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AstraZeneca PLC (AZN)

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Thursday 31 January, 2013

AstraZeneca PLC

Final Results

RNS Number : 7729W
AstraZeneca PLC
31 January 2013
 



Development Pipeline as at

31 December 2012

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Withdrawn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

2016


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




Bydureon Dual Chamber Pen#

GLP-1 receptor agonist

diabetes

III


3Q 2013




Forxiga

(dapagliflozin)/ metformin FDC#

SGLT2 inhibitor + metformin FDC

diabetes

III

3Q 2007


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


1Q 2013



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


Nexium

proton pump inhibitor

peptic ulcer bleeding

III


Filed**

Launched

N/A

Launched

Neuroscience

Diprivan#

sedative and anaesthetic

conscious sedation

III



Launched

1H 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

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

***Excludes Symbicort pMDI post marketing LABA safety study

 

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

2Q  2013

Approved

Forxiga (dapagliflozin)#

SGLT2 inhibitor

diabetes

III


Filed*

Launched

1Q 2013

1Q 2013

metreleptin#

leptin analogue

lipodystrophy

III


2Q 2013


N/A


Infection

CAZ AVI#

(CAZ104)

beta lactamase inhibitor/

cephalosporin

serious infections

III

1Q 2012

N/A

2H 2014

2H 2014

2016

Q-LAIV

Flu Vaccination**

live, attenuated, intranasal influenza virus vaccine  (quadrivalent)

seasonal influenza

III


Approved

Filed



Zinforo# (ceftaroline)

 

extended spectrum cephalosporin 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

Respiratory & Inflammation

brodalumab#

anti-IL-17R MAb

psoriasis

III

3Q 2012

2015

2015



fostamatinib#

spleen tyrosine kinase (SYK) inhibitor

rheumatoid arthritis

III

3Q 2010

4Q 2013

4Q 2013



lesinurad

selective inhibitor of URAT1

chronic management of hyperuricaemia in patients with gout

III

4Q 2011

1H 2014

1H 2014

2017

2017

 

#Partnered product

*CRL received in January 2012

**sBLA in US, MAA in EU

 

 

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

I

4Q 2010





Gastrointestinal

tralokinumab

anti-IL-13 MAb

ulcerative colitis

II

2Q 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





MEDI-550

pandemic influenza virus vaccine

pandemic influenza prophylaxis

I

2Q 2006





MEDI-557

anti-RSV MAb - extended half-life

RSV prevention in high risk adults (COPD/CHF/other)

I

3Q 2007





MEDI-559

paediatric  RSV vaccine

RSV prophylaxis

I

4Q 2008





Neuroscience

AZD3241

myeloper-oxidase (MPO) inhibitor

Parkinson's disease

II

2Q 2012





AZD3480#

alpha4/beta2 neuronal nicotinic receptor agonist

Alzheimer's disease

II

3Q 2007





AZD5213

histamine-3 receptor  antagonist

Alzheimer's disease

II

2Q 2012





AZD6765

NMDA receptor antagonist

major depressive disorder

II

3Q 2007





AZD1446#

alpha4/beta2 neuronal nicotinic receptor agonist 

Alzheimer's disease

I

4Q 2008





AZD3293#

beta secretase

Alzheimer's disease

I

4Q 2012





MEDI5117

anti-IL-6 MAb

rheumatoid arthritis

I

2Q 2012





 

#Partnered product

 

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





fostamatinib#

spleen tyrosine kinase (SYK) inhibitor

haematological malignancies

II

1Q 2012





MEDI-551#

anti-CD19 MAb

haematological malignancies

II

1Q 2012





MEDI-573#

anti-IGF MAb

MBC

II

4Q 2011





MEDI-575#

anti-PDGFR-alpha MAb

NSCLC

II

2Q 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





AZD8330#

(ARRY 424704)

MEK inhibitor

solid tumours

I

1Q 2007





AZD9150

STAT3 inhibitor

haematological malignancies

I

1Q 2012





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





moxetumomab pasudotox#

 

anti-CD22 recombinant immunotoxin

haematological malignancies

I

2Q 2007





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

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





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

II

4Q 2011





sifalimumab#

anti-IFN-alpha MAb

SLE

II

3Q 2008





tralokinumab

anti-IL-13 MAb

asthma / IPF

II

1Q 2008





AZD8848#

inhaled TLR7

asthma

I

2Q 2012





AZD7594#

inhaled SGRM

COPD

I

4Q 2012





MEDI2070#

anti-IL-23 MAb

Crohn's disease

I

2Q 2010





MEDI4212

anti-IgE MAb

asthma

I

1Q 2012





MEDI-551#

anti-CD19 MAb

multiple sclerosis

I

3Q 2012





MEDI5872#

anti-B7RP1 MAb

SLE

I

4Q 2008





MEDI7814

anti-C5/C5a MAb

COPD

I

1Q 2012





MEDI9929#

anti-TSLP MAb

asthma

I

4Q 2008





RDEA3170

selective inhibitor of URAT1

chronic management of hyperuricaemia in patients with gout

I

3Q 2011





 

#Partnered product

 

 

Completed Projects

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Cardiovascular

Crestor#

statin

outcomes in subjects with elevated CRP



Launched

Launched


Launched

Gastrointestinal

Nexium

proton pump inhibitor

GERD



Launched

Launched

Launched

Launched

Infection

FluMist/Fluenz

 

live, attenuated, intranasal influenza virus vaccine

influenza



Launched

Launched



Neuroscience

EMLA

local anaesthetic

topical anaesthesia




Launched

Launched


Oncology

Iressa

EGFR tyrosine kinase inhibitor

1st line EGFR mut+ NSCLC




Launched

Launched

Launched

Faslodex

oestrogen receptor agonist

High dose (500mg) 2nd line advanced breast cancer



Launched

Launched

Launched


Ranmark# (denosumab)

anti-RANKL MAb

Bone disorders stemming from bone metastasis





Launched


Respiratory & Inflammation

Oxis

long-acting β2 agonist

COPD




Launched

Launched

Launched

Symbicort

inhaled steroid/ long-acting β2 agonist

COPD



Launched

Launched

Launched

Launched

Symbicort

inhaled steroid/long acting β2 agonist

SMART




Launched

Launched

Launched

 

Development Pipeline - Discontinued Projects between 30 June 2012 and 31 December 2012

 

Cardiovascular

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD2820

Safety/Efficacy

obesity

NCE

AZD4017

Safety/Efficacy

glaucoma

 

Infection

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD9773

Safety/Efficacy

severe sepsis

 

Oncology

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD1480

Safety/Efficacy

solid tumours

NCE

AZD3514

Safety/Efficacy

prostate cancer

NCE

AZD8931

Safety/Efficacy

breast cancer chemo. combi./solid tumours

NCE

selumetinib (AZD6244) (ARRY-142886)/MK2206#

Study completed

solid tumours

 

Respiratory & Inflammation

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD8683

Safety/Efficacy

COPD

NCE

MEDI-570

Safety/Efficacy

SLE

 

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.

 


This information is provided by RNS
The company news service from the London Stock Exchange
 
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