azn201402066k1.htm
 
 
FORM 6-K
 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934

For the month of February 2014
 
Commission File Number: 001-11960

 
AstraZeneca PLC
 
 
2 Kingdom Street, London W2 6BD
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F X      Form 40-F __

 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______           
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
 
Yes __     No X
 
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 

 

 
Development Pipeline as at
31 December 2013
Line Extensions
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
Brilinta/ Brilique EUCLID
ADP receptor antagonist
outcomes study in patients with PAD
4Q 2012
2016
2016
2016
2017
Brilinta / Brilique PEGASUS-TIMI 54
ADP receptor antagonist
outcomes study in patients with prior MI
4Q 2010
2015
2015
2015
2017
Brilinta/ Brilique SOCRATES1
ADP receptor antagonist
outcomes study in patients with stroke or TIA
1Q 2014
2016
2016
2016
2017 
Brilinta/ Brilique THEMIS
ADP receptor antagonist
outcomes study in patients with Type 2 diabetes and CAD but without previous history of MI or stroke
  
2017
2017
2018
2018
Bydureon Dual Chamber Pen
GLP-1 receptor agonist
diabetes
  
 Filed
 Filed
2Q 2014
  
Bydureon EXSCEL
GLP-1 receptor agonist
outcomes study
2Q 2010
 2018
 2018
2018
  
Bydureon weekly suspension
GLP-1 receptor agonist
diabetes
 1Q 2013
2015
2015
    
Farxiga/Forxiga2 DECLARE
SGLT2 inhibitor
outcomes study
2Q 2013
2020
2020
    
Kombiglyze XR/ Komboglyze FDC3
DPP-4 inhibitor/
metformin FDC
diabetes
  
Launched
Launched
  
Filed
Onglyza SAVOR-TIMI 53
DPP-4 inhibitor
outcomes study
2Q 2010
1Q 2014
1Q 2014
  
 2015
saxagliptin/
dapagliflozin FDC
DPP-4 inhibitor/SGLT2 inhibitor FDC
diabetes
2Q 2012
2015
2015
    
Xigduo
SGLT2 inhibitor/
metformin FDC
diabetes
  
 Filed
Approved4
    
 
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Gastrointestinal
Entocort
glucocorticoid steroid
Crohn's disease/ulcerative colitis
  
Launched
Launched
2015
N/A
Linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation (IBS-C)
  
N/A
N/A
N/A
2015
Nexium
proton pump inhibitor
peptic ulcer bleeding
  
Filed5
Launched
N/A
Launched
Neuroscience
Diprivan#
sedative and anaesthetic
conscious sedation
    
Launched
2H 2014
Launched
Oncology
Caprelsa
VEGFR/
EGFR tyrosine kinase inhibitor with RET kinase activity
differentiated thyroid cancer
2Q 2013
2016
2016
2016
  
Faslodex
oestrogen receptor antagonist
1st line advanced breast cancer
4Q 2012
2016
2016
2016
2016
Iressa
EGFR tyrosine kinase inhibitor
treatment beyond progression
1Q 2012
  
2015
2015
2015
Respiratory, Inflammation & Autoimmunity
Symbicort6
inhaled steroid/ long-acting β2 agonist
Breath Actuated Inhaler asthma /
COPD
4Q 2011
        
 
# Partnered product
1 First subject dosed in January 2014 for SOCRATES
2 Farxiga US; Forxiga rest of world
3 Kombiglyze XR US; Komboglyze FDC EU
4 Approved January 2014
5 2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012 and application remains under FDA review
6 Filing delayed pending evaluation of alternative device design
 
 
NMEs
Phase III/Registration

 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
Brilinta
/Brilique
ADP receptor antagonist
arterial thrombosis
  
Launched
Launched
Filed
Launched
Epanova#
omega-3 free fatty acids
hypertri-glyceridaemia
  
Filed
      
Farxiga/
Forxiga1
SGLT2 inhibitor
diabetes
  
Approved2
Launched
Filed
Filed
metreleptin
leptin analogue
lipodystrophy
  
Filed
2015
N/A
  
Infection
CAZ AVI (CAZ104)#
cephalosporin/beta lactamase inhibitor
serious infections
1Q 2012
N/A
4Q 2014
2015
2016
CAZ AVI (CAZ104)#
cephalosporin/beta lactamase inhibitor
hospital-acquired pneumonia/ventilator-associated pneumonia
2Q 2013
N/A
2017
2017
  
Zinforo (ceftaroline)#
extended spectrum cephalosporin with affinity to penicillin- binding proteins
pneumonia / skin infections
  
N/A
Launched
N/A 
1H 2014
Neuroscience
naloxegol (NKTR-118)#
oral peripherally-acting mu-opioid receptor antagonist
opioid-induced constipation
  
  Filed
  Filed
    
Oncology 
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer
  
Launched
Launched
3Q 2014
Filed
moxetumomab pasudotox#
anti-CD22 recombinant immunotoxin
hairy cell leukaemia
2Q 2013
2018
2018
    
olaparib
PARP inhibitor
gBRCAm
PSR ovarian cancer
  
1Q 2014
Filed
    
olaparib SOLO-1
PARP inhibitor
1st line gBRCAm ovarian cancer
3Q 2013
2017
2017
2017
2017
olaparib SOLO-2
PARP inhibitor
gBRCAm
PSR ovarian cancer
3Q 2013
2016
2016
2016
2016
olaparib GOLD
PARP inhibitor
2nd line gastric cancer
3Q 2013
    
2017
2018
selumetinib (AZD6244) (ARRY-142886)#
MEK inhibitor
2nd line KRAS+ NSCLC
4Q 2013
2017
2017
    
Respiratory, Inflammation & Autoimmunity
benralizumab#
anti-IL-5R MAb
severe asthma
4Q 2013
2016
2016
    
brodalumab#
anti-IL-17R MAb
psoriasis
3Q 2012
2015
2015
    
lesinurad
selective inhibitor of URAT1
chronic management of hyperuricaemia in patients with gout
4Q 2011
2H 2014
2H 2014
  
2017
PT003 GFF
LABA/LAMA
COPD
2Q 2013
2015
2016
    
                         


 
#Partnered product
1Farxiga US; Forxiga rest of world 
2Approved January 2014
 
 
NMEs
Phases I and II
 
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
AZD1722#
NHE3 inhibitor
ESRD-Pi / CKD- with T2DM/ ESRD-Fluid Retention
II
1Q 2013
        
AZD4901
NK3
polycystic ovarian syndrome
II
2Q 2013
        
roxadustat (FG-4592)#
hypoxia-inducible factor inhibitor
anaemia in CKD/end-stage renal disease
II1
  
2018
N/A
N/A
2016
MEDI6012
LCAT
ACS
I
1Q 2012
        
Infection
AZD5847
oxazolidinone anti-bacterial inhibitor
tuberculosis
II
4Q 2012
        
CXL#
beta lactamase inhibitor/ cephalosporin
MRSA
II
4Q 2010
        
ATM AVI
BL/BLI
targeted serious bacterial infections
I
4Q 2012
        
AZD0914
GyrAR
serious bacterial infections
I
4Q 2013
        
MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
2Q 2006
        
MEDI-559 (PRVV)
paediatric RSV vaccine
RSV prophylaxis
I
4Q 2008
        
MEDI4893
staph alpha toxin YTE MAb
hospital-acquired pneumonia / serious S. aureus infection
I
1Q 2013
        
MEDI92872
H7N9 vaccine
avian influenza
I
4Q 2013
        
Neuroscience
AZD3241
myeloper-oxidase (MPO) inhibitor
Parkinson's disease
II
2Q 2012
        
AZD5213
histamine-3 receptor  antagonist
Tourette's syndrome/
neuropathic pain
II
4Q 2013
        
AZD3293#
beta secretase
Alzheimer's disease
I
4Q 2012
        
AZD6423
NMDA
suicidal ideation
I
3Q 2013
        
 
#Partnered product
1In-licensed asset in late-development but the Phase III AstraZeneca programme has yet to randomise its first patient
2Vaccine in development through a CRADA with NIAID
 
 
NMEs
Phases I and II (continued)
 
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Oncology
AZD1775#
Wee-1 inhibitor
ovarian cancer
II
 4Q 2012
        
AZD2014
TOR kinase inhibitor
solid tumours
II
1Q 2013
        
AZD4547
FGFR tyrosine kinase inhibitor
solid tumours
II
4Q 2011
        
MEDI-551#
anti-CD19 MAb
haematological malignancies
II
1Q 2012
        
MEDI-573#
anti-IGF MAb
MBC
II
4Q 2011
        
olaparib
PARP inhibitor
breast cancer
II
1Q 2012
        
selumetinib (AZD6244) (ARRY-142886)#
MEK inhibitor
various cancers
II
4Q 2008
        
tremelimumab
anti-CTLA4 MAb
mesothelioma
II
2Q 2013
        
AZD1208
PIM kinase inhibitor
haematological malignancies
I
1Q 2012
        
AZD5363#
AKT inhibitor
solid tumours
I
4Q 2010
        
AZD6738
ATR
CLL/
head & neck
I
4Q 2013
        
AZD8186
PI3 kinase beta inhibitor
solid tumours
I
2Q 2013
        
AZD9150#
STAT3 inhibitor
haematological malignancies
I
1Q 2012
        
AZD9291
epidermal growth factor inhibitor
solid tumours
I
1Q 2013
        
MEDI-565#
anti-CEA BiTE
solid tumours
I
1Q 2011
        
MEDI0639#
anti-DLL-4 MAb
solid tumours
I
2Q 2012
        
MEDI0680 (AMP-514)
anti-PD-1MAb
solid tumours
I
4Q 2013
        
MEDI3617#
anti-ANG-2 MAb
solid tumours
I
4Q 2010
        
MEDI4736#
anti-PD-L1 MAb
solid tumours
I
3Q 2012
        
MEDI4736# + tremelimumab
anti-PD-L1 MAb + anti-CTLA4 MAb
solid tumours
I
4Q 2013
        
MEDI4736# + dabrafenib + trametinib3
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor
melanoma
I
1Q 2014
        
MEDI6469#
murine anti-OX40 MAb
solid tumours
I
1Q 2006
        
moxetumomab pasudotox#
anti-CD22 recombinant immunotoxin
pALL
I
3Q 2008
        
volitinib# (AZD6094)
MET inhibitor
solid tumours
I
1Q 2012
        
 
#Partnered product
3MedImmune-sponsored study in collaboration with GlaxoSmithKline. First patient dosed in January 2014
 
NMEs
Phases I and II (continued)
 
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory,  Inflammation & Autoimmunity
AZD2115#
MABA
COPD
II
2Q 2012
        
AZD5069
CXCR2
asthma
II
4Q 2010
        
benralizumab#
anti-IL-5R MAb
COPD
II
4Q 2010
        
brodalumab#
anti-IL-17R MAb
asthma / psoriatic arthritis
II
2Q 2013
        
mavrilimumab#
anti-GM-CSFR MAb
rheumatoid arthritis
II
1Q 2010
        
MEDI-546#
anti-IFN-alphaR MAb
SLE
II
1Q 2012
        
MEDI2070#
anti-IL-23 MAb
Crohn's disease
II
1Q 2013
        
MEDI7183#
anti-a4b7 MAb
Crohn's disease / ulcerative colitis
II
4Q 2012
        
MEDI8968#
anti-IL-1R MAb
COPD, HS
II
4Q 2011
        
RDEA3170
selective inhibitor of URAT1
chronic management of hyperuricaemia in patients with gout
II
3Q 2013
        
sifalimumab#
anti-IFN-alpha MAb
SLE
II
3Q 2008
        
tralokinumab
anti-IL-13 MAb
asthma / IPF
II
1Q 2008
        
AZD1419
TLR9
asthma
I
3Q 2013
        
AZD4721
CXCR2
COPD
I
3Q 2013
        
AZD7624
ip38i
COPD
I
1Q 2013
        
AZD8848#
inhaled TLR7
asthma
I
2Q 2012
        
MEDI-551#
anti-CD19 MAb
multiple sclerosis
I
3Q 2012
        
MEDI5872#
anti-B7RP1 MAb
SLE
I
4Q 2008
        
MEDI9929#
anti-TSLP MAb
asthma
I
4Q 2008
        
PT010
LAMA/LABA/ICS
COPD
I
4Q 2013
        
 
#Partnered product
 
Development Pipeline - Discontinued Projects between 1 January 2013 and 31 December 2013
 
Infection
 
NME/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
MEDI-557
Safety/Efficacy
RSV prevention in high risk adults (COPD/CHF/other)
 
Neuroscience
 
NME/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD1446
Safety/Efficacy
Alzheimer's disease
NME
AZD3480#
Safety/Efficacy
Alzheimer's disease
NME
AZD5213
Hypothesis risk
Alzheimer's disease
NME
AZD6765
Safety/Efficacy
major depressive disorder
NME
MEDI5117
Safety/Efficacy
OA pain
 
Oncology
 
NME/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD8330#(ARRY 424704)
Safety/Efficacy
solid tumours
NME
fostamatinib#
Safety/Efficacy
haematological malignancies
NME
MEDI-575#
Safety/Efficacy
NSCLC
 
Respiratory, Inflammation & Autoimmunity
 
NME/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD5423#
Safety/Efficacy
COPD
NME
AZD7594#
Safety/Efficacy
COPD
NME
fostamatinib#
Safety/Efficacy
rheumatoid arthritis
NME
MEDI4212
Safety/Efficacy
asthma
NME
MEDI7814
Economic
COPD
LCM
tralokinumab
Safety/Efficacy
UC
 
#Partnered product
 
Completed Projects
 
 
Compound
Mechanism
Area Under Investigation
Launch Status
US
EU
Japan
China
Cardiovascular
Forxiga (dapagliflozin)
SGLT2 inhibitor
diabetes - add on to DPP-4
 
 
  
Approved
    
Forxiga (dapagliflozin)
SGLT2 inhibitor
diabetes - add on to metformin long-term data
 
 
  
Approved
    
Forxiga (dapagliflozin)1
SGLT2 inhibitor
diabetes -  in patients with high CV risk - study 18 and 19 long-term data
 
        
Forxiga (dapagliflozin)
SGLT2 inhibitor
diabetes - triple therapy (dapa+met+ SU)
  
Approved
    
Infection
Q-LAIV Flu Vaccination
live, attenuated, intranasal influenza virus vaccine  (quadrivalent)
seasonal influenza
 
 
Approved
Approved
    
1Studies 18/19 complete. No filing planned from this data
 
Comments
As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
 
Submission dates shown for assets in Phase III and beyond.
 

 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
AstraZeneca PLC
 
Date: 06 February 2014
By: /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary