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AstraZeneca PLC (AZN)

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Thursday 06 November, 2014

AstraZeneca PLC

3rd Quarter Results

RNS Number : 3116W
AstraZeneca PLC
06 November 2014
 



ASTRAZENECA DEVELOPMENT PIPELINE, 30 SEPTEMBER 2014

Phase III / Pivotal / Registration

NMEs and significant additional indications

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

  Type 2 diabetes


Launched

Launched

Launched

Filed

  Myalept

  leptin analogue

  lipodystrophy


Launched

2015

N/A


  roxadustat#

  hypoxia- inducible  factor  inhibitor

  anaemia in CKD /   ESRD

Q3 2014

2018

N/A

N/A

2016

  Oncology

  AZD9291

  EGFR tyrosine   kinase inhibitor

  advanced EGFRm   T790M NSCLC

Q2 2014

2015

2015

2015

2017

  Caprelsa

  VEGFR / EGFR   tyrosine kinase   inhibitor with RET   kinase activity

  medullary thyroid   cancer


Launched

Launched

Q4 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



  Lynparza   (olaparib)

  PARP inhibitor

  BRCAm PSR ovarian   cancer


Filed

Filed7#



  Lynparza   (olaparib)SOLO-1

  PARP inhibitor

  1st line BRCAm   ovarian cancer

Q3 2013

2017

2017

2017

2018

  Lynparza   (olaparib) SOLO-2

  PARP inhibitor

  BRCAm PSR ovarian   cancer

Q3 2013

2016

2016

2016

2016

  Lynparza   (olaparib) GOLD

  PARP inhibitor

  2nd line gastric  cancer

Q3 2013



2017

2018

  Lynparza   (olaparib)   OlympiA

  PARP inhibitor

  adjuvant breast  cancer

Q2 2014

2020

2020

2020

2021

  Lynparza   (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

2016

2016

2016


 

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,  ZONDA

  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

++

++



  Lesinurad3
  CLEAR 1,2
  CRYSTAL

  selective uric   acid reabsorption   inhibitor (SURI)

  chronic treatment   of patients with   gout

Q4 2011

Q4 2014

Q4 2014



  PT003 GFF

  LAMA / LABA

  COPD

Q2 2013

2015

2016

2017

2017

  PT001 GP

  LAMA

  COPD

Q2 2013

2016

2016

2017

2017

  tralokinumab

  STRATOS 1-2

    TROPOS

  anti-IL-13 MAb

  severe asthma

Q3 2014

2018

2018

2018


  Infection

  CAZ AVI#4  RECLAIM

  cephalosporin /   beta lactamase   inhibitor

  serious infections

Q1 2012

N/A

2015


2016

  CAZ AVI#4   REPROVE

  cephalosporin /   beta lactamase   inhibitor

  hospital-acquired   pneumonia /   ventilator-   associated   pneumonia

Q2 2013

N/A

2017

 

2018

  Zinforo#

  extended   spectrum   cephalosporin   with affinity to   penicillin-binding   proteins

  pneumonia / skin   infections


N/A

Launched

N/A

Filed

  Neuroscience

  Movantik/Moventig5#

  oral  peripherally-   acting mu-opioid   receptor   antagonist

  opioid-induced   constipation


Approved

Filed6



 

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

4    No current plan to launch CAZ AVI in Japan.

5    Movantik in the US; Moventig in EU.

6    Positive opinion received.

7    Positive opinion announced on 24 October 2014.

 

Phases I and II

NMEs and significant additional indications

  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

  ACS

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





  Lynparza   (olaparib)

  PARP inhibitor

  prostate cancer

II

Q3 2014





  selumetinib#

  MEK inhibitor

  2nd line KRAS-   NSCLC

II

Q1 2013





  AZD5363#

  AKT kinase   inhibitor

  breast cancer

II

Q1 2014





  MEDI4736#

  anti-PD-L1  MAb

  solid tumours

II

Q3 2014





  moxetumomab
  pasudotox#

  anti-CD22   recombinant   immunotoxin

  pALL

II

Q3 2014





  volitinib#

  MET tyrosine   kinase inhibitor

  papillary renal cell   carcinoma

II

Q2 2014





  AZD5312#

  androgen   receptor inhibitor

  solid tumours

I

Q2 2014





  AZD6738

  ATR serine /   threonine kinase   inhibitor

  solid tumours

I

Q4 2013





  AZD8186

  PI3 kinase beta   inhibitor

  solid tumours

I

Q2 2013





  AZD9150#

  STAT3 inhibitor

  haematological   malignancies

I

Q1 2012





  AZD9291 +   (MEDI4736# or   selumetinib# or   volitinib#)

  EGFR tyrosine   kinase inhibitor   + (anti-PD-L1 or   MEK inhibitor or   MET tyrosine   kinase inhibitor)

  advanced  EGFRm  NSCLC

I

Q3 2014





Phases I and II (continued)

  Compound

  Mechanism

 Area Under  Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

  Oncology (continued)

  MEDI4736#  after  (AZD9291  or  Iressa or   (selumetinib#   +docetaxel) or   tremelimumab)   TATTON

  anti-PD-L1  MAb
  + (EGFR   tyrosine kinase   inhibitor or MEK   inhibitor or anti-  CTLA-4 MAb)

  NSCLC

I

Q3 2014





  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#

  anti-PD-L1  MAb

  various cancers

I

Q3 2014





  MEDI4736# +   MEDI0680

  anti-PD-L1  MAb  + anti-PD- 1 MAb

  solid tumours

I

Q2 2014





  MEDI4736# +   MEDI6469

  anti-PD-L1  MAb  + murine  OX40  agonist

  solid tumours

I

Q3 2014





  MEDI4736# +   dabrafenib +   trametinib2

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

  melanoma

I

Q1 2014





  MEDI4736# +   Iressa

  anti-PD-L1  MAb  + EGFR  tyrosine  kinase  inhibitor

  NSCLC

I

Q2 2014





  MEDI4736# +   tremelimumab

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

  solid tumors

I

Q4 2013





  MEDI-551# +   rituximab3

  anti-CD19 MAb   + anti-CD20   MAb

  haematological   malignancies

I

Q2 2014





  MEDI6383

  OX40 agonist

  solid tumours

I

Q3 2014





  MEDI6469#

  murine OX40   agonist

  solid tumours

I

Q1 2006





  Respiratory, Inflammation and Autoimmunity

  AZD2115#

  MABA

  COPD

II

Q2 2012





  AZD9412#

  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 (SURI)

  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

  IPF

II

Q4 2012





Phases I and II (continued)

  Compound

  Mechanism

  Area Under   Investigation

Phase

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

  Respiratory, Inflammation and Autoimmunity (continued)

  AZD1419#

  TLR9 agonist

  asthma

I

Q3 2013





  AZD7594

  inhaled SGRM

  asthma / COPD

I

Q3 20124





  AZD7624

  inhaled P38   inhibitor

  COPD

I

Q1 2013





  MEDI-551#

  anti-CD19 MAb

  multiple sclerosis

I

Q3 2012





  MEDI4920

  anti-CD40L- Tn3  fusion  protein

  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





  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





  MEDI3902

  anti-Psl/PcrV

  pseudomonas

I

Q3 2014





  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

2017

2017

2017

2018

  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

  type 2 diabetes


Launched

Approved

Filed


  Bydureon   EXSCEL

  GLP-1 receptor   agonist

  type 2 diabetes   outcomes study

Q2 2010

2018

2018

2018


  Bydureon weekly
  suspension

  GLP-1 receptor   agonist

  type 2 diabetes

Q1 2013

2015

2015



  Farxiga / Forxiga2
  DECLARE-
  TIMI 58

  SGLT-2 inhibitor

  type 2 diabetes   outcomes study

Q2 2013

2020

2020



  Kombiglyze XR   FDC / Komboglyze   FDC3

  DPP-4 inhibitor /   metformin FDC

  type 2 diabetes


Launched

Launched


Filed

  Onglyza SAVOR-  TIMI 53

  DPP-4 inhibitor

  type 2 diabetes   outcomes study

Q2 2010

Filed

Launched


2015

  saxagliptin /   dapagliflozin FDC

  DPP-4 inhibitor /   SGLT-2 inhibitor   FDC

  type 2 diabetes

Q2 2012

2015

2015



  Xigduo XR FDC /   Xigduo FDC4

  SGLT-2 inhibitor /   metformin FDC

  type 2 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 hormone   receptor +ve  advanced breast  cancer

Q4 2012

2016

2016

2016

2016

  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

  refractory reflux   esophagitis


N/A

N/A

Q4 2014

N/A

  Nexium

  proton pump   inhibitor

  stress ulcer   prophylaxis


N/A

N/A

N/A

2017

  Nexium

  proton pump   inhibitor

  paediatrics


Launched

Launched

2016

TBD

 

#    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.

6    Approval announced on 30 October 2014.

 

Completed projects

 

  Compound

  Mechanism

  Area Under   Investigation

Date Commenced Phase

Estimated Filing

US

EU

Japan

China

  Nexium

  proton pump   inhibitor

  peptic ulcer   bleeding


Launched

Launched

N/A

Launched

 

Terminations (discontinued projects between 1 July and 30 September 2014)1

 

NME / Line Extension

Compound

Reason for Discontinuation

Area Under Investigation

NME

AZD1208

Safety / efficacy

haematological malignancies

NME

AZD8848#

Safety / efficacy

asthma

LCM

Iressa IMPRESS

Safety / efficacy

treatment beyond progression

 

#    Partnered product.

1    tremelimumab+Iressa removed from table Q3 2014. Project is not terminated but is an investigator-sponsored study and, therefore, does not meet the requirement for inclusion in this table.

 


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