azn201308016k1.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 August 2013

 
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
30 June 2013
Line Extensions
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
Axanum***
proton pump inhibitor + low dose aspirin FDC
low dose aspirin associated peptic ulcer in high risk CV patients
III
  
Withdrawn
Launched
    
Brilinta/ Brilique EUCLID
ADP receptor antagonist
outcomes study in patients with PAD
III
4Q 2012
2016
2016
2016
2017
Brilinta / Brilique PEGASUS-TIMI 54
ADP receptor antagonist
outcomes study in patients with prior MI
III
4Q 2010
2015
2015
2015
2017
Bydureon EXSCEL#
GLP-1 receptor agonist
outcomes study
III
2Q 2010
2018
2018
2018
  
Bydureon Dual Chamber Pen#
GLP-1 receptor agonist
diabetes
III
  
3Q 2013
4Q 2013
    
Forxiga (dapagliflozin)/ metformin FDC#
SGLT2 inhibitor + metformin FDC
diabetes
III
3Q 2007
4Q 2013
Filed
    
Forxiga (dapagliflozin)#
SGLT2 inhibitor
diabetes - add on to DPP-4
III
1Q 2010
  
Filed
    
Forxiga (dapagliflozin)#
SGLT2 inhibitor
diabetes - add on to insulin and add-on to metformin long-term data
III
2Q 2008
  
Filed
    
Forxiga (dapagliflozin)#
SGLT2 inhibitor
diabetes - in patients with high CV risk - Study 18 and 19 long-term data
III
1Q 2010
  
1H 2014
    
Forxiga (dapagliflozin)#
SGLT2 inhibitor
diabetes - triple therapy (dapa+met+ SU)
III
1Q 2011
  
4Q 2013
    
Forxiga (dapagliflozin) DECLARE#
SGLT2 inhibitor
outcomes study
III
2Q 2013
2020
2020
    
Kombiglyze XR/ Komboglyze FDC#*
DPP-4 inhibitor + metformin FDC
diabetes
III
  
Launched
Launched
  
1H 2014
SaxaDapa FDC#
DPP-4 inhibitor / SGLT2 inhibitor
diabetes
III
2Q 2012
2015
2015
    
Onglyza SAVOR-TIMI 53#
DPP-4 inhibitor
outcomes study
III
2Q 2010
4Q 2013
4Q 2013
  
2H 2014
 
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Gastrointestinal
Entocort
glucocorticoid steroid
Crohn's disease / ulcerative colitis
III
  
Launched
Launched
2015
 N/A
Nexium
proton pump inhibitor
peptic ulcer bleeding
III
  
Filed**
Launched
N/A
Launched
Neuroscience
Diprivan#
sedative and anaesthetic
conscious sedation
III
    
Launched
2H 2014
Launched
Oncology
Faslodex
oestrogen receptor antagonist
1st line advanced breast cancer
III
4Q 2012
2016
2016
2016
2016
Iressa
EGFR tyrosine kinase inhibitor
treatment beyond progression
III
1Q 2012
  
2015
2015
2015
Respiratory, Inflammation & Autoimmunity
Symbicort
inhaled steroid/ long-acting β2 agonist
Breath Actuated Inhaler asthma /
COPD
III
4Q 2011
1H 2014
      
                   
 
#Partnered product
*Kombiglyze XR US; Komboglyze FDC EU
**2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012
***Commercial support now withdrawn, no Japan launch expected
 
NCEs
Phase III/Registration
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
Brilinta/ Brilique
ADP receptor antagonist
arterial thrombosis
III
  
Launched
Launched
Filed
Launched
Epanova#
omega-3 free fatty acids
hypertri-glyceridaemia
III
  
Filed
      
Forxiga (dapagliflozin)#
SGLT2 inhibitor
diabetes
III
  
Filed*
Launched
Filed
Filed
metreleptin#
leptin analogue
lipodystrophy
III
  
Filed
1H 2014
N/A
  
Infection
CAZ AVI# (CAZ104)
beta lactamase inhibitor/ cepha-losporin
intra abdominal infections (cIAI) & urinary tract infections (cUTI); hospital acquired pneumonia (HAP) & ventilator associated pneumonia (VAP) ***
III
1Q 2012
N/A
2H 2014
2015
2016
Q-LAIV Flu Vaccination**
live, attenuated, intranasal influenza virus vaccine  quadrivalent
seasonal influenza
III
  
Approved
Filed
    
Zinforo
(ceftaroline) #
extended spectrum cepha-losporin with affinity to penicillin- binding proteins
pneumonia / skin infections
III
  
N/A
Launched
  
1H 2014
Neuroscience
naloxegol (NKTR-118)#
oral peripherally-acting mu-opioid receptor antagonist
opioid-induced constipation
III
2Q 2011
 3Q 2013
 3Q 2013
    
Oncology 
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer
III
  
Launched
Launched
2015
Filed
moxetumomab pasudotox#
anti-CD22 recombinant immunotoxin
hairy cell leukaemia
III
2Q 2013
2017
2017
    
                     
 
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation & Autoimmunity
brodalumab#
anti-IL-17R MAb
psoriasis
III
3Q 2012
2015
2015
    
PT003 GFF
LABA/LAMA
COPD
III
2Q 2013
2015
2016
    
lesinurad
selective uric acid reabsorption inhibitor (SURI) 
chronic treatment  of patients with gout
III
4Q 2011
2H 2014
2H 2014
2017
2017
                     
 
#Partnered product
*CRL received in January 2012, re-submission 3Q 2013
**sBLA in US, MAA in EU
***HAP/VAP is a follow up filing, EU filing expected in 2017
 
 
NCEs
Phases I and II
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular
AZD1722#
NHE3 inhibitor
end stage renal disease / chronic kidney disorder
II
1Q 2013
        
MEDI6012 (ACP-501)
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
        
MEDI4893
staph alpha toxin YTE MAb
hospital-acquired pneumonia / serious S. aureus infection
I
1Q 2013
        
MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
2Q 2006
        
PRVV
(MEDI-559)
live attenuated paediatric RSV vaccine
RSV prophylaxis
I
4Q 2008
        
Neuroscience
AZD3241
myeloper-oxidase (MPO) inhibitor
Parkinson's disease
II
2Q 2012
        
AZD5213
histamine-3 receptor  antagonist
neuropathic pain*
II
          
AZD6765
NMDA receptor antagonist
major depressive disorder
II
3Q 2007
        
AZD3293#
beta secretase
Alzheimer's disease
I
4Q 2012
        
 
#Partnered product
*Terminated in Alzheimer's Disease - neuropathic pain study due to start 3Q 2013
 
 
NCEs
Phases I and II (continued)
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Oncology
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
gBRCAm ovarian cancer, gBRCAm breast cancer, gastric cancer
II
1Q 2012
        
selumetinib# (AZD6244) (ARRY-142886)
MEK inhibitor
solid tumours
II
4Q 2006
        
tremelimumab
anti-CTLA4 MAb
solid tumours
II
3Q 2004
        
AZD1208
PIM kinase inhibitor
haematological malignancies
I
1Q 2012
        
AZD2014
TOR kinase inhibitor
solid tumours
I
1Q 2010
        
AZD5363#
AKT inhibitor
solid tumours
I
4Q 2010
        
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
        
MEDI0639#
anti-DLL-4 MAb
solid tumours
I
2Q 2012
        
MEDI3617#
anti-ANG-2 MAb
solid tumours
I
4Q 2010
        
MEDI4736#
anti-PD-L1 MAb
solid tumours
I
3Q 2012
        
MEDI-565#
anti-CEA BiTE
solid tumours
I
1Q 2011
        
MEDI6469#
murine anti-OX40 MAb
solid tumours
I
1Q 2006
        
volitinib#
MET inhibitor
solid tumours
I
1Q 2012
        
 
#Partnered product
 
 
NCEs
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
        
AZD5423#
inhaled SGRM
COPD
II
4Q 2010
        
benralizumab#
anti-IL-5R MAb
asthma / COPD
II
4Q 2008
        
mavrilimumab#
anti-GM-CSFR MAb
rheumatoid arthritis
II
1Q 2010
        
MEDI2070#
anti-IL-23 MAb
Crohn's disease
II
1Q 2013
        
MEDI-546#
anti-IFN-alphaR MAb
SLE
II
1Q 2012
        
MEDI7183#
anti-a4b7 MAb
Crohn's disease / ulcerative colitis
II
4Q 2012
        
MEDI8968#
anti-IL-1R MAb
COPD, HS
II
4Q 2011
        
sifalimumab#
anti-IFN-alpha MAb
SLE
II
3Q 2008
        
tralokinumab
anti-IL-13 MAb
asthma / IPF / UC
II
1Q 2008
        
AZD8848#
inhaled TLR7
asthma
I
2Q 2012
        
AZD7594#
inhaled SGRM
COPD
I
4Q 2012
        
AZD7624
ip38i
COPD
I
1Q 2013
        
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
        
RDEA3170
selective uric acid reabsorption inhibitor (SURI)
chronic treatment  of patients with gout
I
3Q 2011
        
 
#Partnered product
 
 
Development Pipeline - Discontinued Projects between 1 January 2013 and 30 June 2013
 
Infection
NCE/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NCE
MEDI-557
 safety / efficacy
RSV prevention in high risk adults (COPD/CHF/other)
 
Neuroscience
NCE/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NCE
AZD1446
 safety / efficacy
Alzheimer's disease
NCE
AZD3480
 safety / efficacy
Alzheimer's disease
NCE
MEDI5117
 safety / efficacy
rheumatoid arthritis
 
Oncology
NCE/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NCE
AZD8330#(ARRY 424704)
 safety / efficacy
solid tumours
NCE
fostamatinib
 safety / efficacy
haematological malignancies
NCE
MEDI-575
 safety / efficacy
NSCLC
 
Respiratory, Inflammation & Autoimmunity
NCE/Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NCE
fostamatinib
 safety / efficacy
rheumatoid arthritis
NCE
MEDI7814
 economic
COPD
NCE
MEDI4212
 safety / efficacy
asthma
 
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.

- ENDS -
 

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: 01 August 2013
By: /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary