azn201404246k2.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 April 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-_____________

 

 

 
ASTRAZENECA DEVELOPMENT PIPELINE
 
AS AT 31 MARCH 2014
 
 
NMEs
 
Phase III / Registration
 
Submission dates shown for assets in Phase III and beyond. 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.
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
Brilinta / Brilique1
ADP receptor antagonist
arterial thrombosis
 
Launched
Launched
Filed
Launched
Epanova#
omega-3 free fatty acids
hypertriglyceridaemia
 
Filed
     
Farxiga / Forxiga2
SGLT-2 inhibitor
diabetes
 
Launched
Launched
Approved
Filed
Myalept
leptin analogue
lipodystrophy
 
Approved
2015
N/A
 
Oncology
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer
 
Launched
Launched
Q3 2014
Filed
moxetumomab pasudotox#
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
2018
2018
   
olaparib
PARP inhibitor
BRCAm PSR ovarian cancer
 
Filed3
Filed
   
olaparib SOLO-1
PARP inhibitor
1st line BRCAm ovarian cancer
Q3 2013
2017
2017
2017
2017
olaparib SOLO-2
PARP inhibitor
BRCAm PSR ovarian cancer
Q3 2013
2016
2016
2016
2016
olaparib GOLD
PARP inhibitor
2nd line gastric cancer
Q3 2013
   
2017
2018
olaparib OlympiAD
PARP inhibitor
metastatic breast cancer
Q2 20144
2016
2016
2017
 
selumetinib#
(ARRY-142886)
SELECT-1
MEK inhibitor
2nd line KRAS+ NSCLC
Q4 2013
2017
2017
   
selumetinib#
(ARRY-142886) ASTRA
MEK inhibitor
differentiated thyroid cancer5
Q3 2013
2017
2017
   
selumetinib#
(ARRY-142886) SUMIT
MEK inhibitor
uveal melanoma5
Q1 20146
2015
2015
   

 
Phase III / Registration (continued)
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
benralizumab#
anti-IL-5R MAb
severe asthma
Q4 2013
2016
2016
   
brodalumab#
AMAGINE-1,2,3
anti-IL-17R MAb
psoriasis
Q3 2012
++
++
   
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
Q4 2014
Q4 2014
 
2017
PT003 GFF
LAMA / LABA
COPD
Q2 2013
2015
2016
   
PT001 GP
LAMA
COPD
Q2 2013
2015
2016
   
Infection
CAZ AVI# (CAZ104) RECLAIM
cephalosporin / beta lactamase inhibitor
serious infections
Q1 2012
N/A
Q4 2014
2015
2016
CAZ AVI# (CAZ104) REPROVE
cephalosporin / beta lactamase inhibitor
hospital-acquired pneumonia / ventilator-associated pneumonia
Q2 2013
N/A
2017
2017
2018
Zinforo#
extended spectrum cephalosporin with affinity to penicillin-binding proteins
pneumonia / skin infections
 
N/A
Launched
N/A
Q2 2014
Neuroscience
naloxegol# (NKTR-118)
oral peripherally-acting mu-opioid receptor antagonist
opioid-induced constipation
 
Filed
Filed
   
# Partnered product.
++ 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 FDA accepted submission April 2014.
4 First patient randomised April 2014.
5 These indications previously included under the broad Phase II project listing.
6 First patient expected to dose early Q2 2014.
 
NMEs
 
Phases I and II
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Cardiovascular and Metabolism
AZD1722#
NHE3 inhibitor
ESRD-Pi CKD with T2DM / ESRD-fluid retention
II
Q1 2013
       
AZD4901
hormone modulator
polycystic ovarian syndrome
II
Q2 2013
       
roxadustat# (FG-4592)
hypoxia-inducible factor inhibitor
anaemia in CKD / ESRD
II1
 
2018
NA
NA
2016
MEDI6012
LCAT
arterial thrombosis
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
haematological malignancies
II
Q1 2012
       
MEDI-573#
anti-IGF MAb
metastatic breast cancer
II
Q2 2012
       
MEDI4736#
anti-PD-L1 MAb
NSCLC
II
Q1 2014
       
selumetinib# (ARRY-142886)
MEK inhibitor
2nd line KRAS- NSCLC
II
Q1 2013
       
tremelimumab
anti-CTLA4 MAb
mesothelioma
II
Q2 2013
       
AZD5363#
AKT kinase inhibitor
breast cancer
II
Q1 2014
       
AZD1208
PIM kinase inhibitor
haematological malignancies
I
Q1 2012
       
AZD6738
ATR serine / threonine kinase inhibitor
CLL / head & neck
I
Q4 2013
       
AZD8186
PI3 kinase beta inhibitor
solid tumours
I
Q2 2013
       
AZD9150#
STAT3 inhibitor
haematological malignancies
I
Q1 2012
       
AZD9291
EGFR tyrosine kinase inhibitor
solid tumours
I
Q1 2013
       
MEDI-565#
anti-CEA BiTE MAb
solid tumours
I
Q1 2011
       
MEDI0639#
anti-DLL-4 MAb
solid tumours
I
Q2 2012
       
MEDI0680 (AMP-514)
anti-PD-1 MAb
solid tumours
I
Q4 2013
       
MEDI3617#
anti-ANG-2 MAb
solid tumours
I
Q4 2010
       
MEDI4736# + tremelimumab
anti-PD-L1 MAb + anti-CTLA4 MAb
solid tumors
I
Q4 2013
       
MEDI4736# + dabrafenib + trametinib2
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor
melanoma
I
Q1 2014
       
MEDI6469#
murine anti-OX40 MAb
solid tumours
I
Q1 2006
       

 
NMEs
 
Phases I and II (continued)
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Oncology (continued)
moxetumomab
pasudotox#
anti-CD22 recombinant immunotoxin
pALL
I
Q3 2008
       
volitinib# (AZD6094)
MET tyrosine kinase inhibitor
solid tumours
I
Q1 2012
       
Respiratory, Inflammation and Autoimmunity
AZD2115#
MABA
COPD
II
Q2 2012
       
AZD5069
CXCR2 antagonist
asthma
II
Q4 2010
       
anifrolumab# (MEDI-546)
anti-IFN-alphaR MAb
SLE
II
Q1 2012
       
benralizumab#
anti-IL-5R MAb
COPD
II
Q4 2010
       
brodalumab#
anti-IL-17R MAb
asthma
II
Q2 2013
       
mavrilimumab#
anti-GM-CSFR MAb
rheumatoid arthritis
II
Q1 2010
       
MEDI2070#
anti-IL-23 MAb
Crohn's disease
II
Q1 2013
       
MEDI7183#
anti-a4b7 MAb
Crohn's disease / ulcerative colitis
II
Q4 2012
       
MEDI8968#
anti-IL-1R MAb
COPD / HS
II
Q4 2011
       
RDEA3170
selective uric acid reabsorption inhibitor (SURI)
chronic management of hyperuricaemia in patients with gout
II
Q3 2013
       
sifalimumab# (MEDI-545)
anti-IFN-alpha MAb
SLE
II
Q3 2008
       
tralokinumab
anti-IL-13 MAb
asthma / IPF
II
Q1 2008
       
AZD1419
TLR9 antagonist
asthma
I
Q3 2013
       
AZD4721
CXCR2 antagonist
COPD
I
Q3 2013
       
AZD7624
inhaled P38 inhibitor
COPD
I
Q1 2013
       
AZD8848#
inhaled TLR7 antagonist
asthma
I
Q2 2012
       
MEDI-551#
anti-CD19 MAb
multiple sclerosis
I
Q3 2012
       
MEDI5872#
anti-B7RP1 MAb
SLE
I
Q4 2008
       
MEDI9929#
anti-TSLP MAb
asthma
I
Q4 2008
       
PT010
LAMA / LABA / ICS
COPD
I
Q4 2013
       
Infection
AZD5847
oxazolidinone anti-bacterial inhibitor
tuberculosis
II
Q4 2012
       
CXL#
beta lactamase inhibitor / cephalosporin
MRSA
II
Q4 2010
       
ATM AVI
monobactam / beta lactamase inhibitor
targeted serious bacterial infections
I
Q4 2012
       
AZD0914
GyrAR
serious bacterial infections
I
Q4 2013
       
MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
Q2 2006
       

 
NMEs
 
Phases I and II (continued)
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Estimated Filing
US
EU
Japan
China
Infection (continued)
MEDI-559 (PRVV)
paediatric RSV vaccine
RSV prophylaxis
I
Q4 2008
       
MEDI4893
MAb binding to S. aureus toxin
hospital-acquired pneumonia / serious S. aureus infection
I
Q1 2013
       
MEDI92873
H7N9 vaccine
avian influenza
I
Q4 2013
       
Neuroscience
AZD3241
myeloperoxidase inhibitor
Parkinson's disease
II
Q2 2012
       
AZD5213
histamine-3 receptor antagonist
Tourette's syndrome / neuropathic pain
II
Q4 2013
       
AZD3293#
beta-secretase inhibitor
Alzheimer's disease
I
Q4 2012
       
AZD6423
NMDA antagonist
suicidal ideation
I
Q3 2013
       
# Partnered product.
1 In-licensed asset in late-development but the Phase III AstraZeneca programme has yet to randomise its first patient.
2 MedImmune-sponsored study in collaboration with GSK.
3 Vaccine in development through a CRADA with NIH.


Line Extensions
 
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
2016
2016
2016
2017
Brilinta / Brilique1
PEGASUS-
TIMI 54
ADP receptor antagonist
outcomes study in patients with prior myocardial infarction
Q4 2010
2015
2015
2015
2017
Brilinta / Brilique1 SOCRATES
ADP receptor antagonist
outcomes study in patients with stroke or TIA
Q1 2014
2016
2016
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
Chamber Pen
GLP-1 receptor agonist
diabetes
 
Approved
Filed
Q2 2014
 
Bydureon EXSCEL
GLP-1 receptor agonist
outcomes study
Q2 2010
2018
2018
2018
 
Bydureon weekly
suspension
GLP-1 receptor agonist
diabetes
Q1 2013
2015
2015
   
Farxiga / Forxiga2
DECLARE-
TIMI 58
SGLT-2 inhibitor
outcomes study
Q2 2013
2020
2020
   
Kombiglyze XR FDC / Komboglyze FDC3
DPP-4 inhibitor / metformin FDC
diabetes
 
Launched
Launched
 
Filed
Onglyza SAVOR-TIMI 53
DPP-4 inhibitor
outcomes study
Q2 2010
Q1 20144
Filed
 
2015
saxagliptin / dapagliflozin FDC
DPP-4 inhibitor / SGLT-2 inhibitor FDC
diabetes
Q2 2012
2015
2015
   
Xigduo XR FDC / Xigduo FDC5
SGLT-2 inhibitor / metformin FDC
diabetes
 
Filed
Approved6
   
Oncology
Caprelsa
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
differentiated thyroid cancer
Q2 2013
2016
2016
2016
 
Faslodex
FALCON
oestrogen receptor antagonist
1st line advanced breast cancer
Q4 2012
2016
2016
2016
2016
Iressa
EGFR tyrosine kinase inhibitor
treatment beyond progression
Q1 2012
 
2015
2015
2015
Respiratory, Inflammation and Autoimmunity
Symbicort7
ICS / LABA
Breath Actuated Inhaler asthma / COPD
         
Neuroscience
Diprivan#
sedative and anaesthetic
conscious sedation
 
N/A
Launched
Q4 2014
Launched
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
 
Approved
Launched
N/A
Launched
# Partnered product.
1 Brilinta in the US; Brilique in rest of world.
2 Farxiga in the US; Forxiga in rest of world.
3 Kombiglyze XR in the US; Komboglyze FDC in the EU.
4 Filed and awaiting regulatory acceptance.
5 Xigduo XR FDC in the US; Xigduo FDC in the EU.
6 Approval granted in January 2014 but reported as a progression for FY2013.
7 Development of a new BAI device is ongoing.
 
 
 
 

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: 24 April 2014
By:  /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary