AstraZeneca PLC — Regulatory Filings 2014

Nov 6, 2014

National Storage Mechanism | Additional information

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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

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