 5µg QD (open-label) Randomised and 3-way cross-over

US

Phase III Moderate to severe COPD 80 Treatments ( 2 week treatment Period) • Change from morning pre-dose trough • FPD: Q2 2015

• GFF MDI 14.4/9.6µg with a spacer FEV1 GFF 14.4/9.6µg with Aerochamber • LPCD: Q1 2016 Other • GFF MDI 14.4/9.6µg without a spacer Plus VHC relative to GFF14.4µg w/o • Data readout: Q2 2016 Randomised, 7-day, cross-over in subjects with moderate to Aerochamber Plus VHC on day eight NCT02454959 severe COPD • PK parameters at all doses will include Cmax, AUC0-12, AUC0-t, tmax, Other US PD/PK parameters may be calculated, as appropriate

LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist GFF= Glycopyrronium and formoterol

25 Approved medicines Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status

Phase III Moderate to very severe 1,614 Treatments (24-week Treatment Period) • For the US/China approach, the primary • FPD: Q2 2015 COPD • GFF 14.4/9.6µg (N=514) endpoint will be the change from • LPCD: H2 2016 NCT02343458 • GP 14.4µg (N=440) baseline in morning pre-dose trough • Data anticipated: H2 2017

• FF 9.6µg (N=440) FEV1 at week 24 of treatment CVMD • Placebo (N=220) • For the Japan approach, the primary • US/China: Trough FEV1 at week 24 of treatment endpoint will be the change from • EU/Hybrid: Co-primary= Trough FEV1 over week 24 of baseline in morning pre-dose trough treatment and TDI score over 24 weeks FEV1 over weeks 12 to 24 of treatment Randomised, Double-Blind, Chronic-Dosing , Placebo-Controlled, • For the EU and Hybrid approaches, the Parallel-Group and Multi-Centre primary endpoint will be the change from baseline in morning pre-dose trough US, UK, Germany, Costa Rica, Hungary, Poland, Russia, South FEV1 over 24 weeks of treatment Korea, Taiwan, China, Japan ▪ TDI score (co-primary endpoint for EU and Hybrid) [Time Frame: Over 24 weeks] Respiratory Phase IIb Moderate to severe COPD 40 Treatments (5-week Treatment Period) • Right Ventricular End Diastolic Volume • FPD: Q4 2016 • GFF MDI (PT003) 14.4/9.6 μg ex-actuator Index (RVEDVi) measured at 2-hours • LPCD: H2 2017 NCT02685293 • Placebo MDI post-dose on day eight • Data anticipated: 2018

Randomised, 2-period, Double-Blind, 2-treatment, Chronic- Dosing (7 Days), Crossover trial

US Other

LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist GFF= Glycopyronium and formoterol

26 Approved medicines Late-stage development Daliresp/Daxas (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 500µg OD vs placebo, in • Rate of moderate or severe COPD • Data readout: Q4 2016 RESPOND COPD on top of ICS/LABA exacerbations per subject per year

NCT01443845 CVMD

Phase IV COPD 1,323 • 12W, randomised, DB to evaluate tolerability and PK of • Percentage of participants prematurely • Data readout: Q4 2016 OPTIMIZE Daliresp 500μg OD with an up-titration regimen during the first discontinuing trial treatment for any 4Ws, including an open label down-titration evaluating reason during the main period NCT02165826 tolerability and PK of 250µg Roflumilast OD in subjects not tolerating 500μg OD

Phase IIIb COPD 158 • 16W, randomised, placebo-controlled, DB, parallel-group trial • Number of inflammatory cells CD8+ in • Data readout: Q4 2016 ROBERT to assess the anti-inflammatory effects of Roflumilast in COPD bronchial biopsy tissue specimen (sub- mucosa) measured at randomisation NCT01509677 and at the end of the intervention period Respiratory ICS= Inhaled corticosteroids LABA= Long Acting Beta Agonist Other

27 AstraZeneca

Late-stage pipeline Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Oncology

Trial Population Patients Design Endpoints Status Phase III Adjuvant NSCLC patients 1,100 • Arm 1: Durvalumab mg/kg IV Q4W x 12m • DFS • FPD: Q1 2015 ADJUVANT IB (≥4cm) – IIIA resected • Arm 2: Placebo • OS • Data anticipated: 2020 NSCLC NCT02273375 (incl. EGFR/ALK positive) Global trial CVMD

Partnered Phase III Unresectable Stage III NSCLC 702 • Arm 1: Durvalumab IV Q2W • PFS • FPD: Q2 2014 PACIFIC patients following platinum- • Arm 2: placebo • OS • LPCD: Q2 2016 based concurrent chemo- • Data anticipated: H2 2017 NCT02125461 radiation therapy Global trial

Phase II/III Lung Master Stage IV squamous NSCLC 140 ; 100 Durvalumab Umbrella trial with 5 arms based on biomarker expression • FPD: Q2 2014 Protocol patients treated • Substudy A: Durvalumab (non-match for other biomarker • ORR, PDL1 + • Data anticipated: 2022 driven substudies) IVQ2W single arm durvalumab PhII only

NCT02154490 Biomarker-targeted • Substudy B: PI3K Inhibitor vs. docetaxel Respiratory 2L therapy • Substudy C: CDK4/6 inhibitor vs. docetaxel Partnered • Substudy D: AZD4547 (FGFR inhibitor) vs. docetaxel • Substudy E: C-MET/HGFR Inhibitor + erlotinib vs. Erlotinib (Substudy is closed) Phase II Stage IIIB-IV NSCLC patients 293 • Arm 1: Durvalumab IV Q2W (EFGR/ALK WT) • Objective Response Rate • FPD: Q1 2014 ATLANTIC • Arm 2: Durvalumab IV Q2W (EFGR/ALK M+) • Secondary endpoints include duration of • LPCD: Q2 2015 PD-L1+ve patients • Arm 3: Durvalumab IV Q2W (EFGR/ALK WT) (90% PD-L1 - response, PFS and OS • Data readout: Q4 2015

NCT02087423 3L expression) Other

Global trial – 18 countries

Phase I/II Sequencing Study Stage IIIB-IV NSCLC patients 72 • Arm 1: Iressa initially then switch to durvalumab IVQ2W • Complete Response Rate • FPD: Q3 2014 • Arm 2: AZD9291 then switch to durvalumab • LPCD: Q2 2016 NCT02179671 • Arm 3: selumetinib + docetaxel then switch to durvalumab • ORR, Disease Control Rate • Data readout: Q3 2016 • Arm 4: tremelimumab then switch to durvalumab

29 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Squamous Cell Carcinoma of the Head & Neck (HNSCC) Oncology and other solid tumours

Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 108 • Dose Escalation: N=36, 3 cohorts receiving Treatment A • Safety and Tolerability • FPD: Q4 2014 (mogamulizumab + durvalumab) and 3 cohorts receiving • MTD • LPCD: Q3 2017 NCT02301130 Treatment B (mogamulizumab + treme), in parallel • ORR, DoR, DCR, PFS, OS • Data anticipated: 2018 • Dose Expansion: N=72, Multiple solid tumour types (NSCLC, Partnered Head and Neck, Pancreatic), Treatment A or B (12 subjects per treatment per disease type, in parallel)

Phase I Solid tumours 176 • Dose Escalation: 3 cohorts at Q2W and 1 cohort at Q3W • Safety • FPD: Q3 2013 (all-comers) • Dose Expansion: Biliary Tract Cancer, Oesophageal Cancer • Optimal biologic dose • LPCD: H2 2017 NCT01938612 and SCCNH, Q2, and Q4 schedule • Data anticipated: 2018 • Dose Expansion of combination: Biliary Tract Cancer and

Oesophageal Cancer, durvalumab Q4W 20mg/kg + Respiratory tremelimumab Q4W 1mg/kg

Trial conducted in Japan Other

30 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Oncology Solid tumours

Trial Population Patients Design Endpoints Status CVMD Phase III Stage IIIB-IV 3L NSCLC 480 • Arm 1: durvalumab + tremelimumab (PD-L1 –ve patients) • PFS • FPD: Q2 2015 ARCTIC patients who have not be • Arm 2: Standard of Care • OS • LPCD: Q3 2016 tested positive for EGFR/ALK • Arm 3: tremelimumab (PD-L1 –ve patients) • Safety • Data anticipated: H1 2017 NCT02352948 mutation • Arm 4: durvalumab (PD-L1 –ve patients)

Phase III NSCLC 1L 1,118 • Arm 1: durvalumab • PFS • FPD: Q3 2015 MYSTIC • Arm 2: durvalumab + tremelimumab • OS • LPCD: Q3 2016 • Arm 3: Standard of care • Safety • Data anticipated: mid 2017 NCT02453282

Phase III NSCLC 1L 800 • Arm 1: durvalumab + tremelimumab • OS • FPD: Q4 2015 Respiratory NEPTUNE • Arm 2: Standard of care • Safety • Data anticipated: 2018

NCT02542293

Phase III HNSCC 2L 720 • Arm 1: durvalumab + tremelimumab • OS • FPD: Q4 2015 EAGLE • Arm 2: durvalumab • PFS • Data anticipated: 2018 • Arm 3: Standard of care • Safety Other NCT02369874

Phase III HNSCC 1L 628 • Arm 1: durvalumab • PFS • FPD: Q4 2015 KESTREL • Arm 2: durvalumab + tremelimumab • OS • Data anticipated: H2 2017 • Arm 3: Standard of care • Safety NCT02551159

Phase III Bladder 1L cis eligible and 525 • Arm 1: durvalumab + tremelimumab • PFS • FPD: Q4 2015 DANUBE ineligible • Arm 2: durvalumab • OS • Data anticipated: 2018 • Arm 3: Standard of care • Safety NCT02516241

31 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Oncology Solid tumours

Trial Population Patients Design Endpoints Status CVMD Phase II Urothelial Bladder Cancer 76 • Arm 1 Tremelimumab in Urothelial Bladder Cancer • Safety • FPD: Q1 2016 Triple-negative Breast Cancer • Arm 2 TremelimumabTriple-negative Breast Cancer • Objective Response rate • Data anticipated: 2018 Pancreatic Ductal- • Arm 3 Tremelimumab Pancreatic Ductal-Adenocarcinoma • Duration of Response NCT02527434 Adenocarcinoma

Phase I combination in Solid tumours (treme Phase I) 22 • Tremelimumab + durvalumab • Safety • FPD: Q2 2014 advanced solid tumours in • Dose Escalation trial • Optimal biologic dose • LPCD: Q2 2015 Japanese patients • Tremelimumab Q4W/Q12W 3-10mg/kg • Data anticipated: H1 2017 • Tremelimumab Q4W/Q12W X mg/kg + durvalumab Q4W X NCT02141347 mg/kg Respiratory Phase 1 Combination in Solid tumours 80 • Arm 2 SCLC. Durvalumab + tremelimumab + carboplatin + • Safety • FPD: Q1 2016 Advanced Solid Tumours etoposide • LPCD: Q4 2016 • Arm 3 TNBC: Durvalumab + tremelimumab + gemcitabine + • Data anticipated: 2018 NCT02658214 carboplatin • Arm 4 TNBC: Durvalumab + tremelimumab + nab-paclitaxel (paclitaxel-albumin) + carboplatin • Arm 5 Gastric/gastro-oOesophageal junction (GEJ): Durvalumab + tremelimumab + oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) Other

32 Approved medicines Late-stage development Acalabrutinib (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Oncology

Trial Population Patients Design Endpoint(s) Status

Phase III Relapsed/refractory chronic 500 • Arm A: acalabrutinib • PFS • FPD: Q4 2015 ACE-CL-006 (ELEVATE-RR) lymphocytic leukaemia (CLL), • Arm B: ibrutinib • Secondary endpoints: comparison of • Data anticipated: 2019 high risk incidence of infections, RTs and atrial NCT02477696 fibrillation, OS CVMD

Phase III Previously untreated CLL 510 • Arm A: chlorambucil + obinutuzumab • PFS (Arm A vs Arm B) • FPD: Q3 2015 ACE-CL-007 (ELEVATE-TN) • Arm B: acalabrutinib + obinutuzumab • Secondary endpoints: IRC assessed • Data anticipated: 2019 • Arm C: acalabrutinib ORR, TTNT, OS (Arm A vs Arm B vs. NCT02475681 Arm C)

Phase III Relapsed/refractory CLL 306 • Arm A: acalabrutinib PFS • Data anticipated: 2020 ACE-CL-309 • Arm B: rituximab + idelalisib or bendamustine (investigator’s Secondary endpoints: IRC assessed ORR, choice) TTNT, OS, DOR, PROs NCT02970318

Phase III Previously untreated Mantle 546 • Arm A: acalabrutinib + bendamustine + rituximab PFS by Lugano Classification for NHL • Data anticipated: 2022 Respiratory ACE-LY-308 cell lymphoma (MCL) • Arm B: bendamustine + rituximab Secondary endpoints: Investigator- assessed (IA) PFS, ORR; IRC assessed NCT02972840 ORR, DOR, time to response; OS

Phase II Relapsed/ refractory CLL, 80 Acalabrutinib monotherapy • ORR at 36 cycles • FPD: Q1 2016 ACE-CL-208 intolerant to ibrutinib • Data anticipated: 2020

NCT02717611 Other Phase II Relapsed/refractory and 48 Acalabrutinib monoherapy • Efficacy • FPD: Q1 2015 15-H-0016 treatment naive/del17p • Arm A: Lymph node biopsy • Secondary endpoints: Safety, TTP, PFS, • Data anticipated: H2 2017 CLL/small lymphocytic • Arm B: Bone marrow biopsy OS NCT02337829 lymphoma (SLL) Phase II Relapsed/refractory MCL 124 Acalabrutinib monotherapy • ORR • FPD: Q1 2015 ACE-LY-004 • Data anticipated: H1 2017

NCT02213926 Phase I/II CLL/SLL/Richter's 286 Acalabrutinib monotherapy • Safety, PK, PD • FPD: Q1 2014 ACE-CL-001 transformation (RT) Dose escalation and expansion • Secondary endpoints: ORR, DOR, and • LPCD: Q2 2016 PFS • Data anticipated: 2019 NCT02029443

33 Approved medicines Late-stage development Acalabrutinib (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Oncology

Trial Population Patients Design Endpoint(s) Status

Phase I/II B-Cell Malignancies 126 Dose escalation and expansion trial of the combination of • Safety • FPD: Q1 2015 ACE-LY-001 acalabrutinib and ACP-319 (Pi3K inhibitor) • ORR • Data anticipated: H2 2017

NCT02328014 CVMD

Phase I/II Hematological Malignancies 187 Acalabrutinib + pembrolizumab • Safety • FPD: Q1 2015 ACE-LY-005 • Secondary endpoints: ORR, DOR, PFS, • Data anticipated: 2021 OS, TTNT NCT02362035

Phase I/II Waldenstrom 88 Acalabrutinib monotherapy • ORR • FPD: Q3 14 ACE-WM-001 Microglobulinemia (WM) • LPCD: Q4 15 • Data anticipated: H1 2017 NCT02180724

Phase Ib Relapsed/refractory de novo 21 Acalabrutinib monotherapy • Safety • FPD: Q3 2014 ACE-LY-002 ABC DLBCL • LPCD: Q2 2016 Respiratory • Data anticipated: H1 2017 NCT02112526

Phase Ib Mantle Cell Lymphoma (MCL) 48 Acalabrutinib in combination with bendamustine and rituximab • Safety • FPD: Q2 2016 ACE-LY-106 • Arm A: Treatment naive • Data anticipated: 2021 • Arm B: Relapsed/refractory NCT02717624

Phase Ib Relapsed/refractory Multiple 40 • Arm A: acalabrutinib • Safety • FPD: Q1 2015 Other ACE-MY-001 Myeloma • Arm B: acalabrutinib + dexamethasone • LPCD: Q1 2016 • Data anticipated: H1 2017 NCT02211014

Phase I Relapsed/refractory Follicular 38 • Arm A: acalabrutinib • Safety • FPD: Q1 2015 ACE-LY-003 Lymphoma • Arm B: acalabrutinib + rituximab • LPCD: Q3 2016 • Data anticipated: 2018 NCT02180711

Phase I Relapsed/refractory CLL/SLL 12 Acalabrutinib in combination with ACP-319 • Safety, PK, PD • FPD: Q3 2014 ACE-CL-002 Dose escalation • LPCD: Q3 2015 • Data anticipated: 2018 NCT02157324

Phase I CLL/SLL/Prolymphocytic 45 Acalabrutinib + obinutuzumab • Safety, ORR • FPD: Q1 2015 ACE-CL-003 leukemia (PLL) • Arm A: Relapsed/refractory • Secondary endpoints: PD, PFS, TTN, • LPCD: Q1 2018 • Arm B: Treatment naive OS • Data anticipated: 2018 NCT02296918 34 Approved medicines Late-stage development Acalabrutinib (BTK inhibitor) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoint(s) Status

Phase II ≥ 2L advanced or metastatic 78 • Arm A: pembrolizumab • ORR • FPD: Q2 2015 ACE-ST-006 head and neck squamous cell • Arm B: acalabrutinib+ pembrolizumab • LPCD: Q2 2016 carcinoma • Data anticipated: H2 2017

NCT02454179 CVMD

Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPD: Q2 2015 ACE-ST-007 NSCLC • Arm B: acalabrutinib+ pembrolizumab • LPCD Q2 2016 • Data anticipated: H1 2017 NCT02448303

Phase II Recurrent ovarian cancer 78 • Arm A: acalabrutinib • ORR • FPD: Q4 2015 ACE-ST-208 • Arm B: acalabrutinib+ pembrolizumab • LPCD Q2 2016 • Data anticipated: H2 2017 NCT02537444

Phase II ≥ 2L advanced or metastatic 77 • Arm A: acalabrutinib • Safety • FPD: Q2 2015 ACE-ST-003 pancreatic cancer • Arm B: acalabrutinib+ pembrolizumab • LPCD: Q1 2016 Respiratory • Data anticipated: H2 2017 NCT02362048

Phase II Platinum-resistant urothelial 78 • Arm A: pembrolizumab • ORR • FPD: Q2 2015 ACE-ST-005 bladder cancer • Arm B: acalabrutinib+ pembrolizumab • LPCD: Q1 2016 • Data anticipated: 2018 NCT02351739 Other Phase Ib/II ≥ 2L glioblastoma multiforme 72 • Arm A: acalabrutinib 200 mg BID • Safety, ORR • FPD: Q1 2016 ACE-ST-209 • Arm B: acalabrutinib 400 mg QD • Secondary Endpoints: DOR, PFS, PFS- • Data anticipated: 2018 6, OS NCT02586857

35 Approved medicines Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancers Oncology

Trial Population Patients Design Endpoints Status

Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial • Primary: Rate of durable CR: CR • FPD: Q2 2013 PLAIT refractory hairy cell leukemia • Moxetumomab pasudotox IV at the recommended dose maintained for > 180 days • Data anticipated: H2 2017 (HCL) • Efficacy: CR rate, ORR, Duration of CR

NCT01829711 and ORR, time to response (TTR), PFS CVMD • Safety and tolerability • PK and immunogenicity

Phase I Adults with relapsed refractory 49 • Open Label dose escalation Phase I trial • MTD and efficacy • FPD: Q2 2007 HCL • Moxetumomab pasudotox IV • LPCD: Q1 2014 NCT00586924 • Data readout: Q2 2015 Respiratory Other

36 Approved medicines Late-stage development Selumetinib (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase III Differentiated thyroid cancer 304 • Arm 1: Selumetinib 75mg BiD 5 weeks duration + RAI 100mCia • Complete remission (CR) rate at 18 • FPD: Q3 2013 ASTRA • Arm 2: Placebo BiD 5 weeks duration + RAI 100mCia months post-radioactive iodine • LPCD: Q1 2016 • Clinical remission rate at 18 months post • Data anticipated: 2018

NCT01843062 Global trial – eight countries RAI (per SoC) CVMD

a Single dose of 100mCi 131I administered following 4 weeks of selumetinib (or placebo)

Phase II Pediatric Neurofibromatosis minimum of 50 • Single Arm: selumetinib 25mg/m2 BID with 2 strata: • Complete partial and complete response • FPD: Q3 2015 type 1 • Stratum 1: PN related morbidity present at enrolment rate measured by volumetric MRI; • LPCD: H2 2016 NCT01362803 • Stratum 2: No PN related morbidity present at enrolment • Duration of response and functional • Data anticipated: 2018 outcomes/QoL Partnered Advanced solid tumours Phase I 40 • Dose escalation trial: Starting dose selumetinib 50mg bd 1 • Safety and tolerability • FPD: Q1 2016 Respiratory week on/1 week off - durvalumab 20mg/kg Q4 – after 7 days of • PK of selumetinib and durvalumab and • LPCD: 2017 NCT02586987 selumetinib dosing preliminary anti-tumour activity • Data anticipated: 2017 • Note: No escalation in durvalumab dose; selumetinib escalation with 25mg bd increment / dose cohort Other

37 Approved medicines Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease Oncology (CKD/ESRD)

Trial Population Patients Design Endpoints Status CVMD Phase III ANDES Anaemia in CKD patients not 600 • Arm 1: Roxadustat Haemoglobin response • FPD: Q4 2012 receiving dialysis • Arm 2: Placebo • Data anticipated: 2018 NCT01750190 Global trial Sponsored by FibroGen

Phase III ALPS 600 • Arm 1: Roxadustat Haemoglobin response • FPD: Q2 2013 • Arm 2: Placebo • Data anticipated: 2018 NCT01887600 Global trial Sponsored by Astellas

Phase III DOLOMITES 570 • Arm 1: Roxadustat Haemoglobin response • FPD: Q1 2014 • Arm 2: Darbepoetin alfa • Data anticipated: H2 2017 Respiratory NCT02021318 Global trial Sponsored by Astellas

Phase III OLYMPUS 2,600 • Arm 1: Roxadustat MACE • FPD: Q3 2014 • Arm 2: Placebo • Data anticipated: 2018 NCT02174627 Global trial Sponsored by AstraZeneca

Phase III ROCKIES Anaemia in CKD in patients 1,425 • Arm 1: Roxadustat MACE • FPD: Q3 2014 Other receiving dialysis • Arm 2: Epoetin alfa •Data anticipated: 2018 NCT02174731 Global trial Sponsored by AstraZeneca

Phase III SIERRAS 600 • Arm 1: Roxadustat Haemoglobin response • FPD: Q4 2014 • Arm 2: Epoetin alfa •Data anticipated: 2018 NCT02273726 Global trial Sponsored by FibroGen

Phase III PYRENEES 750 • Arm 1: Roxadustat Haemoglobin response • FPD: Q4 2014 • Arm 2: Erythropoiesis Stimulating Agent • Data anticipated: H1 2017 NCT02278341 • Arm 3: Darbepoetin alfa Sponsored by Astellas Global trial

HIF-PHI= Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor 38 Approved medicines Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease Oncology (CKD/ESRD)

Trial Population Patients Design Endpoints Status CVMD Phase III HIMALAYAS Anaemia in newly initiated 1,000 • Arm 1: Roxadustat Haemoglobin response • FPD: Q4 2013 dialysis patients • Arm 2: Epoetin alfa • Data anticipated: 2018 NCT02052310 Global trial Sponsored by FibroGen Anemia in CKD patients not 150 Haemoglobin response Phase III • FPD: Q4 2015 receiving dialysis Arm 1: FG-4592 (roxadustat) • LPCD: Q4 2016 NCT02652819 Arm 2: Placebo • Data anticipated: H1 2017 • Primary endpoint met China trial Sponsored by FibroGen

Anemia in CKD patients 300 Haemoglobin response Respiratory Phase III • FPD: Q4 2015 receiving dialysis Arm 1: FG-4592 (roxadustat) • LPCD: Q2 2016 NCT02652806 Arm 2: Epoetin alfa • Data readout: H1 2017 • Primary endpoint met China trial Sponsored by FibroGen

HIF-PHI= Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Other

39 Approved medicines Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalemia Oncology

Trial Population Patients Design Endpoints Status

Phase II Hyperkalemia and moderate 90 • Arm 1: Escalating TID doses (0.3g, 3g and 10g) of ZS • Change in serum potassium levels from • FPD: Q4 2011 chronic kidney disease (CKD) • Arm 2: Placebo TID baseline • LPCD: Q2 2012 NCT01493024 • Data readout: Q2 2012

US CVMD

Phase III Hyperkalemia 754 • Arm 1: ZS 1.25g TID for 48 hrs followed by QD for 12 days • Change in serum potassium levels from • FPD: Q4 2012 • Arm 2: ZS 2.5g TID for 48 hrs followed by QD for 12 days baseline • LPCD: Q4 2013 NCT01737697 • Arm 3: ZS 5g TID for 48 hrs followed by QD for 12 days • Data readout: Q4 2013 • Arm 4: ZS 10g TID for 48 hrs followed by QD for 12 days • Primary endpoint met • Arm 5: Placebo TID for 48 hrs followed by QD for 12 days

Global trial – three countries Phase III Hyperkalemia 258 Open-label ZS 10g TID for 48 hrs followed by: • Maintenance of normokalemia • FPD: Q1 2014 • Arm 1: ZS 5g QD for 28 days • LPCD: Q3 2014 NCT02088073 • Arm 2: ZS 10g QD for 28 days • Data readout: Q4 2014 Respiratory • Arm 3: ZS 15g QD for 28 days • Primary endpoint met • Arm 4: Placebo QD for 28 days

Global trial – three countries Phase III Participation in study 123 • Arm 1: ZS 10g QD for 11 months. Option to uptitrate to 15g QD • Maintenance of normokalemia • FPD: Q2 2014 Open-label Extension to NCT02088073 or downtitrate to 5g QD and 5g QOD • LPCD: Q3 2015

Study NCT02088073 • Data readout: Q3 2015 Other Global trial – three countries NCT02107092

Phase III Hyperkalemia 751 • Arm 1: ZS 5g QD for 12 months. Option to uptitrate to 10 • Safety and tolerability • FPD: Q2 2014 and15g QD or downtitrate to 5g QOD • LPCD: Q4 2016 NCT02163499 Global trial – seven countries

40 Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Severe, uncontrolled asthma, 1,026 HD + ~200 MD • Arm 1: 30mg Q8w SC • Annual asthma exacerbation rate • FPD: Q4 2013 CALIMA despite background controller • Arm 2: 30mg Q4w SC • Assess pulmonary function, asthma • Data readout: Q2 2016 medication, MD & HD ICS + • Arm 3: Placebo SC symptoms, other asthma control metrics,

NCT01914757 LABA ± chronic OCS ER/ED hospitalisation visits, PK, and IM CVMD Age 12-75 years 56-week trial Global trial – 11 countries Phase III Severe, uncontrolled asthma, 1,134 • Arm 1: 30mg Q8w SC • Annual asthma exacerbation rate • FPD: Q4 2013 SIROCCO despite background controller • Arm 2: 30mg Q4w SC • Assess pulmonary function, asthma • Data readout: Q2 2016 medication HD ICS + LABA ± • Arm 3: Placebo SC symptoms, other asthma control metrics, NCT01928771 chronic OCS ER/ED hospitalisation visits, PK, and IM Age 12-75 years 48-week trial Global trial – 17 countries Phase III Severe, uncontrolled asthma 210 • Arm 1: 30mg Q8w SC • Reduction of oral corticosteroid dose • FPD: Q3 2014 ZONDA on HD ICS plus long-acting β2 • Arm 2: 30mg Q4w SC • Data readout: Q3 2016

agonist and chronic oral • Arm 3: Placebo SC Respiratory NCT02075255 corticosteroid therapy Age 18-75 years 46-week trial Global trial – 12 countries Phase III A multicenter, open-label, 770 • Arm 1: 30mg Q4W SC • Safety and tolerability • FPD: Q2 2016 MELTEMI safety extension trial with • Arm 2: 30mg Q8W SC • Data anticipated: 2019 benralizumab for asthmatic NCT02808819 adults on Inhaled

Corticosteroid plus Long- Other acting Beta2 Agonist Age 18-75 years

Phase lll A multicenter, randomised, 100 • Arm1 30mg Q4W SC with one dose of seasonal influenza virus • Post-dose strain-specific • FPD: Q2 2016 ALIZE double-blind, parallel group, vaccine Intramuscular (IM) at week eight. hemagglutination-inhibition (HAI) • Data anticipated: H1 2017 placebo-controlled, Phase IIIb • Arm1 Placebo Q4W SC with one dose of seasonal influenza antibody geometric mean fold rises trial to evaluate the potential virus vaccine Intramuscular (IM) at week (GMFRs effect of benralizumab on the • Post-dose strain-specific serum HAI humoral immune response to antibody geometric meant titers (GMTs) the seasonal influenza • Proportion of patients who experience a vaccination in adolescent and strain-specific post-dose antibody young adult patients with response with antibody response severe asthma defined as a ≥4-fold rise in HAI antibody Ages 12-21 years titer

41 Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status

Phase III Asthmatic with FEV1 (50-90% 200 • Arm 1: 30mg Q4W SC • Pulmonary function (FEV1) • FPD: Q1 2015 BISE predicted) on low to medium • Arm 3: Placebo SC • Data readout: Q1 2016 dose inhaled corticosteroid

NCT02322775 Age 18-75 years 12-week trial CVMD Global trial – six countries

Phase III Severe asthma, inadequately 2,550 • Arm 1: 30mg Q4W SC • Safety and tolerability • FPD: Q4 2014 BORA controlled despite background • Arm 2: 30mg Q8W SC* • Data anticipated: 2018 controller medication, MD & NCT02258542 HD ICS + LABA ± chronic • Placebo administered at select interim visits to OCS maintain blind between treatment arms Age 12-75 years 56-week (adults) 108-week (adolescents) Global trial Respiratory

Phase III Severe asthma, inadequately 120 • Arm 1: 30mg Q4W SC • Functionality, reliability, and • FPD: Q2 2015 GREGALE controlled despite background performance of a pre-filled syringe with • Data readout: Q2 2016 controller medication, MD & 28-week (adults) benralizumab Administered at Home NCT02417961 HD ICS + LABA ± chronic Global trial – two countries OCS

Age 18-75 years Other

Ph lll A Double-Blind, randomised, 38 • Arm 1 : 30mg Q4W SC • Safety and tolerability • FPD Q3 2016 ARIA parallel group, placebo- • Arm 2: Placebo SC • Data anticipated: 2019 controlled multi-centre trial to NCT02821416 evaluate the effect of benralizumab on allergen- induced inflammation in Mild, atopic asthmatic Age 18-65 years

ICS= Inhaled corticosteroids LABA= Long Acting Beta Agonist

42 Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status

Phase III Severe asthma 230 • Arm 1: 30mg Q4W SC • Onset and maintenance of effect on lung • FPD: Q4 2016 function • Data anticipated: 2018 SOLANA Age 18-75 years • Arm 2: Placebo SC

NCT02869438 CVMD 16-week trial Global trial – six countries

Phase III Severe asthma 120 Open label 30mg Q4w • % of patients/ caregivers who • FPD: Q4 2016 successfully self administer at home GRECO Age 18-75 years • Data anticipated: 2018 NCT02918071 28-week trial Global trial - two countries Respiratory

Healthy Volunteer 162 Open label study to compare 30 mg benralizumab PK • PK Comparability • FPD: Q4 2016 AMES Age 18-55years administered by APFS or AI device • Data anticipated: H2 2017 NCT02968914 8-week study

Global study – two countries Other

43 Approved medicines Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase III Moderate to very severe 2,168 • Arm 1: 10mg Q8W SC • Rate of COPD exacerbation • FPD: Q3 2014 TERRANOVA COPD with exacerbation • Arm 2: 30mg Q4W SC • Data anticipated: 2018 history • Arm 3: 100mg Q8W SC

NCT02155660 • Arm 4: Placebo SC CVMD

48-week trial Global trial – 23 countries

Phase III Moderate to very severe 1,626 • Arm 1: 30mg Q4W SC • Rate of COPD exacerbation • FPD: Q3 2014 GALATHEA COPD with exacerbation • Arm 2: 100mg Q8W SC • Data anticipated: 2018 history • Arm 3: Placebo SC NCT02138916 48-week trial Global trial – 17 countries Respiratory Other

44 Approved medicines Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status

Phase III Adults with severe, 1,140 Cohort 1: Primary: • FPD: Q3 2014 STRATOS 1 uncontrolled asthma • Arm 1: Tralokinumab dose regimen 1, SC • Asthma exacerbation rate reduction • LPCD: Q1 2016 • Arm 2: Placebo SC Key secondary: • Data anticipated: H1 2017

NCT02161757 Cohort 2 : • Effect of tralokinumab on measures of CVMD • Arm 1: Tralokinumab dose regimen 2, SC pulmonary function (FEV1), asthma • Arm 2: Placebo SC symptoms (Asthma Daily Diary), asthma control (ACQ-6) and asthma related QoL 2:1 randomisation in both cohorts (AQLQ (S) +12)

Global trial – 14 countries

Phase III Adults with severe, 770 • Arm 1: Tralokinumab SC Primary: • FPD: Q4 2014 STRATOS 2 uncontrolled asthma • Arm 2: Placebo SC • Asthma exacerbation rate reduction • LPCD: Q1 2016 Key secondary: • Data anticipated: H1 2017 NCT02194699 1:1 randomisation • Effect of tralokinumab on measures of

pulmonary function (FEV1), asthma Respiratory Global trial – 12 countries including Japan symptoms (Asthma Daily Diary), asthma control (ACQ-6) and asthma related QoL (AQLQ (S) +12)

Phase III Adults with oral corticosteroid 120 • Arm 1: Tralokinumab SC Primary: • FPD: Q1 2015 TROPOS dependent asthma • Arm 2: Placebo SC • % Change in OCS dose • LPCD: Q3 2016 Key secondary: • Data anticipated: H2 2017 NCT02281357 1:1 randomisation • Proportion of subjects achieving final daily OCS dose ≤5 mg Other Global trial – seven countries • Proportion of subjects achieving ≥50% reduction in OCS dose

Phase II Adults with uncontrolled 80 • Arm 1: Tralokinumab SC Primary: • FPD: Q3 2015 MESOS asthma • Arm 2: Placebo SC • Change in number of airway • LPCD: Q4 2016 • sub-mucosal eosinophils • Data anticipated: H2 2017 NCT02449473 1:1 randomisation Secondary: • Change in blood eosinophils levels Global trial – three countries • Change in eosinophil cationic protein as a measure of activated eosinophils in blood and sputum

45 Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Moderate to very severe 500 Treatments (52-week Treatment Period) Bone Mineral Density sub-study Endpoint: • FPD: Q3 2015 COPD • BGF MDI 320/14.4/9.6µg • Change from baseline in BMD of the • LPCD: Q3 2016 • GFF MDI 14.4/9.6µg lumbar spine measured using DXA • Data anticipated: H2 2017 NCT02536508 • BFF MDI 320/9.6µg scans of L1-L4 at week 52 • Symbicort Turbuhaler 400/1 µg Ocular Sub-study Safety Endpoint: CVMD Randomised, double-blind, chronic-dosing, multi-centre • Change from baseline in LOCS III at week 52 Country – US Phase III Moderate to very severe 8,000 Treatments (1-year Treatment Period) • Rate of moderate or severe COPD • FPD: Q3 2015 COPD (possible increase by • BGF MDI 320/14.4/9.6µg BID exacerbations • Data anticipated: 2019 NCT02465567 4,000 after blinded • BGF MDI 160/14.4/9.6µg BID • Time to first moderate or severe COPD sample size re- • BFF MDI 320/9.6µg BID exacerbation assessment) • GFF MDL 14.4/9.6µg BID Randomised, double-blind, multi-centre and parallel-group

Multi-country Respiratory Phase III Moderate to very severe 1,800 Treatments (24-week Treatment Period) Co-Primary Endpoints (EU): • FPD: Q3 2015 KRONOS COPD • BGF MDI 320/14.4/9.6µg • FEV1 area under curve from 0 to 4 hours • Data anticipated: 2018 • GFF MDI 14.4/9.6µg (AUC0-4) over 24 weeks (BGF MDI vs NCT02497001 • BFF MDI 320/9.6µg BFF MDI and BGF MDI vs Symbicort • Symbicort Turbuhaler 400/12µg Turbuhaler) Randomised, double-blind, parallel-group, and chronic dosing and • Change from baseline in morning pre- multi-centre dose trough FEV1 over 24 weeks (BGF MDI vs GFF MDI) • Transition dyspnea index (TDI) focal Multi-country score over 24 weeks (BGF MDI vs BFF Other MDI and BGF MDI vs GFF MDI) Primary Endpoint (Japan): • Change from baseline in morning pre- dose trough FEV1 over 24 weeks (BGF MDI vs BFF MDI, BGF MDI vs GFF MDI) Primary Endpoint (US): • FEV1 area under curve from 0 to 4 hours (AUC0-4) at week 24 (BGF MDI vs BFF MDI • Change from baseline in morning pre- dose trough FEV1 at week 24 (MDI vs GFF MDI)

46 Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Oncology

Trial Population Patients Design Endpoints Status

Phase II Adult mild to moderate 150 • Arm 1: BD MDI 320μg BiD • Change from baseline in morning pre- • FPD: Q2 2014 persistent asthma • Arm 2: BD MDI 160μg BiD dose trough forced expiratory volume in • LPCD: Q1 2015 • Arm 3: BD MDI 80μg BiD one second (FEV1) • Data readout: Q3 2015

NCT02105012 • Arm 4: BD MDI 40μg BiD • Mean evening pre-dose peak flow rate CVMD • Arm 5: Placebo MDI BiD (PEFR) • Mean number of puffs of rescue Ventolin Randomised, four-period, five-treatment incomplete-block and hydrofluoroalkane (HFA) cross-over • Asthma Control Questionnaire score

US

Phase II Intermittent asthma/mild to 200 Treatment (18-week Treatment Period) • Peak change from baseline in FEV1 • FPD: Q2 2015 moderate persistent asthma • GP MDI 28.8μg BiD within three hours post-dosing on • LPCD: Q4 2015

• GP MDI 14.4μg BiD Day 15 • Data readout: Q2 2016 Respiratory NCT02433834 • GP MDI 7.2µ BID • GP MDI 3.6µ BID • Severent® Diskus® 50µ BID • Placebo MDI

Randomised, double-blind, chronic-dosing, placebo controlled, incomplete block, cross-over, multi-centre, dose-ranging trial Other

47 Approved medicines Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy subjects 60 • Arm 1: BGF MDI 320/14.4/9.6μg • Overall safety • FPD: Q3 2014 • Arm 2: BFF MDI (320/9.6µg) • PK parameters AUC0-12 and Cmax • LPCD: Q3 2014 • Arm 3: Symbicort Turbuhaler 400/12μg • Data readout: Q4 2014

NCT02189304 Randomised, double-blind, single-dose, three-period, three- CVMD treatment and cross-over

US

Phase I Japanese healthy subjects 28 Treatment (2-week Treatment Period) • Overall safety • FPD: Q3 2014 • Arm 1: BGF MDI 320/14.4/9.6μg • PK parameters AUC0-12 and Cmax • LPCD: Q3 2014 • Arm 2: BGF MDI 160/14.4/9.6μg • Data readout: Q4 2014 NCT02197975 • Arm 3: Placebo MDI Randomised, double-blind, placebo-controlled, 2-period, ascending-dose and crossover Respiratory Japan

Phase I Japanese healthy subjects 24 Treatment (four-day Treatment Period) • Overall safety • FPD: Q3 2014 • Arm 1: GFF MDI 14.4/9.6μg • PK parameters AUC0-12 and Cmax • LPCD: Q3 2014 • Arm 2: GFF MDI 28.8/9.6μg • Data readout: Q4 2014 NCT02196714 • Arm 2: GP MDI 14.4μg • Arm 2: GP MDI 28.8μg

Randomised, double-blind, single-dose, four-period, four- Other treatment and cross-over

Japan

LAMA= Long Acting Muscarinic Agonist LABA= Long Acting Beta Agonist ICS= Inhaled corticosteroids

48 Approved medicines Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Oncology

Trial Population Patients Design Endpoints Status

Phase III Moderate to severe SLE 450 • Arm 1: 300mg IV MEDI-546 Q4W for 48 weeks Response in SLE responder index at week • FPD: Q3 2015 TULIP SLE 1 • Arm 2: 150mg IV MEDI-546 Q4W for 48 weeks 52 • LPCD: 2018 NCT02446912 • Arm 3: Placebo IV Q4W for 48 weeks • Data anticipated: 2018 CVMD

Phase III Moderate to severe SLE 360 • Arm 1: 300mg IV MEDI-546 Q4W for 48 weeks Response in SLE responder index at week • FPD: Q3 2015 TULIP SLE 2 • Arm 2: Placebo IV Q4W for 48 weeks 52 • LPCD: 2018 NCT02446899 • Data anticipated: 2018

Phase ll Moderate to severe SLE 307 • Arm 1: 300mg IV MEDI-546 Q4W for 48 weeks Response in SLE responder index at 6 • FPD: Q1 2012 patients • Arm 2: 1000mg IV MEDI-546 Q4W for 48 weeks months • Data readout: Q3 2014 NCT01438489 • Arm 3: Placebo IV Q4W for 48 weeks Respiratory Phase II Moderate to severe SLE 218 • Arm 1: MEDI-546, IV Q4W for 104 weeks Open-label extension to evaluate long-term • FPD: Q1 2013 patients safety and tolerability • Data anticipated: 2017 NCT01753193

Phase II Japanese SLE patients 17 Open-label, dose escalation trial: Safety, tolerability, PK/PD • Data readout: Q1 2015 • Arm 1: 100mg IV Q4W for 48 weeks then 300mg IV Q4W for NCT01559090 104 weeks Other • Arm 2: 300mg IV Q4W for 48 weeks then 300mg IV Q4W for 104 weeks • Arm 3: 1000mg IV Q4W for 48 weeks then1000mg IV Q4W for 104 weeks

Phase I Healthy subjects 30 • Arm 1: 300mg SC single dose Safety, tolerability, PK/PD • FPD: Q4 2015 • Arm 2: 300mg IV single dose • LPCD: H1 2016 NCT02601625 • Arm 3: 600 mg SC single dose • Data readout: Q3 2016

49 Approved medicines Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Oncology

Trial Population Patients Design Endpoints Status

Phase II Active Proliferative LN (TULIP- 150 • Arm 1: 900 mg IV Q4W for 12 weeks then 300mg IV MEDI-546 Response in proteinuria at week 52 • FPD: Q4 2015 LN1) Q4W for 36 weeks • LPCD: 2018 NCT02547922 • Arm 2: 300 mg IV MEDI-546 Q4W for 48 weeks • Data anticipated: 2018

• Arm 3: Placebo IV Q4W for 48 weeks CVMD Respiratory Other

50 Approved medicines Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Oncology

Trial Population Patients Design Endpoints Status Phase III Early Alzheimer’s disease 2,202 • Arm 1: AZD3293 20mg once daily • Changes in cognitive (ADAS-Cog 13) • FPD: Q4 2014 AMARANTH patients • Arm 2: AZD3293 50mg once daily and functional (ADCS-ADL) scales • LPCD: H2 2017 • Arm 3: Placebo once daily • Changes in composite scales (CDR-SB) • Data anticipated: 2019

NCT02245737 • Changes in biomarkers and imaging CVMD 24-month treatment duration assays • Safety and tolerability Global trial – 14 countries

Phase III Mild Alzheimer’s disease 1,899 • Arm 1: AZD3293 20 mg once daily • Changes in cognitive (ADAS-Cog 13) • FPD: Q3 2016 DAYBREAK-ALZ patients • Arm 2: AZD3293 50 mg once daily and functional (ADCS-ADL) scales • LPCD: 2018 • Arm 3: placebo once daily • Changes in composite scales (CDR-SB) • Data anticipated: 2019 NCT02783573 • Changes in biomarkers and imaging 18-month treatment duration + 18-month delayed start extension assays • Safety and tolerability Global trial – 18 countries Respiratory Other

51 Approved medicines Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Oncology

Trial Population Patients Design Endpoint(s) Status

Phase II Rheumatoid Arthritis 31 • Arm A: Acalabrutinib + methotrexate Disease Activity Score 28-CRP at week 4 FPD: Q2 2015 ACE-RA-001 • Arm B: Methotrexate LPCD: Q2 2016 Data readout: Q2 2016

NCT02387762 CVMD Respiratory Other

52 AstraZeneca

Early development - IMED Approved medicines Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, pharmacokinetics • FPD: Q4 2015 • Arm 2: AZD0156 + irinotecan and efficacy • Data anticipated: 2018 NCT02588105 CVMD Trial conducted in North America, Europe and South Korea Respiratory Other

54 Approved medicines Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, Non-Small Cell Lung Cancer (NSCLC) Oncology

Trial Population Patients Design Endpoints Status

Phase II p53 mutant PSR ovarian 136 • Arm 1: Carbo/paclitaxel + AZD1775 225mg • PFS • FPD: Q4 2012 cancer • Arm 2: Carbo/paclitaxel + placebo • Secondary endpoint: OS • LPCD: Q3 2014 NCT01357161 • Data readout Q4 2016

Global trial 10 countries CVMD Partnered

Phase II PR ovarian cancer 70 • Arm C: Carboplatin + AZD1775 • Overall Response Rate (ORR) • FPD: Q1 2015 • Arm D: PLD + AZD1775 • Secondary endpoints: Duration of NCT02272790 Response (DOR), PFS, OS, Disease Control Rate, safety and tolerability Global trial

Phase I/II Advanced solid tumours 152 • Monotherapy • Safety and tolerability • FPD: Q3 2015 Safety Run-in (part A, N=12); solid tumours • Secondary endpoints: Overall response NCT02482311 Expansions into specific tumour types, inc ovarian cancer rate, Disease Control Rate, Duration of (BRCAm PARP failures and BRCAwt with three or more prior Response, PFS Respiratory lines of treatment), triple negative breast cancer (TNBC) and small cell lung cancer (SCLC)

Conducted in US, Canada

Phase I Advanced solid tumours 98 • Monotherapy • Safety and tolerability • FPD: Q4 2015 Dose escalation trial to determine MTD

NCT02610075 Other Conducted in US

Phase I Advanced solid tumours 200 • Dose escalation trial (AZD1775 + Lynparza) • Safety and tolerability • FPD: Q3 2015

NCT02511795 Conducted in US

Phase I Advanced solid tumours 42 • Dose escalation trial (AZD1775 + durvalumab) • Safety and tolerability • FPD: Q4 2015

NCT02617277 Conducted in US

Phase I Advanced solid tumours 20 • Dose escalation trial (AZD1775 + carboplatin + paclitaxel: • Safety and tolerability • FPD: Q1 2015 AZD1775 + Carbo: AZD1775 + PLD) NCT02341456 Conducted in Australia, Japan and Republic of Korea

55 Approved medicines Late-stage development Vistusertib (AZD2014) (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous Non-Small Cell Lung Cancer (NSCLC) Oncology

Trial Population Patients Design Endpoints Status

Phase II 2L ER+ metastatic breast 316 • Arm 1: Faslodex • PFS • FPD: Q2 2014 MANTA cancer • Arm 2: Faslodex + vistusertib 50mg BD continuous dosing • Secondary endpoint: OS • LPCD: H2 2016 • Arm 3: Faslodex + vistusertib 125mg BD two days on, 5 off • Data anticipated: 2018

NCT02216786 • Arm 4: Faslodex + everolimus CVMD

Partnered Multicentre: European sites

Phase I Japanese Patients with 18 Open label • Safety and tolerability of AZD2014 • FPD: Q2 2015 Advanced Solid Malignancies monotherapy and in combination with • LPCD: 2017 NCT02398747 Monotherapy and combination with paclitaxel cohorts paclitaxel • Data anticipated: 2017 • PK

Phase I/II Postmenopausal women with 225 Part A - Phase I triplet dose finding to determine the maximum Primary • FPD: Q1 2016 PASTOR locally advanced/metastatic tolerated dose (MTD) of the triplet (vistusertib + palbociclib + • Part A:Safety and tolerability of the • LPCD: 2018 estrogen receptor positive fulvestrant) triplet. MTD and recommended dose for • Data anticipated: 2019 Respiratory NCT02599714 (ER+) breast cancer Parts B and C Part B - Phase I single arm expansions (vistusertib + palbociclib + • Part B: Safety and tolerability Faslodex) • Part C: PFS Secondary: Best Objective Response Rate Part C - randomised, double-blind, placebo-controlled, stratified, (BOR) and Objective Response Rate parallel group extension at RP2D for triplet combination (ORR) (vistusertib + palbociclib + Faslodex vs matching vistusertib

placebo + palbociclib + Faslodex) Other

56 Approved medicines Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPD: Q4 2015 • Arm 2: AZD2811 dose expansion • Pharmacokinetics and efficacy • Data anticipated: 2019 NCT02579226 AZD2811 + irinotecan CVMD Trial conducted in North America Respiratory Other

57 Approved medicines Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A: MTD of AZD4547 in combination • FPD: Q4 2010 GLOW patients whose disease has with 25mg exemestane with 25mg exemestane in three • LPCD: Q1 2014 progressed following • Part B: schedules of AZD4547 • Data readout: Q3 2014 NCT01202591 treatment with one prior • Part B Interim analysis: Tumour size • Arm 1: AZD4547 (dose from part A) + Faslodex CVMD endocrine therapy • Arm 2: placebo + Faslodex analysis on 30 FGFR amplified patients Patients with FGFR1 polysomy (30 patients) or FGFR1 • Part B Final analysis: PFS amplification (60 patients)

Conducted in eight countries in Europe

Phase II Advanced 71 • Arm 1 (FGFR2 polysomy): AZD4547 vs paclitaxel randomised • PFS • FPD: Q4 2011 SHINE gastro-oesophageal cancer 1:1 (30 to 80 patients) • Key Secondary: OS/Tumour size • LPCD: Q2 2013 • Arm 2 (FGFR 2 low gene amplification: AZD4547 vs paclitaxel • Data readout: Q1 2015 NCT01457846 randomised 3:2 (25 to 80 patients) • Arm 3 (FGFR2 high gene amplification: AZD4547 vs paclitaxel randomised 3:2 (25 to 80 patients) Conducted in 16 countries across Europe and Asia Respiratory

