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AstraZeneca PLC (AZN)

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Thursday 31 July, 2014

AstraZeneca PLC

AstraZeneca Pipeline

RNS Number : 8347N
AstraZeneca PLC
31 July 2014
 



4         PIPELINE UPDATE - ASTRAZENECA DEVELOPMENT PIPELINE,
30 JUNE 2014

NMEs

Phase III / Pivotal / Registration

Submission dates shown for assets in Phase III and beyond. 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.

 

Compound

Mechanism

Area Under Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Cardiovascular and Metabolism

Brilinta / Brilique1

ADP receptor antagonist

arterial thrombosis


Launched

Launched

Filed

Launched

Epanova#

omega-3 free fatty acids

hypertriglyceridaemia


Approved




Farxiga / Forxiga2

SGLT-2 inhibitor

diabetes


Launched

Launched

Launched

Filed

Myalept

leptin analogue

lipodystrophy


Launched

2015

N/A


roxadustat#

hypoxia-inducible factor inhibitor

anaemia in CKD / ESRD

Q3 20143

2018

N/A

N/A

2016

Oncology

AZD9291

EGFR tyrosine kinase inhibitor

advanced T790M+ NSCLC

Q2 2014

2015

2015

2015

2017

Caprelsa

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer


Launched

Launched

Q3 2014

Filed

MEDI4736#
PACIFIC

anti-PD-L1 MAb

stage III NSCLC

Q2 2014

2017

2020

2020


MEDI4736#
ATLANTIC

anti-PD-L1 MAb

3rd line NSCLC

Q1 2014

2016

2017

2017


moxetumomab pasudotox#

anti-CD22 recombinant
immunotoxin

hairy cell leukaemia

Q2 2013

2018

2018



olaparib

PARP inhibitor

BRCAm PSR ovarian cancer


Filed

Filed



olaparib SOLO-1

PARP inhibitor

1st line BRCAm ovarian cancer

Q3 2013

2017

2017

2017

2018

olaparib SOLO-2

PARP inhibitor

BRCAm PSR ovarian cancer

Q3 2013

2016

2016

2016

2016

olaparib GOLD

PARP inhibitor

2nd line gastric cancer

Q3 2013



2017

2018

olaparib OlympiA

PARP Inhibitor

adjuvant breast cancer

Q2 2014

2020

2020

2020

2021

olaparib OlympiAD

PARP inhibitor

metastatic breast cancer

Q2 2014

2016

2016

2016


selumetinib#
SELECT-1

MEK inhibitor

2nd line KRAS+ NSCLC

Q4 2013

2017

2017



selumetinib#
ASTRA

MEK inhibitor

differentiated thyroid cancer

Q3 2013

2017

2017



selumetinib#
SUMIT

MEK inhibitor

uveal melanoma

Q2 2014

2015

2015



tremelimumab

anti-CTLA-4 MAb

mesothelioma

Q2 2014

2017

2017

2017


 

Phase III / Pivotal / Registration (continued)

Compound

Mechanism

Area Under Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Respiratory, Inflammation and Autoimmunity

benralizumab#

CALIMA, SIROCCO, ZONDIA

anti-IL-5R MAb

severe asthma

Q4 2013

2016

2016



benralizumab#

TERRANOVA, GALATHEA

anti-IL-5R MAb

COPD

Q3 20144

2018

2018



brodalumab#
AMAGINE-1,2,3

anti-IL-17R MAb

psoriasis

Q3 2012

++

++



brodalumab# AMVISION-1,2

anti-IL-17R MAb

psoriatic arthritis

Q1 2014

++

++



lesinurad

selective uric acid reabsorption inhibitor (URAT1)

chronic treatment of patients with gout

Q4 2011

Q4 2014

Q4 2014


n/a5

PT003 GFF

LAMA / LABA

COPD

Q2 2013

2015

2016



PT001 GP

LAMA

COPD

Q2 2013

2015

2016



Infection

CAZ AVI# RECLAIM

cephalosporin / beta lactamase inhibitor

serious infections

Q1 2012

N/A

Q4 2014

2015

2016

CAZ AVI# REPROVE

cephalosporin / beta lactamase inhibitor

hospital-acquired pneumonia / ventilator-associated pneumonia

Q2 2013

N/A

2017

2017

2018

Zinforo#

extended spectrum cephalosporin with affinity to penicillin-binding proteins

pneumonia / skin infections


N/A

Launched

N/A

Filed

Neuroscience

Movantik#

oral peripherally-acting mu-opioid receptor antagonist

opioid-induced constipation


Filed

Filed



 

#    Partnered product.

¶        Registrational Phase II/III study.

++  Filing is the responsibility of the partner.

1    Brilinta in the US; Brilique in rest of world.

2    Farxiga in the US; Forxiga in rest of world.

3    First patient enrolled in June and dosed in July 2014.

4    First patient dosed in July 2014.

5    Regulatory approval no longer being sought in China. This market will be served by RDEA3170.

 

 

NMEs

Phases I and II

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Cardiovascular and Metabolism

tenapanor (AZD1722)#

NHE3 inhibitor

ESRD-Pi / CKD with T2DM1

II

Q1 2013





AZD4901

hormone modulator

polycystic ovarian syndrome

II

Q2 2013





AZD1979

melanin-concentrating hormone (MCH) receptor

obesity

I

Q2 2014





MEDI6012

LCAT

arterial thrombosis

I

Q1 2012





MEDI8111

Rh-factor II

trauma / bleeding

I

Q1 2014





Oncology

AZD1775#

WEE-1 inhibitor

ovarian cancer

II

Q4 2012





AZD2014

mTOR serine / threonine kinase inhibitor

solid tumours

II

Q1 2013





AZD4547

FGFR tyrosine kinase inhibitor

solid tumours

II

Q4 2011





MEDI-551#

anti-CD19 MAb

CLL / DLBCL

II

Q1 2012





MEDI-573#

anti-IGF MAb

metastatic breast cancer

II

Q2 2012





selumetinib#

MEK inhibitor

2nd line KRAS- NSCLC

II

Q1 2013





AZD5363#

AKT kinase inhibitor

breast cancer

II

Q1 2014





volitinib#

MET tyrosine kinase inhibitor

papillary renal cell carcinoma

II

Q2 2014





AZD1208

PIM kinase inhibitor

haematological malignancies

I

Q1 2012





AZD5312#

androgen receptor inhibitor

prostate cancer

I

Q2 2014





AZD6738

ATR serine / threonine kinase inhibitor

CLL / head & neck

I

Q4 2013





AZD8186

PI3 kinase beta inhibitor

solid tumours

I

Q2 2013





AZD9150#

STAT3 inhibitor

haematological malignancies

I

Q1 2012





MEDI-565#

anti-CEA BiTE MAb

solid tumours

I

Q1 2011





MEDI0639#

anti-DLL-4 MAb

solid tumours

I

Q2 2012





MEDI0680

anti-PD-1 MAb

solid tumours

I

Q4 2013





MEDI3617#

anti-ANG-2 MAb

solid tumours

I

Q4 2010





MEDI4736# + tremelimumab

anti-PD-L1 MAb + anti-CTLA-4 MAb

solid tumors

I

Q4 2013





MEDI4736# + dabrafenib + trametinib2

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

melanoma

I

Q1 2014





MEDI4736# + Iressa

anti-PD-L1 MAb + EGFR inhibitor

NSCLC

I

Q2 2014





MEDI4736# + MEDI0680

anti-PD-L1 MAb + anti-PD-1 MAb

solid tumours

I

Q2 2014





MEDI-551# + rituximab3

anti-CD19 MAb + anti-CD20 MAb

haematological malignancies

I

Q2 2014





NMEs

Phases I and II (continued)

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Oncology (continued)

MEDI6469#

murine anti-OX40 MAb

solid tumours

I

Q1 2006





moxetumomab
pasudotox#

anti-CD22 recombinant immunotoxin

pALL

I

Q3 2008





tremelimumab + Iressa

anti-CTLA-4 MAb + EGFR inhibitor

NSCLC

I

Q2 2014





Respiratory,  Inflammation and Autoimmunity

AZD2115#

MABA

COPD

II

Q2 2012





AZD9412# (SNG001)

inhaled interferon β

asthma / COPD

II

Q1 2010





anifrolumab#

anti-IFN-alphaR MAb

SLE

II

Q1 2012





brodalumab#

anti-IL-17R MAb

asthma

II

Q2 2013





mavrilimumab#

anti-GM-CSFR MAb

rheumatoid arthritis

II

Q1 2010





MEDI2070#

anti-IL-23 MAb

Crohn's disease

II

Q1 2013





MEDI7183#

anti-a4b7 MAb

Crohn's disease / ulcerative colitis

II

Q4 2012





MEDI9929#

anti-TSLP MAb

asthma

II

Q2 2014





PT010

LAMA / LABA / ICS

COPD

II

Q2 2014





RDEA3170

selective uric acid reabsorption inhibitor (URAT1)

chronic management of hyperuricaemia in patients with gout

II

Q3 2013





sifalimumab#

anti-IFN-alpha MAb

SLE

II

Q3 2008





tralokinumab

anti-IL-13 MAb

asthma / IPF

II

Q1 2008





AZD1419#

TLR9 agonist

asthma

I

Q3 2013





AZD7594

inhaled SGRM

asthma / COPD

I

Q3 20124





AZD7624

inhaled P38 inhibitor

COPD

I

Q1 2013





AZD8848#

inhaled TLR7 agonist

asthma

I

Q2 2012





MEDI-551#

anti-CD19 MAb

multiple sclerosis

I

Q3 2012





MEDI4920

anti-CD40L MAb

primary Sjögren's syndrome

I

Q2 2014





MEDI5872#

anti-B7RP1 MAb

SLE

I

Q4 2008





Infection

AZD5847

oxazolidinone anti-bacterial inhibitor

tuberculosis

II

Q4 2012





CXL#

beta lactamase inhibitor / cephalosporin

MRSA

II

Q4 2010





ATM AVI

monobactam / beta lactamase inhibitor

targeted serious bacterial infections

I

Q4 2012





AZD0914

GyrAR

serious bacterial infections

I

Q4 2013





 

NMEs

Phases I and II (continued)

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Infection (continued)

MEDI-550

pandemic influenza virus vaccine

pandemic influenza prophylaxis

I

Q2 2006





MEDI-559

paediatric RSV vaccine

RSV prophylaxis

I

Q4 2008





MEDI4893

MAb binding to S. aureus toxin

hospital-acquired pneumonia / serious S. aureus infection

I

Q1 2013





MEDI7510

RSV sF+GLA-SE

prevention of RSV disease in older adults

I

Q2 2014





MEDI8897#

anti-RSV MAb-YTE

passive RSV prophylaxis

I

Q2 2014





Neuroscience

AZD3241

myeloperoxidase inhibitor

multiple system atrophy5

II

Q2 2012





AZD5213

histamine-3 receptor antagonist

Tourette's syndrome / neuropathic pain

II

Q4 2013





AZD3293#

beta-secretase inhibitor

Alzheimer's disease

I

Q4 2012





AZD6423

NMDA antagonist

suicidal ideation

I

Q3 2013





MEDI1814

anti-amyloid beta MAb

Alzheimer's disease

I

Q2 2014





 

#    Partnered product.

1    Fluid retention indication for tenapanor terminated in Q2.

2    MedImmune-sponsored study in collaboration with GSK.

3    MedImmune-sponsored study in collaboration with Genentech.

4    Original programme terminated in 2013. Programme now reinitiated.

5    Multiple system atrophy is now the lead indication for this molecule.

 

Line Extensions

Compound

Mechanism

Area Under Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Cardiovascular and Metabolism

Brilinta / Brilique1 EUCLID

ADP receptor antagonist

outcomes study in patients with peripheral artery disease

Q4 2012

2016

2016

2017

2017

Brilinta / Brilique1
PEGASUS-
TIMI 54

ADP receptor antagonist

outcomes study in patients with prior myocardial infarction

Q4 2010

2015

2015

2015

2017

Brilinta / Brilique1 SOCRATES

ADP receptor antagonist

outcomes study in patients with stroke or TIA

Q1 2014

2016

2016

2016

2017

Brilinta / Brilique1 THEMIS

ADP receptor antagonist

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

Q1 2014

2017

2017

2018

2018

Bydureon Dual
Chamber Pen

GLP-1 receptor agonist

diabetes


Approved

Filed

Filed


Bydureon EXSCEL

GLP-1 receptor agonist

outcomes study

Q2 2010

2018

2018

2018


Bydureon weekly
suspension

GLP-1 receptor agonist

diabetes

Q1 2013

2015

2015



Farxiga / Forxiga2
DECLARE-
TIMI 58

SGLT-2 inhibitor

outcomes study

Q2 2013

2020

2020



Kombiglyze XR FDC / Komboglyze FDC3

DPP-4 inhibitor / metformin FDC

diabetes


Launched

Launched


Filed

Onglyza SAVOR-TIMI 53

DPP-4 inhibitor

outcomes study

Q2 2010

Filed

Filed


2015

saxagliptin / dapagliflozin FDC

DPP-4 inhibitor / SGLT-2 inhibitor FDC

diabetes

Q2 2012

2015

2015



Xigduo XR FDC / Xigduo FDC4

SGLT-2 inhibitor / metformin FDC

diabetes


Filed

Launched



Oncology

Caprelsa

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

differentiated thyroid cancer

Q2 2013

2016

2016

2016


Faslodex

FALCON

oestrogen receptor antagonist

1st line advanced breast cancer

Q4 2012

2016

2016

2016

2016

Iressa

IMPRESS

EGFR tyrosine kinase inhibitor

treatment beyond progression

Q1 2012


2015

2015

2015

Respiratory,  Inflammation and Autoimmunity

Symbicort5

ICS / LABA

Breath Actuated Inhaler asthma / COPD






Line Extensions (continued)

Compound

Mechanism

Area Under Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Neuroscience

Diprivan#

sedative and anaesthetic

conscious sedation


N/A

Launched

Q4 2014

Launched

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


Launched

Launched

N/A

Launched

 

#    Partnered product.

1    Brilinta in the US; Brilique in rest of world.

2    Farxiga in the US; Forxiga in rest of world.

3    Kombiglyze XR in the US; Komboglyze FDC in the EU.

4    Xigduo XR FDC in the US; Xigduo FDC in the EU.

5    Development of a new BAI device is ongoing.

 

 

Terminations (discontinued projects between 1 April and 30 June 2014)

 

NME / Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

AZD47211

Safety / efficacy

COPD

NME

AZD50691

Safety / efficacy

asthma

NME

MEDI8968#

Safety / efficacy

COPD / HS

NME

MEDI9287

economic

avian influenza

 

#    Partnered product.

1    Termination decision made July 2014.

 

 

 


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