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AstraZeneca PLC (AZN)

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Thursday 24 April, 2014

AstraZeneca PLC

1st Quarter Results - Part 2

RNS Number : 4032F
AstraZeneca PLC
24 April 2014
 



ASTRAZENECA DEVELOPMENT PIPELINE

AS AT 31 MARCH 2014

NMEs

Phase III / 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


Filed




Farxiga / Forxiga2

SGLT-2 inhibitor

diabetes


Launched

Launched

Approved

Filed

Myalept

leptin analogue

lipodystrophy


Approved

2015

N/A


Oncology

Caprelsa

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer


Launched

Launched

Q3 2014

Filed

moxetumomab pasudotox#

anti-CD22 recombinant
immunotoxin

hairy cell leukaemia

Q2 2013

2018

2018



olaparib

PARP inhibitor

BRCAm PSR ovarian cancer


Filed3

Filed



olaparib SOLO-1

PARP inhibitor

1st line BRCAm ovarian cancer

Q3 2013

2017

2017

2017

2017

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 OlympiAD

PARP inhibitor

metastatic breast cancer

Q2 20144

2016

2016

2017


selumetinib#

(ARRY-142886)

SELECT-1

MEK inhibitor

2nd line KRAS+ NSCLC

Q4 2013

2017

2017



selumetinib#

(ARRY-142886) ASTRA

MEK inhibitor

differentiated thyroid cancer5

Q3 2013

2017

2017



selumetinib#

(ARRY-142886) SUMIT

MEK inhibitor

uveal melanoma5

Q1 20146

2015

2015



 

 

Phase III / Registration (continued)

Compound

Mechanism

Area Under Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Respiratory, Inflammation and Autoimmunity

benralizumab#

anti-IL-5R MAb

severe asthma

Q4 2013

2016

2016



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 (SURI)

chronic treatment of patients with gout

Q4 2011

Q4 2014

Q4 2014


2017

PT003 GFF

LAMA / LABA

COPD

Q2 2013

2015

2016



PT001 GP

LAMA

COPD

Q2 2013

2015

2016



Infection

CAZ AVI# (CAZ104) RECLAIM

cephalosporin / beta lactamase inhibitor

serious infections

Q1 2012

N/A

Q4 2014

2015

2016

CAZ AVI# (CAZ104) 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

Q2 2014

Neuroscience

naloxegol# (NKTR-118)

oral peripherally-acting mu-opioid receptor antagonist

opioid-induced constipation


Filed

Filed



 

#    Partnered product.

++  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    FDA accepted submission April 2014.

4    First patient randomised April 2014.

5    These indications previously included under the broad Phase II project listing.

6    First patient expected to dose early Q2 2014.

 

 

NMEs

Phases I and II

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Cardiovascular and Metabolism

AZD1722#

NHE3 inhibitor

ESRD-Pi CKD with T2DM / ESRD-fluid retention

II

Q1 2013





AZD4901

hormone modulator

polycystic ovarian syndrome

II

Q2 2013





roxadustat# (FG-4592)

hypoxia-inducible factor inhibitor

anaemia in CKD / ESRD

II1


2018

NA

NA

2016

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

haematological malignancies

II

Q1 2012





MEDI-573#

anti-IGF MAb

metastatic breast cancer

II

Q2 2012





MEDI4736#

anti-PD-L1 MAb

NSCLC

II

Q1 2014





selumetinib# (ARRY-142886)

MEK inhibitor

2nd line KRAS- NSCLC

II

Q1 2013





tremelimumab

anti-CTLA4 MAb

mesothelioma

II

Q2 2013





AZD5363#

AKT kinase inhibitor

breast cancer

II

Q1 2014





AZD1208

PIM kinase inhibitor

haematological malignancies

I

Q1 2012





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





AZD9291

EGFR tyrosine kinase  inhibitor

solid tumours

I

Q1 2013





MEDI-565#

anti-CEA BiTE MAb

solid tumours

I

Q1 2011





MEDI0639#

anti-DLL-4 MAb

solid tumours

I

Q2 2012





MEDI0680 (AMP-514)

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-CTLA4 MAb

solid tumors

I

Q4 2013





MEDI4736# + dabrafenib + trametinib2

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

melanoma

I

Q1 2014





MEDI6469#

murine anti-OX40 MAb

solid tumours

I

Q1 2006





 

 

NMEs

Phases I and II (continued)

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Oncology (continued)

moxetumomab
pasudotox#

anti-CD22 recombinant immunotoxin

pALL

I

Q3 2008





volitinib# (AZD6094)

MET tyrosine kinase inhibitor

solid tumours

I

Q1 2012





Respiratory,  Inflammation and Autoimmunity

AZD2115#

MABA

COPD

II

Q2 2012





AZD5069

CXCR2 antagonist

asthma

II

Q4 2010





anifrolumab# (MEDI-546)

anti-IFN-alphaR MAb

SLE

II

Q1 2012





benralizumab#

anti-IL-5R MAb

COPD

II

Q4 2010





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





MEDI8968#

anti-IL-1R MAb

COPD / HS

II

Q4 2011





RDEA3170

selective uric acid reabsorption inhibitor (SURI)

chronic management of hyperuricaemia in patients with gout

II

Q3 2013





sifalimumab# (MEDI-545)

anti-IFN-alpha MAb

SLE

II

Q3 2008





tralokinumab

anti-IL-13 MAb

asthma / IPF

II

Q1 2008





AZD1419

TLR9 antagonist

asthma

I

Q3 2013





AZD4721

CXCR2 antagonist

COPD

I

Q3 2013





AZD7624

inhaled P38 inhibitor

COPD

I

Q1 2013





AZD8848#

inhaled TLR7 antagonist

asthma

I

Q2 2012





MEDI-551#

anti-CD19 MAb

multiple sclerosis

I

Q3 2012





MEDI5872#

anti-B7RP1 MAb

SLE

I

Q4 2008





MEDI9929#

anti-TSLP MAb

asthma

I

Q4 2008





PT010

LAMA / LABA / ICS

COPD

I

Q4 2013





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





MEDI-550

pandemic influenza virus vaccine

pandemic influenza prophylaxis

I

Q2 2006





 

NMEs

Phases I and II (continued)

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

Infection (continued)

MEDI-559 (PRVV)

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





MEDI92873

H7N9 vaccine

avian influenza

I

Q4 2013





Neuroscience

AZD3241

myeloperoxidase inhibitor

Parkinson's disease

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





 

#    Partnered product.

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

2    MedImmune-sponsored study in collaboration with GSK.

3    Vaccine in development through a CRADA with NIH.

 

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

2016

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

Q2 2014


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

Q1 20144

Filed


2015

saxagliptin / dapagliflozin FDC

DPP-4 inhibitor / SGLT-2 inhibitor FDC

diabetes

Q2 2012

2015

2015



Xigduo XR FDC / Xigduo FDC5

SGLT-2 inhibitor / metformin FDC

diabetes


Filed

Approved6



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

EGFR tyrosine kinase inhibitor

treatment beyond progression

Q1 2012


2015

2015

2015

Respiratory,  Inflammation and Autoimmunity

Symbicort7

ICS / LABA

Breath Actuated Inhaler asthma / COPD






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


Approved

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    Filed and awaiting regulatory acceptance.

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

6    Approval granted in January 2014 but reported as a progression for FY2013.

7    Development of a new BAI device is ongoing.


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