Phase I Advanced cancer who have 33 • Part A: AZD4547 in ascending multiple doses given bd and od • Part A: MTD and Recommended dose • FPD: Q4 2010 failed standard therapy or for (c. 30 patients) for Parts B and C • LPCD: Q4 2012 NCT01213160 whom no standard therapy • Part B: AZD4547 in patients whose tumours have FGFR • Part B: Safety and tolerability and • Data readout: Q2 2013 exists amplification (c. eight patients) preliminary anti-tumour activity Conducted in Japan

Phase I Advanced cancer who have 94 • FPD: Q4 2009

• Part A: Ascending oral doses of AZD4547 to define maximum • Part A: MTD and Recommended dose Other failed standard therapy or for tolerated dose (MTD) and /or continuous, tolerable for Parts B and C • LPCD: Q4 2013 NCT00979134 whom no standard therapy recommended dose (RD) • Part B and C: Safety and tolerability, PK • Data readout: Q1 2015 exists • Part B: Dose expansion phase at RD defined in Part A and preliminary anti-tumour activity • Part C: Expansion phase in patiens with FGFR1 and FGFR2 amplified tumours at the RD defined from Part A Conducted in seven countries across North America and Europe

Phase I 2L Muscle Invasive Metastatic 110 • Multi-drug biomarker-directed trial • Safety and tolerability of the • FPD: Q4 2016 BISCAY Bladder Cancer in patients • Arm 1: AZD454 combinations • Data anticipated: 2018 who have failed prior therapy • Arm 2: AZD4547 + durvalumab • PK and preliminary anti-tumour activity NCT02546661 • Arm 3: Lynparza + durvalumab • Arm 4: AZD1775 + durvalumab • Arm 5: durvalumab • Arm 6: vistusertib + durvalumab Planned in North America and Europe

58 Approved medicines Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Solid tumours and Non-Small Cell Lung Cancer (NSCLC) Oncology

Trial Population Patients Design Endpoints Status

Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalation to determine the Maximum Primary Outcome Measure: Safety and • FPD: Q2 2016 advanced solid tumours Tolerated Dose (MTD) of AZD4635 given as monotherapy and tolerability • Data anticipated: 2018 NCT02740985 in combination with durvalumab. When the combination MTD is Secondary Outcome Measures:

determined, additional patients with advanced solid • Pharmacokinetics of AZD4635 as CVMD malignancies will be enrolled to a dose expansion cohort to monotherapy and combination with explore further the safety, tolerability, pharmacokinetics (PK), durvalumab and biological activity. • Preliminary assessment of anti-tumour activity Phase Ib: patients with 15 • Phase 1b will consist of an additional expansion phase in advanced NSCLC who have NSCLC at the combination MTD or maximum feasible dose previously received anti-PD-1 therapy, but either failed to Both parts conducted at sites in the US respond or stopped responding after an initial response Respiratory Other

59 Approved medicines Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase Ib/II Squamous Cell Carcinoma of 213 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial • FPD: Q3 2015 the Head & Neck (HNSCC) • Arm A1: AZD9150/durvalumab • Data anticipated: 2019 NCT02499328 • Arm A2 : AZD5069/durvalumab

Dose Expansion 2L HNSCC: CVMD • Arm B1: AZD9150 • Arm B2: AZD5069 • Arm B3: AZD9150/durvalumab • Arm B4: AZD5069/durvalumab

Phase Ib/II Metastatic Pancreatic Ductal 26 Dose escalation and expansion Arms: • Safety/Efficacy trial • FPD: Q1 2016 Carcinoma • Data anticipated: 2018 NCT02583477 Durvalumab in combination with nab-paclitaxel and gemcitabine Durvalumab in combination with AZD5069 Respiratory Other

* clinicaltrials.gov being updated 60 Approved medicines Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase IIb ER+ breast cancer receiving 100 • Arm 1: AZD5363 + paclitaxel • PFS • FPD: Q1 2014 1st treatment with paclitaxel in • Arm 2: AZD5363 placebo + paclitaxel • ORR & OS are secondary endpoints • Data anticipated: H2 2017 NCT01625286 the advanced setting

Two strata (50 points per stratum): CVMD PIK3CA mutation positive vs Mutation not detected

Phase I Breast and gynaecological 12-24 per arm (Parts E AZD5363 400mg BD 4 days on 3 days off combined with 500mg • Safety and tolerability • Data anticipated: H2 2017 cancers with PIK pathway & F) fulvestrant [initially 12 patients per arm with option to expand to • ORR NCT01226316 mutation 24 patients in one or more arms] • Clinical Benefit Rate at 24 weeks • Part E arm 1: ER+ Breast with AKT-1 mutation (prior Faslodex (CBR24) resistance) [Parts E & F only] • Part E arm 2: ER+ Breast with AKT-1 mutation (first exposure to Faslodex) • Part F arm 1: ER+ Breast with PTEN mutation (prior Faslodex resistance) • Part F arm 2: ER+ Breast with PTEN mutation (first exposure to Respiratory Faslodex) Other

61 Approved medicines Late-stage development Savolitinib (AZD6094) (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Oncology

Trial Population Patients Design Endpoints Status

Phase II Papillary renal cell cancer 90 • Single arm trial: savolitinib 600mg QD • ORR • FPD: Q2 2014 • LPCD: Q4 2015 NCT02127710 Conducted in UK, Spain, US, Canada • Data anticipated: 2017 CVMD

Phase I Advanced cancer ~50 • Dose escalation trial • Safety and tolerability • FPD: Q1 2012 (all comers) • LPCD: Q3 2015 NCT01773018 Conducted in Australia • Data anticipated: Q4 2016

Partnered

Phase I Advanced cancer ~70 • Dose escalation trial • Safety and tolerability • FPD: Q2 2013

(all comers) • LPCD: H2 2017 Respiratory NCT01985555 Conducted in China • Data anticipated: 2018

Partnered

Phase I Non-Small Cell Lung Cancer ~53 • Dose escalation trial • Safety and tolerability • FPD: Q2 2015 • Data anticipated: H2 2017 NCT02374645 Conducted in China Other

62 Approved medicines Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4 2014 • Arm 2: AZD6738 dose escalation, AZD6738 + Lynparza • Pharmacokinetics and efficacy • Data anticipated: 2017 NCT02264678 • Arm 3: AZD6738 + durvalumab CVMD Trial conducted in North America, Europe and South Korea Respiratory Other

63 Approved medicines Late-stage development Early development - IMED AZD8186 (PI3Kb/d) Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Advanced Castrate Resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses • Part A: PK, MTD and Recommended • FPD: Q2 2013 Prostate Cancer /sqNSCLC in 3 schedules dose and schedule(s) for Part B • Data anticipated: 2018 NCT01884285 /TNBC and patients with

known PTEN-deficient/ • Part B: AZD8186 monotherapy at recommended dose and • Part B: Safety, tolerability and CVMD mutated or PIK3CM mutated/ schedule(s) from Part A in PTEN deficient patients with preliminary assessment of anti-tumour amplified advanced solid advanced cancer activity (POM) malignancies. • Part C: Combination AZD8186 added to abiraterone actetate • Part C: PK, safety, tolerability and (with prednisone) in PTEN deficient mCRPC patients. Initial recommended dose/ schedule of dose/ schedule confirmation phase using AZD8186 AZD8186 in combination with mononotherapy recommended dose/ schedule from Part A and abiraterone. Preliminary assessment of the labelled dose of abiraterone followed by an expansion anti-tumour activity of AZD8186 in cohort to explore clinical activity combination with abiraterone.

• Part D: Combination AZD8186 and AZD2014 (a novel dual • Part D: PK, safety, tolerability and

mTORC 1/2 inhibitor). Initial dose/ schedule determination recommended dose and schedule of Respiratory phase in same patient population as Part A followed by an AZD8186 in combination with AZD2014. expansion cohort in PTEN deficient TNBC patients to explore Preliminary assessment of anti-tumour clinical activity activity of AZD8186 in combination with AZD2014. Trial conducted in Canada, US, Spain & UK Other

64 Approved medicines Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid tumours and blood cancers Oncology

Trial Population Patients Design Endpoints Status

Phase Ib/II Squamous Cell Carcinoma of 213 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial • FPD: Q3 2015 the Head & Neck (HNSCC) • Arm A1: AZD9150/durvalumab • Data anticipated: 2019 NCT02499328 • Arm A2 : AZD5069/durvalumab

Dose Expansion 2L HNSCC: CVMD • Arm B1: AZD9150 • Arm B2: AZD5069 • Arm B3: AZD9150/durvalumab • Arm B4: AZD5069/durvalumab

Phase 1b/II Diffuse Large B-cell 186 Dose escalation and expansion Arms: • Safety/Efficacy trial • FPD: Q3 2016 Lymphoma • Data anticipated: 2021 NCT02549651 Experimental Arm: durvalumab monotherapy Experimental Arm: durvalumab and tremelimumab Experimental Arm: durvalumab and AZD9150 Respiratory Other

* clinicaltrials.gov being updated 65 Approved medicines Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Oncology

Trial Population Patients Design Endpoints Status

Phase I ER+ Breast Cancer ~50 • This is a Phase I open label multicentre trial of AZD9496 • Primary Outcome Measures: Safety and • FPD: Q4 2014 administered orally in patients with advanced ER+ HER2 tolerability • LPCD: Q2 2016 NCT02248090 negative breast cancer. The trial design allows an escalation of • Secondary Outcome Measures: Single • Data anticipated: H1 2017

dose with intensive safety monitoring to ensure the safety of and multiple dose pharmacokinetics of CVMD patients. The trial will determine the maximum tolerated dose. AZD9496 In addition, expansion cohort(s) at potential therapeutic dose(s) 4β-hydroxycholesterol concentration in in patients with or without ESR1 mutations will be enrolled to blood further determine the safety, tolerability, pharmacokinetics and • Anti-tumour activity biological activity of AZD9496

Phase I Healthy subjects ~14 • This is a Phase I open label single centre trial to assess the • Primary Outcome Measures: • FPD: Q2 2016 pharmacokinetics and safety of different forms and Pharmacokinetics for AZD9496 and its • LPCD: Q3 2016 NCT02780713 formulations of AZD9496 in healthy subjects metabolites • Data readout: H1 2017 • Secondary Outcome Measures: Safety and tolerability Respiratory Other

66 Approved medicines Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic steatohepatitis (NASH) Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 40 SAD trial (one trial site in US) • Safety and tolerability • FPD: Q4 2015 • 5 different dose levels investigated vs. placebo • PK parameters • LPCD: Q3 2016 NCT02612662 • Sub-cutaneous injection CVMD

Phase I/IIa Type-2 Diabetic patients with ~51 MAD trial (one trial site in US) • Safety and tolerability • FPD: Q3 2016 non-alcoholic fatty liver • Up to 3 different dose levels investigated vs. placebo • Glucose infusion rate at NCT02826525 disease • Sub-cutaneous injection hyperinsulinemic clamp • Reduction in liver fat content (%) per MRI • 24 hour glucose area under the curve • PK parameters Respiratory Other

67 Approved medicines Late-stage development AZD4831 Early development - IMED Early development - MedImmune Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects ~96 SMAD trial (one trial site in Germany) • Safety and tolerability • FPD: Q3 2016 SAD • PK parameters • LPCD: Q4 2016 NCT02712372 • Planned to investigate 6 different dose levels vs. placebo but

up to 10 cohort may be used CVMD

MAD • The planned number of cohorts is three but up to five cohorts may be included Respiratory Other

68 Approved medicines Late-stage development AZD5718 Early development - IMED Early development - MedImmune Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPD: Q1 2016 SAD • PK parameters • LPCD: Q3 2016 NCT02632526 • Planned to investigate 8 different dose levels vs. placebo but • Pharmacodynamic analysis by ex-vivo • Data anticipated: Q4 2016

up to 11 cohort may be used stimulation of LTB4 production using CVMD • Amorphous and crystalline form of AZD5718 will be calcium ionophore investigated • Pharmacodynamics of AZD5718 after • Oral administration single ascending doses and multiple ascending doses MAD • To evaluate the relative bioavailability • The planned number of cohorts is four but up to six cohorts between the amorphous and crystalline may be included form of AZD5718 • Once or twice daily oral administration of AZD5718

Phase 1 Healthy subjects 12 DDI/BA study (one trial site in UK) • To evaluate the PK of rosuvastatin • FPD: H1 2017

when administered alone and in Respiratory NCT02963116 A Randomized, 5-Period, 5-Treatment, Single-Dose, open-label, combination with AZD5718, by crossover study to assessment of AUC, AUC(0-last) and • estimate the effect of AZD5718 on the pharmacokinetics of Cmax of rosuvastatin. Rosuvastatin • To evaluate the relative bioavailability • assess the relative bioavailability of AZD5718 oral of an immediate release (IR) tablet vs suspension vs AZD5718 IR tablet formulation oral suspension formulation of • assess the food effect of AZD5718 AZD5718.

