REG - AstraZeneca PLC - Half Yearly Report <Origin Href="QuoteRef">AZN.L</Origin> - Part 4
30/07/2015 07:13
- Part 4: For the preceding part double click ID:nRSd5111Uc
2017 2017
ARCTIC
durvalumab (MEDI4736)# PD-L1 mAb 2nd-line SCCHN (PD-L1 positive) Q1 2015 H2 2016 H2 2016 H2 2016
HAWK¶
durvalumab (MEDI4736)# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN (PD-L1 negative) Q2 2015 2017 2017 2017
CONDOR¶
moxetumomab pasudotox# anti-CD22 recombinant hairy cell leukaemia Q2 2013 2018 2018
immunotoxin
selumetinib# MEK inhibitor 2nd-line KRASm NSCLC Q4 2013 2017 2017
SELECT-1
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2018 2018
ASTRA
tremelimumab¶ DETERMINE CTLA-4 mAb mesothelioma Q2 2014 H1 2016(Orphan Drug) H2 2016 H2 2016
Infection, Neuroscience and Gastrointestinal
CAZ AVI#RECLAIM cephalosporin/beta lactamase inhibitor serious infections Q1 2012 N/A Filed 2017
CAZ AVI# REPROVE cephalosporin/ beta lactamase inhibitor hospital-acquired pneumonia/ ventilator-associated pneumonia Q2 2013 N/A Filed 2017
Zinforo# extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia/skin infections N/A Launched N/A Filed
pneumonia/skin infections
N/A
Launched
N/A
Filed
# Partnered product.
¶ Registrational Phase II/III study.
++ Amgen recently announced the termination of its co-development and commercialisation agreement with AstraZeneca for
brodalumab; AstraZeneca is proceeding with the transfer of the programme from Amgen and will communicate additional
decisions in due course.
1 First patient dosed July 2015.
2 Brilinta in the US; Brilique in rest of world.
3 Farxiga in the US; Forxiga in rest of world.
4 AZD9291 filed in Q2. US regulatory submission acceptance anticipated in Q3 2015.
5 Cediranib regulatory submission accepted in Q3 2015.
Phases I and II
NMEs and significant additional indications
Compound Mechanism Area Under Investigation Phase Date Commenced Phase Estimated Filing
US EU Japan China
Respiratory, Inflammation and Autoimmunity
abediterol (AZD0548) LABA asthma/COPD II Q4 2007
AZD7624 inhaled P38 inhibitor COPD II Q4 2014
AZD9412# inhaled interferon beta asthma/COPD II Q1 2010
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
MEDI-551# CD19 mAb neuromyelitis optica2 II Q1 2015
MEDI2070# IL-23 mAb Crohn's disease II Q1 2013
abrilimumab (MEDI7183)# alpha(4)beta(7) mAb Crohn's disease / ulcerative colitis II Q4 2012
MEDI9929# TSLP mAb asthma II Q2 2014
PT010 LABA/LAMA/ICS asthma II Q2 2014
RDEA3170 selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of patients with hyperuricaemia or gout II Q3 2013
sifalimumab# IFN-alpha mAb SLE3 II Q3 2008
tralokinumab IL-13 mAb IPF II Q4 2012
tralokinumab IL-13 mAb atopic dermatitis II Q1 2015
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# B7RP1 mAb SLE I Q4 2008
MEDI7836 IL-13 mAb-YTE asthma I Q1 2015
Cardiovascular and Metabolism
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# CD19 mAb CLL / DLBCL II Q1 2012
MEDI-573# IGF mAb metastatic breast cancer II Q2 2012
selumetinib# MEK inhibitor 2nd-line KRAS wt NSCLC II Q1 2013
AZD5363# AKT kinase inhibitor breast cancer II Q1 2014
Compound Mechanism Area Under Investigation Phase Date Commenced Phase Estimated Filing
US EU Japan China
durvalumab (MEDI4736)# PD-L1 mAb solid tumours II Q3 2014
durvalumab (MEDI4736)# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
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 + (durvalumab (MEDI4736)# or selumetinib# or volitinib#)TATTON EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor) advanced EGFRm NSCLC I Q3 2014
AZD9496 selective oestrogen receptor downregulator (SERD) ER+ breast cancer I Q4 2014
durvalumab (MEDI4736)# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab) PD-L1 mAb NSCLC I Q3 2014
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or CTLA-4 mAb)
durvalumab (MEDI4736)# PD-L1 mAb solid tumours I Q3 2014
durvalumab (MEDI4736)# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours I Q2 2014
