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Pipeline table: Second Quarter & Half Year(2 of 2)

26th Jul 2012 07:00

RNS Number : 5549I
AstraZeneca PLC
26 July 2012
 



Development Pipeline as at

30 June 2012

 

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Withdrawn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*

Approved

Brilinta/ Brilique

EUCLID

ADP receptor antagonist

outcomes study in patients with PAD

III

3Q 2012

2016

2016

2016

2016

Brilinta/

Brilique PEGASUS-TIMI 54

ADP receptor antagonist

outcomes study in patients with ACS

III

4Q 2010

2015

2015

2015

2015

Crestor#

statin

outcomes in subjects with elevated CRP

III

Launched

Launched

Launched

ForxigaTM

(dapagliflozin)/ metformin FDC#

SGLT2 inhibitor + metformin FDC

diabetes

III

3Q 2007

3Q 2012

ForxigaTM (dapagliflozin)#

SGLT2 inhibitor

diabetes - add on to DPP-4

III

1Q 2010

3Q 2012

ForxigaTM (dapagliflozin)#

SGLT2 inhibitor

diabetes - add on to insulin and add-on to metformin long-term data

III

2Q 2008

3Q 2012

ForxigaTM (dapagliflozin)#

SGLT2 inhibitor

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

III

1Q 2010

2H 2013

ForxigaTM (dapagliflozin)#

SGLT2 inhibitor

diabetes - triple therapy (dapa+met+ SU)

III

1Q 2011

2H 2013

Kombiglyze XRTM/ KomboglyzeTM FDC#**

DPP-4 inhibitor + metformin FDC

diabetes

III

Launched

Approved

Approved

OnglyzaTM

SAVOR-TIMI 54#

DPP-4 inhibitor

outcomes study

III

2Q 2010

2016

2016

2016

 

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanEmerging

Gastrointestinal

Entocort

glucocorticoid steroid

Crohn's disease / ulcerative colitis

III

Launched

Launched

2014

 Launched

Nexium

proton pump inhibitor

peptic ulcer bleeding

III

Filed***

Launched

Launched

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

Launched

Launched

Oncology

Faslodex

oestrogen receptor antagonist

1st line advanced breast cancer

III

2016

2016

2016

2016

Iressa

EGFR tyrosine kinase inhibitor

treatment beyond progression

III

1Q 2012

2015

2015

2015

Respiratory & Inflammation

Oxis

long-acting β2 agonist

COPD

III

Launched

Approved

Symbicort

inhaled steroid/ long-acting β2 agonist

asthma /

COPD

III

4Q 2011

2014

Symbicort

inhaled steroid/ long-acting β2 agonist

COPD

III

Launched

Launched

Filed

Launched

Symbicort

inhaled steroid/ long-acting β2 agonist

SMART

III

Launched

Launched

Launched

 

#Partnered product

* Nexium low-dose aspirin indications approved in 1H 2012

**Kombiglyze XRTM US; KomboglyzeTM FDC EU

***2nd CRL received in June 2011

 

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

ForxigaTM (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

N/A

2014

2014

2014

Q-LAIV

Flu Vac***

live, attenuated, intranasal influenza virus vaccine (quadrivalent)

seasonal influenza

III

Approved

4Q 2012

Zinforo# (ceftaroline)

 

extended spectrum cephalosporin with affinity to penicillin- binding proteins

pneumonia / skin infections

III

1Q 2007

N/A

Filed**

Filed

Neuroscience

naloxegol (NKTR-118)#

oral peripherally-acting opioid antagonist

opioid-induced constipation

III

2Q 2011

2H 2013

2H 2013

Oncology

Caprelsa

 

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer

III

Launched

Launched

2014

Filed

Ranmark# (denosumab)

anti-RANKL MAb

bone disorders stemming from bone metastasis

III

N/A

N/A

Launched

N/A

Respiratory & Inflammation

fostamatinib#

spleen tyrosine kinase (SYK) inhibitor

rheumatoid arthritis

III

3Q 2010

2H 2013

2H 2013

2H 2013

lesinurad

selective inhibitor of URAT1

chronic management of hyperuricaemia in patients with gout

III

4Q 2011

2014

2014

2016

2014

 

#Partnered product

*CRL received in January 2012

**Positive opinion received from CHMP in 1H 2012

***sBLA in US, MAA in EU

 

 