• To examine the PK profiles of IR Other tablet formulation of AZD5718 when administered in fed and fasted conditions. • To further assess the safety of single doses of AZD5718 in healthy subjects.

69 Approved medicines Late-stage development AZD8601 Early development - IMED Early development - MedImmune Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status

Phase I Type 2 diabetic patients ~60 SAD trial (one trial site in Germany) • Safety and tolerability • FPD: Q1 2017 • Planned to investigate 3 different dose levels vs. placebo but NCT02935712 up to 5 cohort may be used CVMD Respiratory Other

70 Approved medicines Late-stage development Abediterol (AZD0548) (LABA) Early development - IMED Early development - MedImmune Asthma Oncology

Trial Population Patients Design Endpoints Status

Phase II Patients With Asthma on 36 Single-dose 6-way crossover to investigate ultra-low doses of Primary Endpoint. • FPD: Q3 2016 Inhaled Corticosteroids abediterol and to compare 2 different devices (pMDI and 3 DPI). • To assess the PD response • LPCD: Q4 2016 NCT02777827 (bronchodilation) of ultra-low doses of • Data anticipated: H1 2017

• Abediterol 0.156 μg abediterol. CVMD • Drug: Abediterol 2.5 μg • Drug: Abediterol 0.05 μg • To compare the PD response at the • Other: Placebo same doses between the 2 devices

• To compare PK (2.5 μg dose only) between the 2 devices Respiratory Other

71 Approved medicines Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune Asthma Oncology

Trial Population Patients Design Endpoints Status

Phase IIa Adults with eosinophilic, 70 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to loss of asthma control • FPD: Q4 2016 INCONTRO moderate to severe asthma on 8mg) ICS + LABA background • Arm 2: placebo

NCT02898662 treatment CVMD Inhaled (nebulised) administration Trial conducted in EU. ICS= Inhaled corticosteroids LABA= Long Acting Beta Agonist Respiratory Other

72 Approved medicines Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase II Patients with mild to moderate 48 A randomised, double blind, multiple dosing (14 days), placebo- • Forced expiratory volume in one second • FPD: Q3 2015 asthma controlled, incomplete block cross-over, multi-centre trial to (FEV1) NCT02479412 assess efficacy and safety of three dose levels of AZD7594, given

once daily by inhalation, in patients with mild to moderate asthma CVMD

Phase I Healthy subjects 73 SAD/MAD • Safety and tolerability • FPD: Q4 2012 A Phase I, single centre, double-blind, randomised, placebo NCT01636024 controlled, parallel-group trial to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics after single and multiple ascending inhaled doses of AZD7594 in healthy male subjects - suspension inhaled via Spira nebuliser

Trial conducted in the UK

Healthy subjects 24 An open label, partially randomised, four-period trial in healthy • Bioavailability and pharmacokinetics • FPD: Q1 2016 Phase I male subjects to investigate the bioavailability and Respiratory pharmacokinetics of a single dose of AZD7594 when NCT02648438 administered intravenously, orally and inhaled via two different dry powder inhalers (DPI) and a pressurised metered-dose inhaler (pMDI)

Phase I Healthy subjects 36 A phase I, randomised, single-blind, placebo-controlled, • Safety and tolerability • FPD: Q1 2016

sequential-group, single-centre trial to investigate the safety, Other NCT02645253 tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of AZD7594 given once daily as inhaled formulation in healthy Japanese men

73 Approved medicines Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 152 Part 1 (SAD) • Safety and tolerability and PK following • FPD: Q4 2014 • Five different dose levels investigated vs placebo oral administration with single ascending NCT02303574 • oral administration dose

• Preliminary assessment of the effect of CVMD food on the single dose PK parameters of AZD7986

Part 2 (MAD) • Safety and tolerability & PK in healthy • FPD: Q1 2016 • Three different dose levels investigated vs placebo in healthy subjects following administration of subjects multiple ascending oral doses • oral administration • NE activity

Trial conducted in the UK

Phase I Healthy subjects 15 A phase 1, non-randomised, fixed sequence, 3-period, drug-drug • Effect of verapamil and the effect of • FPD: Q1 2016 interaction trial to assess the pharmacokinetics (PK) of itraconazole/diltiazem on the Respiratory NCT02653872 AZD7986 in healthy subjects when administered alone and in pharmacokinetics (PK) of AZD7986 combination with multiple doses of verapamil and itraconazole • Safety and tolerability of AZD7986 or diltiazem. Other

74 Approved medicines Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Oncology

Trial Population Patients Design Endpoints Status

Phase I Part 1: Mild Asthmatic N (Part 1) = 16 Part 1 • To assess the safety and tolerability of Part 1 SAD trial with 6 dose levels - 50 μg, 200 μg, 400 μg, 900 μg, single doses of AZD8871 administered • FPD: Q4 2015 NCT02573155 Part 2: Moderate to severe N (Part 2) = 40 1800 μg, and 2100 μg by inhalation to mild persistent asthmatic • LPCD: Q4 2015

COPD male subjects (Part 1) or moderate to • Data readout: Q4 2016 CVMD Part 2 severe COPD subjects (Part 2) Comprises 5 treatment periods of 36 hours each separated by a Part 2 washout period of at least 7 to 14 days (one exception per patient • To evaluate the pharmacodynamics • FPD: Q2 2016 of up to 28 days would be acceptable). (PD) (bronchodilation) of single doses of • LPCD: Q3 2016 • AZD8871 400 μg once daily (double-blind) AZD8871 in mild persistent asthmatic • Data readout: Q4 2016 • AZD8871 1800 μg once daily (double-blind) male subjects (Part 1) or in in moderate • Indacaterol 150 μg once daily (open-label) to severe COPD subjects (Part 2) • Tiotropium 18 μg once daily (open-label) • Placebo (double-blind)

Phase I Healthy subjects 24 MAD trial with 3 dose levels - 300 μg, 600μg, and 900 μg (TBC) Primary Endpoint: • FPD: Q3 2016 Respiratory and placebo • The primary objective is to investigate • LPCD: Q4 2016 NCT02814656 the safety and tolerability of AZD8871 at • Data anticipated: H1 2017 steady state Secondary Endpoint: • To characterise the PK of AZD8871 and its metabolites LAS191861 and LAS34850 after multiple doses of AZD8871 and assess the time required to reach steady state, the degree of Other accumulation and the time dependency

Phase IIa Moderate to severe COPD 42 Comprises 3 treatment periods of 14 days each separated by a Primary Endpoint: • FPD: Q1 2017 washout period of 28 to 35 days. • To evaluate the efficacy of inhaled • Data anticipated: H2 2017 NCT02971293 • AZD8871 600 μg once daily (double-blind) AZD8871 in patients with moderate to • AZD8871 100 μg once daily (double-blind) severe COPD • Placebo (double-blind) Secondary Endpoint: • To investigate the PK of AZD8871 and Global study – two countries (UK & Germany) its metabolites after multiple dose administration of AZD8871 in patients with moderate to severe COPD

75 Approved medicines Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Respiratory Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 72 SAD trial with 8 dose levels - single ascending doses • A Phase I, Randomised, Single-Blind, • FPD: Q4 2015 (starting at 2 mg up to 155 mg)” Placebo-Controlled trial To Assess The • LPCD: Q2 2016 NCT02512575 Safety, Tolerability, Pharmacokinetics • Data anticipated: H1 2017

And Pharmacodynamics Of Single CVMD Ascending Oral Doses Of AZD9567 In Healthy subjects

Phase I Healthy subjects 64 MAD trial with 4 dose levels – 10 mg, 20mg, 40mg, 80mg and Primary Endpoint: • FPD: Q2 2016 Prednisolone 20 mg • To assess the safety and tolerability of • Data anticipated: H1 2017 NCT02760316 AZD9567 following multiple oral ascending doses in subjects with BMI between 28 and 38 kg/m2 and with a positive glucose tolerance test (7,8 to 11,0 mmol/L). Secondary Endpoints:

• To characterise the pharmacokinetics of Respiratory AZD9567 following multiple oral administration of ascending doses. • To characterise the pharmacodynamics of AZD9567 assessed as effect on glucose homeostasis through OGTT (oral glucose tolerance test) in comparison with prednisolone 20 mg. Other

76 Approved medicines Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Oncology

Trial Population Patients Design Endpoints Status

Phase II Combination therapy trial with 60 • Arm A: Verinurad 2.5mg QD • To assess the PK and PD profiles of • FPD: Q4 2014 febuxostat in subjects with • Arm B: Verinurad 5.0mg QD verinurad administered with febuxostat • LPCD: Q2 2015 NCT02246673 gout • Arm C: Verinurad 10mg QD • Data readout: Q4 2016

• Arm D: Verinurad 15mg QD CVMD • Arm E: Sequential doses of verinurad 10, 15 and 20mg QD in combination with 40mg QD febuxostat

*Arms A-D include combination with 40mg QD febuxostat for 7 days followed by combination with 80mg QD febuxostat for 7 days

Phase II Combination trial with 92 • Arm A: Verinurad 2.5mg QD + 10mg or 20mg QD febuxostat • To assess the PD, PK and safety • FPD: Q4 2014 febuxostat for treating gout or • Arm B: Verinurad 5.0mg QD + 10mg or 20mg QD febuxostat profiles of verinurad administered with • LPCD: Q2 2015 NCT02317861 asymptomatic hyperuricemia • Arm C: Verinurad 5.0mg QD + 20mg or 40mg QD febuxostat febuxostat • Data readout: Q4 2016 in Japanese patients • Arm D: Verinurad 10mg QD + 20mg or 40mg QD febuxostat • Arm E: Benzbromarone 50mg QD Respiratory

Phase II Combination therapy trial with 40 • Arm A: Placebo • To assess the PK and PD profiles of • FPD: Q3 2015 allopurinol in subjects with • Arm B: Verinurad 2.5mg QD verinurad administered with allopurinol • LPCD: Q4 2015 NCT02498652 gout • Arm C: Verinurad 5.0mg QD • Data readout: Q4 2016 • Arm D: Verinurad 7.5mg QD • Arm E: Verinurad 10mg QD • Arm F: Verinurad 15mg QD • Arm G: Verinurad 20mg QD Other

*All arms include combination with 300mg QD allopurinol. Placebo group also includes combination with 300mg BID allopurinol or 600mg QD allopurinol

Phase I Pharmacokinetic and 40 • Part 1: Single doses of verinurad at 4.5mg, 6.0mg, or 12mg • To assess the PK, PD and food effect • FPD: Q4 2015 Pharmacodynamic trial in • Part 2: Multiple doses of verinurad at 12mg QD for 7 days profiles of verinurad • LPCD: Q4 2015 NCT02608710 healthy adult male subjects • Part 3: Food effect trial with single doses of verinurad at 6.0mg • Data readout: Q3 2016

77 Approved medicines Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy (MSA) Oncology

Trial Population Patients Design Endpoints Status

Phase II Parkinson’s disease patients 24 • Arm 1: AZD3241 600mg BID for 8 weeks • Microglia activation represented by • FPD: Q4 2014 • Arm 2: Placebo [11C]PBR28 binding • LPCD: Q2 2015 NCT01527695 Secondary endpoints:

Randomisation 3:1 active to placebo. • PD symptoms measured by UPDRS CVMD Three sites in Sweden and Finland • Plasma MPO activity

Phase II Parkinson’s disease patients 51 • Arm 1: AZD3241 300mg BID for 12 weeks • AEs, labs, vital signs, ECGs • FPD: Q4 2014 • Arm 2: AZD3241 600mg BID for 12 weeks • LPCD: Q2 2015 NCT01603069 • Arm 3: Placebo Secondary endpoints: • PD symptoms measured by UPDRS Randomisation 1:1:1 across arms • Plasma MPO activity 13 sites in US

Phase II MSA 30 • Arm 1: AZD3241 300mg BID for 12 weeks • Microglia activation represented by • FPD: Q2 2015 • Arm 2: AZD3241 600mg BID for 12 weeks [11C]PBR28 binding • LPCD: H2 2016 NCT02388295 • Arm 3: Placebo • AEs, labs, vital signs, ECGs • Data anticipated: H2 2016 Respiratory

Randomisation 1:1:1 across arms Secondary endpoints: Eight sites in US • MSA symptoms measured by UMSARS Nine sites in Europe and MSA QoL • Plasma MPO activity

Phase I Healthy subjects 46 • Active ArmS: SAD • AEs, labs, vital signs, ECGs • FPD: Q4 2014 • Comparator Arm: placebo • PK • LPCD: Q2 2015

