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Final Results - Part 3 of 3

2nd Feb 2012 07:01

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 PhaseEstimated Filing
USEUJapanEmerging
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Withdrawn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 PhaseEstimated Filing
USEUJapanEmerging

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 PhaseEstimated Filing
USEUJapanEmerging
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 PhaseEstimated Filing
USEUJapanEmerging

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

USEUJapanEmerging

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 PhaseEstimated Filing
USEUJapanEmerging

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 PhaseEstimated Filing
USEUJapanEmerging

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
 
END
 
 
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