durvalumab (MEDI4736)# + MEDI6383# OX40 agonist + PD-L1 mAb solid tumours I Q2 2015
durvalumab (MEDI4736)# + MEDI6469# PD-L1 mAb + murine OX40 agonist solid tumours I Q3 2014
durvalumab (MEDI4736)# + dabrafenib + trametinib1 PD-L1 mAb+ BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
Iressa + durvalumab (MEDI4736)# PD-L1 mAb+ EGFR tyrosine kinase inhibitor NSCLC I Q2 2014
durvalumab (MEDI4736)# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI-565# CEA BiTE mAb solid tumours I Q1 2011
MEDI0639# DLL-4 mAb solid tumours I Q2 2012
MEDI0680 PD-1 mAb solid tumours I Q4 2013
MEDI3617# ANG-2 mAb solid tumours I Q4 2010
MEDI-551# +MEDI0680 CD19 mAb + PD-1 mAb DLBCL I Q4 2014
MEDI-551# + rituximab CD19 mAb + 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 + CD20 mAb solid tumours I Q1 2015
MEDI6469# +tremelimumab murine OX40 agonist + CTLA-4 mAb solid tumours I Q4 2014
Infection, Neuroscience and Gastrointestinal
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
AZD5847 oxazolidinone anti-bacterial inhibitor tuberculosis II Q4 2012
AZD8108 NMDA antagonist suicidal ideation I Q4 2014
CXL# beta lactamase inhibitor / cephalosporin MRSA II Q4 2010
MEDI1814 amyloid beta mAb Alzheimer's disease I Q2 2014
MEDI4893 MAb binding to S. aureus toxin hospital-acquired pneumonia / serious S. aureus infection II Q4 2014 (Fast Track)
MEDI8897# RSV mAb-YTE passive RSV prophylaxis II Q1 2015 (Fast Track)
ATM AVI# monobactam/ beta lactamase inhibitor targeted serious bacterial infections I 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 (Fast Track)
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
# Partnered product.
1 MedImmune-sponsored study in collaboration with Novartis.
2 Neuromyelitis optica now lead indication. Multiple sclerosis Phase I study continuing.
3 SLE project stopped but molecule under evaluation for alternative indications.
Significant Life-Cycle Management
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
Symbicort1 ICS/LABA breath actuated Inhaler asthma/COPD 2018
Cardiovascular and Metabolism
Brilinta/Brilique2 EUCLID P2Y12 receptor antagonist outcomes study in patients with peripheral artery disease Q4 2012 2017 2017 2017 2018
Brilinta/Brilique2 HESTIA P2Y12 receptor antagonist prevention of vaso-occlusive crises in paediatric patients with sickle cell disease Q4 2014 2020 2020
Brilinta/Brilique2 P2Y12 receptor antagonist outcomes study in patients with prior myocardial infarction Q4 2010 Filed (Priority Review) Filed Q4 2015 2017
PEGASUS-
TIMI 54
Brilinta/Brilique2 SOCRATES P2Y12 receptor antagonist outcomes study in patients with stroke or TIA Q1 2014 H1 2016 H1 2016 H2 2016 2017
Brilinta/Brilique2 THEMIS P2Y12 receptor antagonist outcomes study in patients with type-2 diabetes and CAD, but without a previous history of MI or stroke Q1 2014 2018 2018 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 carboxylic 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 carboxylic 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
KombiglyzeXR/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 Q4 2015
saxagliptin/dapagliflozin FDC DPP-4 inhibitor/ SGLT-2 inhibitor FDC type-2 diabetes Q2 2012 Filed Filed
XigduoXR/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 2017
Iressa EGFR tyrosine kinase inhibitor EGFRm NSCLC Approved6 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 H2 2016 H2 2016 H2 2016
Lynparza (olaparib) POLO PARP inhibitor pancreatic cancer Q1 2015 2017 2017 2017
Lynparza (olaparib) PARP inhibitor prostate cancer Q3 2014
Infection, Neuroscience and Gastrointestinal
Diprivan# sedative and anaesthetic conscious sedation N/A Launched Filed Launched
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 stress ulcer prophylaxis 2017
Nexium proton pump inhibitor paediatrics Launched Launched H2 2016
# Partnered product.
1 Development of a new BAI device is ongoing.
2 Brilinta in the US; Brilique in rest of world.
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 Approved by FDA in July 2015.
Faslodex 500 mg approved in China in Q2 for the treatment of postmenopausal women with oestrogen receptor positive, locally
advanced or metastatic breast cancer (replaces 250mg dose).
Terminations (discontinued projects between 1 April and 30 June 2015)
NME / Line Extension Compound Reason for Discontinuation Area Under Investigation
NME selumetinib# SUMIT Safety/efficacy uveal melanoma
NME tenapanor (AZD1722)# Safety/efficacy ESRD-Pi/CKD with T2DM
LCM Nexium Regulatory refractory reflux oesphagitis (JP)
Completed Projects / Divestitures
Compound Mechanism Area Under Investigation Phase Estimated Filing
US EU Japan China
Neuroscience
Movantik/Moventig#1 oral peripherally-acting mu-opioid receptor antagonist opioid-induced constipation Launched Launched
# Partnered product.
1 Movantik in the US; Moventig in EU.
Shareholder Information
Announcements and Meetings
Announcement of nine months and third quarter results 5 November 2015
Announcement of full year and fourth quarter results 4 February 2016
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
The record date for the first interim dividend for 2015, payable on 14 September 2015, will be 14 August 2015. Ordinary
Shares listed in London and Stockholm will trade ex-dividend from 13 August 2015. American Depositary Shares listed in New
York will trade ex-dividend from 12 August 2015.
ADR Programme
AstraZeneca announced an intended ratio change to its NYSE-listed sponsored Level 2 American Depositary Receipt (ADR)
programme on 26 June 2015. The prior ratio was one American Depositary Share (ADS) per one Ordinary Share. Effective from
27 July 2015 the new ratio became two ADSs per one Ordinary Share. There was no change to the underlying Ordinary Shares.
ADS holders at the close of business New York time on the record date, 22 July 2015, received a distribution of one
additional ADS for every ADS held. The new ADSs were distributed on 24 July 2015. No action was required by ADS holders to
effect this change.
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 Daliresp, a trademark of
Takeda GmbH; Duaklir Genuair, Duaklir, Eklira, Tudorza and Tudorza Pressair, trademarks of Almirall, S.A.; Epanova, a
trademark of Chrysalis Pharma AG; Imbruvica, a trademark of Pharmacyclics, Inc.; Zinforo, a trademark of Forest
Laboratories; Zydelig, a trademark of GILEAD SCIENCES IRELAND UC; and Zytiga, a trademark of Johnson & Johnson.
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 Statements 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: This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of the Group, including, among other things, statements
about expected revenues, margins, earnings per share or other financial or other measures. 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
this document 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, or limitations to, 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;
effects of patent litigation in respect of IP rights; exchange rate fluctuations; the risk that R&D will not yield new
products that achieve commercial success; the risk that strategic alliances and acquisitions, including licensing and
collaborations, 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 of
outsourcing; the risks associated with manufacturing biologics; 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 of failure to adhere to applicable laws, rules and regulations relating to anti-competitive
behaviour; the risk that new products do not perform as we expect; failure to achieve strategic priorities or to meet
targets or expectations; the risk of an adverse impact of a sustained economic downturn; political and socio-economic
conditions; the risk of environmental liabilities; the risk of occupational health and safety liabilities; the risk
associated with pensions liabilities; the risk of misuse of social medial platforms and new technology; the risks
associated with developing our business in emerging markets; the risk of illegal trade in our products; the risks from
pressures resulting from generic competition; the risk of failure to successfully implement planned cost reduction measures
through productivity initiatives and restructuring programmes; economic, regulatory and political pressures to limit or
reduce the cost of our products; 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. Nothing in this presentation / webcast
should be construed as a profit forecast.
This information is provided by RNS
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