REG - AstraZeneca PLC - 1st Quarter Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 3
15/07/2015 14:30
- Part 3: For the preceding part double click ID:nRSX2049Lb
COPD Q3 2014 2018 2018
brodalumab#AMAGINE-1,2,3 anti-IL-17R MAb psoriasis Q3 2012 2015++ 2015++
brodalumab# AMVISION-1,2 anti-IL-17R MAb psoriatic arthritis Q1 2014 ++ ++
lesinurad selective uric acid reabsorption inhibitor (SURI) chronic treatment of patients with gout Q4 2011 Filed Filed
CLEAR 1,2
CRYSTAL
PT003 GFF LAMA / LABA COPD Q2 2013 Q3 2015 H1 2016 2017 2017
tralokinumabSTRATOS 1,2TROPOS anti-IL-13 MAb severe asthma Q3 2014 2018 2018 2018
Infection
CAZ AVI#RECLAIM cephalosporin / beta lactamase inhibitor serious infections Q1 2012 N/A 2015 H2 2016
CAZ AVI# REPROVE cephalosporin / beta lactamase inhibitor hospital-acquired pneumonia / ventilator-associated pneumonia Q2 2013 N/A 2017 2018
Zinforo# extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia / skin infections N/A Launched N/A Filed
Neuroscience
Movantik/Moventig#3 oral peripherally-acting mu-opioid receptor antagonist opioid-induced constipation Launched Launched
# Partnered product.
¶ Registrational Phase II / III study.
++ Filing is the responsibility of the partner.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Movantik in the US; Moventig in EU.
Phases I and II
NMEs and significant additional indications
Compound Mechanism Area Under Investigation Phase Date Commenced Phase Estimated Filing
US EU Japan China
Cardiovascular and Metabolism
tenapanor (AZD1722)# NHE3 inhibitor ESRD-Pi / CKD with T2DM II Q1 2013
AZD4901 NK3 receptor antagonist polycystic ovarian syndrome II Q2 2013
MEDI0382 GLP-1 / glucagon dual agonist diabetes / obesity I Q1 2015
MEDI6012 LCAT ACS I Q1 2012
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
Oncology
AZD1775# WEE-1 inhibitor ovarian cancer II Q4 2012
AZD2014 mTOR serine / threonine kinase inhibitor solid tumours II Q1 2013
AZD4547 FGFR tyrosine kinase inhibitor solid tumours II Q4 2011
MEDI-551# anti-CD19 MAb CLL / DLBCL II Q1 2012
MEDI-573# anti-IGF MAb metastatic breast cancer II Q2 2012
selumetinib# MEK inhibitor 2nd line KRAS- NSCLC II Q1 2013
AZD5363# AKT kinase inhibitor breast cancer II Q1 2014
MEDI4736# anti-PD-L1 MAb solid tumours II Q3 2014
moxetumomab anti-CD22 recombinant immunotoxin pALL II Q3 2014
pasudotox#
savolitinib/volitinib (AZD6094)# MET tyrosine kinase inhibitor papillary renal cell carcinoma II Q2 2014
AZD3759 EGFR tyrosine kinase inhibitor advanced EGFRm NSCLC I Q4 2014
AZD5312# androgen receptor inhibitor solid tumours I Q2 2014
AZD6738 ATR serine / threonine kinase inhibitor solid tumours I Q4 2013
AZD8186 PI3 kinase beta inhibitor solid tumours I Q2 2013
AZD8835 PI3 kinase alpha inhibitor solid tumours I Q4 2014
AZD9150# STAT3 inhibitor haematological malignancies I Q1 2012
AZD9291 + (MEDI4736# or selumetinib# or volitinib#)TATTON EGFR tyrosine kinase inhibitor + (anti-PD-L1 or MEK inhibitor or MET tyrosine kinase inhibitor) advanced EGFRm NSCLC I Q3 2014
Phases I and II (continued)
Compound Mechanism Area Under Investigation Phase Date Commenced Phase Estimated Filing
US EU Japan China
Oncology (continued)
AZD9496 selective oestrogen receptor downregulator (SERD) ER+ breast cancer I Q4 2014
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI4736# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab) anti-PD-L1 MAb NSCLC I Q3 2014