NCEs

Phases I and II

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanEmerging

Cardiovascular

AZD4017

11BHSD

glaucoma

II

1Q 2011

AZD2820#

melanocortin receptor type 4 (MC4r) partial agonist peptide

obesity

I

2Q 2011

Gastrointestinal

tralokinumab

anti-IL-13 MAb

ulcerative colitis

II

2Q 2012

Infection

AZD9773#

anti-TNF-alpha polyclonal antibody

severe sepsis

II

1Q 2008

CXL#

beta lactamase inhibitor/

cephalosporin

MRSA

II

4Q 2010

AZD5847

oxazolidinone antibacterial inhibitor

tuberculosis

I

4Q 2009

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 / ADHD

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

MEDI-5117

anti-Il-6 MAb

OA Pain

I

2Q 2012

 

#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-551#

anti-CD19 MAb

haematological malignancies

II

1Q 2012

MEDI-573#

anti-IGF MAb

solid tumours

II

2Q 2012

MEDI-575#

anti-PDGFR-alpha MAb

NSCLC / glioblastoma

II

4Q 2010

olaparib

PARP inhibitor

gBRCA ovarian 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

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-0639

anti-DLL-4 MAb

solid tumours

I

2Q 2012

MEDI-3617#

anti-ANG-2 MAb

solid tumours

I

4Q 2010

MEDI-565#

anti-CEA BiTE

solid tumours

I

1Q 2011

MEDI-6469#

murine anti-OX40 MAb

solid tumours

I

1Q 2006

moxetumomab pasudotox#

 

anti-CD22 recombinant immunotoxin

haematological malignancies

I

2Q 2007

selumetinib (AZD6244) (ARRY-142886)

/MK2206#

MEK/AKT inhibitor

solid tumours

I

4Q 2009

volitinib#

MET inhibitor

solid tumours

I

1Q 2012

 

#Partnered product

 

NCEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanEmerging

Respiratory & Inflammation

AZD2115

MABA

COPD

II

2Q 2012

AZD5069

CXCR2

asthma

II

4Q 2010

AZD5423

inhaled SGRM

COPD

II

4Q 2010

AZD8683

muscarinic antagonist

COPD

II

4Q 2010

benralizumab#

anti-IL-5R MAb

asthma / COPD

II

4Q 2008

brodalumab#

anti-IL-17R MAb

psoriasis / psoriatic arthritis / asthma

II

4Q 2009

mavrilimumab#

anti-GM-CSFR MAb

rheumatoid arthritis

II

1Q 2010

MEDI-546#

anti-IFN-alphaR MAb

SLE

II

1Q 2012

MEDI-8968#

anti-IL-1R MAb

COPD

II

4Q 2011

sifalimumab#

anti-IFN-alpha MAb

SLE

II

3Q 2008

tralokinumab

anti-IL-13 MAb

asthma

II

1Q 2008

AZD8848

inhaled TLR7

asthma

I

2Q 2012

MEDI-2070#

anti-IL-23 MAb

Crohn's disease

I

2Q 2010

MEDI-4212

anti-IgE MAb

asthma

I

1Q 2012

MEDI-551#

anti-CD19 MAb

scleroderma

I

2Q 2010

MEDI-570#

anti-ICOS MAb

SLE

I

2Q 2010

MEDI-5872#

anti-B7RP1 MAb

SLE

I

4Q 2008

MEDI-7183#

anti-A4b7 MAb

Crohn's disease / ulcerative colitis

I

3Q 2010

MEDI-7814

anti-C5/C5a MAb

COPD

I

1Q 2012

MEDI-9929#

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

 

 

Development Pipeline - Discontinued Projects between 31 December 2011 and 30 June 2012

 

Cardiovascular

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD2927

Safety/Efficacy

atrial fibrillation

 

Neuroscience

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD2423

Safety/Efficacy

chronic neuropathic pain

NCE

AZD3839

Safety/Efficacy

Alzheimer's disease

NCE

MEDI-578

Regulatory

OA pain

NCE

TC-5214

Safety/Efficacy

major depressive disorder (monotherapy)

NCE

TC-5214

Safety/Efficacy

major depressive disorder (adjunct)

 

Infection

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD5099

Safety/Efficacy

serious infections

NCE

MEDI-534

Safety/Efficacy

RSV/PIV prophylaxis

 

Respiratory & Inflammation

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD1981

Safety/Efficacy

asthma/COPD

NCE

AZD2423

Safety/Efficacy

COPD

 

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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