NCT00729443 One site in Sweden Other

Phase I Healthy subjects 18 • Active ArmS: MAD • AEs, labs, vital signs, ECGs • FPD: Q4 2014 • Comparator Arm: placebo • PK • LPCD: Q2 2015 NCT01457807 One site in UK

Phase I Healthy subjects 59 • Active ArmS: MAD • AEs, labs, vital signs, ECGs • FPD: Q4 2014 • Comparator Arm: placebo • PK • LPCD: Q2 2015 NCT00914303 One site in Sweden

78 MedImmune

Early development - MedImmune Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Oncology

Trial Compound Population Patients Design Endpoints Status

Phase I/II Durvalumab Solid tumours 1,014 • Dose Escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety • FPD: Q3 2012 STUDY 1108 • Dose Expansion: 16 tumour type cohorts at the Q2W MTD • Optimal biologic dose • LPCD: Q4 2015 defined during dose escalation; one cohort at 20mg Q4W • Secondary endpoints include PK, • Data anticipated: H2 2017

NCT01693562 immunogenicity and anti-tumour activity CVMD Global trial – eight countries

Phase I Durvalumab, Myelodysplastic 41 Dose-escalation and dose-expansion trial • Safety and tolerability of monotherapy • FPD: Q2 2014 azacitidine (Vidaza) syndrome • Arm 1: durvalumab and combination • LPCD: Q2 2015 NCT02117219 • Secondary endpoints include duration of • Data anticipated: 2019 Global trial – four countries response, PFS and OS Respiratory Phase 1 Durvalumab Solid tumours 30 Multi-centre, open-label, single-arm trial for adult subjects • Safety, PK, number of subjects reporting • FPD: Q3 2016 infusion related reaction • Data anticipated: 2018 NCT02900157 Other

80 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Oncology Solid and hematologic tumours

Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Gastric or GEJ 236 • Arm A: durvalumab + tremelimumab 2L • Safety & tolerability, ORR, PFS • FPD: Q2 2015 STUDY 21 adenocarcinoma • Arm B: durvalumab 2L • Secondary endpoints include DCR, OS, • Data anticipated: 2018 • Arm C: tremelimumab 2L DoR, PD-L1 Expression NCT02340975 • Arm D: durvalumab + tremelimumab 3L

US and ROW trial centres Phase Ib/II Hepatocellular Carcinoma 144 • Arm A: durvalumab + tremelimumab • Safety & tolerability, ORR, PFS • FPD: Q4 2015 STUDY 22 • Arm B: durvalumab 2L • Secondary endpoints include DCR, OS, • Data anticipated: 2018 • Arm C: tremelimumab 2L DoR, PD-L1 Expression NCT02519348

Phase Ib NSCLC 446 • Dose Escalation: minimum 5 cohorts exploring various treme • Safety • FPD: Q4 2013 Respiratory STUDY 006 (Immunotx naïve and Q4W and durvalumab IV Q4W dose combinations, higher dose • Optimal biologic dose for the • LPCD: H1 2017 Immunotx pretreated patient levels and alternate Q2 schedule added with amendment combination • Data anticipated: 2018 NCT02000947 cohorts) • Dose Expansion: MTD for the combination in escalation to be • Secondary endpoints include Antitumour explored in expansion activity, PK and immunogenicity

North American trial centres, exploration of ex-US countries for expansion into EU and ROW

Phase I Solid tumours (Basket trial) 380 • Dose Exploration: 2 cohorts exploring various Q4W treme and • Safety & tolerability • FPD: Q4 2014 Other STUDY 10 durvalumab dose combinations and 2 cohorts exploring • Optimal biologic dose for the • LPCD: H1 2017 various Q2W treme and durvalumab dose combinations combination • Data anticipated: 2018 NCT02261220 • Dose Expansion: MTD for the combination in escalation to be • Secondary endpoints include explored in expansion cohorts specific for each of 7 tumour anti-tumour activity, PK/PD and types immunogenicity North American trial centres

Phase I HNSCC 69 • Arm A: treatment-naïve, PD-L1+, combo • Safety & tolerability • FPD: Q4 2014 STUDY 11 • Arm B: treatment-naïve, PD-L1-, combo • Secondary endpoints include OR, DC, • LPCD: Q3 2016 • Arm C: PD-1/PD-L1 refractory, combo DoR, PFS, OS, PK/PD, immunogenicity • Data anticipated: H1 2017 NCT02262741 North American trial centres and biomarkers

Phase Ib Diffuse Large B cell 186 • Arm A: durvalumab • Safety & tolerability • FPD: Q3 2016 STUDY 23 Lymphoma • Arm B: durvalumab + tremelimumab • Secondary endpoints include OR, DC, • Data anticipated: 2021 • Arm C: tremelimumab + AZD9150 DoR, PFS, OS, PK/PD, immunogenicity NCT02549651 US and European trial centres and biomarkers

81 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Oncology Non-small cell lung cancer (NSCLC)

Trial Population Patients Design Endpoints Status CVMD Phase I NSCLC 36 Escalation phase • Safety • FPD: Q2 2014 (Escalation phase) Standard 3+3 design with 28 days DLT period • Optimal biologic dose for the • LPCD: Q2 2015 NCT02088112 • Iressa (QD) + durvalumab IV combination • Data anticipated: 2019 EGFR M+ NSCLC naïve to • Secondary endpoints include tumour EGFR-TKI therapy Expansion phase response (CR, PR, SD, PD), Objective (Expansion phase) • Iressa (QD) + durvalumab IV recommended dose response rate, disease control rate, progression-free survival, Global trial – three countries immunogenicity, pharmacokinetics, pharmacodynamics Respiratory Other

82 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) + MEDI0680 (PD-1 mAb) Early development - IMED Early development - MedImmune Advanced cancers Oncology

Trial Population Patients Design Endpoints Status

Phase I Advanced malignancies 150 Dose-escalation phase • Safety • FPD: Q2 2014 (escalation phase) • Durvalumab IV + MEDI0680 IV • Determination of MTD • Data anticipated: 2019 NCT02118337 • Secondary endpoints include tumour

RCC Dose-expansion phase at selected dose from dose-escalation response such as objective response CVMD (expansion phase) phase rate, disease control rate, progression- • Durvalumab IV + MEDI0680 IV recommended dose free survival, duration of response, OS, immunogenicity, pharmacokinetics, pharmacodynamics

Phase I Advanced malignancies 58 Dose-escalation phase • Safety & Tolerability • FPD: Q4 2013 (escalation phase) • MEDI0680 IV • Secondary endpoints include tumour • Data readout: Q4 2016 NCT02013804 response such as objective response rate, immunogenicity, pharmacokinetics, pharmacodynamics Respiratory Other

83 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) + dabrafenib (BRAF inhibitor) Early development - IMED Early development - MedImmune / trametinib (MEK inhibitor) Oncology Melanoma

Trial Population Patients Design Endpoints Status CVMD Phase I/II Metastatic or unresectable 69 Dose Escalation: • Safety • FPD: Q1 2014 melanoma • Cohort A • Optimal biologic dose for the • LPCD: Q2 2015 NCT02027961 dabrafenib 150mg BiD/ trametinib 2mg QD/ durvalumab IV combination • Data anticipated: H1 2017 BRAF mutation+ • Cohort B • Secondary endpoints include objective (Cohort A) trametinib 2mg QD/ durvalumab IV response and disease control, duration • Cohort C of response, progression-free survival BRAF wild type trametinib 2mg QD/ durvalumab IV and OS, pharmacokinetics and (Cohorts B&C) immunogenicity Dose Expansion: • Each cohort will be expanded at the MTD to enroll a total of 20 subjects per cohort Respiratory Global trial – two countries Other

84 Approved medicines Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + Monalizumab (NKG2a mAb) Oncology Advanced Solid Tumours

Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumours 175 Escalation phase • Safety • FPD: Q2 2016 • Monalizumab + durvalumab IV • Optimal biologic dose for the • Data anticipated: 2019 NCT02671435 combination Expansion phase • Secondary endpoints include tumour • Monalizumab + durvalumab IV recommended dose response (CR, PR, SD, PD), Objective response rate, disease control rate, Global Trial progression-free survival, immunogenicity, pharmacokinetics, pharmacodynamics Respiratory Other

85 Approved medicines Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + durvalumab Oncology (PD-L1 mAb) or tremelimumab (CTLA-4 mAb)

Advanced cancers CVMD

Trial Population Patients Design Endpoints Status

Phase I Advanced malignancies 196 Dose-escalation phase • Safety • FPD: Q1 2015 • MEDI0562 IV • Determination of MTD • Data anticipated: H2 2017 NCT02318394 • Secondary endpoints include preliminary Dose-expansion phase anti-tumour activity, pharmacokinetics, • MEDI0562 IV recommended dose biomarker activity, and immunogenicity Respiratory

Phase I Advanced malignancies 182 • ARM A: MEDI0562 IV + durvalumab IV • Safety • FPD: Q2 2016 • ARM B: MEDI0562 IV + tremelimumab IV • Secondary endpoints include preliminary • Data anticipated: 2018 NCT02705482 anti-tumour activity, pharmacokinetics, and immunogenicity Other

86 Approved medicines Late-stage development Inebilizumab (MEDI-551, CD19 mAb) Early development - IMED Early development - MedImmune Blood cancers Oncology

Trial Population Patients Design Endpoints Status

Phase II Adults with relapsed or 170 • Arm 1: MEDI-551 dose level 1 and ICE/DHAP • ORR, including Complete Response • FPD: Q1 2012 refractory B-cell diffuse large • Arm 2: MEDI-551 dose level 2 and ICE/DHAP (CR) or Partial Response (PR) • LPCD: Q2 2016 NCT01453205 B-cell lymphoma • Arm 2: rituximab + ICE/DHAP • Data readout: Q3 2016 CVMD Open-label trial

Phase I Adults with relapsed or 18 • Dose-escalation trial IV • MTD and efficacy • FPD: Q2 2011 refractory B-cell malignancies • LPCD: Q3 2015 NCT01957579 Conducted in Japan • Data readout: Q3 2015 Respiratory Other

87 Approved medicines Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Adult subjects with select 42 Dose-escalation phase • Safety • FPD: Q4 2015 advanced solid tumours • MEDI1873 IV • Determination of MTD • LPCD: Q4 2016 NCT02583165 • Secondary endpoints include preliminary • Data anticipated: 2018

US trial centres anti-tumour activity, pharmacokinetics, CVMD pharmacodynamics, and immunogenicity Respiratory Other

88 Approved medicines Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Advanced cancers Oncology

Trial Population Patients Design Endpoints Status

Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1, multi-centre, open-label, single- • Primary: safety • FPD: Q4 2015 breast and gastric cancer 21-36 arm, dose-escalation, and dose-expansion trial for adult • Data anticipated: 2019 NCT02576548 subjects • Secondary endpoints include anti-

Dose expansion tumour activity, overall response, CVMD 80 disease control, PFS, OS and change from baseline tumour size Respiratory Other

89 Approved medicines Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Population Patients Design Endpoints Status

Phase I Advanced solid tumour 43 Dose-escalation phase • Safety • FPD: Q4 2015 malignancies readily • MEDI9197 IT • Determination of MTD • Data anticipated: H2 2017 NCT02556463 accessible for injection • Secondary endpoints include:

– Objective response, disease control CVMD and duration of response . US trial centres- Ex US under evaluation – Intratumoural and systemic PK and PD profiles/relationships Respiratory Other

90 Approved medicines Late-stage development MEDI9447 (CD73 mAb) + durvalumab Early development - IMED Early development - MedImmune (PD-L1 mAb) Oncology Advanced cancers

Trial Population Patients Design Endpoints Status CVMD Phase I Advanced malignancies 188 Dose-escalation phase • Safety • FPD: Q3 2015 • MEDI9447 IV • Determination of MTD • Data anticipated: 2019 NCT02503774 • MEDI9447 IV + durvalumab IV • Secondary endpoints include preliminary anti-tumour activity, pharmacokinetics, pharmacodynamics, and Dose expansion phase immunogenicity • MEDI9447 IV recommended dose • MEDI9447 IV recommended dose + Durvalumab IV

US and Australian trial centres Respiratory Other

91 Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Oncology

Trial Compound Population Patients Design Endpoints Status Phase I/II Anti-IGF ligand mAb Patients with HR+ 176 • Arm 1: MEDI-573 IV and Aromatase Inhibitor • PFS • FPD: Q2 2012 (MEDI-573) HER2-, 1L, • Arm 2: Aromatase Inhibitor alone • Retrospective evaluation of predictive • LPCD: Q2 2013 NCT01446159 metastatic breast biomarker +ve subgroups • Data anticipated: H2 2017

cancer taking Open label trial CVMD aromatase inhibitors

Phase I Anti-CEA BiTE mAb Adults with 51 max • Dose-escalation (3+3), IV • MTD and safety profile • FPD: Q1 2011 (MEDI-565) gastrointestinal (GI) • LPCD Q3 2014 NCT01284231 adenocarcinoma • Data readout: Q1 2015 with no available Partnered standard or curative treatments. Respiratory

