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Pipeline Table

6th Feb 2014 07:00

RNS Number : 4404Z
AstraZeneca PLC
06 February 2014
 



Development Pipeline as at

31 December 2013

Line Extensions

Compound

Mechanism

Area Under Investigation

Date Commenced PhaseEstimated Filing
USEUJapanChina
Cardiovascular

Brilinta/ Brilique EUCLID

ADP receptor antagonist

outcomes study in patients with PAD

4Q 2012

2016

2016

2016

2017

Brilinta / Brilique PEGASUS-TIMI 54

ADP receptor antagonist

outcomes study in patients with prior MI

4Q 2010

2015

2015

2015

2017

Brilinta/ Brilique SOCRATES1

ADP receptor antagonist

outcomes study in patients with stroke or TIA

1Q 2014

2016

2016

2016

2017 

Brilinta/ Brilique THEMIS

ADP receptor antagonist

outcomes study in patients with Type 2 diabetes and CAD but without previous history of MI or stroke

2017

2017

2018

2018

Bydureon Dual Chamber Pen

GLP-1 receptor agonist

diabetes

 Filed

 Filed

2Q 2014

Bydureon EXSCEL

GLP-1 receptor agonist

outcomes study

2Q 2010

 2018

 2018

2018

Bydureon weekly suspension

GLP-1 receptor agonist

diabetes

 1Q 2013

2015

2015

Farxiga/Forxiga2 DECLARE

SGLT2 inhibitor

outcomes study

2Q 2013

2020

2020

Kombiglyze XR/ Komboglyze FDC3

DPP-4 inhibitor/

metformin FDC

diabetes

Launched

Launched

Filed

Onglyza SAVOR-TIMI 53

DPP-4 inhibitor

outcomes study

2Q 2010

1Q 2014

1Q 2014

 2015

saxagliptin/

dapagliflozin FDC

DPP-4 inhibitor/SGLT2 inhibitor FDC

diabetes

2Q 2012

2015

2015

Xigduo

SGLT2 inhibitor/

metformin FDC

diabetes

 Filed

Approved4

 

 

Compound

Mechanism

Area Under Investigation

Date Commenced PhaseEstimated Filing
USEUJapanChina

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

Filed5

Launched

N/A

Launched

Neuroscience

Diprivan#

sedative and anaesthetic

conscious sedation

Launched

2H 2014

Launched

Oncology

Caprelsa

VEGFR/

EGFR tyrosine kinase inhibitor with RET kinase activity

differentiated thyroid cancer

2Q 2013

2016

2016

2016

Faslodex

oestrogen receptor antagonist

1st line advanced breast cancer

4Q 2012

2016

2016

2016

2016

Iressa

EGFR tyrosine kinase inhibitor

treatment beyond progression

1Q 2012

2015

2015

2015

Respiratory, Inflammation & Autoimmunity

Symbicort6

inhaled steroid/ long-acting β2 agonist

Breath Actuated Inhaler asthma /

COPD

4Q 2011

 

# Partnered product

1 First subject dosed in January 2014 for SOCRATES

2  Farxiga US; Forxiga rest of world

3 Kombiglyze XR US; Komboglyze FDC EU

4 Approved January 2014

5 2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012 and application remains under FDA review

6 Filing delayed pending evaluation of alternative device design

 

 

NMEs

Phase III/Registration

 

Compound

Mechanism

Area Under Investigation

Date Commenced PhaseEstimated Filing
USEUJapanChina
Cardiovascular

Brilinta

/Brilique

ADP receptor antagonist

arterial thrombosis

Launched

Launched

Filed

Launched

Epanova#

omega-3 free fatty acids

hypertri-glyceridaemia

Filed

Farxiga/

Forxiga1

SGLT2 inhibitor

diabetes

Approved2

Launched

Filed

Filed

metreleptin

leptin analogue

lipodystrophy

Filed

2015

N/A

Infection

CAZ AVI (CAZ104)#

cephalosporin/beta lactamase inhibitor

serious infections

1Q 2012

N/A

4Q 2014

2015

2016

CAZ AVI (CAZ104)#

cephalosporin/beta lactamase inhibitor

hospital-acquired pneumonia/ventilator-associated pneumonia

2Q 2013

N/A

2017

2017

Zinforo (ceftaroline)#

extended spectrum cephalosporin with affinity to penicillin- binding proteins

pneumonia / skin infections

N/A

Launched

N/A 

1H 2014

Neuroscience

naloxegol (NKTR-118)#

oral peripherally-acting mu-opioid receptor antagonist

opioid-induced constipation

Filed

Filed

Oncology

Caprelsa

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer

Launched

Launched

3Q 2014

Filed

moxetumomab pasudotox#

anti-CD22 recombinant immunotoxin

hairy cell leukaemia

2Q 2013

2018

2018

olaparib

PARP inhibitor

gBRCAm

PSR ovarian cancer

1Q 2014

Filed

olaparib SOLO-1

PARP inhibitor

1st line gBRCAm ovarian cancer

3Q 2013

2017

2017

2017

2017

olaparib SOLO-2

PARP inhibitor

gBRCAm

PSR ovarian cancer

3Q 2013

2016

2016

2016

2016

olaparib GOLD

PARP inhibitor

2nd line gastric cancer

3Q 2013

2017

2018

selumetinib (AZD6244) (ARRY-142886)#

MEK inhibitor

2nd line KRAS+ NSCLC

4Q 2013

2017

2017

Respiratory, Inflammation & Autoimmunity

benralizumab#

anti-IL-5R MAb

severe asthma

4Q 2013

2016

2016

brodalumab#

anti-IL-17R MAb

psoriasis

3Q 2012

2015

2015

lesinurad

selective inhibitor of URAT1

chronic management of hyperuricaemia in patients with gout

4Q 2011

2H 2014

2H 2014

2017

PT003 GFF

LABA/LAMA

COPD

2Q 2013

2015

2016

 

#Partnered product

1Farxiga US; Forxiga rest of world 

2Approved January 2014

 

NMEs

Phases I and II

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Cardiovascular

AZD1722#

NHE3 inhibitor

ESRD-Pi / CKD- with T2DM/ ESRD-Fluid Retention

II

1Q 2013

AZD4901

NK3

polycystic ovarian syndrome

II

2Q 2013

roxadustat (FG-4592)#

hypoxia-inducible factor inhibitor

anaemia in CKD/end-stage renal disease

II1

2018

N/A

N/A

2016

MEDI6012

LCAT

ACS

I

1Q 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

AZD0914

GyrAR

serious bacterial infections

I

4Q 2013

MEDI-550

pandemic influenza virus vaccine

pandemic influenza prophylaxis

I

2Q 2006

MEDI-559 (PRVV)

paediatric RSV vaccine

RSV prophylaxis

I

4Q 2008

MEDI4893

staph alpha toxin YTE MAb

hospital-acquired pneumonia / serious S. aureus infection

I

1Q 2013

MEDI92872

H7N9 vaccine

avian influenza

I

4Q 2013

Neuroscience

AZD3241

myeloper-oxidase (MPO) inhibitor

Parkinson's disease

II

2Q 2012

AZD5213

histamine-3 receptor antagonist

Tourette's syndrome/

neuropathic pain

II

4Q 2013

AZD3293#

beta secretase

Alzheimer's disease

I

4Q 2012

AZD6423

NMDA

suicidal ideation

I

3Q 2013

 

#Partnered product

1In-licensed asset in late-development but the Phase III AstraZeneca programme has yet to randomise its first patient

2Vaccine in development through a CRADA with NIAID

 

 

NMEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Oncology

AZD1775#

Wee-1 inhibitor

ovarian cancer

II

 4Q 2012

AZD2014

TOR kinase inhibitor

solid tumours

II

1Q 2013

AZD4547

FGFR tyrosine kinase inhibitor

solid tumours

II

4Q 2011

MEDI-551#

anti-CD19 MAb

haematological malignancies

II

1Q 2012

MEDI-573#

anti-IGF MAb

MBC

II

4Q 2011

olaparib

PARP inhibitor

breast cancer

II

1Q 2012

selumetinib (AZD6244) (ARRY-142886)#

MEK inhibitor

various cancers

II

4Q 2008

tremelimumab

anti-CTLA4 MAb

mesothelioma

II

2Q 2013

AZD1208

PIM kinase inhibitor

haematological malignancies

I

1Q 2012

AZD5363#

AKT inhibitor

solid tumours

I

4Q 2010

AZD6738

ATR

CLL/

head & neck

I

4Q 2013

AZD8186

PI3 kinase beta inhibitor

solid tumours

I

2Q 2013

AZD9150#

STAT3 inhibitor

haematological malignancies

I

1Q 2012

AZD9291

epidermal growth factor inhibitor

solid tumours

I

1Q 2013

MEDI-565#

anti-CEA BiTE

solid tumours

I

1Q 2011

MEDI0639#

anti-DLL-4 MAb

solid tumours

I

2Q 2012

MEDI0680 (AMP-514)

anti-PD-1MAb

solid tumours

I

4Q 2013

MEDI3617#

anti-ANG-2 MAb

solid tumours

I

4Q 2010

MEDI4736#

anti-PD-L1 MAb

solid tumours

I

3Q 2012

MEDI4736# + tremelimumab

anti-PD-L1 MAb + anti-CTLA4 MAb

solid tumours

I

4Q 2013

MEDI4736# + dabrafenib + trametinib3

anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor

melanoma

I

1Q 2014

MEDI6469#

murine anti-OX40 MAb

solid tumours

I

1Q 2006

moxetumomab pasudotox#

anti-CD22 recombinant immunotoxin

pALL

I

3Q 2008

volitinib# (AZD6094)

MET inhibitor

solid tumours

I

1Q 2012

 

#Partnered product

3MedImmune-sponsored study in collaboration with GlaxoSmithKline. First patient dosed in January 2014

 

NMEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Respiratory, Inflammation & Autoimmunity

AZD2115#

MABA

COPD

II

2Q 2012

AZD5069

CXCR2

asthma

II

4Q 2010

benralizumab#

anti-IL-5R MAb

COPD

II

4Q 2010

brodalumab#

anti-IL-17R MAb

asthma / psoriatic arthritis

II

2Q 2013

mavrilimumab#

anti-GM-CSFR MAb

rheumatoid arthritis

II

1Q 2010

MEDI-546#

anti-IFN-alphaR MAb

SLE

II

1Q 2012

MEDI2070#

anti-IL-23 MAb

Crohn's disease

II

1Q 2013

MEDI7183#

anti-a4b7 MAb

Crohn's disease / ulcerative colitis

II

4Q 2012

MEDI8968#

anti-IL-1R MAb

COPD, HS

II

4Q 2011

RDEA3170

selective inhibitor of URAT1

chronic management of hyperuricaemia in patients with gout

II

3Q 2013

sifalimumab#

anti-IFN-alpha MAb

SLE

II

3Q 2008

tralokinumab

anti-IL-13 MAb

asthma / IPF

II

1Q 2008

AZD1419

TLR9

asthma

I

3Q 2013

AZD4721

CXCR2

COPD

I

3Q 2013

AZD7624

ip38i

COPD

I

1Q 2013

AZD8848#

inhaled TLR7

asthma

I

2Q 2012

MEDI-551#

anti-CD19 MAb

multiple sclerosis

I

3Q 2012

MEDI5872#

anti-B7RP1 MAb

SLE

I

4Q 2008

MEDI9929#

anti-TSLP MAb

asthma

I

4Q 2008

PT010

LAMA/LABA/ICS

COPD

I

4Q 2013

 

#Partnered product

 

Development Pipeline - Discontinued Projects between 1 January 2013 and 31 December 2013

 

Infection

NME/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

MEDI-557

Safety/Efficacy

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

 

Neuroscience

NME/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

AZD1446

Safety/Efficacy

Alzheimer's disease

NME

AZD3480#

Safety/Efficacy

Alzheimer's disease

NME

AZD5213

Hypothesis risk

Alzheimer's disease

NME

AZD6765

Safety/Efficacy

major depressive disorder

NME

MEDI5117

Safety/Efficacy

OA pain

 

Oncology

NME/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

AZD8330#(ARRY 424704)

Safety/Efficacy

solid tumours

NME

fostamatinib#

Safety/Efficacy

haematological malignancies

NME

MEDI-575#

Safety/Efficacy

NSCLC

 

Respiratory, Inflammation & Autoimmunity

NME/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

AZD5423#

Safety/Efficacy

COPD

NME

AZD7594#

Safety/Efficacy

COPD

NME

fostamatinib#

Safety/Efficacy

rheumatoid arthritis

NME

MEDI4212

Safety/Efficacy

asthma

NME

MEDI7814

Economic

COPD

LCM

tralokinumab

Safety/Efficacy

UC

 

#Partnered product

 

Completed Projects

 

Compound

Mechanism

Area Under InvestigationLaunch Status
USEUJapanChina

Cardiovascular

Forxiga (dapagliflozin)

SGLT2 inhibitor

diabetes - add on to DPP-4

 

 

Approved

Forxiga (dapagliflozin)

SGLT2 inhibitor

diabetes - add on to metformin long-term data

 

 

Approved

Forxiga (dapagliflozin)1

SGLT2 inhibitor

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

 

Forxiga (dapagliflozin)

SGLT2 inhibitor

diabetes - triple therapy (dapa+met+ SU)

Approved

Infection

Q-LAIV Flu Vaccination

live, attenuated, intranasal influenza virus vaccine (quadrivalent)

seasonal influenza

 

 

Approved

Approved

1Studies 18/19 complete. No filing planned from this data

 

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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