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Astrazeneca Clinical Programmes Summary

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Astrazeneca Clinical Programmes Summary AstraZeneca Clinical Programmes Summary 2Q 2014 Results Update The following information about ongoing AstraZeneca clinical studies in Phases I-IV has been created with selected information from clinicaltrials.gov to facilitate understanding of key aspects of our clinical programmes and is correct to the best of our knowledge as at 30 June 2014. It includes estimated timelines with regards to study completion and first external presentations of primary data. These estimates are subject to change as programmes recruit faster or slower than anticipated. 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. 2Q 2014: 4 new NME pivotal study starts contributing to growing late stage pipeline Pivotal study starts in 2Q 2014 Number of NMEs in pivotal studies 14 roxadustat (HIF) CKD & ESRD tremelimumab (CTLA-4) mesothelioma 11 NMEs AZD9291 (EGFR) 2L NSCLC 9-10 PD-L1 (MEDI4736) 8 NSCLC 8 6 benralizumab (IL-5R) COPD LEs olaparib (PARP) adjuvant BRCAm BC HY 2013 FY 2013 HY 2014 Oncology RIA CVMD 2 2 2014: Continued strong momentum in late stage pipeline BACE (AZD3293) Alzheimer’s disease tenapanor (NHE3) ESRD anifrolumab (IFN-αR) SLE roxadustat (HIF) sifalimumab (IFN-α) CKD & ESRD SLE NMEs tremelimumab (CTLA-4) mavrilimumab (GM-CSF) mesothelioma RA AZD9291 (EGFR) cediranib (VEGF) 2L NSCLC ovarian PD-L1 (MEDI4736) tralokinumab (IL-13) CD19 (MEDI-551) NSCLC severe asthma CLL benralizumab (IL-5R) Forxiga (SGLT-2) PD-L1 (MEDI4736) COPD Type 1 diabetes additional tumours brodalumab (IL-17R) Symbicort (ICS/LABA) PD-L1 combinations psoriatic arthritis mild asthma additional tumours olaparib (PARP) AZD9291 (EGFR) AZD9291 combinations adjuvant BRCAm BC 1L NSCLC EGFRM+ NSCLC LEs olaparib (PARP) PD-L1 +/- tremelimumab metastatic BRCAm BC SCCHN selumetinib (MEK) PD-L1 + tremelimumab metastatic uveal melanoma NSCLC Pivotal study starts Pivotal study decision Pivotal study decision 1H 2014 made 1H 2014 pending 2H 2014 3 Oncology RIA CVMD Neuroscience 3 Movements since Q1 2014 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NMEs MCH (AZD1979) IFNβ (AZD9412) (SNG001)¥ AZD9291 obesity asthma, COPD EGFR T790M+ NSCLC Androgen (AZD5312) TSLP (MEDI9929) PD-L1 (MEDI4736) prostate cancer asthma Stage III NSCLC CD19 (MEDI-551) + rituximab LABA/LAMA/ICS (PT010) Roxadustat (HIF) haems COPD anaemia in CKD/ESRD Amyloidβ (MEDI1814) Volitinib (MET) Tremelimumab (CTLA-4) Alzheimer’s solid tumours mesothelioma PD-L1 (MEDI4736) + Iressa EGFR M+ NSCLC Additional indications PD-L1 (MEDI4736) + PD-1 Benralizumab (IL-5R) (MEDI0680) solid tumours COPD CD40L (MEDI4920) PD-L1 (MEDI4736) Primary Sjögren’s syndrome 3L NSCLC RSV sF+GLA –SE (MEDI7510) olaparib RSV prophylaxis PARP adjuvant breast cancer RSV Mab YTE (MEDI8897) RSV prophylaxis Tremelimumab (CTLA-4) + Iressa EGFR M+ NSCLC Added back to pipeline SGRM (AZD7594) asthma, COPD Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration NMEs NMEs Epanova (US)* CXCR2 (AZD4721) CXCR2 (AZD5069) hypertriglyceridaemia COPD asthma HtN9 vaccine (MEDI9287) IL-1R (MEDI8968) avian flu COPD, HS Additional indications Tenapanor (NHE3) fluid retention ¥ New business development; *Approved Q2 2014 4 A growing and accelerating late stage pipeline Phase 1 Phase 2 Phase 3 / Registration 35 New Molecular Entities 24 New Molecular Entities 14 New Molecular Entities Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule PIM (AZD1208) DLL-4 (MEDI0639) WEE-1 (AZD1775) CD19 (MEDI-551) AZD9291 (EGFRm+ t790m+) PD-L1 (MEDI4736) haems solid tumours ovarian, 1L NSCLC CLL, DLBCL NSCLC NSCLC Androgen (AZD5312) PD-1 (MEDI0680) TORC ½ (AZD2014) IGF (MEDI-573) olaparib (PARP) Moxetumomab (CD22) prostate solid tumours solid tumours metastatic breast cancer BRCA ovarian, gastric, breast HCL ATR (AZD6738) CEA BiTE (MEDI-565) FGFR (AZD4547) anifrolumab selumetinib (MEK) tremelimumab (CTLA-4) CLL, H&N GI tumours solid tumours IFNaR SLE 2L KRAS+ve NSCLC, uveal melanoma, DTC mesothelioma PI3Kβδ (AZD8186) ANG-2 (MEDI3617) AKT (AZD5363) AZD9412 (Inhaled βIFN) lesinurad (URAT1) brodalumab (IL-17R) solid tumours solid tumours breast cancer asthma, COPD gout psoriasis, psoriatic arthritis STAT3 (AZD9150) mOX40 (MEDI6469) volitinib (MET) mavrilimumab (GM-CSFR) LABA/LAMA (PT003) benralizumab (IL-5R) haems + solids solid tumours solid tumours rheumatoid arthritis COPD severe asthma, COPD TLR9 (AZD1419) CD40L (MEDI4920) MABA (AZD2115) IL-23 (MEDI2070) LAMA (PT001) asthma Primary Sjögren’s Syndrome COPD Crohn’s COPD SGRM (AZD7594) B7RP1 (MEDI5872) LABA/LAMA/ICS (PT010) α4β7 (MEDI7183) roxadustat (HIF) asthma, COPD SLE COPD Crohn’s, ulcerative colitis anaemia CKD/ESRD p38 inhibitor (AZD7624) LCAT (MEDI6012) URAT1 (RDEA3170) TSLP (MEDI9929) Movantik (PAMORA) COPD ACS gout asthma opioid induced constipation TLR7 agonist (AZD8848) Rh-Factor II (MEDI8111) Hormone mod. (AZD4901) sifalimumab (IFNa) CAZ AVI (BLI/cephalosporin) asthma rauma/bleeding PCOS SLE SBI MCH (AZD1979) Amyloidβ (MEDI1814) tenapanor (AZD1722) IL-13 (tralokinumab) obesity Alzheimer’s NHE3 inhibitor ESRD-Pi/CKD asthma, IPF BACE (AZD3293) MEDI-550 MPO (AZD3241) Alzheimer's pandemic influenza virus vaccine Multiple System Atrophy New approvals 1 New Molecular Entity NMDA (AZD6423) staph alpha tox. (MEDI4893) H3R (AZD5213) suicidal ideation SSI Tourette’s, neuropathic pain Small molecule Large molecule ATM AVI MEDI7510 Oxazolidinone (AZD5847) Epanova BL/BLI SBI RSV sF+GLA-SE RSV prevention TB hypertriglyceridaemia GyrAr (AZD0914) MEDI8897 BLI/cephalosporin (CXL) serious infection RSV Mab YTE passive RSV prophylaxis MRSA PRVV (MEDI-559) Paediatric RSV vaccine Oncology combinations PD-L1 + dabrafenib + trametinib PD-L1 + PD-1 melanoma solid tumours Oncology RIA CVMD Neuroscience Infection PD-L1 + Iressa CD-19 + rituximab Terminations in Q2 2014 EGFR M+ NSCLC haems AZD5069 (asthma) in Phase 2, MEDI8968 (COPD, HS) in Phase 2, AZD4721 (COPD) in Phase 1, MEDI9287 (avian flu) in Phase 1 (AZD5069 and AZD4721 termination decisions made in July 2014) PD-L1 + tremelimumab tremelimumab + Iressa solid5 tumours| NSCLC Pipeline table as of 30th June 2014 5 2H 2014: Key data readouts Compound Indication Milestone lesinurad gout Ph III topline results CAZ AVI cIAI Ph III topline results brodalumab psoriasis Ph III topline results sifalimumab SLE Ph IIb (ACR) mavrilimumab RA Ph IIb (ACR) MEDI4736 solid tumours Ph I (ESMO) MEDI4736 + tremelimumab NSCLC Ph I (ESMO) AZD9291 NSCLC Ph I (ESMO) AZD3293 Alzheimer’s disease Ph I (CTAD) 6 6 2H 2014: Key regulatory milestones Compound Indication Potential milestones Iressa EGFRm NSCLC US filing Movantik OIC US approval (PDUFA 16 Sep 2014) Movantik OIC EU approval Brilinta ACS JP approval olaparib PSR BRCAm ovarian cancer US approval (PDUFA 3 Jan 2015) Xigduo XR type 2 diabetes US approval (PDUFA 29 Oct 2014) saxagliptin/dapagliflozin FDC type 2 diabetes US filing lesinurad gout EU, US filing CAZ AVI cIAI EU filing 7 7 Potential NME & LE submissions 2014-16 Myalept EU lipodystrophy PT003 LABA/LAMA COPD PT001 LAMA COPD CAZ AVI EU brodalumab* PD-L1 (MEDI4736) cephalosporin/BLI SBI IL-17R psoriasis NSCLC lesinurad AZD9291 US/EU/JP benralizumab NMEs URAT1 gout EGFR T790M NSCLC IL-5R asthma olaparib US selumetinib roxadustat (FG-4592) CH PARP PSR BRCAm ovarian MEK uveal melanoma HIF anaemia CKD/ESRD 2014 2015 2016 Bydureon Dual Chamber Pen JP Brilinta PEGASUS US/EU/JP Brilinta EUCLID US/EU GLP-1 T2D ADP receptor antagonist ADP receptor antagonist Onglyza SAVOR US/EU Bydureon Autoinjector US/EU Brilinta SOCRATES US/EU/JP DPP-4 T2D GLP-1 T2D ADP receptor antagonist saxa-dapa FDC US/EU Iressa IMPRESS EU/JP/CH Caprelsa US/EU/JP DPP-4/SGLT-2 T2D EGFRm+ NSCLC differentiated thyroid cancer Iressa US Faslodex US/EU/JP/CH EGFRm+ NSCLC ER antagonist olaparib SOLO-2 US/EU/JP/CH LEs PSR BRCAm ovarian cancer olaparib OlympiAD US/EU/JP New since 1Q 14 results update PARP metastatic breast cancer lesinurad FDC US/EU SURI/XOI gout 8 * Filing is the responsibility of partner Oncology RIA CVMD Neuroscience Infection 8 AstraZeneca LE development programmes 2Q 2014 Results Update Brilinta/Brilique (ADP receptor antagonist) PARTHENON development programme Patient Phase # of Design Endpoint(s) Status Population Study patients Patients with Phase III N = 21000 • ARM 1: Ticagrelor 90 mg BiD • Composite of CV death, • FSI Q4 10 prior MI PEGASUS • ARM 2: Ticagrelor 60 mg BiD non-fatal MI and non-fatal • LSI Q2 13 • ARM 3: Placebo BiD stroke • Est. completion date Q1 15 NCT01225562 on a background of ASA • Est. external presentation Q3 15 (ESC) Global study – 31 countries Patients with Phase III N = 13500 • ARM 1: Ticagrelor 90 mg BiD • Composite of CV death, • FSI Q3 12 PAD EUCLID • ARM 2: Clopidogrel 75 mg QD non-fatal MI and ischemic • LSI Q1 14 monotherapy trial stroke • Est. completion date Q1 16 NCT01732822 • Est. external presentation 2016 Global study – 28 countries Patients with Phase III N = 9600 • ARM 1: Ticagrelor 90 mg BiD • Composite of non-fatal • FSI Q1 14 Stroke or TIA SOCRATES • ARM 2: ASA 100mg/day stroke, non-fatal MI and all • Est. completion date Q4 15 monotherapy trial cause death • Est. external presentation 2016 NCT01994720 Global study – approx. 32 countries Patients with Phase III N = 17000 • ARM 1: Ticagrelor 90 mg BiD • Composite of CV death, • FSI Q1 14 Type 2 Diabetes THEMIS • ARM 2: Placebo BiD non-fatal MI and non-fatal • Est. completion date Q1 17 and Coronary on a background of ASA if not contra stroke • Est. external presentation beyond Artery Disease NCT01991795 indicated or not tolerated planning horizon without a previous history Global study – approx. 40 countries of MI or Stroke 10 Forxiga/Farxiga (SGLT-2 inhibitor) Type 2 Diabetes development programme Patient Phase # of Design Endpoint(s) Status Population Study patients Typ 2 diabetes Phase III/IV N = 17150 • ARM 1: Dapagliflozin 10 mg QD + standard • Time to first • FSI Q2 13 mellitus with DECLARE of care therapy QD event included in • LSI Q2 16 high risk for CV • ARM 2: Placebo + standard of care therapy the composite • Est.
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