Refractory 60 max, • Dose expansion trial, IV pancreatic, 20 in each cohort colorectal and gastro- Oesophageal cancers Other Phase I Anti-DLL4 mAb Adults with up to 28 • Dose-escalation trial (3+3); IV • MTD and safety profile • FPD: Q2 2012 (MEDI0639) advanced solid • LPCD: Q2 2015 NCT01577745 tumours including • Data readout: Q4 2015 SCLC

92 Approved medicines Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease Oncology

Trial Compound Population Patients Design Endpoints Status

Phase IIa rhLCAT Adults with stable 56 • SAD in stable CAD patients • Safety profile in terms of adverse events (AE), vital signs, ECG, • FPD: Q4 2015 MEDI6012 coronary artery telemetry, lab variables, immunogenicity and physical • LPCD: Q2 2016 NCT02601560 disease (CAD) and examination • Data readout: H2 2016

low High-density • Changes in baseline adjusted post dose CVMD lipoprotein (HDL) HDL-C

Phase IIa rhLCAT Adults with Stable 24 • MAD in stable ACD patients • Safety profile in terms of adverse events (AE), vital signs, ECG, • FPD: Q1 2017 MEDI6012 Atherosclerotic lab variables • Data anticipated: H2 2017 NCT03004638 Cardiovascular • Changes in baseline adjusted post dose HDL-C, HDL-CE, and Disease (ACD) CE AUC • PK, immunogenicity, Apolipoprotein A,LDL, and Apolipoprotein B

Phase II GLP-1-Glu Healthy male 64 • SAD SC administration • Safety profile in terms of adverse events (AE), vital signs, ECG, • FPD: Q1 2015 MEDI0382 subjects telemetry, lab variables, nausea, immunogenicity and physical • LPCD: Q4 2015

NCT02394314 • Germany examination • Data readout: Q4 2015 Respiratory

Phase II GLP-1-Glu Male Adults with 75 • MAD SC administration • Safety profile in terms of adverse events (AE), vital signs, ECG, • FPD: Q1 2016 MEDI0382 type-2 diabetes • Germany telemetry, lab variables, nausea, immunogenicity and physical • LPCD: H2 2016 NCT02548585 examination • Data anticipated: H1 2017 • Efficacy: MMT glucose AUC, HbA1c, fructosamine and body weight loss

Phase I/lla MEDI4166 Adults with type-2 124 • SAD/MAD SC administration Part A (Ph1) • FPD: Q4 2015 Other diabetes • Safety/tolerability following SC dosing of 4166 • LPCD: H2 2016 NCT02524782 Part B (Ph2a) • Data readout: H1 2017 • Characterise the effect of multiple-ascending SC doses on glucose metabolism following an MMTT as measured by glucose AUC • Characterise the effect of multiple-ascending SC doses on LDL-c level

93 Approved medicines Late-stage development Tezepelumab (MEDI9929, TSLP mAb) Early development - IMED Early development - MedImmune Asthma Oncology

Trial Population Patients Design Endpoints Status

Phase II Adult subjects with 552 • Arm 1: Placebo • Reduction in the annualised asthma • FPD: Q2 2014 PATHWAY inadequately controlled, • Arm 2: Low dose tezepelumumab 70mg SC exacerbation rate (AER) measured at • LPCD: Q4 2015 severe asthma • Arm 3: Medium dose tezepelumumab 210mg SC week 52 • Data readout: H1 2017

NCT02054130 • Arm 4: High dose tezepelumumab 280mg SC CVMD

Partnered

Phase II Adult subjects with moderate- 100 • Arm 1: Placebo • 50% reduction from baseline in the • FPD: Q2 2015 to-severe atopic dermatitis • Arm 2: Dose of tezepelumumab SC eczema area and severity index • LPCD: Q2 2016 NCT02525094 measured at week 12 • Data readout: Q4 2016

Partnered Respiratory Other

94 Approved medicines Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy subjects 32 • Arm 1: 30mg MEDI7836 (6) or placebo (2) as a single • Safety and tolerability • FPD: Q1 2015 SC dose • LPCD: Q3 2015 NCT02388347 • Arm 2: 105mg MEDI7836 (6) or placebo (2) as a single SC dose • Data readout: Q1 2016

• Arm 3: 300mg MEDI7836 (6) or placebo (2) as a single SC dose CVMD • Arm 4: 600mg MEDI7836 (6) or placebo (2) as a single SC dose Respiratory Other

95 Approved medicines Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Oncology

Trial Population Patients Design Endpoints Status

Phase Ia Healthy Subjects 40 Single Ascending Dose • Safety and tolerability • FPD: Q1 2016 • Arm 1: MEDI0700 administered as single SC dose • PK/PD • Data anticipated: H2 2017 NCT02618967

• Arm 2: Dose levels of Placebo administered as single SC dose CVMD Partnered Respiratory Other

96 Approved medicines Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Oncology

Trial Population Patients Design Endpoints Status

Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPD: Q2 2014 elderly • Up to 10 iv cohorts are planned vs. placebo • LPCD: Q2 2016 NCT02036645 • 2 SC cohorts are planned vs. placebo • Data readout: Q4 2016 CVMD US only Respiratory Other

97 Approved medicines Late-stage development MEDI5872 - AMG 557 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Oncology

Trial Population Patients Design Endpoints Status

Phase IIa Primary Sjögren's syndrome 42 • Arm 1: MEDI5872 210mg SC QW for 3 weeks and then Q2W • Safety and tolerability • FPD: Q3 2015 for 9 weeks • Change in the ESSDAI score from • Data anticipated: H2 2017 NCT02334306 • Arm 2: placebo SC QW for 3 weeks and then Q2W for 9 weeks baseline to Day 99 CVMD Partnered Global trial – five countries

Phase I SLE and lupus related 40 Dose escalation trial: • Safety and tolerability • FPD: Q2 2012 inflammatory arthritis • Arm 1: MEDI5872 SC • Lupus Arthritis Response Rate • LPCD: Q4 2015 NCT01683695 • Arm 2: placebo SC • Data readout: Q2 2016

Partnered Global trial – eight countries Completed Respiratory Other

98 Approved medicines Late-stage development MEDI7352 (NGF TNF Bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Oncology

Trial Compound Population Patients Design Endpoints Status Phase I MEDI7352 (NGF Painful 160 • SAD & MAD • Safety, tolerability, PK, PD • FPD: Q1 2016 TNF Bispecific) osteoarthritis of the • Up to 10 iv cohorts are planned vs. placebo • LPCD: H1 2017 NCT02508155 knee • 2 SC cohorts are planned vs. placebo • Data anticipated: H2 2017 CVMD Europe only Respiratory Other

99 Approved medicines Late-stage development MEDI9314 (IL-4Ra mAb) Early development - IMED Early development - MedImmune Atopic Dermatitis Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy subjects 44 • Arm 1: 45mg MEDI9314 (4) or placebo (2) as a single SC dose • Safety and tolerability • FPD: Q1 2016 • Arm 2: 150mg MEDI9314 (4) or placebo (2) as a single SC • Pharmacokinetic and immunogenicity • LPCD: Q4 2016 NCT02669667 dose profile • Data readout: Q4 2016

• Arm 3: 300mg MEDI9314 (6) or placebo (2) as a single SC CVMD dose • Arm 4: MEDI9314 (6) or placebo (2) as a single IV dose • Arm 5: 300300mg mg MEDI9314 (6) or placebo (2) as a single SC dose (Japanese subjects) • Arm 6: 450mg MEDI9314 (6) or placebo (2) as a single IV dose Respiratory Other

100 Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Oncology

Trial Compound Population Patients Design Endpoints Status

Phase II/III Inebilizumab Adults with 212 (estimated) • Arm 1: MEDI-551 500mg IV • Primary: Time to attack • FPD: Q1 2015 Anti-CD19 mAb Neuromyelitis • Arm 2: placebo IV • Secondary: Attack rate, safety and • Data anticipated: 2018 NCT02200770 (MEDI-551) Optica and • Open-label extension 300mg tolerability

Neuromyelitis CVMD Optica Spectrum Global trial - 26 Countries Disorders (NMO/NMOSD)

Phase I Anti-CD40L Healthy adults 56 • Arm 1: 3mg MEDI4920 • Safety, tolerability, and • FPD: Q2 2014 (MEDI4920) (2) or placebo (1) as a single IV dose pharmacokinetics, anti-drug antibody, • LPCD: Q4 2015 NCT02151110 • Arm 2: 10mg MEDI4920 inhibition of T-cell dependent antibody • Data readout: Q2 2016 (2) or placebo (1) as a single IV dose response • Arm 3: 3mg MEDI4920 (3) or placebo (2) as a single IV dose Respiratory • Arm 4: 100mg MEDI4920 (8) or placebo (2) as a single IV dose • Arm 5: 300mg MEDI4920 (8) or placebo (2) as a single IV dose • Arm 6: 1000mg MEDI4920 (8) or placebo (2) as a single IV dose • Arm 7: 2000mg MEDI4920

(8) or placebo (2) as a single IV dose Other

Phase I Anti-ILT7 Patients with Type I 36 • Arm 1: 1mg MEDI7734 (3) or placebo (1) as a single SC dose • Safety, tolerability • FPD Q3 2016 (MEDI7734) Interferon-Mediated • Arm 2: 5mg MEDI7734 (6) or placebo (2) as a single SC dose • Pharmacokinetics and • Data anticipated: H2 2017 NCT02780674 Autoimmune • Arm 3: 15mg MEDI7734 (6) or placebo (2) as a single SC dose pharmacodynamics Diseases: • Arm 4: 50mg MEDI7734 (6) or placebo (2) as a single SC dose Dermatomyositis, • Arm 5: 150mg MEDII7734 (6) or placebo (2) as a single SC Polymyositis, dose Sjögren’s Syndrome, Systemic Lupus Erythematosus, Systemic Sclerosis

101 Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Oncology

Trial Compound Population Patients Design Endpoints Status Phase II Anti-Staph AT Intubated ICU 462 • Placebo-controlled, single-dose, dose-ranging • Efficacy and safety • FPD: Q4 2014 (MEDI4893) • Route of administration: intravenous • Data anticipated: 2018 EudraCT 2014-

001097-34 CVMD Phase IIb Anti-Respiratory 32-35 WK GA 1,500 • Randomised, double-blind, placebo-controlled trial • Safety and efficacy • FPD: Q4 2016 Syncytial Virus infants • Route of administration: IM • Data anticipated: 2018 NCT02878330 mAb-YTE (MEDI8897) Phase Ib/IIa 32-35 WK GA 89 • Randomised, double-blind, placebo-controlled, • Evaluate Safety, tolerability, PK and • FPD: Q1 2015 infants Dose-escalation trial ADA • LPCD: Q3 2015 NCT02290340 • Route of administration: IM • Data anticipated: Q3 2016

Phase Ia Healthy adults 136 • Randomised, double-blind, placebo-controlled, • Evaluate Safety, tolerability, PK and • FPD: Q2 2014 Dose-escalation trial ADA • LPCD: Q2 2014 NCT02114268 • Route of administration: IV and IM • Data readout: Q2 2015 Respiratory Competed Other

102 Approved medicines Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Oncology

Trial Compound Population Patients Design Endpoints Status Phase Ib/IIa Anti-influenza A Adults 160 • Randomised, partial double-blind, single dose, • Evaluate safety in adults with acute, • FPD: Q4 2015 mAb (MEDI8852) active-controlled, dose ranging trial uncomplicated Influenza • LPCD: H2 2016 NCT02603952 • Route of administration: intravenous • Data readout: Q4 2016 CVMD Phase I Healthy adults 40 • Double-blind, single-dose, placebo-controlled, • Evaluate the safety and • FPD: Q1 2015 dose-escalation trial pharmacokinetics • LPCD: Q1 2015 NCT02350751 • Route of administration: intravenous • Data readout: Q2 2015 Completed

Phase I Anti-Pseudomonas Healthy adults 56 • Randomised, double-blind, placebo-controlled, dose-escalation • Evaluate the safety, tolerability, and • FPD: Q3 2014 A mAb (MEDI3902) trial pharmacokinetics • LPCD: Q1 2015 NCT02255760 • Route of administration: intravenous • Data readout: Q2 2015 Completed

Phase II Intubated ICU 429 • Placebo-controlled, single-dose, dose-ranging • Efficacy and safety • FPD: H1 2016

• Route of administration: intravenous • LPCD: 2018 Respiratory NCT02696902 • Data anticipated: 2018 Other

103 Clinical trials appendix Full-Year and Q4 2016 Results update