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or anti-CTLA-4 MAb)
MEDI-565# anti-CEA BiTE MAb solid tumours I Q1 2011
MEDI0639# anti-DLL-4 MAb solid tumours I Q2 2012
MEDI0680 anti-PD-1 MAb solid tumours I Q4 2013
MEDI3617# anti-ANG-2 MAb solid tumours I Q4 2010
MEDI4736# anti-PD-L1 MAb solid tumours I Q3 2014
MEDI4736# + MEDI0680 anti-PD-L1 MAb + anti-PD-1 MAb solid tumours I Q2 2014
MEDI4736# + MEDI6469# anti-PD-L1 MAb + murine OX40 agonist solid tumours I Q3 2014
MEDI4736# + dabrafenib + trametinib1 anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
MEDI4736# + Iressa anti-PD-L1 MAb + EGFR tyrosine kinase inhibitor NSCLC I Q2 2014
MEDI4736# + tremelimumab anti-PD-L1 MAb + anti-CTLA-4 MAb solid tumours I Q4 2013
MEDI-551# +MEDI0680 anti-CD19 MAb + anti-PD-1 MAb DLBCL I Q4 2014
MEDI-551# + rituximab anti-CD19 MAb + anti-CD20 MAb haematological malignancies I Q2 2014
MEDI6383# OX40 agonist solid tumours I Q3 2014
MEDI6469# murine OX40 agonist solid tumours I Q1 2006
MEDI6469# + rituximab murine OX40 agonist + anti-CD20 MAb solid tumours I Q1 2015
MEDI6469# +tremelimumab murine OX40 agonist + anti-CTLA-4 MAb solid tumours I Q4 2014
Respiratory, Inflammation and Autoimmunity
albediterol (AZD0548) LABA asthma / COPD II Q4 2007
AZD7624 inhaled P38 inhibitor COPD II Q4 2014
AZD9412# inhaled interferon β asthma / COPD II Q1 2010
anifrolumab# anti-IFN-alphaR MAb SLE II Q1 2012
mavrilimumab# anti-GM-CSFR MAb rheumatoid arthritis II Q1 2010
MEDI-551# anti-CD19 MAb neuromyelitis optica2 II Q1 2015
MEDI2070# anti-IL-23 MAb Crohn's disease II Q1 2013
MEDI7183# anti-a4b7 MAb Crohn's disease / ulcerative colitis II Q4 2012
MEDI9929# anti-TSLP MAb asthma II Q2 2014
PT010 LAMA / LABA / ICS COPD II Q2 2014
RDEA3170 selective uric acid reabsorption inhibitor (SURI) chronic treatment of patients with hyperuricemia or gout II Q3 2013
sifalimumab# anti-IFN-alpha MAb SLE II Q3 2008
tralokinumab anti-IL-13 MAb IPF II Q4 2012
tralokinumab anti-IL-13 MAb atopic dermatitis II Q1 2015
Phases I and II (continued)
Compound Mechanism Area Under Investigation Phase Date Commenced Phase Estimated Filing
US EU Japan China
Respiratory, Inflammation and Autoimmunity (continued)
AZD1419# TLR9 agonist asthma I Q3 2013
AZD7594 inhaled SGRM asthma / COPD I Q3 2012
AZD7986 DPP1 COPD I Q4 2014
AZD8999 MABA COPD I Q4 2013
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI5872# anti-B7RP1 MAb SLE I Q4 2008
MEDI7836 anti-IL-13 MAb-YTE asthma I Q1 2015
Infection
ATM AVI# monobactam / beta lactamase inhibitor targeted serious bacterial infections II Q1 2015
AZD5847 oxazolidinone anti-bacterial inhibitor tuberculosis II Q4 2012
CXL# beta lactamase inhibitor / cephalosporin MRSA II Q4 2010
MEDI4893 MAb binding to S. aureus toxin hospital-acquired pneumonia / serious S. aureus infection II Q4 2014
MEDI8897# anti-RSV MAb-YTE passive RSV prophylaxis II Q1 2015
MEDI-550 pandemic influenza virus vaccine pandemic influenza prophylaxis I Q2 2006
MEDI3902 anti-Psl/PcrV Prevention of nosocomial pseudomonas pneumonia I Q3 2014
MEDI7510 RSV sF+GLA-SE prevention of RSV disease in older adults I Q2 2014
MEDI8852 influenza A MAb influenza A treatment I Q1 2015
Neuroscience
AZD3241 myeloperoxidase inhibitor multiple system atrophy II Q2 2012
AZD3293# beta-secretase inhibitor Alzheimer's disease II Q4 2014
AZD5213 histamine-3 receptor antagonist Tourette's syndrome / neuropathic pain II Q4 2013
AZD8108 NMDA antagonist suicidal ideation I Q4 2014
MEDI1814 anti-amyloid beta MAb Alzheimer's disease I Q2 2014
# Partnered product.
1 MedImmune-sponsored study in collaboration with Novartis.
2 Neuromyelitis optica now lead indication. Multiple sclerosis Phase I study continuing.
Significant Life-Cycle Management
Compound Mechanism Area Under Investigation Date Commenced Phase Estimated Filing
US EU Japan China
Cardiovascular and Metabolism
Brilinta / Brilique1 EUCLID ADP receptor antagonist outcomes study in patients with peripheral artery disease Q4 2012 2017 2017 2017 2018
Brilinta / Brilique1 HESTIA ADP receptor antagonist prevention of vaso-occlusive crises in paediatric patients with sickle cell disease Q4 2014 2020 2020
Brilinta / Brilique1 ADP receptor antagonist outcomes study in patients with prior myocardial infarction Q4 2010 Filed2 Filed2 Q4 2015 2017
PEGASUS-
TIMI 54
Brilinta / Brilique1 SOCRATES ADP receptor antagonist outcomes study in patients with stroke or TIA Q1 2014 H1 2016 H1 2016 H2 2016 2017
Brilinta / Brilique1 THEMIS ADP receptor antagonist outcomes study in patients with type 2 diabetes and CAD, but without a previous history of MI or stroke Q1 2014 2017 2017 2018 2018
Bydureon Dual GLP-1 receptor agonist type 2 diabetes Launched Launched Approved
Chamber Pen
Bydureon EXSCEL GLP-1 receptor agonist type 2 diabetes outcomes study Q2 2010 2018 2018 2018
Bydureon weekly GLP-1 receptor agonist type 2 diabetes Q1 2013 Q4 2015 Q4 2015
suspension
EpanovaSTRENGTH omega-3 free fatty acids outcomes study in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol Q4 2014 2020 2020 2020 2020
Epanova / Farxiga/Forxiga3 omega-3 free fatty acids / SGLT-2 inhibitor Non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH) Q1 2015
Farxiga / Forxiga3 SGLT-2 inhibitor type 2 diabetes outcomes study Q2 2013 2020 2020
DECLARE-
TIMI 58
Farxiga / Forxiga3 SGLT-2 inhibitor type 1 diabetes Q4 2014 2018 2017 2018
Kombiglyze XR / Komboglyze4 DPP-4 inhibitor / metformin FDC type 2 diabetes Launched Launched Filed
Onglyza SAVOR-TIMI 53 DPP-4 inhibitor type 2 diabetes outcomes study Q2 2010 Filed Launched 2015
saxagliptin / dapagliflozin FDC DPP-4 inhibitor / SGLT-2 inhibitor FDC type 2 diabetes Q2 2012 Filed Q2 2015
Xigduo XR / Xigduo5 SGLT-2 inhibitor / metformin FDC type 2 diabetes Launched Launched
Oncology
Caprelsa VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity differentiated thyroid cancer Q2 2013 H1 2016 H1 2016 H1 2016
FaslodexFALCON oestrogen receptor antagonist 1st line hormone receptor +ve advanced breast cancer Q4 2012 H2 2016 H2 2016 H2 2016 H2 2016
Iressa EGFR tyrosine kinase inhibitor EGFRm NSCLC Filed Launched Launched Launched
Lynparza (olaparib) SOLO-1 PARP inhibitor 1st line BRCAm ovarian cancer Q3 2013 2017 2017 2017
Lynparza (olaparib) SOLO-2 PARP inhibitor 2nd line or greater BRCAm PSR ovarian cancer, maintenance monotherapy Q3 2013 H1 2016 H1 2016 H2 2016
Lynparza (olaparib) SOLO-3 PARP inhibitor gBRCA PSR ovarian cancer Q1 2015 2018
Lynparza (olaparib) GOLD PARP inhibitor 2nd line gastric cancer Q3 2013 2017
Lynparza (olaparib) OlympiA PARP inhibitor gBRCA adjuvant triple negative breast cancer Q2 2014 2020 2020 2020
Lynparza (olaparib) OlympiAD PARP inhibitor gBRCA metastatic breast cancer Q2 2014 2016 2016 2016
Lynparza (olaparib) POLO PARP inhibitor pancreatic cancer Q1 2015 2016 2017 2017
Lynparza (olaparib) PARP inhibitor prostate cancer Q3 2014
Respiratory, Inflammation and Autoimmunity
Duaklir Genuair# LAMA / LABA COPD 2018 Launched 2018 2018
SymbicortSYGMA ICS / LABA as needed use in mild asthma Q4 2014 N/A 2018 2019
Symbicort6 ICS / LABA Breath Actuated Inhaler asthma / COPD 2018
Life-Cycle Management (continued)
Compound Mechanism Area Under Investigation Date Commenced Phase Estimated Filing
US EU Japan China
Neuroscience
Diprivan# sedative and anaesthetic conscious sedation N/A Launched Filed Launched
Movantik / Moventig# oral peripherally-acting mu-opioid receptor antagonist paediatrics
Gastrointestinal
Entocort glucocorticoid steroid Crohn's disease / ulcerative colitis Launched Launched Q3 2015 N/A
linaclotide# GC-C receptor peptide agonist irritable bowel syndrome with constipation N/A N/A N/A Q4 2015
(IBS-C)
