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AstraZeneca PLC (AZN)

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Thursday 02 February, 2012

AstraZeneca PLC

Final Results - Part 3 of 3

RNS Number : 6676W
AstraZeneca PLC
02 February 2012
 



Development Pipeline as at

31 December 2011

 

 

Line Extensions

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Cardiovascular

Axanum

proton pump inhibitor + low dose aspirin FDC

low dose aspirin associated peptic ulcer in high risk CV patients

III


Withdrawn

Launched

1H 2013

Filed

Brilinta/

Brilique PEGASUS-TIMI

ADP receptor antagonist

outcomes study

III

4Q 2010

2014

2014

2014

2014

Crestor#

statin

outcomes in subjects with elevated CRP

III


Launched

Launched


Filed

dapagliflozin/ metformin FDC#

SGLT2 inhibitor + metformin FDC

diabetes

III

3Q 2007


3Q 2012



dapagliflozin#

SGLT2 inhibitor

diabetes - add on to DPP-4

III

1Q 2010


3Q 2012



dapagliflozin#

SGLT2 inhibitor

diabetes - add on to insulin and add-on to metformin LT data

III

2Q 2008


3Q 2012



dapagliflozin#

SGLT2 inhibitor

diabetes - in patients with high CV risk - Study 18 and 19 data

III

1Q 2010


2H 2013



Kombiglyze XRTM/ KomboglyzeTM FDC#* 

DPP-4 inhibitor + metformin FDC

diabetes

III


Launched

Approved


Approved

OnglyzaTM

SAVOR-TIMI#

DPP-4 inhibitor

outcomes study

III

2Q 2010

2016

2016


2016

Gastrointestinal

Entocort

glucocorticoid steroid

Crohn's disease and ulcerative colitis

III


Launched

Launched

2014

TBC

Nexium

proton pump inhibitor

peptic ulcer bleeding

III


Filed**

Launched


Launched

Nexium

proton pump inhibitor

GERD

III


Launched

Launched

Launched

Launched

 

#Partnered product

*Kombiglyze XRTM US; KomboglyzeTM FDC EU

**2nd CRL received in June 2011



Line Extensions (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Infection

FluMist/Fluenz

 

live, attenuated, intranasal influenza virus vaccine

influenza

III


Launched

Approved


Launched

Neuroscience

Diprivan#

sedative and anaesthetic

conscious sedation

III



Launched

2H 2013

Launched

EMLA#

local anaesthetic

topical anaesthesia

III



Launched

Approved

Launched

Oncology

Faslodex

oestrogen receptor antagonist

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

III


Launched

Launched

Launched

Launched

Faslodex

oestrogen receptor antagonist

1st line advanced breast cancer

III


2016

2016

2016

2016

Iressa

EGFR tyrosine kinase inhibitor

1st line EGFR mut+ NSCLC

III



Launched

Launched

Launched

Iressa

EGFR tyrosine kinase inhibitor

treatment beyond progression

III



2015

2015

2015

Respiratory & Inflammation

Oxis

long-acting β2 agonist

COPD

III



Launched

Filed


Symbicort

inhaled steroid/ long-acting β2 agonist

asthma/

COPD

III


1H 2013




Symbicort

inhaled steroid/ long-acting β2 agonist

COPD

III


Launched

Launched

Filed

Launched

Symbicort

inhaled steroid/ long-acting β2 agonist

SMART

III



Launched

Filed

Launched

 

#Partnered product



NCEs

Phase III/Registration

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Cardiovascular

Brilinta/Brilique

ADP receptor antagonist

arterial thrombosis

III


Launched

Launched

1H 2013

Launched

dapagliflozin#

SGLT2 inhibitor

diabetes

III

3Q 2007

Filed*

Filed

1H 2013

Filed

Infection

CAZ AVI#

(CAZ104)

beta lactamase inhibitor/

cephalosporin

serious infections

    III**

1Q 2012


2014

2014

2014

Q-LAIV Flu Vac 

(MEDI-3250***)

live, attenuated, intranasal influenza virus vaccine  (quadrivalent)

seasonal influenza

III

1Q 2009

Filed

4Q 2012



Zinforo# (ceftaroline)

extended spectrum cephalosporin with affinity to penicillin- binding proteins

pneumonia / skin infections

III

1Q 2007


Filed


Filed

Neuroscience

NKTR-118#

oral peripherally-acting opioid antagonist

opioid-induced constipation

III

2Q 2011****

2H 2013

2H 2013



TC-5214#

neuronal nicotinic channel modulator

major depressive disorder (adjunct)

III

2Q 2010

3Q 2012

2015



Oncology 

Caprelsa

 

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer

III


Launched

Filed

2014

Filed

Ranmark# (denosumab)

anti-RANKL MAb

bone disorders stemming from bone metastasis

III




Approved


Respiratory & Inflammation

fostamatinib#

spleen tyrosine kinase (SYK) inhibitor

rheumatoid arthritis

III

3Q 2010

2H 2013

2H 2013


2H 2013

 

#Partnered product

*CRL received in January 2012

**Phase 3 dosing expected in 1Q 2012

***sBLA in US, MAA in EU

****Enrolment began in 1Q 2011

 



 

NCEs

Phases I and II

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Cardiovascular

AZD2927

ion channel blocker / inhibitor

atrial fibrillation

II

4Q 2011


 

 

 



AZD4017

11BHSD

glaucoma

II

1Q 2011





AZD2820#

melanocortin receptor type 4 (MC4r) partial agonist peptide

obesity

I

2Q 2011





Gastrointestinal

tralokinumab

 (CAT-354)

anti-IL-13 MAb

ulcerative colitis

I

2Q 2011





Infection

AZD9773#

anti-TNF-alpha polyclonal antibody

severe sepsis

II

1Q 2008





CXL# (CEF104)

beta lactamase inhibitor/

cephalosporin

MRSA

II

4Q 2010





AZD5099

gyrase B

serious infections

I

2Q 2011





AZD5847

oxazolidinone antibacterial inhibitor

tuberculosis

I

4Q 2009





MEDI-534

 

RSV/PIV-3 vaccine

RSV/PIV prophylaxis

I

2Q 2005





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





 

#Partnered product



 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Neuroscience

AZD2423

CCR2b antagonist

chronic neuropathic pain

II

4Q 2010





AZD3480#

alpha4/beta2 neuronal nicotinic receptor agonist

Alzheimer's disease

II

3Q 2007





AZD6765

NMDA receptor antagonist

major depressive disorder

II

3Q 2007





TC-5214#

neuronal nicotinic channel modulator

major depressive disorder (monotherapy)

II

1Q 2011





AZD1446#

alpha4/beta2 neuronal nicotinic receptor agonist 

Alzheimer's disease

I

4Q 2008





AZD3241

myeloper-oxidase (MPO) inhibitor

Parkinson's disease

I

2Q 2007





AZD3839#

beta-secretase (BACE) inhibitor

Alzheimer's disease

I

3Q 2011





AZD5213

histamine-3 receptor  antagonist

Alzheimer's disease / ADHD

I

2Q 2010





MEDI-578

anti-NGF MAb

OA pain

I

1Q 2010





 

#Partnered product



NCEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Oncology

AZD4547

FGFR tyrosine kinase inhibitor

solid tumours

II

4Q 2011





AZD8931

erbB kinase inhibitor

breast cancer chemo. combi./solid tumours

II

2Q 2010





fostamatinib#*

spleen tyrosine kinase (SYK) inhibitor

haematological malignancies

II

1Q 2012





MEDI-575#

anti-PDGFR-alpha MAb

NSCLC / glioblastoma

II

4Q 2010





selumetinib# (AZD6244)

(ARRY-142886)

MEK inhibitor

solid tumours

II

4Q 2006





tremelimumab#

anti-CTLA4 MAb

solid tumours

II

3Q 2004





AZD1480

JAK1, 2 inhibitor

solid tumours

I

2Q 2009





AZD2014

TOR kinase inhibitor

solid tumours

I

1Q 2010





AZD3514

androgen receptor down-regulator

prostate cancer

I

3Q 2010





AZD5363#

AKT inhibitor

solid tumours

I

4Q 2010





AZD8330#

(ARRY 424704)

MEK inhibitor

solid tumours

I

1Q 2007





MEDI-551#

anti-CD19 MAb

haematological malignancies

I

2Q 2010





MEDI-565#

anti-CEA BiTE

solid tumours

I

1Q 2011





MEDI-573#

anti-IGF MAb

solid tumours

I

1Q 2009





MEDI-3617#

anti-ANG-2 MAb

solid tumours

I

4Q 2010





moxetumomab pasudotox#

(CAT-8015)

anti-CD22 recombinant immunotoxin

haematological malignancies

I

2Q 2007





olaparib

PARP inhibitor

solid tumours

I

4Q 2008





selumetinib (AZD6244)  (ARRY-142886)

/MK2206#

MEK/AKT inhibitor

solid tumours

I

4Q 2009





 

#Partnered product

*Added to pipeline table after starting Phase 2 in January 2012



 

 

NCEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

Emerging

Respiratory & Inflammation

AZD1981

CRTh2 receptor antagonist

asthma/COPD

II

3Q 2005





AZD2423

CCR2b antagonist

COPD

II

4Q 2010





AZD5069

CXCR2

COPD

II

4Q 2010





AZD5423

inhaled SEGRA

COPD

II

4Q 2010





AZD8683

muscarinic antagonist

COPD

II

4Q 2010





benralizumab (MEDI-563)#

anti-IL-5R MAb

asthma/COPD

II

4Q 2008





mavrilimumab

(CAM-3001)#

anti-GM-CSFR MAb

rheumatoid arthritis

II

1Q 2010





MEDI-8968#

anti-IL-1R MAb

COPD

II

4Q 2011





sifalimumab

(MEDI-545)#

anti-IFN-alpha MAb

SLE

II

3Q 2008





tralokinumab

(CAT-354)

anti-IL-13 MAb

asthma

II

1Q 2008





AZD2115

MABA

COPD

I

1Q 2011





MEDI-546#

anti-IFN-alphaR MAb

scleroderma

I

3Q 2009





MEDI-551#

anti-CD19 MAb

scleroderma

I

2Q 2010





MEDI-570#

anti-ICOS MAb

SLE

I

2Q 2010





 

#Partnered product



 

Development Pipeline - Discontinued Projects between 27 January 2011 and 31 December 2011

 

Cardiovascular

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD1656

Safety/Efficacy

diabetes

NCE

AZD5658

Safety/Efficacy

diabetes

NCE

AZD6714

Safety/Efficacy

diabetes

NCE

AZD7687

Safety/Efficacy

diabetes

NCE

AZD8329

Safety/Efficacy

diabetes

 

Neuroscience

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD2066

Safety/Efficacy

major depressive disorder

NCE

AZD2066

Safety/Efficacy

chronic neuropathic pain

NCE

AZD3043

Economic

short acting sedative/anaesthetic

NCE

TC-5619

Economic

cognitive disorders in schizophrenia

 

Oncology

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD1152

Economic

haematological malignancies

NCE

AZD2461

Safety/Efficacy

solid tumours

NCE

AZD7762

Safety/Efficacy

solid tumours

NCE

AZD8055

Safety/Efficacy

range of tumours

NCE

olaparib (AZD2281)

Safety/Efficacy

serous ovarian cancer

NCE

Recentin

Safety/Efficacy

NSCLC

NCE

zibotentan (ZD4054)

Safety/Efficacy

castrate resistant prostate cancer

 

Infection

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD9742

Safety/Efficacy

MRSA

NCE

motavizumab

Regulatory

early and late treatment of RSV in paeds >1 yr

 

Respiratory & Inflammation

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD3199

Economic/Regulatory

asthma/COPD

NCE

AZD9819

Economic

COPD

NCE

MEDI-528

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.

 


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