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Half Yearly Pipeline Update

1st Aug 2013 07:00

RNS Number : 6877K
AstraZeneca PLC
01 August 2013
 



Development Pipeline as at

30 June 2013

Line Extensions

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina
Cardiovascular

Axanum***

proton pump inhibitor + low dose aspirin FDC

low dose aspirin associated peptic ulcer in high risk CV patients

III

Withdrawn

Launched

Brilinta/ Brilique EUCLID

ADP receptor antagonist

outcomes study in patients with PAD

III

4Q 2012

2016

2016

2016

2017

Brilinta / Brilique PEGASUS-TIMI 54

ADP receptor antagonist

outcomes study in patients with prior MI

III

4Q 2010

2015

2015

2015

2017

Bydureon EXSCEL#

GLP-1 receptor agonist

outcomes study

III

2Q 2010

2018

2018

2018

Bydureon Dual Chamber Pen#

GLP-1 receptor agonist

diabetes

III

3Q 2013

4Q 2013

Forxiga (dapagliflozin)/ metformin FDC#

SGLT2 inhibitor + metformin FDC

diabetes

III

3Q 2007

4Q 2013

Filed

Forxiga (dapagliflozin)#

SGLT2 inhibitor

diabetes - add on to DPP-4

III

1Q 2010

Filed

Forxiga (dapagliflozin)#

SGLT2 inhibitor

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

III

2Q 2008

Filed

Forxiga (dapagliflozin)#

SGLT2 inhibitor

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

III

1Q 2010

1H 2014

Forxiga (dapagliflozin)#

SGLT2 inhibitor

diabetes - triple therapy (dapa+met+ SU)

III

1Q 2011

4Q 2013

Forxiga (dapagliflozin) DECLARE#

SGLT2 inhibitor

outcomes study

III

2Q 2013

2020

2020

Kombiglyze XR/ Komboglyze FDC#*

DPP-4 inhibitor + metformin FDC

diabetes

III

Launched

Launched

1H 2014

SaxaDapa FDC#

DPP-4 inhibitor / SGLT2 inhibitor

diabetes

III

2Q 2012

2015

2015

Onglyza SAVOR-TIMI 53#

DPP-4 inhibitor

outcomes study

III

2Q 2010

4Q 2013

4Q 2013

2H 2014

 

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Gastrointestinal

Entocort

glucocorticoid steroid

Crohn's disease / ulcerative colitis

III

Launched

Launched

2015

 N/A

Nexium

proton pump inhibitor

peptic ulcer bleeding

III

Filed**

Launched

N/A

Launched

Neuroscience

Diprivan#

sedative and anaesthetic

conscious sedation

III

Launched

2H 2014

Launched

Oncology

Faslodex

oestrogen receptor antagonist

1st line advanced breast cancer

III

4Q 2012

2016

2016

2016

2016

Iressa

EGFR tyrosine kinase inhibitor

treatment beyond progression

III

1Q 2012

2015

2015

2015

Respiratory, Inflammation & Autoimmunity

Symbicort

inhaled steroid/ long-acting β2 agonist

Breath Actuated Inhaler asthma /

COPD

III

4Q 2011

1H 2014

 

#Partnered product

*Kombiglyze XR US; Komboglyze FDC EU

**2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012

***Commercial support now withdrawn, no Japan launch expected

 

NCEs

Phase III/Registration

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina
Cardiovascular

Brilinta/ Brilique

ADP receptor antagonist

arterial thrombosis

III

Launched

Launched

Filed

Launched

Epanova#

omega-3 free fatty acids

hypertri-glyceridaemia

III

Filed

Forxiga (dapagliflozin)#

SGLT2 inhibitor

diabetes

III

Filed*

Launched

Filed

Filed

metreleptin#

leptin analogue

lipodystrophy

III

Filed

1H 2014

N/A

Infection

CAZ AVI# (CAZ104)

beta lactamase inhibitor/ cepha-losporin

intra abdominal infections (cIAI) & urinary tract infections (cUTI); hospital acquired pneumonia (HAP) & ventilator associated pneumonia (VAP) ***

III

1Q 2012

N/A

2H 2014

2015

2016

Q-LAIV Flu Vaccination**

live, attenuated, intranasal influenza virus vaccine quadrivalent

seasonal influenza

III

Approved

Filed

Zinforo

(ceftaroline) #

extended spectrum cepha-losporin with affinity to penicillin- binding proteins

pneumonia / skin infections

III

N/A

Launched

1H 2014

Neuroscience

naloxegol (NKTR-118)#

oral peripherally-acting mu-opioid receptor antagonist

opioid-induced constipation

III

2Q 2011

 3Q 2013

 3Q 2013

Oncology

Caprelsa

VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity

medullary thyroid cancer

III

Launched

Launched

2015

Filed

moxetumomab pasudotox#

anti-CD22 recombinant immunotoxin

hairy cell leukaemia

III

2Q 2013

2017

2017

 

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Respiratory, Inflammation & Autoimmunity

brodalumab#

anti-IL-17R MAb

psoriasis

III

3Q 2012

2015

2015

PT003 GFF

LABA/LAMA

COPD

III

2Q 2013

2015

2016

lesinurad

selective uric acid reabsorption inhibitor (SURI)

chronic treatment of patients with gout

III

4Q 2011

2H 2014

2H 2014

2017

2017

 

#Partnered product

*CRL received in January 2012, re-submission 3Q 2013

**sBLA in US, MAA in EU

***HAP/VAP is a follow up filing, EU filing expected in 2017

 

 

NCEs

Phases I and II

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Cardiovascular

AZD1722#

NHE3 inhibitor

end stage renal disease / chronic kidney disorder

II

1Q 2013

MEDI6012 (ACP-501)

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

MEDI4893

staph alpha toxin YTE MAb

hospital-acquired pneumonia / serious S. aureus infection

I

1Q 2013

MEDI-550

pandemic influenza virus vaccine

pandemic influenza prophylaxis

I

2Q 2006

PRVV

(MEDI-559)

live attenuated paediatric RSV vaccine

RSV prophylaxis

I

4Q 2008

Neuroscience

AZD3241

myeloper-oxidase (MPO) inhibitor

Parkinson's disease

II

2Q 2012

AZD5213

histamine-3 receptor antagonist

neuropathic pain*

II

AZD6765

NMDA receptor antagonist

major depressive disorder

II

3Q 2007

AZD3293#

beta secretase

Alzheimer's disease

I

4Q 2012

 

#Partnered product

\* Terminated in Alzheimer's Disease - neuropathic pain study due to start 3Q 2013

 

 

NCEs

Phases I and II (continued)

 

Compound

Mechanism

Area Under Investigation

Phase

Date Commenced PhaseEstimated Filing
USEUJapanChina

Oncology

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

gBRCAm ovarian cancer, gBRCAm breast cancer, gastric 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

AZD2014

TOR kinase inhibitor

solid tumours

I

1Q 2010

AZD5363#

AKT inhibitor

solid tumours

I

4Q 2010

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

MEDI0639#

anti-DLL-4 MAb

solid tumours

I

2Q 2012

MEDI3617#

anti-ANG-2 MAb

solid tumours

I

4Q 2010

MEDI4736#

anti-PD-L1 MAb

solid tumours

I

3Q 2012

MEDI-565#

anti-CEA BiTE

solid tumours

I

1Q 2011

MEDI6469#

murine anti-OX40 MAb

solid tumours

I

1Q 2006

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
USEUJapanChina

Respiratory, Inflammation & Autoimmunity

AZD2115#

MABA

COPD

II

2Q 2012

AZD5069

CXCR2

asthma

II

4Q 2010

AZD5423#

inhaled SGRM

COPD

II

4Q 2010

benralizumab#

anti-IL-5R MAb

asthma / COPD

II

4Q 2008

mavrilimumab#

anti-GM-CSFR MAb

rheumatoid arthritis

II

1Q 2010

MEDI2070#

anti-IL-23 MAb

Crohn's disease

II

1Q 2013

MEDI-546#

anti-IFN-alphaR MAb

SLE

II

1Q 2012

MEDI7183#

anti-a4b7 MAb

Crohn's disease / ulcerative colitis

II

4Q 2012

MEDI8968#

anti-IL-1R MAb

COPD, HS

II

4Q 2011

sifalimumab#

anti-IFN-alpha MAb

SLE

II

3Q 2008

tralokinumab

anti-IL-13 MAb

asthma / IPF / UC

II

1Q 2008

AZD8848#

inhaled TLR7

asthma

I

2Q 2012

AZD7594#

inhaled SGRM

COPD

I

4Q 2012

AZD7624

ip38i

COPD

I

1Q 2013

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

RDEA3170

selective uric acid reabsorption inhibitor (SURI)

chronic treatment of patients with gout

I

3Q 2011

 

#Partnered product

 

 

Development Pipeline - Discontinued Projects between 1 January 2013 and 30 June 2013

 

Infection

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

MEDI-557

 safety / efficacy

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

 

Neuroscience

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD1446

 safety / efficacy

Alzheimer's disease

NCE

AZD3480

 safety / efficacy

Alzheimer's disease

NCE

MEDI5117

 safety / efficacy

rheumatoid arthritis

 

Oncology

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

AZD8330#(ARRY 424704)

 safety / efficacy

solid tumours

NCE

fostamatinib

 safety / efficacy

haematological malignancies

NCE

MEDI-575

 safety / efficacy

NSCLC

 

Respiratory, Inflammation & Autoimmunity

NCE/Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NCE

fostamatinib

 safety / efficacy

rheumatoid arthritis

NCE

MEDI7814

 economic

COPD

NCE

MEDI4212

 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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