Nexium proton pump inhibitor refractory reflux esophagitis Filed
Nexium proton pump inhibitor stress ulcer prophylaxis 2017
Nexium proton pump inhibitor paediatrics Launched Launched H2 2016
# Partnered product.
1 Brilinta in the US; Brilique in rest of world.
2 Submission made in Q1 2015, acceptance anticipated Q2 2015.
3 Farxiga in the US; Forxiga in rest of world.
4 Kombiglyze XR in the US; Komboglyze in the EU.
5 Xigduo XR in the US; Xigduo in the EU.
6 Development of a new BAI device is ongoing.
Terminations (discontinued projects between 1 January and 31 March 2015)
NME / Line Extension Compound Reason for Discontinuation Area Under Investigation
NME AZD2115# Strategic COPD
NME MEDI-559 Safety / efficacy passive RSV prophylaxis
LCM brodalumab# Lack of efficacy asthma
# Partnered product.
Completed Projects / Divestitures
Compound Mechanism Area Under Investigation Phase Estimated Filing
US EU Japan China
Cardiovascular
Myalept leptin analogue lipodystrophy Launched
Oncology
Lynparza (olaparib) capsule PARP inhibitor BRCAm PSR ovarian cancer Launched Launched
Infection
AZD0914 GyrAR serious bacterial infections II
Shareholder Information
ANNOUNCEMENTS AND MEETINGS
______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Annual General Meeting 24 April 2015
Announcement of half year and second quarter results 30 July 2015
Announcement of nine months and third quarter results 5 November 2015
DIVIDENDS
______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Future dividends will normally be paid as follows:
First interim Announced with half year and second quarter results and paid in September
Second interim Announced with full year and fourth quarter results and paid in March
On 6 February 2015 the Company transferred its US American Depositary Receipt (ADR) Programme to Citibank, N.A.
TRADEMARKS
______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Trademarks of the AstraZeneca group of companies and of companies other than AstraZeneca appear throughout this document in
italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of
companies. Trademarks of companies other than AstraZeneca that appear in this document include Duaklir Genuair, Duaklir,
Eklira, Tudorza and Tudorza Pressair, trademarks of Almirall, S.A.; Tissue Phenomics and Cognition Network Technology,
trademarks of Definiens AG; Epanova, a trademark of Chrysalis Pharma AG; Zinforo, a trademark of Forest Laboratories;
Zydelig, a trademark of GILEAD SCIENCES IRELAND UC; Zytiga, a trademark of Johnson & Johnson; Imbruvica, a trademark of
Pharmacyclics, Inc.; and Daliresp, a trademark of Takeda GmbH.
ADDRESSES FOR CORRESPONDENCE
______________________________________________________________________________________________________________________________________________________________________________________________________________________________
Registrar andTransfer OfficeEquiniti LimitedAspect HouseSpencer RoadLancingWest SussexBN99 6DAUK US DepositaryCitibank Shareholder ServicesPO Box 43077ProvidenceRI 02940-3077USA Registered Office2 Kingdom StreetLondonW2 6BDUK Swedish Central Securities DepositoryEuroclear Sweden ABPO Box 191SE-101 23 StockholmSweden
Tel (freephone in UK): Tel: +44 (0)207 500 2030or +1 877 248 4237 (1 877-CITI-ADR)/E-mail: citiadr@citi.com Tel: +44 (0)20 7604 8000 Tel: +46 (0)8 402 9000
0800 389 1580Tel (outside UK):
+44 (0)121 415 7033
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
______________________________________________________________________________________________________________________________________________________________________________________________________________________________
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act
1995, we are providing the following cautionary statement: The interim financial statements contain certain forward-looking
statements with respect to the operations, performance and financial condition of the Group. Although we believe our
expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from
those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of
the interim financial statements and AstraZeneca undertakes no obligation to update these forward-looking statements. We
identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar
expressions in such statements. Important factors that could cause actual results to differ materially from those contained
in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration
of patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection; the risk
of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate
fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic
alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation
risks; the risk of substantial product liability claims; the impact of any delays in the manufacturing, distribution and
sale of any of our products; the impact of any failure by third parties to supply materials or services; the risk of
failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining
regulatory approvals for products; the risk of failure to adhere to applicable laws, rules and regulations; the risk that
new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting
business in emerging markets; the risk of reputational damage; the risk of illegal trade in our products; the risk of
failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring
programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial
prospects; the impact of failing to attract and retain key personnel and to successfully engage with our employees; the
impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; and the
risk of failure of information technology and cybercrime.
This information is provided by RNS
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